# Official Journal L 387/2021

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 387 |
| | |
| English edition | Legislation | Volume 643 November 2021 |

ISSN 1977-0677

Official Journal

of the European Union

L 387

English edition

Legislation

Volume 643 November 2021

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Council Decision (EU) 2021/1897 of 28 June 2021 on the signing, on behalf of the European Union, and provisional application of the Common Aviation Area Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part | 1 |
| | * | Common Aviation Area Agreement – Between the European Union and its Member States, of the One Part, and Ukraine, of the Other Part | 3 |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2021/1898 of 20 July 2021 supplementing Regulation (EU) 2019/1700 of the European Parliament and of the Council by specifying the number and titles of the variables for the use of information and communication technologies statistics domain for reference year 2022 (
  1
  ) | 58 |
| | * | Commission Implementing Regulation (EU) 2021/1899 of 25 October 2021 entering a name in the register of protected designations of origin and protected geographical indications (Fertőd vidéki sárgarépa (PGI)) | 77 |
| | * | Commission Implementing Regulation (EU) 2021/1900 of 27 October 2021 amending Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council (
  1
  ) | 78 |
| | * | Commission Regulation (EU) 2021/1901 of 29 October 2021 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council as regards statistics on health care expenditure and financing (
  1
  ) | 110 |
| | * | Commission Regulation (EU) 2021/1902 of 29 October 2021 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction (
  1
  ) | 120 |
| | * | Commission Implementing Regulation (EU) 2021/1903 of 29 October 2021 amending Implementing Regulation (EU) 2018/764 on the fees and charges payable to the European Union Agency for Railways and their conditions of payment (
  1
  ) | 126 |
| | * | Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance (
  1
  ) | 133 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Council Decision (EU) 2021/1897 of 28 June 2021 on the signing, on behalf of the European Union, and provisional application of the Common Aviation Area Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part

1

*

Common Aviation Area Agreement – Between the European Union and its Member States, of the One Part, and Ukraine, of the Other Part

3

REGULATIONS

*

Commission Delegated Regulation (EU) 2021/1898 of 20 July 2021 supplementing Regulation (EU) 2019/1700 of the European Parliament and of the Council by specifying the number and titles of the variables for the use of information and communication technologies statistics domain for reference year 2022 (
  1
  )

1

58

*

Commission Implementing Regulation (EU) 2021/1899 of 25 October 2021 entering a name in the register of protected designations of origin and protected geographical indications (Fertőd vidéki sárgarépa (PGI))

77

*

Commission Implementing Regulation (EU) 2021/1900 of 27 October 2021 amending Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council (
  1
  )

1

78

*

Commission Regulation (EU) 2021/1901 of 29 October 2021 implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council as regards statistics on health care expenditure and financing (
  1
  )

1

110

*

Commission Regulation (EU) 2021/1902 of 29 October 2021 amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction (
  1
  )

1

120

*

Commission Implementing Regulation (EU) 2021/1903 of 29 October 2021 amending Implementing Regulation (EU) 2018/764 on the fees and charges payable to the European Union Agency for Railways and their conditions of payment (
  1
  )

1

126

*

Commission Implementing Regulation (EU) 2021/1904 of 29 October 2021 adopting the design of a common logo for the retail of veterinary medicinal products at a distance (
  1
  )

1

133

| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

INTERNATIONAL AGREEMENTS

| 3.11.2021 | EN | Official Journal of the European Union | L 387/1 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/1

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COUNCIL DECISION (EU) 2021/1897

of 28 June 2021

on the signing, on behalf of the European Union, and provisional application of the Common Aviation Area Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part

THE COUNCIL OF THE EUROPEAN UNION

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2), in conjunction with Article 218(5) and (7) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | On 12 December 2006 the Council authorised the Commission to open negotiations with Ukraine for a common aviation area agreement. As a result of those negotiations, the Common Aviation Area Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part (‘the Agreement’) was initialled on 28 November 2013. |
| --- | --- |

(1)

On 12 December 2006 the Council authorised the Commission to open negotiations with Ukraine for a common aviation area agreement. As a result of those negotiations, the Common Aviation Area Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part (‘the Agreement’) was initialled on 28 November 2013.

| (2) | The signing of the Agreement on behalf of the Union and its provisional application do not affect the allocation of competences between the Union and its Member States. This Decision should not be interpreted as making use of the possibility for the Union to exercise its external competence with regard to areas covered by the Agreement falling within shared competence to the extent that such competence has not yet been exercised internally by the Union. |
| --- | --- |

(2)

The signing of the Agreement on behalf of the Union and its provisional application do not affect the allocation of competences between the Union and its Member States. This Decision should not be interpreted as making use of the possibility for the Union to exercise its external competence with regard to areas covered by the Agreement falling within shared competence to the extent that such competence has not yet been exercised internally by the Union.

| (3) | In order to bring about the benefits of the Agreement as early as possible, it should be signed and applied on a provisional basis, pending the completion of the procedures necessary for its entry into force. |
| --- | --- |

(3)

In order to bring about the benefits of the Agreement as early as possible, it should be signed and applied on a provisional basis, pending the completion of the procedures necessary for its entry into force.

| (4) | It is appropriate to lay down the procedure to be followed with respect to the position to be taken on behalf of the Union as regards decisions of the Joint Committee under point (a) of Article 15(3) of the Agreement concerning the inclusion of Union legislation in Annex I thereto, |
| --- | --- |

(4)

It is appropriate to lay down the procedure to be followed with respect to the position to be taken on behalf of the Union as regards decisions of the Joint Committee under point (a) of Article 15(3) of the Agreement concerning the inclusion of Union legislation in Annex I thereto,

HAS ADOPTED THIS DECISION:

Article 1

The signing on behalf of the Union of the Common Aviation Area Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part, is hereby approved, subject to the conclusion of the said Agreement (1).

Article 2

The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.

Article 3

The Agreement shall be applied on a provisional basis in accordance with Article 38(3) thereof, pending the completion of the procedures necessary for its entry into force.

Article 4

The Commission is authorised to adopt, after consultation sufficiently in advance of the Council or its preparatory bodies, as the Council may decide, the position to be taken on behalf of the Union as regards decisions of the Joint Committee under point (a) of Article 15(3) of the Agreement concerning the revision of Annex I to the Agreement, insofar as it concerns the inclusion of Union legislation in that Annex, subject to any technical adjustments needed.

Article 5

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 28 June 2021.

For the Council

The President

M. do C. ANTUNES

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(1)  See page 3 of this Official Journal.

1

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| 3.11.2021 | EN | Official Journal of the European Union | L 387/3 |
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3.11.2021

EN

Official Journal of the European Union

L 387/3

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COMMON AVIATION AREA AGREEMENT

Between the European Union and its Member States, of the One Part, and Ukraine, of the Other Part

THE KINGDOM OF BELGIUM,

THE REPUBLIC OF BULGARIA,

THE CZECH REPUBLIC,

THE KINGDOM OF DENMARK,

THE FEDERAL REPUBLIC OF GERMANY,

THE REPUBLIC OF ESTONIA,

IRELAND,

THE HELLENIC REPUBLIC,

THE KINGDOM OF SPAIN,

THE FRENCH REPUBLIC,

THE REPUBLIC OF CROATIA,

THE ITALIAN REPUBLIC,

THE REPUBLIC OF CYPRUS,

THE REPUBLIC OF LATVIA,

THE REPUBLIC OF LITHUANIA,

THE GRAND DUCHY OF LUXEMBOURG,

HUNGARY,

THE REPUBLIC OF MALTA,

THE KINGDOM OF THE NETHERLANDS,

THE REPUBLIC OF AUSTRIA,

THE REPUBLIC OF POLAND,

THE PORTUGUESE REPUBLIC,

ROMANIA,

THE REPUBLIC OF SLOVENIA,

THE SLOVAK REPUBLIC,

THE REPUBLIC OF FINLAND,

THE KINGDOM OF SWEDEN,

being parties to the Treaty on European Union and the Treaty on the Functioning of the European Union (hereinafter referred to as "the EU Treaties") and being Member States of the European Union (hereinafter referred to as the "EU Member States"),

and

THE EUROPEAN UNION, hereinafter also referred to as "the EU",

of the one part,

and

UKRAINE, of the other part,

hereinafter jointly referred to as "the Parties";

DESIRING to create a common aviation area (CAA) based on mutual market access to the air transport markets of the Parties, with equal conditions of competition and respect for the same rules – including in the areas of safety, security, air traffic management, social harmonisation and the environment;

RECOGNISING the integrated character of international civil aviation and the rights and obligations of Ukraine and the EU Member States stemming from their membership of international aviation organisations, in particular the International Civil Aviation Organisation (ICAO) and the European Organisation for the Safety of Air Navigation, as well as their rights and obligations under international agreements with third parties and international organisations;

DESIRING to deepen relations between the Parties in the field of air transport, including in the area of industrial cooperation, and to build upon the framework of the existing system of air services agreements in order to promote economic, cultural and transport links between the Parties;

DESIRING to facilitate the expansion of air transport opportunities, including through the development of air transport networks in order to meet the needs of passengers and shippers for convenient air transport services;

RECOGNISING the importance of air transport in promoting trade, tourism and investment;

NOTING the Convention on International Civil Aviation, opened for signature at Chicago on 7 December 1944;

BEARING IN MIND that the Association Agreement between the European Union and the European Atomic Energy Community and their Member States and Ukraine provides that, with a view to assuring a coordinated development of transport between the Parties adapted to their commercial needs, the conditions of mutual market access and provision of services in air transport may be dealt with by specific agreements;

DESIRING to make it possible for air carriers to offer passengers and shippers competitive prices and services in open markets;

DESIRING to have all sectors of the air transport industry, including air carrier workers, benefit from a liberalised agreement;

INTENDING to build upon the framework of existing air transport agreements with the goal of gradually opening access to markets and maximising benefits for the consumers, air carriers, workers and communities of both Parties;

AGREEING that it is appropriate to base the CAA rules on the relevant legislation within the European Union, as laid down in Annex I to this Agreement, without prejudice to the EU Treaties and the Constitution of Ukraine;

NOTING the intention of Ukraine to incorporate into its aviation legislation the corresponding requirements and standards of the European Union, including with regard to future legislative developments within the EU;

DESIRING to ensure the highest degree of safety and security in international air transport and reaffirming their grave concern with regard to acts or threats against the security of aircraft which jeopardise the safety of persons or property, adversely affect the operation of aircraft and undermine the confidence of the travelling public in the safety of civil aviation;

RECOGNISING the benefits that both Parties can reap from full compliance with the CAA rules, including the opening of access to markets and the maximisation of benefits for the consumers and the industries of both Parties;

RECOGNISING that the creation of the CAA and implementation of its rules cannot be achieved without transitional arrangements and that adequate assistance is important in this perspective;

EMPHASISING that air carriers should be treated in a transparent and non-discriminatory manner regarding their access to air transport infrastructures, especially where these infrastructures are limited, including access to airports;

DESIRING to ensure a level playing field for air carriers, allowing fair and equal opportunity for their air carriers to operate the agreed services;

RECOGNISING that government subsidies may adversely affect air carrier competition and may jeopardise the basic objectives of this Agreement;

AFFIRMING the importance of protecting the environment in developing and implementing international aviation policy and recognising the rights of sovereign States to take appropriate measures to this effect;

NOTING the importance of protecting consumers, including the protections afforded by the Convention for the Unification of Certain Rules for International Carriage by Air, done at Montreal 28 May 1999;

WELCOMING the ongoing dialogue between the Parties to deepen their relations in other areas, in particular to facilitate the movement of people,

HAVE AGREED AS FOLLOWS:

TITLE I

GENERAL PROVISIONS

Article 1

Objectives and scope

The aim of this Agreement is the gradual creation of a CAA between the European Union, its Member States and Ukraine founded on, in particular, identical rules in the areas of safety, security, air traffic management, the environment, consumer protection and computerised reservation systems, as well as identical rules with regard to social aspects. For this purpose, this Agreement sets out the rules, technical requirements, administrative procedures, basic operational standards and implementing rules applicable between the Parties.

That CAA shall be based on free access to the air transportation market and equal conditions of competition.

Article 2

Definitions

For the purposes of this Agreement, unless otherwise stated, the following definitions apply:

| (1) | "agreed services" and "specified routes" mean international air transport pursuant to Article 16 and Annex II to this Agreement; |
| --- | --- |

(1)

"agreed services" and "specified routes" mean international air transport pursuant to Article 16 and Annex II to this Agreement;

| (2) | "Agreement" means this Agreement, its Annexes and any amendments thereto; |
| --- | --- |

(2)

"Agreement" means this Agreement, its Annexes and any amendments thereto;

| (3) | "air transport" means the public carriage by aircraft of passengers, baggage, cargo and mail, separately or in combination, for remuneration or hire; for the avoidance of doubt, this includes scheduled and non-scheduled (charter) services and full cargo services; |
| --- | --- |

(3)

"air transport" means the public carriage by aircraft of passengers, baggage, cargo and mail, separately or in combination, for remuneration or hire; for the avoidance of doubt, this includes scheduled and non-scheduled (charter) services and full cargo services;

| (4) | "air carrier" means a company or undertaking with a valid operating licence or equivalent; |
| --- | --- |

(4)

"air carrier" means a company or undertaking with a valid operating licence or equivalent;

| (5) | "competent authorities" means the government agencies or public bodies responsible for the administrative functions under this Agreement; |
| --- | --- |

(5)

"competent authorities" means the government agencies or public bodies responsible for the administrative functions under this Agreement;

| (6) | "companies or undertakings" means entities constituted under civil or commercial law, including cooperative societies, and other legal persons governed by public or private law, save for those which are non-profit-making; |
| --- | --- |

(6)

"companies or undertakings" means entities constituted under civil or commercial law, including cooperative societies, and other legal persons governed by public or private law, save for those which are non-profit-making;

| (7) | "Convention" means the Convention on International Civil Aviation, opened for signature at Chicago on 7 December 1944 and includes:






  (a) | any amendment that has come into force under Article 94(a) of the Convention and has been ratified by both Ukraine and an EU Member State or the EU Member States; and |
| --- | --- | --- |

(7)

"Convention" means the Convention on International Civil Aviation, opened for signature at Chicago on 7 December 1944 and includes:

(a)

any amendment that has come into force under Article 94(a) of the Convention and has been ratified by both Ukraine and an EU Member State or the EU Member States; and

| (b) | any annex or any amendment thereto adopted under Article 90 of the Convention, insofar as such annex or amendment is at any given time effective for both Ukraine and an EU Member State or the EU Member States as is relevant to the issue in question; |
| --- | --- |

(b)

any annex or any amendment thereto adopted under Article 90 of the Convention, insofar as such annex or amendment is at any given time effective for both Ukraine and an EU Member State or the EU Member States as is relevant to the issue in question;

| (8) | "ECAA Agreement" means the multilateral Agreement between the European Community and its Member States, the Republic of Albania, Bosnia and Herzegovina, the Republic of Bulgaria, the Republic of Croatia, the former Yugoslav Republic of Macedonia, the Republic of Iceland, the Republic of Montenegro, the Kingdom of Norway, Romania, the Republic of Serbia and the United Nations Interim Administration Mission in Kosovo (1) on the establishment of a European Common Aviation Area; |
| --- | --- |

(8)

"ECAA Agreement" means the multilateral Agreement between the European Community and its Member States, the Republic of Albania, Bosnia and Herzegovina, the Republic of Bulgaria, the Republic of Croatia, the former Yugoslav Republic of Macedonia, the Republic of Iceland, the Republic of Montenegro, the Kingdom of Norway, Romania, the Republic of Serbia and the United Nations Interim Administration Mission in Kosovo (1) on the establishment of a European Common Aviation Area;

1

| (9) | "EASA" means the European Aviation Safety Agency, established by Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC; |
| --- | --- |

(9)

"EASA" means the European Aviation Safety Agency, established by Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC;

| (10) | "effective control" means a relationship constituted by rights, contracts or any other means which, either separately or jointly, and having regard to the considerations of fact or law involved, confer the possibility of directly or indirectly exercising a decisive influence on an undertaking, in particular by means of:






  (a) | the right to use all or part of the assets of an undertaking; |
| --- | --- | --- |

(10)

"effective control" means a relationship constituted by rights, contracts or any other means which, either separately or jointly, and having regard to the considerations of fact or law involved, confer the possibility of directly or indirectly exercising a decisive influence on an undertaking, in particular by means of:

(a)

the right to use all or part of the assets of an undertaking;

| (b) | rights or contracts which confer a decisive influence on the composition, voting or decisions of the bodies of an undertaking or otherwise confer a decisive influence on the running of the business of the undertaking; |
| --- | --- |

(b)

rights or contracts which confer a decisive influence on the composition, voting or decisions of the bodies of an undertaking or otherwise confer a decisive influence on the running of the business of the undertaking;

| (11) | "effective regulatory control" means that the competent licensing authority of a Party which issued an operating licence or permit to an air carrier:






  (a) | continuously verifies that the applicable criteria for the operation of international air services, on the basis of which an operating licence or permit is issued, are met by that air carrier, in accordance with relevant national laws and regulations; and |
| --- | --- | --- |

(11)

"effective regulatory control" means that the competent licensing authority of a Party which issued an operating licence or permit to an air carrier:

(a)

continuously verifies that the applicable criteria for the operation of international air services, on the basis of which an operating licence or permit is issued, are met by that air carrier, in accordance with relevant national laws and regulations; and

| (b) | maintains appropriate oversight as regards safety and security in compliance with at least ICAO standards; |
| --- | --- |

(b)

maintains appropriate oversight as regards safety and security in compliance with at least ICAO standards;

| (12) | "EU Treaties" means the Treaty on European Union and the Treaty on the Functioning of the European Union; |
| --- | --- |

(12)

"EU Treaties" means the Treaty on European Union and the Treaty on the Functioning of the European Union;

| (13) | "EU Member State" means a Member State of the European Union; |
| --- | --- |

(13)

"EU Member State" means a Member State of the European Union;

| (14) | "fitness" means whether an air carrier is fit to operate international air services, i.e. whether it has satisfactory financial capability and adequate managerial expertise and is disposed to comply with the laws, regulations and requirements which govern the operation of such services; |
| --- | --- |

(14)

"fitness" means whether an air carrier is fit to operate international air services, i.e. whether it has satisfactory financial capability and adequate managerial expertise and is disposed to comply with the laws, regulations and requirements which govern the operation of such services;

| (15) | "fifth freedom right" means the right or privilege granted by one State ("the Granting State") to the air carriers of another State ("the Recipient State") to provide international air transport services between the territory of the Granting State and the territory of a third State, subject to the condition that such services originate or terminate in the territory of the Recipient State; |
| --- | --- |

(15)

"fifth freedom right" means the right or privilege granted by one State ("the Granting State") to the air carriers of another State ("the Recipient State") to provide international air transport services between the territory of the Granting State and the territory of a third State, subject to the condition that such services originate or terminate in the territory of the Recipient State;

| (16) | "full cost" means the cost of providing air service plus reasonable charge for administrative overhead and, where relevant, any applicable charges aimed at reflecting environmental costs and applied without distinction as to nationality; |
| --- | --- |

(16)

"full cost" means the cost of providing air service plus reasonable charge for administrative overhead and, where relevant, any applicable charges aimed at reflecting environmental costs and applied without distinction as to nationality;

| (17) | "ICAO" means the International Civil Aviation Organization established according to the Convention; |
| --- | --- |

(17)

"ICAO" means the International Civil Aviation Organization established according to the Convention;

| (18) | "international air transport" means air transport between points in at least two States; |
| --- | --- |

(18)

"international air transport" means air transport between points in at least two States;

| (19) | "intermodal transportation" means the public carriage by aircraft and by one or more surface modes of transport of passengers, baggage, cargo and mail, separately or in combination, for remuneration or hire; |
| --- | --- |

(19)

"intermodal transportation" means the public carriage by aircraft and by one or more surface modes of transport of passengers, baggage, cargo and mail, separately or in combination, for remuneration or hire;

| (20) | "measure" means any measure by a Party, whether in the form of a law, regulation, rule, procedure, decision or administrative action, or in any other form; |
| --- | --- |

(20)

"measure" means any measure by a Party, whether in the form of a law, regulation, rule, procedure, decision or administrative action, or in any other form;

| (21) | "national" means:






  (a) | in the case of Ukraine, any person having Ukrainian nationality or, in the case of the European Union and its Member States, any person having the nationality of an EU Member State; or |
| --- | --- | --- |

(21)

"national" means:

(a)

in the case of Ukraine, any person having Ukrainian nationality or, in the case of the European Union and its Member States, any person having the nationality of an EU Member State; or

| (b) | any legal entity:






  (i) | which is owned directly or through majority ownership and is at all times effectively controlled by, in the case of Ukraine, persons or entities having Ukrainian nationality or, in the case of the European Union and its Member States, persons or entities having the nationality of an EU Member State or one of the other States listed in Annex V to this Agreement, and |
| --- | --- | --- |

(b)

any legal entity:

(i)

which is owned directly or through majority ownership and is at all times effectively controlled by, in the case of Ukraine, persons or entities having Ukrainian nationality or, in the case of the European Union and its Member States, persons or entities having the nationality of an EU Member State or one of the other States listed in Annex V to this Agreement, and

| (ii) | the principal place of business of which is, in the case of Ukraine, in Ukraine or, in the case of the European Union and its Member States, in a Member State; |
| --- | --- |

(ii)

the principal place of business of which is, in the case of Ukraine, in Ukraine or, in the case of the European Union and its Member States, in a Member State;

| (22) | "nationality", in the context of an air carrier, means whether an air carrier satisfies requirements regarding such issues as its ownership, effective control and principal place of business; |
| --- | --- |

(22)

"nationality", in the context of an air carrier, means whether an air carrier satisfies requirements regarding such issues as its ownership, effective control and principal place of business;

| (23) | "operating licence" means:






  (a) | in the case of the European Union and its Member States, an authorisation granted by the competent licensing authority to a company or undertaking, permitting it to provide air services under the relevant EU legislation; and |
| --- | --- | --- |

(23)

"operating licence" means:

(a)

in the case of the European Union and its Member States, an authorisation granted by the competent licensing authority to a company or undertaking, permitting it to provide air services under the relevant EU legislation; and

| (b) | in the case of Ukraine, a licence for carriage by air of passengers and/or cargo, given under the relevant legislation of Ukraine; |
| --- | --- |

(b)

in the case of Ukraine, a licence for carriage by air of passengers and/or cargo, given under the relevant legislation of Ukraine;

| (24) | "price" means:






  (a) | air fares to be paid to air carriers or their agents or other ticket sellers for the carriage of passengers and baggage on air services and any conditions under which those prices apply, including remuneration and conditions offered to agency and other auxiliary services; and |
| --- | --- | --- |

(24)

"price" means:

(a)

air fares to be paid to air carriers or their agents or other ticket sellers for the carriage of passengers and baggage on air services and any conditions under which those prices apply, including remuneration and conditions offered to agency and other auxiliary services; and

| (b) | air rates to be paid for the carriage of mail and cargo and the conditions under which those prices apply, including remuneration and conditions offered to agency and other auxiliary services. |
| --- | --- |

(b)

air rates to be paid for the carriage of mail and cargo and the conditions under which those prices apply, including remuneration and conditions offered to agency and other auxiliary services.

This definition covers, where applicable, the surface transport in connection with international air transport, and the conditions to which the application of air fares and air rates is subject;

| (25) | "Association Agreement" means the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, done at Brussels on 21 March 2014 and 27 June 2014, and any successor instrument; |
| --- | --- |

(25)

"Association Agreement" means the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, done at Brussels on 21 March 2014 and 27 June 2014, and any successor instrument;

| (26) | "principal place of business" means the head office or registered office of an air carrier, within which the principal financial functions and operational control, including continued airworthiness management, of the air carrier are exercised; |
| --- | --- |

(26)

"principal place of business" means the head office or registered office of an air carrier, within which the principal financial functions and operational control, including continued airworthiness management, of the air carrier are exercised;

| (27) | "public service obligation" means any obligation imposed upon air carriers to ensure on a specified route the minimum provision of scheduled air services satisfying fixed standards of continuity, regularity, pricing and minimum capacity which air carriers would not assume if they were solely considering their commercial interest. Air carriers may be compensated by the Party concerned for fulfilling public service obligations; |
| --- | --- |

(27)

"public service obligation" means any obligation imposed upon air carriers to ensure on a specified route the minimum provision of scheduled air services satisfying fixed standards of continuity, regularity, pricing and minimum capacity which air carriers would not assume if they were solely considering their commercial interest. Air carriers may be compensated by the Party concerned for fulfilling public service obligations;

| (28) | "SESAR" means the Single European Sky ATM Research Programme, which is the technological element of the Single European Sky and aims to give the EU a high-performance air traffic control infrastructure to enable the safe and environmentally friendly development of air transport; |
| --- | --- |

(28)

"SESAR" means the Single European Sky ATM Research Programme, which is the technological element of the Single European Sky and aims to give the EU a high-performance air traffic control infrastructure to enable the safe and environmentally friendly development of air transport;

| (29) | "subsidy" means any financial contribution granted by a government, regional public body or other public organisation, i.e. where:






  (a) | a practice of a government, regional public body or other public organisation involves a direct transfer of funds such as grants, loans or equity infusion, a potential direct transfer of funds to the company, the assumption of liabilities of the company such as loan guarantees, capital injections, ownership, protection against bankruptcy or insurance; |
| --- | --- | --- |

(29)

"subsidy" means any financial contribution granted by a government, regional public body or other public organisation, i.e. where:

(a)

a practice of a government, regional public body or other public organisation involves a direct transfer of funds such as grants, loans or equity infusion, a potential direct transfer of funds to the company, the assumption of liabilities of the company such as loan guarantees, capital injections, ownership, protection against bankruptcy or insurance;

| (b) | revenue of a government, regional public body or other public organisation that is otherwise due is foregone, not collected or unduly diminished; |
| --- | --- |

(b)

revenue of a government, regional public body or other public organisation that is otherwise due is foregone, not collected or unduly diminished;

| (c) | a government, regional public body or other public organisation provides goods or services other than general infrastructure, or purchases goods or services; or |
| --- | --- |

(c)

a government, regional public body or other public organisation provides goods or services other than general infrastructure, or purchases goods or services; or

| (d) | a government, regional public body or other public organisation makes payments to a funding mechanism or entrusts or directs a private body to carry out one or more of the types of functions referred to in points (a), (b) and (c) which would normally be vested in the government and, in practice, in no real sense differ from practices normally followed by governments; |
| --- | --- |

(d)

a government, regional public body or other public organisation makes payments to a funding mechanism or entrusts or directs a private body to carry out one or more of the types of functions referred to in points (a), (b) and (c) which would normally be vested in the government and, in practice, in no real sense differ from practices normally followed by governments;

and where a benefit is thereby conferred;

| (30) | "territory" means, for Ukraine, the land areas and territorial waters adjacent thereto under the sovereignty of Ukraine and, for the European Union, the land areas (mainland and islands), internal waters and territorial sea in which the Treaty on European Union and the Treaty on the Functioning of the European Union are applied and under the conditions laid down in those Treaties and any successor instrument; |
| --- | --- |

(30)

"territory" means, for Ukraine, the land areas and territorial waters adjacent thereto under the sovereignty of Ukraine and, for the European Union, the land areas (mainland and islands), internal waters and territorial sea in which the Treaty on European Union and the Treaty on the Functioning of the European Union are applied and under the conditions laid down in those Treaties and any successor instrument;

| (31) | "Transit Agreement" means the International Air Services Transit Agreement, done at Chicago on 7 December 1944; |
| --- | --- |

(31)

"Transit Agreement" means the International Air Services Transit Agreement, done at Chicago on 7 December 1944;

| (32) | "user charge" means a charge imposed on air carriers by the competent authority or permitted by that authority for the use by aircrafts, their crews, passengers, cargo and mail of facilities and services related to air navigation (including in the case of overflights), air traffic control, and airport and aviation security. |
| --- | --- |

(32)

"user charge" means a charge imposed on air carriers by the competent authority or permitted by that authority for the use by aircrafts, their crews, passengers, cargo and mail of facilities and services related to air navigation (including in the case of overflights), air traffic control, and airport and aviation security.

Article 3

Implementation of the Agreement

1.   The Parties shall take all appropriate measures, whether general or particular, to ensure fulfilment of the obligations arising out of this Agreement and shall abstain from any measure which could jeopardise the attainment of the objectives of this Agreement.

2.   The implementation of the measures referred to in paragraph 1 of this Article shall be without prejudice to the rights and obligations of any Party stemming from its participation in international organisations and/or international agreements, in particular the Convention and the Transit Agreement.

3.   In applying the measures of paragraph 1 of this Article, the Parties shall, within the scope of this Agreement:

| (a) | abolish all unilateral administrative, technical or other measures which could constitute an indirect restriction and have discriminatory effects on the provision of air services under this Agreement; and |
| --- | --- |

(a)

abolish all unilateral administrative, technical or other measures which could constitute an indirect restriction and have discriminatory effects on the provision of air services under this Agreement; and

| (b) | refrain from implementing administrative, technical or legislative measures which could have the effect of discriminating against nationals or companies or undertakings of the other Party in the provision of services under this Agreement. |
| --- | --- |

(b)

refrain from implementing administrative, technical or legislative measures which could have the effect of discriminating against nationals or companies or undertakings of the other Party in the provision of services under this Agreement.

Article 4

Non-discrimination

Within the scope of this Agreement, and without prejudice to any special provisions contained therein, any discrimination on grounds of nationality shall be prohibited.

TITLE II

REGULATORY COOPERATION

Article 5

General principles of regulatory cooperation

1.   The Parties shall cooperate through all possible means to ensure the progressive incorporation in Ukraine's legislation of the requirements and standards of the European Union acts listed in Annex I to this Agreement, as well as the implementation by Ukraine of these provisions via:

| (a) | periodic consultations, within the framework of the Joint Committee referred to in Article 29 ("Joint Committee") of this Agreement on the interpretation of the European Union acts listed in Annex 1 to this Agreement related to aviation safety and security, air traffic management, environmental protection, market access and ancillary issues, social matters, consumer protection and other areas covered by this Agreement; |
| --- | --- |

(a)

periodic consultations, within the framework of the Joint Committee referred to in Article 29 ("Joint Committee") of this Agreement on the interpretation of the European Union acts listed in Annex 1 to this Agreement related to aviation safety and security, air traffic management, environmental protection, market access and ancillary issues, social matters, consumer protection and other areas covered by this Agreement;

| (b) | provision of adequate assistance in specific areas identified by the Parties; |
| --- | --- |

(b)

provision of adequate assistance in specific areas identified by the Parties;

| (c) | consultations and exchange of information on new legislation according to Article 15 of this Agreement. |
| --- | --- |

(c)

consultations and exchange of information on new legislation according to Article 15 of this Agreement.

2.   Ukraine shall adopt the necessary measures to incorporate into the Ukrainian legal system and implement the requirements and standards of the European Union acts listed in Annex I to this Agreement in accordance with the transitional arrangements specified in Article 33 and the related Annex III to this Agreement.

3.   The Parties shall inform each other on their respective authorities responsible in the area of safety oversight, airworthiness, air carriers licensing, airport matters, aviation security, air traffic management, accident and incident investigation, establishment of air navigation and airport charges without delay through the Joint Committee.

Article 6

Compliance with laws and regulations

1.   While entering, within or leaving the territory of one Party, the laws and regulations applicable within that territory relating to the admission to or departure from its territory of aircraft engaged in air transport, or to the operation and navigation of aircraft shall be complied with by the other Party's air carriers.

2.   While entering, within or leaving the territory of one Party, the laws and regulations applicable within that territory relating to the admission to or departure from its territory of passengers, crew or cargo on aircraft (including regulations relating to entry, clearance, immigration, passports, customs and quarantine or, in the case of mail, postal regulations) shall be complied with by, or on behalf of, such passengers, crew or cargo of the other Party's air carriers.

Article 7

Aviation safety

1.   Subject to the transitional provisions set out in Annex III to this Agreement, the Parties shall act in conformity with their respective legislation concerning the requirements and standards relating to aviation safety specified in Annex I, Part C, to this Agreement under the conditions set out in this Article.

2.   While continuing to carry out functions and tasks of the State of design, manufacture, registration and operator, as provided by the Convention, Ukraine shall incorporate in its legislation and effectively implement the requirements and standards referred to in paragraph 1 of this Article, in accordance with the transitional provisions stipulated in Annex III to this Agreement.

3.   The Parties shall cooperate to ensure the effective implementation by Ukraine of its legislation adopted with the aim of incorporating the requirements and standards referred to in paragraph 1 of this Article. For this purpose, Ukraine shall be involved in the work of EASA as an observer from the date of entry into force of this Agreement, as provided for in Annex VI to this Agreement.

4.   To ensure operating of agreed services under points (a), (b), (c) and (d) of Article 16(1) of this Agreement, each Party shall recognise as valid certificates of airworthiness, certificates of competency and licences issued or validated by the other Party and still in force, provided that the requirements for such certificates or licences at least equal to the minimum standards that may be established pursuant to the Convention.

5.   The recognition by the EU Member States of certificates issued by Ukraine referred to in Annex IV, Section 1, to this Agreement shall be decided in accordance with the provisions stipulated in Annex III to this Agreement.

6.   The Parties shall cooperate towards the convergence of certification systems in the areas of initial and continuing airworthiness.

7.   The Parties shall ensure that aircraft registered in one Party suspected of non-compliance with international aviation safety standards established pursuant to the Convention and landing at airports open to international air traffic in the territory of the other Party shall be subject to ramp inspections by the competent authorities of that other Party, on board and around the aircraft, to check both the validity of the aircraft documents and those of its crew and the apparent condition of the aircraft and its equipment.

8.   The Parties shall exchange information, including on any findings, identified during ramp inspections carried out in accordance with paragraph 7 of this Article through the relevant means.

9.   The competent authorities of a Party may request consultations with the competent authorities of the other Party at any time concerning the safety standards maintained by the other Party, including in areas other than those covered by the acts referred to in Annex I to this Agreement, or on findings, identified during the ramp inspections. Such consultations shall take place within 30 days of that request.

10.   Nothing in this Agreement shall be construed so as to limit the authority of a Party to take all appropriate and immediate measures whenever it ascertains that an aircraft, a product or an operation may:

| (a) | fail to satisfy the minimum standards established pursuant to the Convention or the requirements and standards specified in Annex I, Part C, to this Agreement whichever is applicable; |
| --- | --- |

(a)

fail to satisfy the minimum standards established pursuant to the Convention or the requirements and standards specified in Annex I, Part C, to this Agreement whichever is applicable;

| (b) | give rise to serious concerns – established through an inspection referred to in paragraph 7 of this Article – that an aircraft or the operation of an aircraft does not comply with the minimum standards established pursuant to the Convention or the requirements and standards specified in Annex I, Part C, to this Agreement whichever is applicable; or |
| --- | --- |

(b)

give rise to serious concerns – established through an inspection referred to in paragraph 7 of this Article – that an aircraft or the operation of an aircraft does not comply with the minimum standards established pursuant to the Convention or the requirements and standards specified in Annex I, Part C, to this Agreement whichever is applicable; or

| (c) | give rise to serious concerns that there is a lack of effective maintenance and administration of minimum standards established pursuant to the Convention or the requirements and standards specified in Annex I, Part C, to this Agreement whichever is applicable. |
| --- | --- |

(c)

give rise to serious concerns that there is a lack of effective maintenance and administration of minimum standards established pursuant to the Convention or the requirements and standards specified in Annex I, Part C, to this Agreement whichever is applicable.

11.   Where a Party takes action under paragraph 10 of this Article, it shall promptly inform the competent authorities of the other Party of taking such action, providing reasons for its action.

12.   Where measures taken in application of paragraph 10 of this Article are not discontinued even though the basis for taking them has ceased to exist, either Party may refer the matter to the Joint Committee.

13.   Any amendments to national law with respect to the status of the competent authorities of Ukraine or any competent authority of the EU Member States shall be notified, without delay, by the Party concerned to the other Parties.

Article 8

Aviation security

1.   Ukraine shall incorporate in its legislation and effectively implement the provisions contained in the European Civil Aviation Conference (ECAC) Document 30, Part II, in accordance with the transitional provisions stipulated in Annex III to this Agreement. In the context of the assessments provided for in Article 33(2) of this Agreement, European Commission inspectors may participate as observers in the inspections carried out by the Ukrainian competent authorities in airports located in the territory of Ukraine, according to a mechanism agreed by the two Parties. This Agreement shall be without prejudice to the rights and obligations of Ukraine and the EU Member States under Annex 17 to the Convention.

2.   The assurance of safety for civil aircraft, their passengers and crew being a fundamental pre-condition for the operation of international air services, the Parties reaffirm their obligations to each other to provide for the security of civil aviation against acts of unlawful interference, and in particular their obligations under the Convention, the Convention on Offences and Certain Other Acts Committed on Board Aircraft, signed at Tokyo on 14 September 1963, the Convention for the Suppression of Unlawful Seizure of Aircraft, signed at The Hague on 16 December 1970, the Convention for the Suppression of Unlawful Acts against the Safety of Civil Aviation, signed at Montreal on 23 September 1971, the Protocol for the Suppression of Unlawful Acts of Violence at Airports Serving International Civil Aviation, signed at Montreal on 24 February 1988 and the Convention on the Marking of Plastic Explosives for purpose of Detection, signed at Montreal on 1 March 1991, insofar as both Parties are parties to these conventions, as well as all other conventions and protocols relating to civil aviation security of which both Parties are parties.

3.   The Parties shall provide upon request all necessary assistance to each other to prevent acts of unlawful seizure of civil aircraft and other unlawful acts against the safety of such aircraft, their passengers and crew, airports and air navigation facilities, and any other threat to the security of civil aviation.

4.   The Parties shall, in their mutual relations, act in conformity with the aviation security Standards and, so far as they are applied by them, the Recommended Practices established by the ICAO and designated as Annexes to the Convention, to the extent that such security provisions are applicable to the Parties. Both Parties shall require that operators of aircraft of their registry, operators who have their principal place of business or permanent residence in their territory, and the operators of airports in their territory, act in conformity with such aviation security provisions.

5.   Each Party shall ensure that effective measures are taken within its territory to protect civil aviation against acts of unlawful interference, including, but not limited to, screening of passengers and their cabin baggage, screening of hold baggage and security controls for cargo and mail prior to boarding or loading of aircraft, as well as security controls for in-flight supplies and airport supplies and access control and screening of persons other than passengers upon entering to security restricted areas. Those measures shall be adjusted as necessary, to address vulnerabilities and threats in civil aviation. Each Party agrees that their air carriers may be required to observe the aviation security provisions referred to in paragraph 4 of this Article required by the other Party, for entry into, departure from or while within the territory of that other Party.

6.   Each Party shall also give positive consideration to any request from the other Party for reasonable special security measures to meet a particular threat. Except where not reasonably possible in case of emergency, each Party will inform the other Party in advance of any special security measures it intends to introduce which could have a significant financial or operational impact on the air transport services provided under this Agreement. Either Party may request a meeting of the Joint Committee to discuss such security measures, as provided for in Article 29 of this Agreement.

7.   When an incident or threat of an incident of unlawful seizure of civil aircraft or other unlawful acts against the safety of such aircraft, their passengers and crew, airports or air navigation facilities occurs, the Parties shall assist each other by facilitating communications and other appropriate measures intended to terminate rapidly and safely such incident or threat.

8.   Each Party shall take all measures it finds practicable to ensure that an aircraft subjected to an act of unlawful seizure or other acts of unlawful interference which is on the ground in its territory is detained on the ground unless its departure is necessitated by the overriding duty to protect human life. Wherever practicable, such measures shall be taken on the basis of mutual consultations.

9.   When a Party has reasonable grounds to believe that the other Party has departed from the aviation security provisions of this Article, that Party shall request immediate consultations with the other Party.

10.   Without prejudice to Article 19 of this Agreement, failure to reach a satisfactory agreement within 15 days from the date of such request shall constitute grounds to withhold, revoke, limit or impose conditions on the operating authorisation of one or more air carriers of such other Party.

11.   When required by an immediate and extraordinary threat, a Party may take interim action prior to the expiry of 15 days.

12.   Any action taken in accordance with the paragraph 10 or 11 of this Article shall be discontinued upon compliance by the other Party with the full provisions of this Article.

Article 9

Air traffic management

1.   Subject to the transitional provisions set out in Annex III to this Agreement, the Parties shall act in conformity with their respective legislation concerning the requirements and standards relating to air traffic management specified in Annex I, Part B, to this Agreement under the conditions set out in this Article.

2.   Ukraine shall incorporate in its legislation and effectively implement the requirements and standards referred to in paragraph 1 of this Article in accordance with the transitional provisions stipulated in Annex III to this Agreement.

3.   The Parties shall cooperate in the field of air traffic management to ensure the effective implementation by Ukraine of its legislation adopted with the aim of incorporating the requirements and standards referred to in paragraph 1 of this Article, as well as with a view to extending the Single European Sky to Ukraine in order to enhance current safety standards and overall efficiency of general air traffic operations in Europe, to optimise air traffic control capacities, to minimise delays and to increase environmental efficiency.

4.   To this purpose, Ukraine shall be involved as an observer in the Single Sky Committee from the date of entry into force of this Agreement and Ukrainian competent entities and/or authorities shall be associated on a non-discriminatory basis, through appropriate coordination regarding SESAR in accordance with the relevant legislation.

5.   The Joint Committee shall be responsible for monitoring and facilitating cooperation in the field of air traffic management.

6.   With a view to facilitating the application of the Single European Sky legislation:

| (a) | Ukraine shall take the necessary measures to adjust its air traffic management institutional structures to the Single European Sky; and |
| --- | --- |

(a)

Ukraine shall take the necessary measures to adjust its air traffic management institutional structures to the Single European Sky; and

| (b) | the European Union shall facilitate the participation of Ukraine in operational activities in the fields of air navigation services, airspace use and interoperability that stem from the Single European Sky. |
| --- | --- |

(b)

the European Union shall facilitate the participation of Ukraine in operational activities in the fields of air navigation services, airspace use and interoperability that stem from the Single European Sky.

7.   This Agreement shall be without prejudice to the rights and obligations of Ukraine under the Convention, as well as regional air navigation agreements in force and approved by the ICAO Council. After the entry into force of this Agreement, any subsequent regional agreement should comply with its provisions.

8.   With a view to maintaining a high level of safety in order to maximise the capacity of airspace and efficiency of air traffic management and subject to the transitional provisions set out in Annex III to this Agreement, Ukraine shall organise the airspace under its responsibility in line with the EU requirements concerning the establishment of functional airspace blocks (FABs), as referred to in Annex I, Part B, to this Agreement.

The Parties shall cooperate to consider the possible integration of the airspace under Ukraine's responsibility into a FAB, in line with EU legislation and taking into consideration the operational benefits of such integration.

9.   The recognition by the EU Member States of the relevant certificates issued by Ukraine referred to in Annex IV, Section 2, to this Agreement shall be decided in accordance with Annex III to this Agreement.

Article 10

Environment

1.   The Parties recognise the importance of protecting the environment when developing and implementing aviation policy. The Parties acknowledge that effective global, regional, national and/or local action is needed to minimise civil aviation's impact on the environment.

2.   Subject to the transitional provisions set out in Annex III to this Agreement, the Parties shall act in conformity with their respective legislation concerning the requirements and standards relating to the environment specified in Annex I, Part D, to this Agreement under the conditions set out in this Article.

3.   Ukraine shall incorporate in its legislation and effectively implement the requirements and standards referred to in paragraph 2 of this Article, in accordance with the transitional provisions stipulated in Annex III to this Agreement.

4.   The Parties shall cooperate to ensure the effective implementation by Ukraine of its legislation adopted with the aim of incorporating the requirements and standards referred to in paragraph 2 of this Article, while recognising the importance of working together, and within the framework of multilateral discussions, to consider the effects of aviation on the environment, and to ensure that any mitigating measures are fully consistent with the objectives of this Agreement.

5.   Nothing in this Agreement shall be construed to limit the authority of the competent authorities of a Party to take all appropriate measures to prevent or otherwise address the environmental impacts of air transport provided that such measures are applied without distinction as to nationality and do not contradict rights and obligations of the Parties under international law.

Article 11

Consumer protection

1.   Subject to the transitional provisions set out in Annex III to this Agreement, the Parties shall act in conformity with their respective legislation concerning the requirements and standards relating to consumer protection specified in Annex I, Part F, to this Agreement.

2.   Ukraine shall incorporate in its legislation and effectively implement the requirements and standards referred to in paragraph 1 of this Article, in accordance with the transitional provisions stipulated in Annex III to this Agreement.

3.   The Parties shall cooperate to ensure the effective implementation by Ukraine of its legislation adopted with the aim of incorporating the requirements and standards referred to in paragraph 1 of this Article.

4.   The Parties shall also cooperate to ensure the protection of consumers' rights ensuing from this Agreement.

Article 12

Industrial cooperation

1.   The Parties shall aim at enhancing industrial cooperation, and in particular by means of:

| (i) | development of business links between aviation manufacturers of both sides; |
| --- | --- |

(i)

development of business links between aviation manufacturers of both sides;

| (ii) | promotion and development of joint projects aiming at the sustainable development of the air transport sector, including its infrastructure; |
| --- | --- |

(ii)

promotion and development of joint projects aiming at the sustainable development of the air transport sector, including its infrastructure;

| (iii) | technical cooperation for the implementation of EU standards; |
| --- | --- |

(iii)

technical cooperation for the implementation of EU standards;

| (iv) | promotion of opportunities for aviation manufacturers and designers; and |
| --- | --- |

(iv)

promotion of opportunities for aviation manufacturers and designers; and

| (v) | promotion of investment within the scope of this Agreement. |
| --- | --- |

(v)

promotion of investment within the scope of this Agreement.

2.   This Agreement shall be without prejudice to existing technical and industrial standards in Ukraine for the manufacturing of aircraft and their components that are not covered by Annex I to this Agreement.

3.   The Joint Committee shall monitor and facilitate industrial cooperation.

Article 13

Computerised reservation systems

1.   Subject to the transitional provisions set out in Annex III to this Agreement, the Parties shall act in conformity with their respective legislation concerning the requirements and standards relating to computerised reservation systems specified in Annex I, Part G, to this Agreement. The Parties shall guarantee free access by one Party's computerised reservation systems to the other Party's market.

2.   Ukraine shall incorporate in its legislation and effectively implement the requirements and standards referred to in paragraph 1 of this Article, in accordance with transitional provisions stipulated in Annex III to this Agreement.

3.   The Parties shall cooperate to ensure the implementation by Ukraine of its legislation adopted with the aim of incorporating the requirements and standards referred to in paragraph 1 of this Article.

Article 14

Social aspects

1.   Subject to the transitional provisions set out in Annex III to this Agreement, the Parties shall act in conformity with their respective legislation concerning the requirements and standards relating to social aspects specified in Annex I, Part E, to this Agreement.

2.   Ukraine shall adopt the necessary measures to incorporate in its legislation and effectively implement the requirements and standards referred to in paragraph 1 of this Article, in accordance with transitional provisions stipulated in Annex III to this Agreement.

3.   The Parties shall cooperate to ensure the implementation by Ukraine of its legislation adopted with the aim of incorporating the requirements and standards referred to in paragraph 1 of this Article.

Article 15

New legislation

1.   This Agreement shall be without prejudice to the right of each Party, subject to compliance with the principle of non-discrimination and the provisions of this Article and of Article 4 of this Agreement, to unilaterally adopt new legislation or amend its existing legislation in the field of air transport or an associated area mentioned in Annex I to this Agreement.

2.   When one Party considers adopting new legislation within the scope of this Agreement or an amendment to its legislation it shall inform the other Party. Upon the request of either Party, the Joint Committee shall within two months thereafter hold an exchange of views on the implications of such new legislation or amendment for the proper functioning of this Agreement.

3.   The Joint Committee shall:

| (a) | adopt a decision revising Annex I to this Agreement so as to integrate therein, if necessary on a basis of reciprocity, the new legislation or amendment in question; |
| --- | --- |

(a)

adopt a decision revising Annex I to this Agreement so as to integrate therein, if necessary on a basis of reciprocity, the new legislation or amendment in question;

| (b) | adopt a decision to the effect that the new legislation or amendment in question is to be regarded as in accordance with this Agreement; or |
| --- | --- |

(b)

adopt a decision to the effect that the new legislation or amendment in question is to be regarded as in accordance with this Agreement; or

| (c) | recommend any other measures for adoption within a reasonable period of time to ensure the proper functioning of this Agreement. |
| --- | --- |

(c)

recommend any other measures for adoption within a reasonable period of time to ensure the proper functioning of this Agreement.

TITLE III

ECONOMIC PROVISIONS

Article 16

Grant of rights

1.   Each Party shall grant to the other Party in accordance with Annexes II and III to this Agreement the following rights for the conduct of international air transport by the air carriers of the other Party:

| (a) | the right to fly over its territory without landing; |
| --- | --- |

(a)

the right to fly over its territory without landing;

| (b) | the right to make stops in its territory for any purpose other than taking on or discharging passengers, baggage, cargo and/or mail in air transport (non-traffic purposes); |
| --- | --- |

(b)

the right to make stops in its territory for any purpose other than taking on or discharging passengers, baggage, cargo and/or mail in air transport (non-traffic purposes);

| (c) | while operating an agreed service on a specified route, the right to make stops in its territory for the purpose of taking up and discharging international traffic in passengers, cargo and/or mail, separately or in combination; and |
| --- | --- |

(c)

while operating an agreed service on a specified route, the right to make stops in its territory for the purpose of taking up and discharging international traffic in passengers, cargo and/or mail, separately or in combination; and

| (d) | the rights otherwise specified in this Agreement. |
| --- | --- |

(d)

the rights otherwise specified in this Agreement.

2.   Nothing in this Agreement shall be deemed to confer on the air carriers of Ukraine the right to take on board, in the territory of any EU Member State, passengers, baggage, cargo and/or mail carried for compensation and destined for another point in the territory of that Member State.

Article 17

Operating authorisation and technical permission

On receipt of applications for operating authorisation or technical permission from an air carrier of one Party, which should be submitted in the form and manner prescribed for operating authorisations or technical permissions, the competent authorities of the other Party shall grant appropriate authorisations with minimum procedural delay, provided that:

| (a) | for an air carrier of Ukraine:






  (i) | the air carrier has its principal place of business in Ukraine and holds a valid operating licence in accordance with the applicable law of Ukraine; |
| --- | --- | --- |

(a)

for an air carrier of Ukraine:

(i)

the air carrier has its principal place of business in Ukraine and holds a valid operating licence in accordance with the applicable law of Ukraine;

| (ii) | effective regulatory control of the air carrier is exercised and maintained by Ukraine and the relevant competent authority is clearly identified; and |
| --- | --- |

(ii)

effective regulatory control of the air carrier is exercised and maintained by Ukraine and the relevant competent authority is clearly identified; and

| (iii) | unless otherwise determined under Article 20 of this Agreement, the air carrier is owned directly or through majority ownership and effectively controlled by Ukraine and/or its nationals; |
| --- | --- |

(iii)

unless otherwise determined under Article 20 of this Agreement, the air carrier is owned directly or through majority ownership and effectively controlled by Ukraine and/or its nationals;

| (b) | for an air carrier of the European Union:






  (i) | the air carrier has its principal place of business in the territory of an EU Member State under the EU Treaties and holds a valid operating licence in accordance with the applicable European Union law; |
| --- | --- | --- |

(b)

for an air carrier of the European Union:

(i)

the air carrier has its principal place of business in the territory of an EU Member State under the EU Treaties and holds a valid operating licence in accordance with the applicable European Union law;

| (ii) | effective regulatory control of the air carrier is exercised and maintained by the EU Member State responsible for issuing its Air Operators Certificate and the relevant competent authority is clearly identified; and |
| --- | --- |

(ii)

effective regulatory control of the air carrier is exercised and maintained by the EU Member State responsible for issuing its Air Operators Certificate and the relevant competent authority is clearly identified; and

| (iii) | unless otherwise determined under Article 20 of this Agreement, the air carrier is owned directly or through majority ownership and effectively controlled by one or more EU Member States and/or by their nationals or by other States listed in Annex V to this Agreement and/or by their nationals; |
| --- | --- |

(iii)

unless otherwise determined under Article 20 of this Agreement, the air carrier is owned directly or through majority ownership and effectively controlled by one or more EU Member States and/or by their nationals or by other States listed in Annex V to this Agreement and/or by their nationals;

| (c) | the air carrier meets the conditions prescribed under the laws and regulations referred to in Article 6 of this Agreement; and |
| --- | --- |

(c)

the air carrier meets the conditions prescribed under the laws and regulations referred to in Article 6 of this Agreement; and

| (d) | the provisions set forth in Articles 7 and 8 of this Agreement are being maintained and administered. |
| --- | --- |

(d)

the provisions set forth in Articles 7 and 8 of this Agreement are being maintained and administered.

Article 18

Reciprocal recognition of regulatory determinations with regard to air carrier fitness and nationality

1.   On receipt of an application for operating authorisation or technical permission from an air carrier of one Party, the competent authorities of the other Party shall recognise any fitness or nationality determination made by the competent authorities of the first Party with respect to that air carrier as if such determination had been made by its own competent authorities and not inquire further into such matters, except as provided for in paragraph 2 of this Article.

2.   If, after receipt of an application for operating authorisation or technical permission from an air carrier, or after the grant of such operating authorisation or technical permission, the competent authorities of the receiving Party have a specific reason for concern that, despite the determination made by the competent authorities of the other Party the conditions prescribed in Article 17 of this Agreement for the grant of appropriate operating authorisations or technical permissions have not been met, then they are to promptly advise those authorities, giving substantive reasons for their concern. In that event, either Party may seek consultations, which may include representatives of the relevant competent authorities and/or additional information relevant to this concern and such requests are to be met as soon as practicable. If the matter remains unresolved, either Party may bring the matter to the Joint Committee.

Article 19

Refusal, revocation, suspension, limitation of operating authorisation or technical permission

1.   The competent authorities of either Party may refuse, revoke, suspend or limit the operating authorisations or technical permissions or otherwise suspend or limit the operations of an air carrier of another Party where:

| (a) | for an air carrier of Ukraine:






  (i) | the air carrier does not have its principal place of business in Ukraine or does not hold a valid operating licence in accordance with the applicable law of Ukraine; |
| --- | --- | --- |

(a)

for an air carrier of Ukraine:

(i)

the air carrier does not have its principal place of business in Ukraine or does not hold a valid operating licence in accordance with the applicable law of Ukraine;

| (ii) | effective regulatory control of the air carrier is not exercised or maintained by Ukraine or the relevant competent authority is not clearly identified; or |
| --- | --- |

(ii)

effective regulatory control of the air carrier is not exercised or maintained by Ukraine or the relevant competent authority is not clearly identified; or

| (iii) | unless otherwise determined under Article 20 of this Agreement, the air carrier is not owned directly or through majority ownership or effectively controlled by Ukraine and/or its nationals; |
| --- | --- |

(iii)

unless otherwise determined under Article 20 of this Agreement, the air carrier is not owned directly or through majority ownership or effectively controlled by Ukraine and/or its nationals;

| (b) | for an air carrier of the European Union:






  (i) | the air carrier does not have its principal place of business in the territory of a EU Member State under the EU Treaties, or does not hold a valid operating licence in accordance with the applicable European Union law; or |
| --- | --- | --- |

(b)

for an air carrier of the European Union:

(i)

the air carrier does not have its principal place of business in the territory of a EU Member State under the EU Treaties, or does not hold a valid operating licence in accordance with the applicable European Union law; or

| (ii) | effective regulatory control of the air carrier is not exercised or maintained by the EU Member State responsible for issuing its Air Operators Certificate or the competent authority is not clearly identified; or |
| --- | --- |

(ii)

effective regulatory control of the air carrier is not exercised or maintained by the EU Member State responsible for issuing its Air Operators Certificate or the competent authority is not clearly identified; or

| (iii) | unless otherwise determined under Article 20 of this Agreement, the air carrier is not owned, directly or through majority ownership or effectively controlled by one or more EU Member States and/or their nationals or by the other States listed in Annex V to this Agreement and/or their nationals; |
| --- | --- |

(iii)

unless otherwise determined under Article 20 of this Agreement, the air carrier is not owned, directly or through majority ownership or effectively controlled by one or more EU Member States and/or their nationals or by the other States listed in Annex V to this Agreement and/or their nationals;

| (c) | the air carrier has failed to comply with the laws and regulations referred to in Article 6 of this Agreement; |
| --- | --- |

(c)

the air carrier has failed to comply with the laws and regulations referred to in Article 6 of this Agreement;

| (d) | the provisions set forth in Articles 7 and 8 of this Agreement are not being maintained or administered; or |
| --- | --- |

(d)

the provisions set forth in Articles 7 and 8 of this Agreement are not being maintained or administered; or

| (e) | a Party has made the determination in accordance with Article 26(5) of this Agreement that the conditions for a competitive environment are not being fulfilled. |
| --- | --- |

(e)

a Party has made the determination in accordance with Article 26(5) of this Agreement that the conditions for a competitive environment are not being fulfilled.

2.   Unless immediate action is essential to prevent further non-compliance with point (c) or (d) of paragraph 1 of this Article, the rights established by this Article shall be exercised only after consultation with the competent authorities of the other Party.

3.   Neither Party shall use its rights established by this Article to refuse, revoke, suspend or limit operating authorisations or technical permissions of any air carriers of a Party on the grounds that majority ownership and/or effective control of that air carrier is vested in one or more Parties to the ECAA Agreement or their nationals, provided that such Party or Parties to the ECAA Agreement offer reciprocal treatment and apply the terms and conditions of the ECAA Agreement.

Article 20

Investment in air carriers

1.   Notwithstanding Articles 17 and 19 of this Agreement, the majority ownership or the effective control of an air carrier of Ukraine by the EU Member States and/or their nationals, or of an air carrier of the European Union by Ukraine and/or its nationals, shall be permitted by virtue of a prior decision of the Joint Committee.

2.   That decision shall specify the conditions associated with the operation of the agreed services under this Agreement and with the services between third countries and the Parties. Article 29(8) of this Agreement shall not apply to this type of decision.

Article 21

Abolition of quantitative restrictions

1.   Without prejudice to more favourable provisions in existing agreements and within the scope of this Agreement, the Parties shall abolish quantitative restrictions and measures having an equivalent effect on the transfer of equipment, supplies, spare parts and other devices when they are necessary for an air carrier to continue to provide air transport services under the conditions foreseen by this Agreement.

2.   The obligation referred to in paragraph 1 of this Article shall not preclude the Parties from prohibiting or imposing restrictions on such transfers justified on the grounds of public policy or public security, of the protection of health and life of humans, animals or plants, or of the protection of intellectual, industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between the Parties.

Article 22

Commercial opportunities

Doing business

| 1. | The Parties agree that obstacles to doing business encountered by commercial operators would hamper the benefits to be achieved by this Agreement. The Parties therefore agree to engage in an effective and reciprocal process to remove obstacles to doing business encountered by commercial operators of both Parties where such obstacles may hamper commercial operations, create distortions to competition or hamper the development of a level playing field. |
| --- | --- |

1.

The Parties agree that obstacles to doing business encountered by commercial operators would hamper the benefits to be achieved by this Agreement. The Parties therefore agree to engage in an effective and reciprocal process to remove obstacles to doing business encountered by commercial operators of both Parties where such obstacles may hamper commercial operations, create distortions to competition or hamper the development of a level playing field.

| 2. | The Joint Committee shall develop a process of cooperation in relation to doing business and commercial opportunities, shall monitor progress in effectively addressing obstacles to doing business encountered by commercial operators and shall regularly review developments, including, if necessary, those concerning legislative and regulatory changes. In accordance with Article 29 of this Agreement, a Party may request a meeting of the Joint Committee to discuss any question related to the application of this Article. |
| --- | --- |

2.

The Joint Committee shall develop a process of cooperation in relation to doing business and commercial opportunities, shall monitor progress in effectively addressing obstacles to doing business encountered by commercial operators and shall regularly review developments, including, if necessary, those concerning legislative and regulatory changes. In accordance with Article 29 of this Agreement, a Party may request a meeting of the Joint Committee to discuss any question related to the application of this Article.

Air carrier representatives

| 3. | The air carriers of each Party shall have the right to establish offices in the territory of the other Party for the promotion and sale of air transport and related activities, including the right to sell and to issue any ticket and/or air waybill, both its own tickets and/or air waybills of any other carrier. |
| --- | --- |

3.

The air carriers of each Party shall have the right to establish offices in the territory of the other Party for the promotion and sale of air transport and related activities, including the right to sell and to issue any ticket and/or air waybill, both its own tickets and/or air waybills of any other carrier.

| 4. | The air carriers of each Party shall be entitled, in accordance with the laws and regulations of the other Party relating to entry, residence and employment, to bring in and maintain in the territory of the other Party managerial, sales, technical, operational and other specialist staff who are required to support the provision of air transport. These staff requirements may, at the option of the air carriers, be satisfied by its own personnel or by using the services of any other organisation, company or air carrier operating in the territory of the other Party, authorised to perform such services in the territory of that Party. Both Parties shall facilitate and expedite the granting of employment authorisations, where required, for personnel employed in the offices according to this paragraph, including those performing certain temporary duties not exceeding 90 days, subject to the relevant laws and regulations in force. |
| --- | --- |

4.

The air carriers of each Party shall be entitled, in accordance with the laws and regulations of the other Party relating to entry, residence and employment, to bring in and maintain in the territory of the other Party managerial, sales, technical, operational and other specialist staff who are required to support the provision of air transport. These staff requirements may, at the option of the air carriers, be satisfied by its own personnel or by using the services of any other organisation, company or air carrier operating in the territory of the other Party, authorised to perform such services in the territory of that Party. Both Parties shall facilitate and expedite the granting of employment authorisations, where required, for personnel employed in the offices according to this paragraph, including those performing certain temporary duties not exceeding 90 days, subject to the relevant laws and regulations in force.

Ground handling

| 5. | Subject to the transitional provisions set out in Annex III to this Agreement:






  (a) | without prejudice to point (b), each air carrier shall have in relation to ground handling in the territory of the other Party:






  (i) | the right to perform its own ground handling ("self-handling"); or |
| --- | --- | --- | --- |

5.

Subject to the transitional provisions set out in Annex III to this Agreement:

(a)

without prejudice to point (b), each air carrier shall have in relation to ground handling in the territory of the other Party:

(i)

the right to perform its own ground handling ("self-handling"); or

| (ii) | the right to select among competing suppliers that provide ground handling services in whole or in part where such suppliers are allowed market access on the basis of the laws and regulations of each Party, and where such suppliers are present in the market; |
| --- | --- |

(ii)

the right to select among competing suppliers that provide ground handling services in whole or in part where such suppliers are allowed market access on the basis of the laws and regulations of each Party, and where such suppliers are present in the market;

| (b) | for baggage handling, ramp handling, fuel and oil handling, and freight and mail handling as regards the physical handling of freight and mail between the air terminal and the aircraft, the rights under point (a)(i) and (ii) may be subject to constraints according to the laws and regulations applicable in the territory of the other Party. Where such constraints preclude self-handling and where there is no effective competition between suppliers that provide ground handling services, all such services shall be available on both an equal and non-discriminatory basis to all air carriers; |
| --- | --- |

(b)

for baggage handling, ramp handling, fuel and oil handling, and freight and mail handling as regards the physical handling of freight and mail between the air terminal and the aircraft, the rights under point (a)(i) and (ii) may be subject to constraints according to the laws and regulations applicable in the territory of the other Party. Where such constraints preclude self-handling and where there is no effective competition between suppliers that provide ground handling services, all such services shall be available on both an equal and non-discriminatory basis to all air carriers;

| (c) | any ground handling provider of each Party, whether an air carrier or not, shall have in relation to ground handling in the territory of the other Party the right to provide ground handling services for air carriers of the Parties operating at the same airport, where authorised and consistent with applicable laws and regulations. |
| --- | --- |

(c)

any ground handling provider of each Party, whether an air carrier or not, shall have in relation to ground handling in the territory of the other Party the right to provide ground handling services for air carriers of the Parties operating at the same airport, where authorised and consistent with applicable laws and regulations.

Allocation of slots at airports

| 6. | The allocation of available slots at the airports in the territories of the Parties shall be carried out in an independent, transparent, non-discriminatory and timely manner. |
| --- | --- |

6.

The allocation of available slots at the airports in the territories of the Parties shall be carried out in an independent, transparent, non-discriminatory and timely manner.

Sales, local expenses and transfer of funds

| 7. | Any air carrier of each Party may engage in the sale of air transportation and related services in the territory of the other Party directly and/or, at the air carrier's discretion, through its sales agents, other intermediaries appointed by the air carrier, through another air carrier or through the internet. Each air carrier shall have the right to sell such transportation and related services, and any person shall be free to purchase such transportation and services, in the currency of that territory or in freely convertible currencies in accordance with the local currency legislation. |
| --- | --- |

7.

Any air carrier of each Party may engage in the sale of air transportation and related services in the territory of the other Party directly and/or, at the air carrier's discretion, through its sales agents, other intermediaries appointed by the air carrier, through another air carrier or through the internet. Each air carrier shall have the right to sell such transportation and related services, and any person shall be free to purchase such transportation and services, in the currency of that territory or in freely convertible currencies in accordance with the local currency legislation.

| 8. | Each air carrier shall have the right to convert into freely convertible currencies and remit local revenues from the territory of the other Party to its home territory or to the country or countries of its choice according to the applicable legislation. Conversion and remittance shall be permitted promptly without restrictions or taxation in respect thereof at the official rate of exchange applicable to current transactions and remittance on the date the carrier makes the initial application for remittance. |
| --- | --- |

8.

Each air carrier shall have the right to convert into freely convertible currencies and remit local revenues from the territory of the other Party to its home territory or to the country or countries of its choice according to the applicable legislation. Conversion and remittance shall be permitted promptly without restrictions or taxation in respect thereof at the official rate of exchange applicable to current transactions and remittance on the date the carrier makes the initial application for remittance.

| 9. | The air carriers of each Party shall be permitted to pay for local expenses, including purchases of fuel, in the territory of the other Party in national currency. At their discretion, the air carriers of each Party may pay for such expenses in the territory of the other Party in freely convertible currencies in accordance with local currency legislation. |
| --- | --- |

9.

The air carriers of each Party shall be permitted to pay for local expenses, including purchases of fuel, in the territory of the other Party in national currency. At their discretion, the air carriers of each Party may pay for such expenses in the territory of the other Party in freely convertible currencies in accordance with local currency legislation.

Cooperative arrangements

| 10. | In operating or holding out services under this Agreement, any air carrier of a Party may enter into cooperative marketing arrangements, such as blocked-space agreements or code-sharing arrangements, with:






  (a) | any air carrier or carriers of the Parties; |
| --- | --- | --- |

10.

In operating or holding out services under this Agreement, any air carrier of a Party may enter into cooperative marketing arrangements, such as blocked-space agreements or code-sharing arrangements, with:

(a)

any air carrier or carriers of the Parties;

| (b) | any air carrier or carriers of a third country; and |
| --- | --- |

(b)

any air carrier or carriers of a third country; and

| (c) | any surface (land or maritime) transport provider, |
| --- | --- |

(c)

any surface (land or maritime) transport provider,

provided that: (i) the operating carrier holds the appropriate authority; (ii) the marketing carriers hold the appropriate route rights within the relevant bilateral provisions and (iii) the arrangements meet the requirements relating to safety and competition normally applied to such arrangements. In respect of passenger transport sold involving code-shares, the purchaser shall be informed at the point of sale, or in any case at check-in, or on boarding where no check-in is required for a connecting flight, which transportation providers will operate each sector of the service.

Intermodal transportation

| 11. | In relation to the transport of passengers, surface transport providers shall not be subject to laws or regulations governing air transport on the sole basis that such surface transport is held out by an air carrier under its own name. Surface transport providers have the discretion to decide whether to enter into cooperative arrangements. In deciding on any particular arrangement, surface transport providers may consider, among other things, consumer interests and technical, economic, space, and capacity constraints. |
| --- | --- |

11.

In relation to the transport of passengers, surface transport providers shall not be subject to laws or regulations governing air transport on the sole basis that such surface transport is held out by an air carrier under its own name. Surface transport providers have the discretion to decide whether to enter into cooperative arrangements. In deciding on any particular arrangement, surface transport providers may consider, among other things, consumer interests and technical, economic, space, and capacity constraints.

| 12. | Without prejudice to applicable laws and regulations requirements and notwithstanding any other provision of this Agreement, air carriers and indirect providers of cargo transport of the Parties shall be permitted, without restriction, to employ in connection with international air transport under the same air waybill any surface transport for cargo to or from any points in the territories of Ukraine and the European Union or in third countries including transport to and from all airports with customs facilities, and including, where applicable, the right to transport cargo in bond. Such cargo, whether moving by surface or by air, shall have access to airport customs processing and facilities. Air carriers may elect to perform their own surface transport or to provide it through arrangements with other surface carriers, including surface transport operated by other air carriers and indirect providers of cargo air transport. Such intermodal cargo services may be offered at a single, through price for the air and surface transport combined, provided that shippers are not misled as to the facts concerning such transport.
  For the purposes of the first subparagraph of this paragraph, "surface transport" shall include both land and maritime transportation. |
| --- | --- |

12.

Without prejudice to applicable laws and regulations requirements and notwithstanding any other provision of this Agreement, air carriers and indirect providers of cargo transport of the Parties shall be permitted, without restriction, to employ in connection with international air transport under the same air waybill any surface transport for cargo to or from any points in the territories of Ukraine and the European Union or in third countries including transport to and from all airports with customs facilities, and including, where applicable, the right to transport cargo in bond. Such cargo, whether moving by surface or by air, shall have access to airport customs processing and facilities. Air carriers may elect to perform their own surface transport or to provide it through arrangements with other surface carriers, including surface transport operated by other air carriers and indirect providers of cargo air transport. Such intermodal cargo services may be offered at a single, through price for the air and surface transport combined, provided that shippers are not misled as to the facts concerning such transport.

For the purposes of the first subparagraph of this paragraph, "surface transport" shall include both land and maritime transportation.

Leasing

| 13. | The air carriers of each Party shall be entitled to provide the agreed services using aircraft with or without crew leased from any air carrier, including from third countries, provided that all participants in such arrangements meet the conditions prescribed under the laws and regulations normally applied by the Parties to such arrangements.
  Neither Party shall require the air carriers leasing out their equipment to hold traffic rights under this Agreement.
  The leasing with crew (wet-leasing) by an air carrier of Ukraine of an aircraft of an air carrier of a third country, or by an air carrier of the European Union of an aircraft of an air carrier of a third country, other than those mentioned in Annex V to this Agreement, in order to exploit the rights set out in this Agreement, shall remain exceptional or meet temporary needs. It shall be submitted for prior approval to the licensing authority of the air carrier which is the lessee of the wet-leased aircraft and to the competent authority of the other Party. |
| --- | --- |

13.

The air carriers of each Party shall be entitled to provide the agreed services using aircraft with or without crew leased from any air carrier, including from third countries, provided that all participants in such arrangements meet the conditions prescribed under the laws and regulations normally applied by the Parties to such arrangements.

Neither Party shall require the air carriers leasing out their equipment to hold traffic rights under this Agreement.

The leasing with crew (wet-leasing) by an air carrier of Ukraine of an aircraft of an air carrier of a third country, or by an air carrier of the European Union of an aircraft of an air carrier of a third country, other than those mentioned in Annex V to this Agreement, in order to exploit the rights set out in this Agreement, shall remain exceptional or meet temporary needs. It shall be submitted for prior approval to the licensing authority of the air carrier which is the lessee of the wet-leased aircraft and to the competent authority of the other Party.

Franchising, branding and commercial concession arrangements

| 14. | The air carriers of each Party shall be entitled to enter into franchising, branding or commercial concession arrangements with companies, including air carriers, of either Party or third countries provided that the air carriers hold the appropriate authority and meet the conditions prescribed under the laws and regulations applied by the Parties to such arrangements, particularly those requiring the disclosure of the identity of the air carrier operating the service. |
| --- | --- |

14.

The air carriers of each Party shall be entitled to enter into franchising, branding or commercial concession arrangements with companies, including air carriers, of either Party or third countries provided that the air carriers hold the appropriate authority and meet the conditions prescribed under the laws and regulations applied by the Parties to such arrangements, particularly those requiring the disclosure of the identity of the air carrier operating the service.

Night-stops

| 15. | The air carriers of each Party shall have the right to make night-stops at airports of the other Party that are open to international traffic. |
| --- | --- |

15.

The air carriers of each Party shall have the right to make night-stops at airports of the other Party that are open to international traffic.

Article 23

Customs duties and taxation

1.   On arriving in the territory of one Party, aircraft operated in international air transport by the air carriers of the other Party, their regular equipment, fuel, lubricants, consumable technical supplies, ground equipment, spare parts (including engines), aircraft stores (including but not limited to such items as food, beverages and liquor, tobacco and other products destined for sale to or use by passengers in limited quantities during flight) and other items intended for or used solely in connection with the operation or servicing of aircraft engaged in international air transport shall be exempt, on the basis of reciprocity, under its relevant applicable legislation, from all import restrictions, property taxes and capital levies, customs duties, excise duties and similar fees and charges that are:

| (a) | imposed by the national or local authorities or the European Union; and |
| --- | --- |

(a)

imposed by the national or local authorities or the European Union; and

| (b) | not based on the cost of services provided, provided that such equipment and supplies remain on board the aircraft. |
| --- | --- |

(b)

not based on the cost of services provided, provided that such equipment and supplies remain on board the aircraft.

2.   The following shall also be exempt, on the basis of reciprocity, under relevant applicable legislation of a Party, from the taxes, levies, duties, fees and charges referred to in paragraph 1 of this Article, with the exception of charges based on the cost of the service provided:

| (a) | aircraft stores introduced into or supplied in the territory of a Party and taken on board, within reasonable limits, for use on outbound aircraft of an air carrier of the other Party engaged in international air transport, including in cases where such stores are to be used on a part of the journey performed over that territory; |
| --- | --- |

(a)

aircraft stores introduced into or supplied in the territory of a Party and taken on board, within reasonable limits, for use on outbound aircraft of an air carrier of the other Party engaged in international air transport, including in cases where such stores are to be used on a part of the journey performed over that territory;

| (b) | ground equipment and spare parts (including engines) introduced into the territory of a Party for the servicing, maintenance or repair of aircraft of an air carrier of the other Party used in international air transport; |
| --- | --- |

(b)

ground equipment and spare parts (including engines) introduced into the territory of a Party for the servicing, maintenance or repair of aircraft of an air carrier of the other Party used in international air transport;

| (c) | fuel, lubricants and consumable technical supplies introduced into or supplied in the territory of a Party for use in or on an aircraft of an air carrier of the other Party engaged in international air transport, including in cases where such supplies are to be used on a part of the journey performed over that territory; |
| --- | --- |

(c)

fuel, lubricants and consumable technical supplies introduced into or supplied in the territory of a Party for use in or on an aircraft of an air carrier of the other Party engaged in international air transport, including in cases where such supplies are to be used on a part of the journey performed over that territory;

| (d) | printed material, as provided for by the customs legislation of each Party, introduced into or supplied in the territory of a Party and taken on board for use on outbound aircraft of an air carrier of the other Party engaged in international air transport, including in cases where such material are to be used on a part of the journey performed over that territory; and |
| --- | --- |

(d)

printed material, as provided for by the customs legislation of each Party, introduced into or supplied in the territory of a Party and taken on board for use on outbound aircraft of an air carrier of the other Party engaged in international air transport, including in cases where such material are to be used on a part of the journey performed over that territory; and

| (e) | safety and security equipment for use at airports or cargo terminals. |
| --- | --- |

(e)

safety and security equipment for use at airports or cargo terminals.

3.   Notwithstanding any other provision to the contrary, nothing in this Agreement shall prevent a Party from imposing taxes, levies, duties, fees or charges on fuel supplied in its territory on a non-discriminatory basis for use in an aircraft of an air carrier that operates between two points in its territory.

4.   Equipment and supplies referred to in paragraphs 1 and 2 of this Article may be required to be kept under the supervision or control of the appropriate authorities and not to be transferred without payment of relevant customs duties and taxes.

5.   The exemptions provided for by this Article shall also be available where the air carriers of one Party have contracted with another air carrier which similarly enjoys such exemptions from the other Party for the loan or transfer in the territory of the other Party of the items specified in paragraphs 1 and 2 of this Article.

6.   Nothing in this Agreement shall prevent either Party from imposing taxes, levies, duties, fees or charges on goods sold other than for consumption on board to passengers during a sector of an air service between two points within its territory at which embarkation or disembarkation is permitted.

7.   Baggage and cargo in direct transit across the territory of a Party shall be exempt from taxes, customs duties, fees and other similar charges that are not based on the cost of the service provided.

8.   The regular airborne equipment, as well as the material and supplies normally retained on board the aircraft of an air carrier of either Party, may be unloaded in the territory of the other Party only with the approval of the customs authorities of that territory. In such case, they may be placed under the supervision of the said authorities up to such time as they are re-exported or otherwise disposed of in accordance with customs regulations.

9.   The stipulations of this Agreement shall not affect the field of VAT, with the exception of turnover tax on imports. The provisions of this Agreement shall not affect the provisions of any convention between a Member State and Ukraine for the avoidance of double taxation on income and on capital that may be in force at the relevant time.

Article 24

User charges for airports and aviation facilities and services

1.   Each Party shall ensure that user charges that may be imposed by its competent charging authorities or bodies on the air carriers of the other Party for the use of air navigation and air traffic control, airport, aviation security and related facilities and services are just, reasonable, not unjustly discriminatory, and equitably apportioned among categories of users. Without prejudice to Article 9 of this Agreement, these charges may reflect, but shall not exceed, the full cost to the competent charging authorities or bodies of providing the appropriate airport and aviation security facilities and services at that airport or within that airport's system. These charges may include a reasonable return on assets, after depreciation. Facilities and services for which user charges are made shall be provided on an efficient and economic basis. In any event, these charges shall be imposed on the air carriers of the other Party on terms not less favourable than the most favourable terms available to any other air carrier at the time the charges are assessed. User charges shall be established by the competent charging authorities or bodies of the Parties in national or foreign currency.

2.   Each Party shall encourage or require consultations in accordance with the existing applicable legislation, between the competent charging authorities or bodies in its territory and the air carriers and/or their representative bodies using the services and facilities, and shall ensure that the competent charging authorities or bodies and the air carriers or their representative bodies exchange such information as may be necessary to permit an accurate review of the reasonableness of the user charges in accordance with the principles of paragraph 1 of this Article. Each Party shall ensure that the competent charging authorities or bodies provide users with reasonable notice of any proposal for changes in user charges in order to enable those authorities to consider the views expressed by the users before changes are made.

Article 25

Pricing

1.   The Parties shall permit the air carriers to freely establish prices on the basis of free and fair competition.

2.   The Parties shall not require prices to be filed or notified.

3.   If the competent authorities of either Party believe that any price is inconsistent with the considerations set out in this Article, they shall send appropriate notice to the competent authorities of the other Party concerned and may request consultations with these authorities. Consultations between the competent authorities may be held on matters such as prices which may be unjust, unreasonable, discriminatory or subsidised. Such consultations shall be held not later than 30 days after the date of receipt of the request.

Article 26

Competitive environment

1.   Within the scope of this Agreement, Title IV of the Association Agreement or any successor agreement between the European Union, its Member States and Ukraine shall apply, except where more specific rules on competition and State aid for the aviation sector are included in this Agreement.

2.   The Parties acknowledge that it is their joint objective to have a fair and competitive environment for the operation of air services. The Parties recognise that fair competitive practices by air carriers are most likely to occur where these air carriers operate on a fully commercial basis and are not subsidised.

3.   State aid which distorts or threatens to distort competition by favouring certain companies or undertakings or certain aviation products or services, is incompatible with the proper functioning of this Agreement, insofar as it may affect trade between the Parties in the aviation sector.

4.   As regards State aid, any practices contrary to this Article shall be assessed on the basis of criteria arising from the application of the competition rules applicable in the European Union and in particular the ones specified in Annex VII to this Agreement.

5.   If one Party finds that conditions exist in the territory of the other Party, in particular due to a subsidy, which would adversely affect the fair and equal opportunity of its air carriers to compete, it may submit observations to the other Party. Furthermore, it may request a meeting of the Joint Committee, as provided for in Article 29 of this Agreement. From the receipt of such a request, consultations shall start within 30 days. Failure to reach a satisfactory agreement within 30 days from the start of consultations shall constitute grounds for the Party that requested the consultations to take action to refuse, revoke, suspend or limit the authorisations of the air carrier(s) concerned, in accordance with Article 19 of this Agreement.

6.   The actions, referred to in paragraph 5 of this Article, shall be appropriate, proportionate and restricted with regard to scope and duration to what is strictly necessary. They shall be exclusively directed towards the air carrier or air carriers benefiting from a subsidy or the conditions referred to in this Article, and shall be without prejudice to the right of either Party to take action under Article 31 of this Agreement.

7.   Each Party, upon notification to the other Party, may approach responsible government entities in the territory of the other Party including entities at the State, provincial or local level to discuss matters relating to this Article.

8.   Nothing in this Agreement shall limit or jeopardise the power of the competition authorities of the Parties in that all matters relating to the enforcement of competition law fall under their exclusive competence. Any action taken pursuant to this Article shall be without prejudice to actions taken by these authorities, which shall be fully independent from actions taken pursuant to this Article.

9.   This Article shall apply without prejudice to the Parties' laws and regulations regarding public service obligations in the territories of the Parties.

10.   The Parties shall exchange information taking into account the limitations imposed by the requirements of professional and business confidentiality.

Article 27

Statistics

1.   Each Party shall provide the other Party with statistics that are required by domestic laws and regulations and, upon request, other available statistical information as may be reasonably required for the purpose of reviewing the operation of the air services.

2.   The Parties shall cooperate in the framework of the Joint Committee to facilitate the exchange of statistical information between them for the purpose of monitoring the development of air services under this Agreement.

TITLE IV

INSTITUTIONAL PROVISIONS

Article 28

Interpretation and enforcement

1.   The Parties shall take all appropriate measures, whether general or specific, to ensure fulfilment of the obligations arising out of this Agreement and shall refrain from any measures which would jeopardise attainment of the objectives of this Agreement.

2.   Each Party shall be responsible, in its own territory, for the proper enforcement of this Agreement. Ukraine shall be responsible as well for the implementation of its legislation adopted with the aim of incorporating into its legal system the requirements and standards of the European Union acts relating to civil aviation referred to in Annex I to this Agreement.

3.   Each Party shall give the other Party all necessary information and assistance in relation to investigations on possible infringements of provisions of this Agreement which the other Party carries out under its respective competences as provided for in this Agreement.

4.   Whenever the Parties act under the powers granted to them by this Agreement on matters which are of substantial interest to the other Party and which concern the authorities or companies or undertakings of the other Party, the competent authorities of the other Party shall be fully informed and given the opportunity to comment before a final decision is taken.

5.   Insofar as the provisions of this Agreement and the provisions of the acts specified in Annex I to this Agreement are identical in substance to corresponding rules of the EU Treaties and to acts adopted pursuant to the EU Treaties, those provisions shall, in their implementation and application, be interpreted in conformity with the relevant rulings and decisions of the Court of Justice of the European Union, hereinafter referred to as "the Court of Justice", and the European Commission respectively.

Article 29

Joint Committee

1.   A Joint Committee composed of representatives of the Parties is hereby established and shall be responsible for the administration of this Agreement and shall ensure its proper implementation. For this purpose it shall make recommendations and take decisions where expressly provided for by this Agreement.

2.   The decisions of the Joint Committee shall be adopted by consensus and be binding upon the Parties. They shall be put into effect by the Parties, in accordance with their internal procedures. The Parties will inform each other of the finalisation of such procedures and the date of entry into force of the decisions. Whenever a decision taken by the Joint Committee contains a requirement for action to be taken by a Party, that Party shall take the necessary measures and inform the Joint Committee thereof.

3.   The Joint Committee shall adopt, by a decision, its rules of procedure.

4.   The Joint Committee shall meet as and when necessary at the request of a Party.

5.   A Party may also request a meeting of the Joint Committee to seek to resolve any question relating to the interpretation or application of this Agreement. Such a meeting shall take place at the earliest possible date, but not later than two months from the date of receipt of the request, unless otherwise agreed by the Parties.

6.   For the purpose of the proper implementation of this Agreement, the Parties shall exchange information and, at the request of either Party, shall hold consultations within the Joint Committee.

7.   If, in the view of one of the Parties, a decision of the Joint Committee is not properly implemented by the other Party, the former Party may request that the issue be discussed by the Joint Committee. If the Joint Committee cannot solve the issue within two months of its referral, the requesting Party may take appropriate safeguard measures under Article 31 of this Agreement.

8.   Without prejudice to paragraph 2 of this Article, if the Joint Committee does not take a decision on an issue which has been referred to it within six months of the date of referral, the Parties may take appropriate temporary safeguard measures under Article 31 of this Agreement.

9.   In accordance with Article 20 of this Agreement, the Joint Committee shall examine questions relating to bilateral investments of majority ownership, or changes in the effective control of air carriers of the Parties.

10.   The Joint Committee shall also develop cooperation between the Parties by:

| (a) | reviewing market conditions affecting air services under this Agreement; |
| --- | --- |

(a)

reviewing market conditions affecting air services under this Agreement;

| (b) | addressing and as far as possible effectively resolve "doing business" issues that may, inter alia, hamper market access and smooth operation of agreed services under this Agreement as a means to ensure a level playing field, regulatory convergence and minimising the regulatory burden of commercial operators; |
| --- | --- |

(b)

addressing and as far as possible effectively resolve "doing business" issues that may, inter alia, hamper market access and smooth operation of agreed services under this Agreement as a means to ensure a level playing field, regulatory convergence and minimising the regulatory burden of commercial operators;

| (c) | fostering expert-level exchanges on new legislative or regulatory initiatives and developments, as well as the adoption of new instruments of international public and private aviation law, in particular in the fields of security, safety, the environment, aviation infrastructure (including slots), airports, industrial cooperation, air traffic management, competitive environment and consumer protection; |
| --- | --- |

(c)

fostering expert-level exchanges on new legislative or regulatory initiatives and developments, as well as the adoption of new instruments of international public and private aviation law, in particular in the fields of security, safety, the environment, aviation infrastructure (including slots), airports, industrial cooperation, air traffic management, competitive environment and consumer protection;

| (d) | regularly examining the social effects of this Agreement as it is implemented, in particular in the area of employment and developing appropriate responses to concerns found to be legitimate; |
| --- | --- |

(d)

regularly examining the social effects of this Agreement as it is implemented, in particular in the area of employment and developing appropriate responses to concerns found to be legitimate;

| (e) | considering potential areas for the further development of this Agreement, including the recommendation of amendments to this Agreement; |
| --- | --- |

(e)

considering potential areas for the further development of this Agreement, including the recommendation of amendments to this Agreement;

| (f) | agreeing, on the basis of consensus, on proposals, approaches or documents of a procedural nature directly related to the functioning of this Agreement; |
| --- | --- |

(f)

agreeing, on the basis of consensus, on proposals, approaches or documents of a procedural nature directly related to the functioning of this Agreement;

| (g) | considering and developing technical assistance in the areas covered by this Agreement; and |
| --- | --- |

(g)

considering and developing technical assistance in the areas covered by this Agreement; and

| (h) | fostering cooperation in relevant international fora and endeavour to establish coordinated positions. |
| --- | --- |

(h)

fostering cooperation in relevant international fora and endeavour to establish coordinated positions.

Article 30

Dispute resolution and arbitration

1.   If any dispute arises between the Parties relating to the interpretation or application of this Agreement, they shall in the first place endeavour to settle it through formal consultations within the Joint Committee in accordance with Article 29(5) of this Agreement. In cases where the Joint Committee takes decisions under this procedure concerning the interpretation or application of requirements and standards referred to in Annex I to this Agreement, such decisions shall respect the rulings of the Court of Justice relating to the interpretation of the pertinent requirements and standards, as well as the decisions of the European Commission which are taken under the terms of the corresponding requirements and standards.

2.   Either Party may refer any dispute relating to the application or interpretation of this Agreement which it has not been possible to resolve in accordance with paragraph 1 of this Article to an arbitration panel of three arbitrators in accordance with the following procedure:

| (a) | each Party shall appoint an arbitrator within 60 days from the date of reception of the notification for the request for arbitration by the arbitration panel addressed by the other Party through diplomatic channels; the third arbitrator should be appointed by the other two arbitrators within 60 additional days. If one of the Parties has not appointed an arbitrator within the agreed period, or if the third arbitrator is not appointed within the agreed period, each Party may request the President of the ICAO Council to appoint an arbitrator or arbitrators, whichever is applicable. If the President of the ICAO Council is of the same nationality as one of the Parties, the most senior Vice President of the ICAO Council who is not disqualified on that ground shall make the appointment; |
| --- | --- |

(a)

each Party shall appoint an arbitrator within 60 days from the date of reception of the notification for the request for arbitration by the arbitration panel addressed by the other Party through diplomatic channels; the third arbitrator should be appointed by the other two arbitrators within 60 additional days. If one of the Parties has not appointed an arbitrator within the agreed period, or if the third arbitrator is not appointed within the agreed period, each Party may request the President of the ICAO Council to appoint an arbitrator or arbitrators, whichever is applicable. If the President of the ICAO Council is of the same nationality as one of the Parties, the most senior Vice President of the ICAO Council who is not disqualified on that ground shall make the appointment;

| (b) | the third arbitrator appointed under the terms of point (a) shall be a national of a third State and shall act as a President of the arbitration panel; |
| --- | --- |

(b)

the third arbitrator appointed under the terms of point (a) shall be a national of a third State and shall act as a President of the arbitration panel;

| (c) | the arbitration panel shall agree its rules of procedure; and |
| --- | --- |

(c)

the arbitration panel shall agree its rules of procedure; and

| (d) | subject to the final decision of the arbitration panel, the initial expenses of the arbitration shall be shared equally by the Parties. |
| --- | --- |

(d)

subject to the final decision of the arbitration panel, the initial expenses of the arbitration shall be shared equally by the Parties.

3.   At the request of a Party the arbitration panel may order the other Party to implement interim relief measures pending the panel's final decision.

4.   Any provisional decision or final decision of the arbitration panel shall be binding upon the Parties. The arbitration panel shall seek to adopt any provisional decision or final decision by consensus. Where consensus is not possible, it shall adopt its decisions by majority voting.

5.   If one of the Parties does not act in conformity with a decision of the arbitration panel taken under the terms of this Article within 30 days from the date of receipt of the notification of the aforementioned decision, the other Party may, for as long as this failure endures, limit, suspend or revoke the rights or privileges which it had granted under the terms of this Agreement from the Party at fault.

Article 31

Safeguard measures

1.   Without prejudice to Articles 7 and 8 of this Agreement and to the safety and security assessments mentioned in Annex III to this Agreement, a Party may take appropriate safeguard measures if it considers that the other Party has failed to fulfil an obligation under this Agreement. Safeguard measures shall be restricted with regard to their scope and duration to what is strictly necessary in order to remedy the situation or maintain the balance of this Agreement. Priority shall be given to such measures that will least disturb the functioning of this Agreement.

2.   A Party which is considering taking safeguard measures shall without delay notify the other Party through the Joint Committee and shall provide all relevant information.

3.   The Parties shall immediately enter into consultations in the Joint Committee with a view to finding a commonly acceptable solution.

4.   Without prejudice to Articles 7 and 8 of this Agreement, the Party concerned may not take safeguard measures until one month has elapsed after the date of notification under paragraph 2 of this Article, unless the consultation procedure under paragraph 3 of this Article has been concluded before the expiry of the stated time limit.

5.   The Party concerned shall, without delay, notify the measures taken to the Joint Committee and shall provide all relevant information.

6.   Any action taken under the terms of this Article shall be suspended, as soon as the Party at fault satisfies the provisions of this Agreement.

Article 32

Disclosure of information

The representatives, delegates and experts of the Parties, as well as other officials acting under this Agreement, shall be required, even after their duties have ceased, not to disclose to third parties information covered by the obligation of professional confidentiality, in particular relevant security information and information about companies or undertakings, their business relations or their cost components.

Article 33

Transitional arrangements

1.   Annex III to this Agreement establishes the transitional arrangements and corresponding transitional periods applying between the Parties.

2.   The gradual transition of Ukraine to the effective implementation of the requirements and standards of the European Union acts relating to civil aviation referred to in Annex I to this Agreement and the fulfilment of the conditions under Annex III to this Agreement shall be subject to assessments, which shall be carried out by the European Commission in cooperation with Ukraine and, as regards aviation safety standardisation inspections carried out by the EASA, in accordance with the requirements and standards specified in Annex I, Part C, to this Agreement.

When Ukraine is satisfied that the relevant legislative requirements and standards are incorporated in the Ukrainian legislation and implemented, it shall inform the European Commission that an assessment should be carried out.

3.   If the European Commission determines that Ukraine fulfils the relevant requirements and standards, it shall submit the matter to the Joint Committee for it to take a decision that Ukraine qualifies for passing to the next transitional period or complies with all these requirements.

4.   If the European Commission determines that Ukraine does not fulfil the relevant requirements and standards, it shall so report to the Joint Committee. The European Commission shall thereafter recommend to Ukraine specific improvements and determine, in consultation with Ukraine, an implementing period within which the relevant deficiencies can reasonably be addressed. Before the end of the implementing period, a second and, if necessary, further assessments shall be made whether the recommended improvements have effectively and satisfactorily been implemented.

5.   If the European Commission determines that the relevant deficiencies have been addressed, it shall submit the matter to the Joint Committee to decide accordingly and as stipulated in paragraph 3 of this Article.

Article 34

Relationship to other agreements and/or arrangements

1.   The provisions of this Agreement shall prevail over the relevant provisions of the bilateral air transport agreements and/or arrangements between the Parties.

2.   Notwithstanding paragraph 1 of this Article, the provisions concerning ownership, traffic rights, capacity, frequencies, type or change of aircraft, code-sharing and pricing of a bilateral agreement or arrangement between Ukraine and the European Union or an EU Member State, shall apply between the Parties if such bilateral agreement and/or arrangement is more favourable, in terms of freedom for the air carriers concerned, or otherwise more favourable and provided that there is no discrimination between EU Member States and their nationals. The same applies for provisions that are not covered by this Agreement.

3.   If the Parties become parties to a multilateral agreement or endorse a decision adopted by the ICAO or another international organisation that addresses matters covered by this Agreement, they shall consult in the Joint Committee to determine whether this Agreement should be revised to take into account such developments.

Article 35

Financial provisions

Without prejudice to point (b) of Article 5(1) of this Agreement, the Parties shall allocate necessary financial resources, including related to the Joint Committee, for the implementation of this Agreement in their respective territories.

TITLE V

ENTRY INTO FORCE, REVIEW, TERMINATION AND FINAL PROVISIONS

Article 36

Amendments

1.   The Joint Committee may, upon the proposal of one Party and in accordance with this Article, decide by consensus to modify the Annexes to this Agreement as provided for in point (a) of Article 15(3) of this Agreement.

2.   Amendments to the Annexes to this Agreement shall enter into force after completion by the Parties of the necessary internal procedures.

3.   At the request of any Party and in accordance with the relevant procedures, taking into account possible recommendations by the Joint Committee, this Agreement shall be reviewed in the light of the application of its provisions, in order to consider any necessary future development. Any resulting amendment of this Agreement shall enter into force as provided for in Article 38 of this Agreement.

Article 37

Termination

Either Party may, at any time, give notice in writing, through diplomatic channels, to the other Party of its decision to terminate this Agreement. Such notice shall be sent simultaneously to the ICAO. This Agreement shall terminate at midnight GMT at the end of the International Air Transport Association traffic season in effect one year following the date of written notification of termination, unless the notice is withdrawn by mutual agreement of the Parties before the expiry of this period.

Article 38

Entry into force and provisional application

1.   This Agreement shall be subject to ratification or approval by the signatories in accordance with their own procedures.

2.   This Agreement shall enter into force on the first day of the second month after the date of the last note of the exchange of diplomatic notes between the Parties confirming that all necessary procedures for entry into force of this Agreement have been completed. For the purpose of this exchange, Ukraine shall deliver to the General Secretariat of the Council of the European Union its diplomatic note to the European Union and its Member States and the General Secretariat of the Council of the European Union shall deliver to Ukraine the diplomatic note from the European Union and its Member States. The diplomatic note from the European Union and its Member States shall contain communications from each Member State confirming that its necessary procedures for entry into force of this Agreement have been completed.

3.   Notwithstanding paragraph 2 of this Article, the Parties agree to provisionally apply this Agreement, in accordance with their internal procedures or national legislation, as applicable, from the first day of the month following the date of the latest note by which the Parties have notified each other of the completion of the relevant national procedures to provisionally apply or as the case may be to conclude this Agreement.

4.   The Secretary-General of the Council of the European Union shall act as the depositary of this Agreement.

Article 39

Registration with the ICAO and the United Nations Secretariat

This Agreement and all amendments thereto shall be registered by Ukraine with the ICAO and with the United Nations Secretariat, in accordance with Article 102 of the Charter of the United Nations, following its entry into force.

Article 40

Authentic texts

This Agreement shall be drawn up in duplicate in the Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Ukrainian languages, each text being equally authentic.

IN WITNESS WHEREOF the undersigned Plenipotentiaries, duly authorised to this effect, have signed this Agreement.

Съставено в Киев на дванадесети октомври две хиляди двадесет и първа година.

Hecho en Kiev, el doce de octubre de dos mil veintiuno.

V Kyjevě dne dvanáctého října dva tisíce dvacet jedna.

Udfærdiget i Kiev den tolvte oktober to tusind og enogtyve.

Geschehen zu Kiew am zwölften Oktober zweitausendeinundzwanzig.

Kahe tuhande kahekümne esimese aasta oktoobrikuu kaheteistkümnendal päeval Kiievis.

Έγινε στο Κίεβο, στις δώδεκα Οκτωβρίου δύο χιλιάδες είκοσι ένα.

Done at Kyiv on the twelfth day of October in the year two thousand and twenty one.

Fait à Kiev, le douze octobre deux mille vingt et un.

Arna dhéanamh i gCív, an dóú lá déag de Dheireadh Fómhair an bhliain dhá mhíle fiche agus haon.

Sastavljeno u Kijevu dvanaestog listopada godine dvije tisuće dvadeset prve.

Fatto a Kiev, addì dodici ottobre duemilaventuno.

Kijevā, divi tūkstoši divdesmit pirmā gada divpadsmitajā oktobrī.

Priimta du tūkstančiai dvidešimt pirmų metų spalio dvyliktą dieną Kijeve.

Kelt Kijevben, a kétezer-huszonegyedik év október havának tizenkettedik napján.

Magħmul f'Kiev, fit-tnax-il jum ta’ Ottubru fis-sena elfejn u wieħed u għoxrin.

Gedaan te Kiev, twaalf oktober tweeduizend eenentwintig.

Sporządzono w Kijowie dnia dwunastego października roku dwa tysiące dwudziestego pierwszego.

Feito em Kiev, em doze de outubro de dois mil e vinte e um.

Întocmit la Kiev la doisprezece octombrie două mii douăzeci și unu.

V Kyjeve dvanásteho októbra dvetisícdvadsaťjeden.

V Kijevu, dne dvanajstega oktobra leta dva tisoč enaindvajset.

Tehty Kiovassa kahdentenatoista päivänä lokakuuta vuonna kaksituhattakaksikymmentäyksi.

Som skedde i Kiev den tolfte oktober år tjugohundratjugoett.

Учинено в Києвi дванадцятого жовтня двi тисячi двадцять першого року.

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(1)  This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

1

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ANNEX I

LIST OF APPLICABLE REQUIREMENTS AND STANDARDS ADOPTED BY THE EUROPEAN UNION IN THE FIELD OF CIVIL AVIATION TO BE INCORPORATED IN THE LEGISLATION OF UKRAINE

The applicable requirements and standards of the following European Union acts shall be incorporated into Ukrainian legislation and deemed to be part of this Agreement and shall be applicable in accordance with this Agreement and Annex III to this Agreement, unless otherwise specified. Where necessary, specific adaptations for each individual act are set out in this Annex.

The applicable requirements and standards of acts referred to in this Annex shall be binding upon the Parties and be, or be made, part of their internal legal order as follows:

| (a) | European Union regulations and directives shall be binding upon the European Union and its Member States in accordance with the EU Treaties; |
| --- | --- |

(a)

European Union regulations and directives shall be binding upon the European Union and its Member States in accordance with the EU Treaties;

| (b) | a national act of Ukraine adopted with the aim of implementing the provisions of the corresponding European Union regulations and directives shall be legally binding upon Ukraine, while the form and method of implementation are to be decided by Ukraine. |
| --- | --- |

(b)

a national act of Ukraine adopted with the aim of implementing the provisions of the corresponding European Union regulations and directives shall be legally binding upon Ukraine, while the form and method of implementation are to be decided by Ukraine.

A.   Market Access and Ancillary Issues

No 1008/2008

Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the Community

Applicable requirements and standards: Chapter IV.

No 95/93

Council Regulation (EEC) No 95/93 of 18 January 1993 on common rules for the allocation of slots at Community airports,

as amended by:

Regulation (EC) No 894/2002 of the European Parliament and of the Council of 27 May 2002 amending Council Regulation (EEC) No 95/93 on common rules for the allocation of slots at Community airports,

Regulation (EC) No 1554/2003 of the European Parliament and of the Council of 22 July 2003 amending Council Regulation (EEC) No 95/93 on common rules for the allocation of slots at Community airports,

Regulation (EC) No 793/2004 of the European Parliament and of the Council of 21 April 2004 amending Council Regulation (EEC) No 95/93 on common rules for the allocation of slots at Community airports.

Applicable requirements and standards: Articles 1 to 12, 14 and 14a(2).

As regards the application of Article 12(2), the term "the Commission" shall read "the Joint Committee".

No 96/67

Council Directive 96/67/EC of 15 October 1996 on access to the groundhandling market at Community airports.

Applicable requirements and standards: Articles 1 to 25 and the Annex.

As regards the application of Article 10, the term "Member States" shall read "EU Member States".

As regards the application of Article 20(2), the term "the Commission" shall read "the Joint Committee".

No 785/2004

Regulation (EC) No 785/2004 of the European Parliament and of the Council of 21 April 2004 on insurance requirements for air carriers and aircraft operators,

as amended by:

Commission Regulation (EU) No 285/2010 of 6 April 2010 amending Regulation 785/2004 of the European Parliament and of the Council on insurance requirements for air carriers and aircraft operators.

Applicable requirements and standards: Articles 1 to 8, and 10(2).

No 2009/12

Directive 2009/12/EC of the European Parliament and of the Council of 11 March 2009 on airport charges.

Applicable requirements and standards: all except Articles 12 (1), 13 and 14.

B.   Air Traffic Management

No 549/2004

Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation),

as amended by:

Regulation (EC) No 1070/2009 of the European Parliament and of the Council of 21 October 2009 amending Regulations (EC) No 549/2004, (EC) No 550/2004, (EC) No 551/2004 and (EC) No 552/2004 in order to improve the performance and sustainability of the European aviation system.

Applicable requirements and standards: Articles 1 to 4, 6, and 9 to 14.

No 550/2004

Regulation (EC) No 550/2004 of the European Parliament and of the Council of 10 March 2004 on the provision of air navigation services in the single European sky (the service provision Regulation),

as amended by:

Regulation (EC) No 1070/2009 of the European Parliament and of the Council of 21 October 2009 to improve the performance and sustainability of the European aviation system.

Applicable requirements and standards: Articles 1 to 19, Annexes I and II.

No 551/2004

Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the single European sky (the airspace Regulation),

as amended by:

Regulation (EC) No 1070/2009 of the European Parliament and of the Council of 21 October 2009 to improve the performance and sustainability of the European aviation system.

Applicable requirements and standards: Articles 1 to 11.

No 552/2004

Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network (the interoperability Regulation),

as amended by:

Regulation (EC) No 1070/2009 of the European Parliament and of the Council of 21 October 2009 to improve the performance and sustainability of the European aviation system.

Applicable requirements and standards: Articles 1 to 12, Annexes I to V.

Implementing Legislation

No 691/2010

Commission Regulation (EU) No 691/2010 of 29 July 2010 laying down a performance scheme for air navigation services and network functions and amending Regulation (EC) No 2096/2005 laying down common requirements for the provision of air navigation services,

as amended by:

Commission Regulation (EU) No 677/2011 of 7 July 2011 laying down detailed rules for the implementation of air traffic management (ATM) network functions and amending Regulation (EU) No 691/2010,

Commission Regulation (EU) No 1216/2011 of 24 November 2011 amending Commission Regulation (EU) No 691/2010 laying down a performance scheme for air navigation services and network functions,

Commission Regulation (EU) No 390/2013 of 03 May 2013 laying down a performance scheme for air navigation services and network functions.

Applicable requirements and standards: Articles 1 to 25, Annexes I to IV.

No 1794/2006

Commission Regulation (EC) No 1794/2006 of 6 December 2006 laying down a common charging scheme for air navigation services,

as amended by:

Commission Regulation (EU) No 1191/2010 of 16 December 2010 amending Regulation (EC) No 1794/2006 laying down a common charging scheme for air navigation services,

Commission Regulation (EU) No 391/2013 of 3 May 2013 laying down a common charging scheme for air navigation services.

Applicable requirements and standards: Articles 1 to 17, Annexes I to VI.

No 482/2008

Commission Regulation (EC) No 482/2008 of 30 May 2008 establishing a software safety assurance system to be implemented by air navigation service providers and amending Annex II to Regulation (EC) No 2096/2005,

as amended by:

Commission Regulation (EU) No 1035/2011 of 17 October 2011 laying down common requirements for the provision of air navigation services and amending Regulations (EC) No 482/2008 and (EU) No 691/2010.

Applicable requirements and standards: Articles 1 to 6, Annexes I to II.

No 1034/2011

Commission Regulation (EU) No 1034/2011 of 17 October 2011 on safety oversight in air traffic management and air navigation services and amending Regulation (EU) No 691/2010.

Applicable requirements and standards: Articles 1 to 19.

No 1035/2011

Commission Implementing Regulation (EU) No 1035/2011 of 17 October 2011 laying down common requirements for the provision of air navigation services and amending Regulations (EC) No 482/2008 and (EU) No 691/2010,

as amended by:

Commission Implementing Regulation (EU) No 923/2012 of 26 September 2012 laying down the common rules of the air and operational provisions regarding services and procedures in air navigation and amending Implementing Regulation (EU) No 1035/2011 and Regulations (EC) No 1265/2007, (EC) No 1794/2006, (EC) No 730/2006, (EC) No 1033/2006 and (EU) No 255/2010.

Applicable requirements and standards: Articles 1 to 14, Annexes I to V.

No 409/2013

Commission Regulation (EU) No 409/2013 of 03 May 2013 on the definition of common projects, the establishment of governance and identification of incentives supporting the implementation of the European ATM Master Plan.

Applicable requirements and standards: Articles 1 to 15.

No 2150/2005

Commission Regulation (EC) No 2150/2005 of 23 December 2005 laying down common rules for the flexible use of airspace.

Applicable requirements and standards: Articles 1 to 9 and the Annex.

No 730/2006

Commission Regulation (EC) No 730/2006 of 11 May 2006 on airspace classification and access of flights operated under visual flight rules above flight level 195.

Applicable requirements and standards: Articles 1 to 4.

No 255/2010

Commission Regulation (EU) No 255/2010 of 25 March 2010 laying down common rules on air traffic flow management.

Applicable requirements and standards: Articles 1 to 15.

No 176/2011

Commission Regulation (EU) No 176/2011 of 24 February 2011 on the information to be provided before the establishment and modification of a functional airspace block.

No 923/2012

Commission Regulation (EU) No 923/2012 of 26 September 2012 laying down the common rules of the air and operational provisions regarding services and procedures in air navigation and amending Implementing Regulation (EU) No 1035/2011 and Regulations (EC) No 1265/2007, (EC) No 1794/2006, (EC) No 730/2006, (EC) No 1033/2006 and (EU) No 255/2010.

Applicable requirements and standards: Articles 1 to 10 and the Annex.

No 1032/2006

Commission Regulation (EC) No 1032/2006 of 6 July 2006 laying down requirements for automatic systems for the exchange of flight data for the purpose of notification, coordination and transfer of flights between air traffic control units,

as amended by:

Commission Regulation (EC) No 30/2009 of 16 January 2009 amending Regulation (EC) No 1032/2006 as far as the requirements for automatic systems for the exchange of flight data supporting data link services are concerned.

Applicable requirements and standards: Articles 1 to 10, Annexes I to V.

No 1033/2006

Commission Regulation (EC) No 1033/2006 of 4 July 2006 laying down the requirements on procedures for flight plans in the pre-flight phase for the single European sky,

as amended by:

Commission Regulation (EU) No 428/2013 of 08 May 2013 amending Regulation (EC) No 1033/2006 as regards the ICAO provisions referred to in Article 3(1) and repealing Regulation (EU) No 929/2010.

Applicable requirements and standards: Articles 1 to 5 and the Annex.

No 633/2007

Commission Regulation (EC) No 633/2007 of 7 June 2007 laying down requirements for the application of a flight message transfer protocol used for the purpose of notification, coordination and transfer of flights between air traffic control units,

as amended by:

Commission Regulation (EU) No 283/2011 of 22 March 2011 amending Regulation (EC) No 633/2007 as regards the transitional arrangements referred to in Article 7.

Applicable requirements and standards: Articles 1 to 7, the second and third sentences of Article 8, Annexes I to IV.

No 29/2009

Commission Regulation (EC) No 29/2009 of 16 January 2009 laying down requirements on data link services for the single European sky.

Applicable requirements and standards: Articles 1 to 14, Annexes I to VII.

No 262/2009

Commission Regulation (EC) No 262/2009 of 30 March 2009 laying down requirements for the coordinated allocation and use of Mode S interrogator codes for the single European sky.

Applicable requirements and standards: Articles 1 to 12, Annexes I to VI.

No 73/2010

Commission Regulation (EU) No 73/2010 of 26 January 2010 laying down requirements on the quality of aeronautical data and aeronautical information for the single European sky.

Applicable requirements and standards: Articles 1 to 13, Annexes I to X.

No 1206/2011

Commission Implementing Regulation (EU) No 1206/2011 of 22 November 2011 laying down requirements on aircraft identification for surveillance for the single European sky.

Applicable requirements and standards: Articles 1 to 11, Annexes I to VII.

No 1207/2011

Commission Implementing Regulation (EU) No 1207/2011 of 22 November 2011 laying down requirements for the performance and the interoperability of surveillance for the single European sky.

Applicable requirements and standards: Articles 1 to 14, Annexes I to IX.

No 1079/2012

Commission Regulation (EU) No 1079/2012 of 16 November 2012 laying down requirements for voice channels spacing for the single European sky.

Applicable requirements and standards: Articles 1 to 15, Annexes I to V.

SESAR Regulation

No 219/2007

Council Regulation (EC) No 219/2007 of 27 February 2007 on the establishment of a Joint Undertaking to develop the new generation European air traffic management system (SESAR),

as amended by:

Commission Regulation (EC) No 1361/2008 of 16 December 2008 amending Regulation (EC) No 219/2007 on the establishment of a joint undertaking to develop the new generation European air traffic management system (SESAR).

Applicable requirements and standards: Article 1(1),(2) and (5) to (7), Articles 2 to 3, Article 4(1) and the Annex.

Air traffic controllers' licences

No 805/2011

Commission Regulation (EU) No 805/2011 of 10 August 2011 laying down detailed rules for air traffic controllers' licences and certain certificates pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council.

Applicable requirements and standards: Articles 1 to 32, Annexes I to IV.

Commission Decisions

No 2011/121

Commission Decision 2011/121/EU of 21 February 2011 setting the European Union-wide performance targets and alert thresholds for the provision of air navigation services for the years 2012 to 2014.

Applicable requirements and standards: Articles 1 to 4.

No 2011/2611 final

Commission Decision C(2011) 2611 final of 20 May 2011 on exemptions under Article 14 of Commission Regulation (EC) No 29/2009.

Applicable requirements and standards: Articles 1 to 3, Annexes I and II.

No 2011/9074 final

Commission Implementing Decision C(2011) 9074 final of 9 December 2011 on exemptions under Article 14 of Commission Regulation (EC) No 29/2009.

Applicable requirements and standards: Articles 1 to 3, Annexes I and II.

No 2012/9604 final

Commission Implementing Decision C (2012) 9604 final of 19 December 2012 on the approval of the Network Strategy Plan for the air traffic management network functions of the single European sky for the period 2012-2019.

Applicable requirements and standards: Articles 1 to 3.

C.   Aviation Safety

No 216/2008 (Basic Regulation)

Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC,

as amended by:

Commission Regulation (EC) No 690/2009 of 30 July 2009 amending Regulation (EC) No 216/2008 of the European Parliament and the Council on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC,

Regulation (EC) No 1108/2009 of the European Parliament and of the Council of 21 October 2009 amending Regulation (EC) No 216/2008 in the field of aerodromes, air traffic management and air navigation services and repealing Directive 2006/23/EC,

Commission Regulation (EU) No 6/2013 of 8 January 2013 amending Regulation (EC) No 216/2008 of the European Parliament and of the Council on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC)No 1592/2002 and Directive 2004/36/EC.

Applicable requirements and standards: Articles 1 to 11, 13 to 16, 20 to 25, 54, 55, 68 and Annexes I to VI.

Regulation (EC) No 216/2008 and its implementing rules shall be applied to Ukraine according to the following provisions:

| 1. | Ukraine does not delegate to the EASA any of its safety related functions as envisaged under the Convention and its Annexes; |
| --- | --- |

1.

Ukraine does not delegate to the EASA any of its safety related functions as envisaged under the Convention and its Annexes;

| 2. | Ukraine shall be subject to standardisation inspections conducted by the EASA under Article 54 of Regulation (EC) No 216/2008; |
| --- | --- |

2.

Ukraine shall be subject to standardisation inspections conducted by the EASA under Article 54 of Regulation (EC) No 216/2008;

| 3. | the application of Article 11 of Regulation (EC) No 216/2008 to certificates issued by Ukraine will be decided by the Joint Committee, according to the provisions of Annex III to this Agreement; |
| --- | --- |

3.

the application of Article 11 of Regulation (EC) No 216/2008 to certificates issued by Ukraine will be decided by the Joint Committee, according to the provisions of Annex III to this Agreement;

| 4. | Article 11, paragraph 1, of Regulation (EC) No 216/2008 shall not apply to certificates of Ukraine issued in the areas of flight operations and initial and continuing airworthiness (Implementing Regulations (EU) No 965/2012, (EU) No 748/2012 and (EC) No 2042/2003); |
| --- | --- |

4.

Article 11, paragraph 1, of Regulation (EC) No 216/2008 shall not apply to certificates of Ukraine issued in the areas of flight operations and initial and continuing airworthiness (Implementing Regulations (EU) No 965/2012, (EU) No 748/2012 and (EC) No 2042/2003);

| 5. | the European Commission shall enjoy in Ukraine the powers granted to it for decisions pursuant to Article 11(2), Article 14(5) and (7), Article 24(5) and Article 25(1) of Regulation (EC) No 216/2008 in the areas where Article 11(1) is declared applicable by the Joint Committee; |
| --- | --- |

5.

the European Commission shall enjoy in Ukraine the powers granted to it for decisions pursuant to Article 11(2), Article 14(5) and (7), Article 24(5) and Article 25(1) of Regulation (EC) No 216/2008 in the areas where Article 11(1) is declared applicable by the Joint Committee;

| 6. | in the field of airworthiness, where no tasks are carried out by the EASA, Ukraine may issue certificates, licences or approvals in application of an agreement or arrangement concluded by Ukraine with a third country. |
| --- | --- |

6.

in the field of airworthiness, where no tasks are carried out by the EASA, Ukraine may issue certificates, licences or approvals in application of an agreement or arrangement concluded by Ukraine with a third country.

No 748/2012

Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations,

as amended by:

Commission Regulation (EU) No 7/2013 of 8 January 2013 amending Regulation (EU) No 748/2012 laying down Implementing Rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations.

Applicable requirements and standards: Articles 1, 2, 8 to 10 and the Annex.

No 2042/2003

Commission Regulation (EC) No 2042/2003 of 20 November 2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks,

as amended by:

Commission Regulation (EC) No 707/2006 of 8 May 2006 amending Regulation (EC) No 2042/2003 as regards approvals of a limited duration and Annexes I and III,

Commission Regulation (EC) No 376/2007 of 30 March 2007 amending Regulation (EC) No 2042/2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks,

Commission Regulation (EC) No 1056/2008 of 27 October 2008 amending Regulation (EC) No 2042/2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks,

Commission Regulation (EU) No 127/2010 of 5 February 2010 amending Regulation (EC) No 2042/2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks,

Commission Regulation (EU) No 962/2010 of 26 October 2010 amending Regulation (EC) No 2042/2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks,

Commission Regulation (EU) No 1149/2011 of 21 October 2011 amending Regulation (EC) No 2042/2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks,

Commission Regulation (EU) No 593/2012 of 5 July 2012 amending Regulation (EC) No 2042/2003 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks.

Applicable requirements and standards: Articles 1 to 6, Annexes I to IV.

No 996/2010

Regulation (EU) No 996/2010 of the European Parliament and of the Council of 20 October 2010 on investigation and prevention of accidents and incidents in civil aviation and repealing Directive 94/56/EC.

Applicable requirements and standards: Articles 1 to 26, with the exception of Articles 7(4) and 24.

No 2003/42

Directive 2003/42/EC of the European Parliament and the Council of 13 June 2003 on occurrence reporting in civil aviation.

Applicable requirements and standards: Articles 1 to 11, Annexes I and II.

No 1321/2007

Commission Regulation (EC) No 1321/2007 of 12 November 2007 laying down implementing rules for the integration into a central repository of information on civil aviation occurrences exchanged in accordance with Directive 2003/42/EC of the European Parliament and of the Council.

Applicable requirements and standards: Articles 1 to 4.

No 1330/2007

Commission Regulation (EC) No 1330/2007 of 24 September 2007 laying down implementing rules for the dissemination to interested parties of information on civil aviation occurrences referred to in Article 7(2) of Directive 2003/42/EC of the European Parliament and of the Council.

Applicable requirements and standards: Articles 1 to 10, Annexes I to II.

No 104/2004

Commission Regulation (EC) No 104/2004 of 22 January 2004 laying down rules on the organisation and composition of the Board of Appeal of the European Aviation Safety Agency.

Applicable requirements and standards: Articles 1 to 7 and the Annex.

No 628/2013

Commission Implementing Regulation (EU) No 628/2013 of 28 June 2013 on working methods of the European Aviation Safety Agency for conducting standardisation inspections and for monitoring the application of the rules of Regulation (EC) No 216/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 736/2006.

Applicable requirements and standards: Articles 1 to 27.

No 2111/2005

Regulation (EC) No 2111/2005 of the European Parliament and of the Council of 14 December 2005 on the establishment of a Community list of air carriers subject to an operating ban within the Community and on informing air transport passengers of the identity of the operating air carrier, and repealing Article 9 of Directive 2004/36/EC.

Applicable requirements and standards provisions: Articles 1 to 13 and the Annex.

No 473/2006

Commission Regulation (EC) No 473/2006 of 22 March 2006 laying down implementing rules for the Community list of air carriers which are subject to an operating ban within the Community referred to in Chapter II of Regulation (EC) No 2111/2005 of the European Parliament and of the Council.

Applicable requirements and standards provisions: Articles 1 to 6, Annexes A to C.

No 474/2006

Commission Regulation (EC) No 474/2006 of 22 March 2006 establishing the Community list of air carriers which are subject to an operating ban within the Community referred to in Chapter II of Regulation (EC) No 2111/2005 of the European Parliament and of the Council,

as last amended by:

Commission Implementing Regulation (EU) No 659/2013 of 10 July 2013 amending Regulation (EC) No 474/2006 establishing the Community list of air carriers which are subject to an operating ban within the Community.

Applicable requirements and standards: Articles 1 to 3, Annexes A to B.

No 1178/2011

Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council,

as amended by:

Commission Regulation (EU) No 290/2012 of 30 March 2012 amending Regulation (EU) No 1178/2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council.

Applicable requirements and standards: Articles 1 to 11, Annexes I to VII.

No 965/2012

Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council,

as amended by:

Commission Regulation (EU) No 800/2013 of 14 August 2013 amending Regulation (EU) No 965/2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council.

Applicable requirements and standards: Articles 1 to 9, Annexes I to VII.

No 1332/2011

Commission Regulation (EU) No 1332/2011 of 16 December 2011 laying down common airspace usage requirements and operating procedures for airborne collision avoidance.

Applicable requirements and standards: Articles 1 to 4 and the Annex.

D.   Environment

No 2003/96

Council Directive 2003/96/EC of 27 October 2003 restructuring the Community framework for the taxation of energy products and electricity.

Applicable requirements and standards: Article 14(1)(b) and (2).

No 2006/93

Directive 2006/93/EC of the European Parliament and of the Council of 12 December 2006 on the regulation of the operation of aeroplanes covered by Part II, Chapter 3, Volume 1 of Annex 16 to the Convention on International Civil Aviation, second edition (1988).

Applicable requirements and standards: Articles 1 to 5.

No 2002/49

Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise.

Applicable requirements and standards: Articles 1 to 16, Annexes I to VI.

No 2002/30

Directive 2002/30/EC of the European Parliament and of the Council of 26 March 2002 on the establishment of rules and procedures with regard to the introduction of noise-related operating restrictions at Community airports,

Applicable requirements and standards: Articles 1 to 15, Annexes I and II.

E.   Social Aspects

No 1989/391

Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work,

as amended by:

Directive 2007/30/EC of the European Parliament and of the Council of 20 June 2007 amending Council Directive 89/391/EEC, its individual Directives and Council Directives 83/477/EEC, 91/383/EEC, 92/29/EEC and 94/33/EC with a view to simplifying and rationalising the reports on practical implementation.

Applicable requirements and standards: Articles 1 to 16, and 18 to 19.

No 2003/88

Directive 2003/88/EC of the European Parliament and of the Council of 4 November 2003 concerning certain aspects of the organisation of working time.

Applicable provisions: Articles 1 to 19, 21 to 24 and 26 to 29.

No 2000/79

Council Directive 2000/79/EC of 27 November 2000 concerning the European Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation concluded by the Association of European Airlines (AEA), the European Transport Workers' Federation (ETF), the European Cockpit Association (ECA), the European Regions Airline Association (ERA) and the International Air Carrier Association (IACA).

Applicable requirements and standards: Articles 2 to 3 and the Annex.

F.   Consumer Protection

No 90/314

Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours.

Applicable provisions: Articles 1 to 10.

No 93/13

Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts.

Applicable provisions: Articles 1 to 10 and the Annex.

As regards the application of Article 10, the term "the Commission" shall read "all other ECAA Contracting Parties".

No 95/46

Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

Applicable requirements and standards: Articles 1 to 34.

No 2027/97

Council Regulation (EC) No 2027/97 of 9 October 1997 on air carrier liability in the event of accidents,

as amended by:

Regulation (EC) No 889/2002 of the European Parliament and of the Council of 13 May 2002 amending Council Regulation (EC) No 2027/97 on air carrier liability in the event of accidents.

Applicable requirements and standards: Articles 1 to 8.

No 261/2004

Regulation (EC) No 261/2004 of the European Parliament and of the Council of 11 February 2004 establishing common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights, and repealing Regulation (EEC) No 295/91.

Applicable requirements and standards: Articles 1 to 17.

No 1107/2006

Regulation (EC) No 1107/2006 of the European Parliament and of the Council of 5 July 2006 concerning the rights of disabled persons and persons with reduced mobility when travelling by air.

Applicable requirements and standards: Articles 1 to 16, Annexes I and II.

G.   Computerised Reservation Systems

No 80/2009

Regulation (EC) No 80/2009 of the European Parliament and of the Council of 14 January 2009 on a Code of Conduct for computerised reservation systems and repealing Council Regulation (EEC) No 2299/89.

Applicable requirements and standards: Articles 1 to 19 and the Annexes.

H.   Other Legislation

No 437/2003

Regulation (EC) No 437/2003 of the European Parliament and of the Council of 27 February 2003 on statistical returns in respect of the carriage of passengers, freight and mail by air,

as amended by:

Commission Regulation (EC) No 1358/2003 of 31 July 2003 implementing Regulation (EC) No 437/2003 of the European Parliament and of the Council on statistical returns in respect of the carriage of passengers, freight and mail by air and amending Annexes I and II thereto,

Commission Regulation (EC) No 546/2005 of 8 April 2005 adapting Regulation (EC) No 437/2003 of the European Parliament and of the Council as regards the allocation of reporting-country codes and amending Commission Regulation (EC) No 1358/2003 as regards the updating of the list of Community airports.

Applicable requirements and standards: Articles 1 to 11, Annexes I and II.

No 1358/2003

Commission Regulation (EC) No 1358/2003 of 31 July 2003 implementing Regulation (EC) No 437/2003 of the European Parliament and of the Council on statistical returns in respect of the carriage of passengers, freight and mail by air and amending Annexes I and II thereto,

as amended by:

Commission Regulation (EC) No 158/2007 of 16 February 2007 amending Commission Regulation (EC) No 1358/2003 as regards the list of Community airports.

Applicable requirements and standards: Articles 1 to 4, Annexes I to III.

---

ANNEX II

AGREED SERVICES AND SPECIFIED ROUTES

1.

| (a) | for air carriers of the European Union: any point in the European Union – any intermediate points in the territories of European Neighbourhood Policy partners (1), ECAA countries (2) or countries listed in Annex V to this Agreement – any point in Ukraine – any points beyond; |
| --- | --- |

(a)

for air carriers of the European Union: any point in the European Union – any intermediate points in the territories of European Neighbourhood Policy partners (1), ECAA countries (2) or countries listed in Annex V to this Agreement – any point in Ukraine – any points beyond;

| (b) | for air carriers of Ukraine: any point in Ukraine – any intermediate points in the territories of European Neighbourhood Policy partners, ECAA countries or countries listed in Annex V to this Agreement – any point in the European Union.
  Existing and new rights, including rights to serve beyond points under bilateral agreements or other arrangements between Ukraine and EU Member States, which are not covered under this Agreement can be exercised and agreed, provided that there is no discrimination between air carriers on the basis of nationality; |
| --- | --- |

(b)

for air carriers of Ukraine: any point in Ukraine – any intermediate points in the territories of European Neighbourhood Policy partners, ECAA countries or countries listed in Annex V to this Agreement – any point in the European Union.

Existing and new rights, including rights to serve beyond points under bilateral agreements or other arrangements between Ukraine and EU Member States, which are not covered under this Agreement can be exercised and agreed, provided that there is no discrimination between air carriers on the basis of nationality;

| (c) | air carriers of the European Union shall also be entitled to perform air transport services between points in Ukraine, whether or not such air transport services originate or terminate within the EU. |
| --- | --- |

(c)

air carriers of the European Union shall also be entitled to perform air transport services between points in Ukraine, whether or not such air transport services originate or terminate within the EU.

2.

The services operated in accordance with points (a) and (b) of paragraph 1 of this Annex shall originate or terminate in the territory of Ukraine, for air carriers of Ukraine, and in the territory of the European Union for air carriers of the European Union.

3.

| (a) | operate flights in either or both directions; |
| --- | --- |

(a)

operate flights in either or both directions;

| (b) | combine different flight numbers within one aircraft operation; |
| --- | --- |

(b)

combine different flight numbers within one aircraft operation;

| (c) | serve intermediate and beyond points, as specified in points (a) and (b) of paragraph 1 of this Annex, and points in the territories of the Parties in any combination and in any order; |
| --- | --- |

(c)

serve intermediate and beyond points, as specified in points (a) and (b) of paragraph 1 of this Annex, and points in the territories of the Parties in any combination and in any order;

| (d) | omit stops at any point or points; |
| --- | --- |

(d)

omit stops at any point or points;

| (e) | transfer traffic from any of its aircraft to any of its other aircraft at any point; |
| --- | --- |

(e)

transfer traffic from any of its aircraft to any of its other aircraft at any point;

| (f) | make stopovers at any points whether within or outside the territory of either Party; |
| --- | --- |

(f)

make stopovers at any points whether within or outside the territory of either Party;

| (g) | carry transit traffic through the other Party's territory; and |
| --- | --- |

(g)

carry transit traffic through the other Party's territory; and

| (h) | combine traffic on the same aircraft regardless of where such traffic originates. |
| --- | --- |

(h)

combine traffic on the same aircraft regardless of where such traffic originates.

4.

Each Party shall allow each air carrier to determine the frequency and capacity of the international air transport it offers based upon commercial considerations in the marketplace. Consistent with this right, neither Party shall unilaterally limit the volume of traffic, frequency or regularity of service, or the aircraft type or types operated by the air carriers of the other Party, except for customs, technical, operational, environmental, protection of health reasons or in application of Article 26 of this Agreement.

5.

The air carriers of each Party may serve, including within the framework of code share arrangements, any point located in a third country that is not included on the specified routes, provided that they do not exercise fifth freedom rights.

6.

This Annex is subject to the transitional arrangements contained in Annex III to this Agreement and the extension of rights foreseen therein.

---

(1)  
  "European Neighbourhood Policy partners" shall here be understood as Algeria, Armenia, Azerbaijan, Belarus, Egypt, Georgia, Israel, Jordan, Lebanon, Libya, Morocco, Palestine, Syria, Tunisia and the Republic of Moldova, i.e. shall here not include Ukraine.

1

(2)  
  "ECAA countries" are the Parties to the Multilateral Agreement establishing a European Common Aviation Area, which are: The Member States of the European Union, the Republic of Albania, Bosnia and Herzegovina, the former Yugoslav Republic of Macedonia, the Republic of Iceland, the Republic of Montenegro, the Kingdom of Norway, the Republic of Serbia and Kosovo (This designation is without prejudice to positions on status, and is in line with UNSCR 1244 and the ICJ Opinion on the Kosovo Declaration of Independence).

2

---

ANNEX III

TRANSITIONAL ARRANGEMENTS

SECTION 1

Transitional periods

| 1. | The transition of Ukraine towards the effective implementation of all provisions and conditions stemming from this Agreement shall be carried out through two transitional periods. |
| --- | --- |

1.

| 2. | Such transition shall be subject to assessments and standardisation inspections, which shall be conducted by the European Commission and the EASA respectively, as well as a decision of the Joint Committee, as provided for in Article 33 of this Agreement. |
| --- | --- |

2.

SECTION 2

Specifications applicable during the first transitional period

| 1. | During the first transitional period:






  (a) | air carriers of the European Union and air carriers licensed by Ukraine shall be permitted to exercise unlimited traffic rights between any point in the European Union and any point in Ukraine; |
| --- | --- | --- |

1.

(a)

air carriers of the European Union and air carriers licensed by Ukraine shall be permitted to exercise unlimited traffic rights between any point in the European Union and any point in Ukraine;

| (b) | subject to an assessment regarding the implementation by Ukraine of the relevant European Union requirements and standards and following the information of the Joint Committee, Ukraine shall be involved as observer in the work of the Committee established under the terms of Regulation (EEC) No 95/93 on common rules for the allocation of slots at Community airports; and |
| --- | --- |

(b)

subject to an assessment regarding the implementation by Ukraine of the relevant European Union requirements and standards and following the information of the Joint Committee, Ukraine shall be involved as observer in the work of the Committee established under the terms of Regulation (EEC) No 95/93 on common rules for the allocation of slots at Community airports; and

| (c) | Article 22(5), point (c), of this Agreement shall not apply. |
| --- | --- |

(c)

Article 22(5), point (c), of this Agreement shall not apply.

| 2. | The conditions for the transition towards the second transitional period shall involve for Ukraine the following:






  (a) | incorporation in the national legislation and implementation of the applicable requirements and standards of:






  — | Regulation (EC) 216/2008 (on common rules in the field of civil aviation and establishing a European Aviation Safety Agency); |
| --- | --- | --- | --- |

2.

(a)

incorporation in the national legislation and implementation of the applicable requirements and standards of:

—

Regulation (EC) 216/2008 (on common rules in the field of civil aviation and establishing a European Aviation Safety Agency);

| — | Regulation (EU) 748/2012 (implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations); |
| --- | --- |

—

Regulation (EU) 748/2012 (implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations);

| — | Regulation (EC) No 2042/2003 (on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks) as amended; |
| --- | --- |

—

Regulation (EC) No 2042/2003 (on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks) as amended;

| — | Regulation (EU) No 965/2012 (laying down technical requirements and administrative procedures related to air operations); |
| --- | --- |

—

Regulation (EU) No 965/2012 (laying down technical requirements and administrative procedures related to air operations);

| — | Regulation (EU) No 1178/2011 (laying down technical requirements and administrative procedures related to civil aviation aircrew); |
| --- | --- |

—

Regulation (EU) No 1178/2011 (laying down technical requirements and administrative procedures related to civil aviation aircrew);

| — | Regulation (EU) No 996/2010 (on investigation and prevention of accidents and incidents); |
| --- | --- |

—

Regulation (EU) No 996/2010 (on investigation and prevention of accidents and incidents);

| — | Directive 2009/12/EC (on airport charges); |
| --- | --- |

—

Directive 2009/12/EC (on airport charges);

| — | Directive 96/67/EC (on access to the groundhandling market at Community airports); |
| --- | --- |

—

Directive 96/67/EC (on access to the groundhandling market at Community airports);

| — | Regulation (EEC) No 95/93 (on common rules for the allocation of slots); |
| --- | --- |

—

Regulation (EEC) No 95/93 (on common rules for the allocation of slots);

| — | Directive 2000/79/EC (concerning the European Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation); |
| --- | --- |

—

Directive 2000/79/EC (concerning the European Agreement on the Organisation of Working Time of Mobile Workers in Civil Aviation);

| — | Chapter IV of Regulation (EC) No 1008/2008 (on operation of air services); |
| --- | --- |

—

Chapter IV of Regulation (EC) No 1008/2008 (on operation of air services);

| — | Regulation (EC) No 785/2004 (on insurance requirements for air carriers and aircraft operators); |
| --- | --- |

—

Regulation (EC) No 785/2004 (on insurance requirements for air carriers and aircraft operators);

| — | Regulation (EEC) No 80/2009 (on computer reservation systems); |
| --- | --- |

—

Regulation (EEC) No 80/2009 (on computer reservation systems);

| — | Regulation (EC) No 2027/97 (on air carrier liability in the event of accidents); |
| --- | --- |

—

Regulation (EC) No 2027/97 (on air carrier liability in the event of accidents);

| — | Regulation (EC) 261/2004 (common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights); |
| --- | --- |

—

Regulation (EC) 261/2004 (common rules on compensation and assistance to passengers in the event of denied boarding and of cancellation or long delay of flights);

| — | Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation); |
| --- | --- |

—

Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation);

| — | Regulation (EC) No 550/2004 of the European Parliament and of the Council of 10 March 2004 on the provision of air navigation services in the single European sky (the service provision Regulation); |
| --- | --- |

—

Regulation (EC) No 550/2004 of the European Parliament and of the Council of 10 March 2004 on the provision of air navigation services in the single European sky (the service provision Regulation);

| — | Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the single European sky (the airspace Regulation); |
| --- | --- |

—

Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the single European sky (the airspace Regulation);

| — | Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network (the interoperability Regulation); |
| --- | --- |

—

Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network (the interoperability Regulation);

| — | Regulation (EU) No 691/2010 of the European Commission of 29 July 2010 laying down a performance scheme for air navigation services and network functions and amending Regulation (EC) No 2096/2005 laying down common requirements for the provision of air navigation services; |
| --- | --- |

—

Regulation (EU) No 691/2010 of the European Commission of 29 July 2010 laying down a performance scheme for air navigation services and network functions and amending Regulation (EC) No 2096/2005 laying down common requirements for the provision of air navigation services;

| — | Regulation (EC) No 1794/2006 of the European Commission of 6 December 2006 laying down a common charging scheme for air navigation services; |
| --- | --- |

—

Regulation (EC) No 1794/2006 of the European Commission of 6 December 2006 laying down a common charging scheme for air navigation services;

| — | Regulation (EU) No 1034/2011 of the European Commission of 17 October 2011 on safety oversight in air traffic management and air navigation services and amending Regulation (EU) No 691/2010; |
| --- | --- |

—

Regulation (EU) No 1034/2011 of the European Commission of 17 October 2011 on safety oversight in air traffic management and air navigation services and amending Regulation (EU) No 691/2010;

| — | Regulation (EC) No 2150/2005 of the European Commission of 23 December 2005 laying down common rules for the flexible use of airspace; and |
| --- | --- |

—

Regulation (EC) No 2150/2005 of the European Commission of 23 December 2005 laying down common rules for the flexible use of airspace; and

| — | Regulation (EU) No 255/2010 of the European Commission of 25 March 2010 laying down common rules on air traffic flow management, |
| --- | --- |

—

Regulation (EU) No 255/2010 of the European Commission of 25 March 2010 laying down common rules on air traffic flow management,

as these are stipulated, including their amendments in Annex I to this Agreement;

| (b) | application of operating licensing rules substantially equivalent to those contained in Chapter II of Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the European Union; and |
| --- | --- |

(b)

application of operating licensing rules substantially equivalent to those contained in Chapter II of Regulation (EC) No 1008/2008 of the European Parliament and of the Council of 24 September 2008 on common rules for the operation of air services in the European Union; and

| (c) | as regards aviation security, implementation of ECAC Document 30, Part II, in its latest applicable amendment. |
| --- | --- |

(c)

as regards aviation security, implementation of ECAC Document 30, Part II, in its latest applicable amendment.

SECTION 3

Specifications applicable during the second transitional period

| 1. | Following the decision of the Joint Committee, as provided for Article 33 of this Agreement, confirming that Ukraine fulfils all the conditions stipulated under Section 2(2) of this Annex:






  (a) | the relevant certificates issued by Ukraine, as listed in Annex IV, Section 1, to this Agreement, shall be recognised by the EU Member States in accordance with the conditions stipulated in the decision of the Joint Committee and pursuant to Article 11 of Regulation (EC) 216/2008; |
| --- | --- | --- |

1.

(a)

the relevant certificates issued by Ukraine, as listed in Annex IV, Section 1, to this Agreement, shall be recognised by the EU Member States in accordance with the conditions stipulated in the decision of the Joint Committee and pursuant to Article 11 of Regulation (EC) 216/2008;

| (b) | point (c) of Article 22(5) of this Agreement shall apply; and |
| --- | --- |

(b)

point (c) of Article 22(5) of this Agreement shall apply; and

| (c) | subject to an assessment regarding the implementation by Ukraine of the relevant European Union requirements and standards and following the information of the Joint Committee, Ukraine shall be involved as observer in the work of the Committee established under the terms of Regulation (EC) No 2111/2005 on the establishment of a Community list of carriers subject to an operating ban within the Community. |
| --- | --- |

(c)

subject to an assessment regarding the implementation by Ukraine of the relevant European Union requirements and standards and following the information of the Joint Committee, Ukraine shall be involved as observer in the work of the Committee established under the terms of Regulation (EC) No 2111/2005 on the establishment of a Community list of carriers subject to an operating ban within the Community.

| 2. | The conditions for the transition towards the full implementation of this Agreement shall involve for Ukraine the following:






  (a) | incorporation in the national legislation and implementation of all applicable requirements and standards of the European Union acts set out in Annex I to this Agreement; and |
| --- | --- | --- |

2.

(a)

incorporation in the national legislation and implementation of all applicable requirements and standards of the European Union acts set out in Annex I to this Agreement; and

| (b) | the airspace under its responsibility shall be organised in line with the EU requirements applicable for the establishment of FABs. |
| --- | --- |

(b)

the airspace under its responsibility shall be organised in line with the EU requirements applicable for the establishment of FABs.

SECTION 4

Full implementation of this agreement

Following the decision of the Joint Committee, as provided for in Article 33 of this Agreement, confirming that Ukraine fulfils all conditions stipulated under Section 3(2) of this Annex, the following shall apply:

| 1. | In addition to the traffic rights set out in Section 2(1) of this Annex:






  (a) | air carriers of the European Union shall be permitted to exercise unlimited traffic rights between points in Ukraine, intermediate points in the European Neighbourhood Policy and ECAA countries, as well as points in countries listed in Annex V to this Agreement and points beyond, provided that the flight is a part of a service that serves a point in a Member State.
  Air carriers of the European Union shall also be permitted to exercise unlimited traffic rights between points in Ukraine, whether or not such air services originate or terminate within the EU; and |
| --- | --- | --- |

1.

In addition to the traffic rights set out in Section 2(1) of this Annex:

(a)

air carriers of the European Union shall be permitted to exercise unlimited traffic rights between points in Ukraine, intermediate points in the European Neighbourhood Policy and ECAA countries, as well as points in countries listed in Annex V to this Agreement and points beyond, provided that the flight is a part of a service that serves a point in a Member State.

Air carriers of the European Union shall also be permitted to exercise unlimited traffic rights between points in Ukraine, whether or not such air services originate or terminate within the EU; and

| (b) | air carriers of Ukraine shall be permitted to exercise unlimited traffic rights between any point in the European Union, intermediate points in the European Neighbourhood Policy and ECAA countries, as well as in countries listed in Annex V to this Agreement, provided that the flight is a part of a service that serves a point in Ukraine. |
| --- | --- |

(b)

air carriers of Ukraine shall be permitted to exercise unlimited traffic rights between any point in the European Union, intermediate points in the European Neighbourhood Policy and ECAA countries, as well as in countries listed in Annex V to this Agreement, provided that the flight is a part of a service that serves a point in Ukraine.

| 2. | All the relevant certificates comprised in Annex IV, Section 2, to this Agreement issued by Ukraine shall be recognised by the EU Member States in accordance with the conditions foreseen by these provisions. |
| --- | --- |

2.

All the relevant certificates comprised in Annex IV, Section 2, to this Agreement issued by Ukraine shall be recognised by the EU Member States in accordance with the conditions foreseen by these provisions.

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ANNEX IV

LIST OF CERTIFICATES REFERRED TO IN ANNEX III TO THIS AGREEMENT

1.   Air crew

Pilots' licences (issuing, maintaining, amending, limiting, suspending or revoking licences) (Regulations (EC) No 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Certification of persons responsible for providing flight training or flight simulation training and for assessing pilots' skills (Regulations (EC) No 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Cabin crew attestations (issuing, maintaining, amending, limiting, suspending or revoking cabin crew attestations) (Regulations (EC) 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Medical certificates for pilots (issuing, maintaining, amending, limiting, suspending or revoking) (Regulations (EC) No 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Certification of aero-medical examiners, as well as the conditions under which general medical practitioners may act as aero-medical examiners (Regulations (EC) 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Periodical aero-medical assessment of cabin crew members - the qualification of persons responsible for this assessment (Regulations (EC) 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Conditions for issuing, maintaining, amending, limiting, suspending or revoking certificates of pilot training organisations (Regulations (EC) 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Conditions for issuing, maintaining, amending, limiting, suspending or revoking certificates of aero-medical centres involved in the qualification and aero-medical assessment of civil aviation aircrew (Regulations (EC) 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

Certification of flight simulation training devices and the requirements for organisations operating and using those devices (Regulations (EC) 216/2008, (EU) No 1178/2011, (EU) No 290/2012 amending (EU) No 1178/2011).

2.   Air traffic management and air navigation services

Certificates of air traffic services providers (Regulations (EC) 216/2008, (EU) No 1034/2011, (EU) No 1035/2011 Annex II Specific requirements for the provision of air traffic services).

Certificates of meteorological services providers (Regulations (EC) 216/2008, (EU) No 1034/2011, (EU) No 1035/2011 Annex III Specific requirements for the provision of meteorological services).

Certificates of aeronautical information services providers (Regulations (EC) 216/2008, (EU) No 1034/2011, (EU) No 1035/2011 Annex IV Specific requirements for the provision of aeronautical information services).

Certificates of communication, navigation or surveillance services providers (Regulations (EC) 216/2008, (EU) No 1034/2011, (EU) No 1035/2011 Annex V Specific requirements for the provision of communication, navigation or surveillance service).

Licences of air traffic controllers (ATCO) and student air traffic controllers (issue, suspension and revocation) and associated ratings, endorsements (Regulations (EC) 216/2008, (EU) No 805/2011).

Medical certificates of air traffic controllers (Regulations (EC) 216/2008, (EU) No 805/2011).

Certificates of training organisations for air traffic controllers (ATCO) (validity, renewal, revalidation and use) (Regulations (EU) No 216/2008, (EU) No 805/2011).

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ANNEX V

LIST OF OTHER STATES REFERRED TO IN ARTICLES 17, 19 AND 22 OF THIS AGREEMENT AND ANNEXES II AND III TO THIS AGREEMENT

| 1. | The Republic of Iceland (under the Agreement on the European Economic Area); |
| --- | --- |

1.

The Republic of Iceland (under the Agreement on the European Economic Area);

| 2. | The Principality of Liechtenstein (under the Agreement on the European Economic Area); |
| --- | --- |

2.

The Principality of Liechtenstein (under the Agreement on the European Economic Area);

| 3. | The Kingdom of Norway (under the Agreement on the European Economic Area); and |
| --- | --- |

3.

The Kingdom of Norway (under the Agreement on the European Economic Area); and

| 4. | The Swiss Confederation (under the Agreement between the European Community and the Swiss Confederation on Air Transport). |
| --- | --- |

4.

The Swiss Confederation (under the Agreement between the European Community and the Swiss Confederation on Air Transport).

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ANNEX VI

PROCEDURAL RULES

This Agreement shall be applicable in accordance with the procedural rules set out here under:

1.   INVOLVEMENT OF UKRAINE IN COMMITTEES

When according to this Agreement Ukraine is involved in a Committee established by the relevant European Union acts, it shall acquire an observer status and shall be exposed to all relevant discussions and be encouraged to engage in debate, in accordance with its rules of procedure, while it shall be excluded from sessions involving voting.

As regards the field of Air Traffic Management, in order to implement the relevant Single European Sky legislation, Ukraine shall also be involved in all bodies established by the European Commission, such as the Industry Consultation Body (ICB) and the Network Manager (NM).

2.   ACQUIREMENT OF OBSERVER STATUS IN THE EASA

The observer status in the EASA entitles Ukraine to participate in technical groups and bodies of the EASA open for the EU Member States and other Partner countries in the European neighbourhood, subject to the established conditions for such participation. Observer status shall not cover the right to vote. This status shall not be acquired as regards the EASA Management Board.

3.   COOPERATION AND EXCHANGE OF INFORMATION

To facilitate the exercise of the relevant powers of the competent authorities of the Parties, such authorities shall upon request mutually exchange all information necessary for the proper functioning of this Agreement.

4.   REFERENCE TO LANGUAGES

The Parties shall be entitled to use, in the procedures established in the ambit of this Agreement, any official language of the institutions of the European Union or the Ukrainian language. The Parties are aware, however, that the utilisation of English facilitates those procedures. If a language which is not an official language of the institutions of the European Union is used in an official document, a translation into an official language of the institutions of the European Union shall be simultaneously submitted, taking into account the provision of the preceding sentence. If a Party intends to use, in an oral procedure, a language that is not an official language of the institutions of the European Union, that Party shall ensure simultaneous interpretation into English.

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ANNEX VII

CRITERIA REFERRED TO IN ARTICLE 26(4) OF THIS AGREEMENT

1.

| (a) | aid having a social character, granted to individual consumers, provided that such aid is granted without discrimination related to the origin of the services concerned; and |
| --- | --- |

(a)

aid having a social character, granted to individual consumers, provided that such aid is granted without discrimination related to the origin of the services concerned; and

| (b) | aid to make good the damage caused by natural disasters or exceptional occurrences. |
| --- | --- |

(b)

aid to make good the damage caused by natural disasters or exceptional occurrences.

2.

| (a) | aid to promote the economic development of areas where the standard of living is abnormally low or where there is serious underemployment; |
| --- | --- |

(a)

aid to promote the economic development of areas where the standard of living is abnormally low or where there is serious underemployment;

| (b) | aid to facilitate the development of certain economic activities or of certain economic areas where such aid does not adversely affect commercial operations of air carriers to the interests of the Parties; and |
| --- | --- |

(b)

aid to facilitate the development of certain economic activities or of certain economic areas where such aid does not adversely affect commercial operations of air carriers to the interests of the Parties; and

| (c) | aid to achieve objectives, allowed under the EU horizontal block exemption regulations and horizontal and sectorial State aid rules granted in line with the conditions set out therein. |
| --- | --- |

(c)

aid to achieve objectives, allowed under the EU horizontal block exemption regulations and horizontal and sectorial State aid rules granted in line with the conditions set out therein.

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REGULATIONS

| 3.11.2021 | EN | Official Journal of the European Union | L 387/58 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/58

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COMMISSION DELEGATED REGULATION (EU) 2021/1898

of 20 July 2021

supplementing Regulation (EU) 2019/1700 of the European Parliament and of the Council by specifying the number and titles of the variables for the use of information and communication technologies statistics domain for reference year 2022

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2019/1700 of the European Parliament and of the Council of 10 October 2019 establishing a common framework for European statistics relating to persons and households, based on data at individual level collected from samples, amending Regulations (EC) No 808/2004, (EC) No 452/2008 and (EC) No 1338/2008 of the European Parliament and of the Council, and repealing Regulation (EC) No 1177/2003 of the European Parliament and of the Council and Council Regulation (EC) No 577/98 (1), and in particular Article 6(1) thereof,

Whereas:

| (1) | In order to cover the needs in statistics for the relevant detailed topics set out in Annex I to Regulation (EU) 2019/1700, the Commission should specify the number and titles of the variables for the dataset in the use of information and communication technologies domain for reference year 2022. |
| --- | --- |

(1)

In order to cover the needs in statistics for the relevant detailed topics set out in Annex I to Regulation (EU) 2019/1700, the Commission should specify the number and titles of the variables for the dataset in the use of information and communication technologies domain for reference year 2022.

| (2) | The number of variables to be collected pursuant to this Regulation is not to exceed by more than 5 % the number of variables collected for the use of information and communication technologies domain at the time when Regulation (EU) 2019/1700 entered into force, |
| --- | --- |

(2)

The number of variables to be collected pursuant to this Regulation is not to exceed by more than 5 % the number of variables collected for the use of information and communication technologies domain at the time when Regulation (EU) 2019/1700 entered into force,

HAS ADOPTED THIS REGULATION:

Article 1

The number and titles of the variables for the use of information and communication technologies domain for reference year 2022 shall be as set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 July 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 261 I, 14.10.2019, p. 1.

1

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ANNEX

Number and titles of the variables for the use of information and communication technologies domain for reference year 2022

| Topic | Detailed topic | Variable identifier | Variable title/variable description |
| --- | --- | --- | --- |
| 01.Technical Items – 15 mandatory technical variables,


  – 2 optional technical variables | Data collection information | REFYEAR | Year of survey |
| Data collection information | INTDATE | Reference date – first interview date |
| Data collection information | STRATUM_ID | Stratum |
| Data collection information | PSU | Primary sampling unit |
| Identification | HH_ID | Household ID |
| Identification | IND_ID | Individual ID |
| Identification | HH_REF_ID | ID of the household the individual belongs to |
| Weights | HH_WGHT | Household weight |
| Weights | IND_WGHT | Individual weight |
| Interview characteristics | TIME | Interview duration |
| Interview characteristics | INT_TYPE | Interview type |
| Localisation | COUNTRY | Country of residence |
| Localisation | GEO_NUTS1 | Region of residence |
| Localisation | GEO_NUTS2
  (optional) | Region of residence (optional) |
| Localisation | GEO_NUTS3
  (optional) | Region of residence
  (optional) |
| Localisation | DEG_URBA | Degree of urbanisation |
| Localisation | GEO_DEV | Geographical location |
| 02.Person and household characteristics


  – 7 collected variables,


  – 1 derived variable, – 7 optional variables | Demography | SEX | Sex |
| Demography | YEARBIR | Year of birth |
| Demography | PASSBIR | Passing of birthday |
| Demography | AGE | Age in completed years |
| Citizenship and migrant background | CITIZENSHIP | Country of main citizenship |
| Citizenship and migrant background | CNTRYB | Country of birth |
| Household composition | HH_POP | Household size (number of members in the household) |
| Household composition | HH_POP_16_24 (optional) | Number of members of the household aged from 16 to 24 (optional) |
| Household composition | HH_POP_16_24S (optional) | Number of students of the household aged 16 to 24
  (optional) |
| Household composition | HH_POP_25_64 (optional) | Number of members of the household aged from 25 to 64 (optional) |
| Household composition | HH_POP_65_MAX (optional) | Number of members of the household aged more than or equal to 65 (optional) |
| Household composition | HH_CHILD | Number of children under 16 |
| Household composition | HH_CHILD_14_15
  (optional) | Number of children aged from 14 to 15
  (optional) |
| Household composition | HH_CHILD_5_13
  (optional) | Number of children aged from 5 to 13 (optional) |
| Household composition | HH_CHILD_LE_4
  (optional) | Number of children aged less than or equal to 4 (optional) |
| 03.Labour market participation


  – 5 collected variables,


  – 3 optional variables | Main activity status (self-defined) | MAINSTAT | Main activity status (self-defined) |
| Elementary job characteristics | STAPRO | Status in employment in main job |
| Elementary job characteristics | NACE1D
  (optional) | Economic activity of the local unit for main job
  (optional) |
| Elementary job characteristics | ISCO2D | Occupation in main job |
| Elementary job characteristics | OCC_ICT | ICT professional or non-ICT professional |
| Elementary job characteristics | OCC_MAN | Manual worker or non-manual worker |
| Elementary job characteristics | EMPST_WKT
  (optional) | Full- or part-time main job (self-defined)
  (optional) |
| Duration of contract | EMPST_CONTR
  (optional) | Permanency of main job
  (optional) |
| 04.Educational attainment and background


  – 1 collected variable,


  – 1 derived variable | Educational attainment level | ISCEDD | Educational attainment level (highest level of education successfully completed) |
| Educational attainment level | ISCED | Educational attainment level aggregated |
| 5. Health: status and disability, access to, availability and use of health care and health determinants


  – 1 collected variable | Elements of the Minimum European Health Module | GALI | Limitation in activities because of health problems |
| 06. Income, consumption and elements of wealth, including debts


  – 1 collected variable | Total monthly household income | HH_IQ5 | Total average net current monthly income |
| 07. Information society participation


  – 119 collected variables


  – 3 derived variables


  – 14 optional variables | Access to ICT | IACC | Access of the household to the internet at home (by any device) |
| Use and frequency of use of ICT | IU | Most recent internet use, at any location, with any enabling device |
| Use and frequency of use of ICT | IFUS | Average frequency of internet use in the last 3 months |
| Internet activities | IUEM | Internet use in the last 3 months for private purpose for sending/receiving e-mails |
| Internet activities | IUPH1 | Internet use in the last 3 months for private purpose for making calls (including video calls) over the internet |
| Internet activities | IUSNET | Internet use in the last 3 months for private purpose for participating in social networks (creating user profile, posting messages or other contributions) |
| Internet activities | IUCHAT1 | Internet use in the last 3 months for private purpose for instant messaging (exchanging messages) |
| Internet activities | IUIF | Internet use in the last 3 months for private purpose for finding information about goods or services |
| Internet activities | IUNW1 | Internet use in the last 3 months for private purpose for reading online news sites, newspapers or news magazines |
| Internet activities | IUPOL2 | Internet use in the last 3 months for private purpose for expressing opinions on civic or political issues on websites or in social media |
| Internet activities | IUVOTE | Internet use in the last 3 months for private purpose for taking part in online consultations or voting to define civic or political issues (such as urban planning, signing a petition) |
| Internet activities | IUMUSS1 | Internet use in the last 3 months for private purpose for listening to music (such as web radio, music streaming) or downloading music |
| Internet activities | IUSTV | Internet use in the last 3 months for private purpose for watching internet streamed TV (live or catch-up) from TV broadcasters (such as [national examples]) |
| Internet activities | IUVOD | Internet use in the last 3 months for private purpose for watching Video on Demand from commercial services |
| Internet activities | IUVSS | Internet use in the last 3 months for private purpose for watching video content from sharing services |
| Internet activities | IUPDG | Internet use in the last 3 months for private purpose for playing or downloading games |
| Internet activities | IUPCAST
  (optional) | Internet use in the last 3 months for private purpose for listening to podcasts or downloading podcasts
  (optional) |
| Internet activities | IHIF | Internet use in the last 3 months for private purpose for seeking health-related information (such as about injuries, diseases, nutrition, improving health) |
| Internet activities | IUMAPP | Internet use in the last 3 months for private purpose for making an appointment with a practitioner via a website or app (such as of a hospital or a health care centre) |
| Internet activities | IUAPR | Internet use in the last 3 months for private purpose for accessing personal health records online |
| Internet activities | IUOHC | Internet use in the last 3 months for private purpose for using other health services via a website or app instead of having to go to the hospital or visit a doctor (such as by getting a prescription or a consultation online) |
| Internet activities | IUSELL | Internet use in the last 3 months for private purpose for selling goods or services via a website or app |
| Internet activities | IUBK | Internet use in the last 3 months for private purpose for internet banking (including mobile banking) |
| Internet activities | IUOLC | Internet use in the last 3 months for conducting learning activities for educational, professional or private purposes, by doing an online course |
| Internet activities | IUOLM | Internet use in the last 3 months for conducting learning activities for educational, professional or private purposes, by using online learning material other than a complete online course (such as video tutorials, webinars, electronic textbooks, learning apps or platforms) |
| Internet activities | IUOCIS1 | Internet use in the last 3 months for conducting learning activities for educational, professional or private purposes, by communicating with educators or learners using audio or video online tools |
| Internet activities | IUOFE | Learning activities the respondent participated in, in the last 3 months, for formal education (e.g. school or university) |
| Internet activities | IUOW | Learning activities the respondent participated in, in the last 3 months, for professional/work-related purposes |
| Internet activities | IUOPP | Learning activities the respondent participated in, in the last 3 months, for private purpose |
| Interaction with public authorities | IGOVIP | Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in accessing by the respondent information about himself/herself stored by public authorities or public services |
| Interaction with public authorities | IGOVIDB | Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in accessing by the respondent information from public databases or registers (such as information about availability of books in public libraries, cadastral registers, enterprise registers) |
| Interaction with public authorities | IGOV12IF | Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in obtaining by the respondent information (e.g. about services, benefits, entitlements, laws, opening hours) |
| Interaction with public authorities | IGOVIX | Respondent has not accessed any personal records or databases nor obtained any information via a website or app of public authorities or public services for private purpose in the last 12 months |
| Interaction with public authorities | IGOV12FM | Downloading/printing official forms by the respondent from a website or app of public authorities or public services for private purpose in the last 12 months |
| Interaction with public authorities | IGOVAPR | Making an appointment or reservation by the respondent via a website or app with public authorities or public services (such as reservation of a book in a public library, appointment with a government servant or a state healthcare provider) for private purpose in the last 12 months |
| Interaction with public authorities | IGOVPOST
  (Optional) | Receiving by the respondent any official communication or documents sent by public authorities via the respondent’s account on a website or app (name of the service, if applicable in the country) of public authorities or services (such as notifications of fines or invoices, letters; service of court summons, court documents, [national examples]) for private purpose in the last 12 months? Usage of email or SMS based information messages or notifications that a document is available should be excluded.(optional) |
| Interaction with public authorities | IGOVTAX1 | Submitting the respondent’s own tax declaration via a website or app for private purpose in the last 12 months |
| Interaction with public authorities | IGOVODC | Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in requesting by the respondent official documents or certificates (such as graduation, birth, marriage, divorce, death, residence certificates, police or criminal records, [national examples]) |
| Interaction with public authorities | IGOVBE | Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in requesting by the respondent benefits or entitlements (such as pension, unemployment, child allowance, enrolment in schools, universities, [national examples]) |
| Interaction with public authorities | IGOVRCC | Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in making by the respondent other requests, claims or complaints (such as reporting theft to the police, launching a legal complaint, requesting legal aid, initiating a civil claim procedure in front of a court, [national examples]) |
| Interaction with public authorities | IRGOVNN | Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – respondent did not have to request any documents or to make any claims |
| Interaction with public authorities | IRGOVLS | Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – lack of skills or knowledge (e.g. respondent did not know how to use the website or app or it was too complicated to use) |
| Interaction with public authorities | IRGOVSEC | Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – concerns about the security of personal data or unwillingness to pay online (credit card fraud) |
| Interaction with public authorities | IRGOVEID
  (Optional) | Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – lack of electronic signature, activated electronic identification (eID) or any other tool to use the eID (required for using the services) [national examples] (optional) |
| Interaction with public authorities | IRGOVOP | Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – another person did it on the respondent’s behalf (e.g. consultant, adviser, relative) |
| Interaction with public authorities | IRGOVOTH | Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – other reason |
| Interaction with public authorities | IGOVANYS | Respondent has interacted with public authorities |
| Interaction with public authorities | IIGOVDU | Issues when using a website or app of public authorities or public services in the last 12 months –
  website or app was difficult to use (e.g. it was not user-friendly, the wording was not clear, procedure was not well explained) |
| Interaction with public authorities | IIGOVTP | Issues when using a website or app of public authorities or public services in the last 12 months –
  technical problems experienced when using website or app (e.g. long loading, website crashed) |
| Interaction with public authorities | IIGOVEID
  (Optional) | Issues when using a website or app of public authorities or public services in the last 12 months –
  problems in using the electronic signature or electronic identification (eID) (optional) |
| Interaction with public authorities | IIGOVPAY
  (Optional) | Issues when using a website or app of public authorities or public services in the last 12 months – the respondent was not able to pay via the website or app (e.g. due to lack of access to the payment methods required) (optional) |
| Interaction with public authorities | IIGOVMOB | Issues when using a website or app of public authorities or public services in the last 12 months – the respondent was not able to access the service on smartphone or tablet (e.g. non compatible device version or non-available applications) |
| Interaction with public authorities | IIGOVOTH | Issues when using a website or app of public authorities or public services in the last 12 months –
  other issue |
| Interaction with public authorities | IIGOVX | The respondent has not encountered any issues when using a website or app of public authorities or public services in the last 12 months |
| e-Commerce | IBUY | Last purchase or order of goods or services over the internet for private use |
| e-Commerce | BCLOT1 | Internet use for buying clothes (including sport clothing), shoes or accessories (such as bags, jewellery) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BSPG | Internet use for buying sports goods (excluding sport clothing) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BCG | Internet use for buying children toys or childcare items (such as nappies, bottles, baby strollers) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BFURN1 | Internet use for buying furniture, home accessories (such as carpets or curtains) or gardening products (such as tools, plants) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BMUSG | Internet use for buying music as CDs, vinyls etc. from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BFLMG | Internet use for buying films or series as DVDs, Blu-ray etc. from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BBOOKNLG | Internet use for buying printed books, magazines or newspapers from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BHARD1 | Internet use for buying computers, tablets, mobile phones or accessories from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BEEQU1 | Internet use for buying consumer electronics (such as TV-sets, stereos, cameras, sound bars or smart speakers, virtual assistants) or household appliances (such as washing machines) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BMED1 | Internet use for buying medicine or dietary supplements such as vitamins (excluding online renewal of prescriptions) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BFDR | Internet use for buying deliveries from restaurants, fast-food chains, catering services from enterprises or private persons via a website or app for private use in the last 3 months |
| e-Commerce | BFDS | Internet use for buying food or beverages from stores or from meal-kits providers from enterprises or private persons via a website or app for private use in the last 3 months |
| e-Commerce | BCBW | Internet use for buying cosmetics, beauty or wellness products from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BCPH | Internet use for buying cleaning products or personal hygiene products (such as toothbrushes, handkerchiefs, washing detergents, cleaning cloths) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BBMC | Internet use for buying bicycles, mopeds, cars, or other vehicles or their spare parts from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BOPG | Internet use for buying other physical goods from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BPG_ANY | Internet use for buying any of the listed physical goods from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months |
| e-Commerce | BPG_DOM | Internet use for buying goods via a website or app in the last 3 months from national sellers (from enterprises or private persons) |
| e-Commerce | BPG_EU | Internet use for buying goods via a website or app in the last 3 months from sellers from other EU countries (from enterprises or private persons) |
| e-Commerce | BPG_WRLD | Internet use for buying goods via a website or app in the last 3 months from sellers from the rest of the world (from enterprises or private persons) |
| e-Commerce | BPG_UNK | Internet use for buying goods via a website or app in the last 3 months from sellers which country of origin is not known (from enterprises or private persons) |
| e-Commerce | BPG_PP | Goods bought from private persons via a website or app |
| e-Commerce | BMUSS | Internet use for buying or subscribing to music as a streaming service or downloads via a website or app for private use in the last 3 months |
| e-Commerce | BFLMS | Internet use for buying or subscribing to films or series as a streaming service or downloads via a website or app for private use in the last 3 months |
| e-Commerce | BBOOKNLS | Internet use for buying or subscribing to e-books, online-magazines or online-newspapers via a website or app for private use in the last 3 months |
| e-Commerce | BGAMES | Internet use for buying or subscribing to games online or as downloads for smartphones, tablets, computers or consoles via a website or app for private use in the last 3 months |
| e-Commerce | BSOFTS | Internet use for buying or subscribing to computer software or other software as downloads including upgrades via a website or app for private use in the last 3 months |
| e-Commerce | BHLFTS | Internet use for buying or subscribing to apps related to health or fitness (excluding free apps) via a website or app for private use in the last 3 months |
| e-Commerce | BAPP | Internet use for buying or subscribing to other apps (such as apps related to learning languages, travelling, weather) (excluding free apps) via a website or app for private use in the last 3 months |
| e-Commerce | BSTICK | Internet use for buying tickets to sports events via a website or app for private use in the last 3 months |
| e-Commerce | BCTICK | Internet use for buying tickets to cultural or other events (such as tickets to cinema, concerts, fairs) via a website or app for private use in the last 3 months |
| e-Commerce | BSIMC | Internet use for buying subscriptions to the internet or mobile phone connections via a website or app for private use in the last 3 months |
| e-Commerce | BSUTIL | Internet use for buying subscriptions to electricity, water or heating supply, waste disposal or similar services via a website or app for private use in the last 3 months |
| e-Commerce | BHHS | Internet use for buying household services (such as cleaning, babysitting, repair work, gardening) (also when bought from private persons) via a website or app for private use in the last 3 months |
| e-Commerce | BHHS_PP | Internet use for buying household services from private persons via a website or app for private use in the last 3 months |
| e-Commerce | BTPS_E | Internet use for buying transport services from a transport enterprise, such as local bus, flight or train ticket or taxi ride via a website or app for private use in the last 3 months |
| e-Commerce | BTPS_PP | Internet use for buying transport services from a private person via a website or app for private use in the last 3 months |
| e-Commerce | BRA_E | Internet use for renting accommodation from enterprises such as hotels or travel agencies via a website or app for private use in the last 3 months |
| e-Commerce | BRA_PP | Internet use for renting accommodation from a private person via a website or app for private use in the last 3 months |
| e-Commerce | BOTS (optional) | Internet use for buying any other services (excluding financial and insurance services) via a website or app for private use in the last 3 months
  (optional) |
| e-Commerce | BFIN_IN1 | Internet use for buying insurance policies, including travel insurance, also as a package together with for example a plane ticket, via a website or app for private purposes in the last 3 months |
| e-Commerce | BFIN_CR1 | Internet use for taking a loan or mortgage or arranging credit from banks or other financial providers via a website or app for private purposes in the last 3 months |
| e-Commerce | BFIN_SH1 | Internet use for buying or selling shares, bonds, units in funds or other financial assets via a website or app for private purposes in the last 3 months |
| Connection to the internet from anywhere | IOT_DEM | Use of internet-connected thermostat, utility meter, lights, plug-ins or other internet-connected solutions for energy management for the respondent’s home for private purposes |
| Connection to the internet from anywhere | IOT_DSEC | Use of internet-connected home alarm system, smoke detector, security cameras, door locks or other internet-connected security or safety solutions for the respondent’s home for private purposes |
| Connection to the internet from anywhere | IOT_DHA | Use of internet-connected home appliances such as robot vacuums, fridges, ovens, coffee machines for private purposes |
| Connection to the internet from anywhere | IOT_DVA | Use of a virtual assistant in the form of a smart speaker or of an app for private purposes |
| Connection to the internet from anywhere | IOT_DX | Respondent did not use any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes |
| Connection to the internet from anywhere | IOT_BDK | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – respondent did not know that such devices or systems exist |
| Connection to the internet from anywhere | IOT_BNN | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – respondent had no need to use those connected devices or systems |
| Connection to the internet from anywhere | IOT_BCST | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – costs too high |
| Connection to the internet from anywhere | IOT_BLC | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – lack of compatibility with other devices or systems |
| Connection to the internet from anywhere | IOT_BLSK | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – lack of skills to use those devices or systems |
| Connection to the internet from anywhere | IOT_BCPP | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – concerns about the privacy and protection of data about the respondent generated by those devices or systems |
| Connection to the internet from anywhere | IOT_BCSC | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – concerns about security (e.g. that the device or system will be hacked) |
| Connection to the internet from anywhere | IOT_BCSH | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – concerns about safety or health (e.g. that the use of the device or system could lead to an accident, injury or health problem) |
| Connection to the internet from anywhere | IOT_BOTH | Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – other reasons |
| Connection to the internet from anywhere | IOT_IUTV | Internet use on an internet-connected TV in the respondent’s home for private purposes |
| Connection to the internet from anywhere | IOT_IUGC | Internet use on an internet-connected game console in the respondent’s home for private purposes |
| Connection to the internet from anywhere | IOT_IUHA | Internet use on an internet-connected home audio system or smart speakers in the respondent’s home for private purposes |
| Connection to the internet from anywhere | IOT_DCS | Use of an internet-connected smart watch, fitness band, internet-connected goggles or headsets, safety- trackers, internet-connected accessories, internet-connected clothes or shoes for private purposes |
| Connection to the internet from anywhere | IOT_DHE | Use of internet-connected devices for monitoring blood pressure, sugar level, body weight (such as smart scales) or other internet-connected devices for health and medical care for private purposes |
| Connection to the internet from anywhere | IOT_DTOY | Use of toys connected to the internet, such as robot toys (including educational) or dolls for private purposes |
| Connection to the internet from anywhere | IOT_DCAR | Use of a car with built-in wireless internet connection for private purposes |
| Connection to the internet from anywhere | IOT_USE | Respondent used internet of things |
| Connection to the internet from anywhere | IOT_PSEC | Problems encountered with the mentioned internet-connected devices or systems – security or privacy problems (e.g. the device or system was hacked, problems with the protection of information about the respondent and his/her family generated by those devices or systems) |
| Connection to the internet from anywhere | IOT_PSHE | Problems encountered with the mentioned internet-connected devices or systems – safety or health problems (e.g. the use of the device or system lead to an accident, injury or health problem) |
| Connection to the internet from anywhere | IOT_PDU | Problems encountered with the mentioned internet-connected devices or systems – difficulties with using the device (e.g. setting-up, installing, connecting, pairing the device) |
| Connection to the internet from anywhere | IOT_POTH | Problems encountered with the mentioned internet-connected devices or systems – other problems (such as connection problems, support problems) |
| Connection to the internet from anywhere | IOT_PX | Respondent has not encountered any problem with the mentioned internet-connected devices or systems |
| Effect of use | ECO_DMOB | Way in which the respondent dealt with his/her mobile phone or smartphone that he/she replaced or no longer use |
| Effect of use | ECO_DLT | Way in which the respondent dealt with his/her laptop or tablet that he/she replaced or no longer use |
| Effect of use | ECO_DPC | Way in which the respondent dealt with his/her desktop computer that he/she replaced or no longer use |
| Effect of use | ECO_PP
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – price
  (Optional) |
| Effect of use | ECO_PHD
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – hard drive characteristics (storage, speed), processor speed
  (Optional) |
| Effect of use | ECO_PECD
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – eco-design of the device e.g. durable, upgradeable and reparable designs that require fewer materials; environmentally friendly materials used for packaging, etc.
  (Optional) |
| Effect of use | ECO_PEG
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – possibility to extend the life span of the device by buying extra guarantee
  (Optional) |
| Effect of use | ECO_PEE
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – energy efficiency of the device
  (Optional) |
| Effect of use | ECO_PTBS
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – a take-back scheme offered by manufacturer or seller (i.e. the manufacturer or seller takes the device which becomes obsolete at no cost or offers discounts to the client to purchase another device)
  (Optional) |
| Effect of use | ECO_PX
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – the respondent has not considered any of the mentioned characteristics
  (Optional) |
| Effect of use | ECO_PBX
  (Optional) | Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – the respondent never bought any of these devices
  (Optional) |

Topic

Detailed topic

Variable identifier

Variable title/variable description

01.Technical Items – 15 mandatory technical variables,

– 2 optional technical variables

Data collection information

REFYEAR

Year of survey

Data collection information

INTDATE

Reference date – first interview date

Data collection information

STRATUM_ID

Stratum

Data collection information

PSU

Primary sampling unit

Identification

HH_ID

Household ID

Identification

IND_ID

Individual ID

Identification

HH_REF_ID

ID of the household the individual belongs to

Weights

HH_WGHT

Household weight

Weights

IND_WGHT

Individual weight

Interview characteristics

TIME

Interview duration

Interview characteristics

INT_TYPE

Interview type

Localisation

COUNTRY

Country of residence

Localisation

GEO_NUTS1

Region of residence

Localisation

GEO_NUTS2

(optional)

Region of residence (optional)

Localisation

GEO_NUTS3

(optional)

Region of residence

(optional)

Localisation

DEG_URBA

Degree of urbanisation

Localisation

GEO_DEV

Geographical location

02.Person and household characteristics

– 7 collected variables,

– 1 derived variable, – 7 optional variables

Demography

SEX

Sex

Demography

YEARBIR

Year of birth

Demography

PASSBIR

Passing of birthday

Demography

AGE

Age in completed years

Citizenship and migrant background

CITIZENSHIP

Country of main citizenship

Citizenship and migrant background

CNTRYB

Country of birth

Household composition

HH_POP

Household size (number of members in the household)

Household composition

HH_POP_16_24 (optional)

Number of members of the household aged from 16 to 24 (optional)

Household composition

HH_POP_16_24S (optional)

Number of students of the household aged 16 to 24

(optional)

Household composition

HH_POP_25_64 (optional)

Number of members of the household aged from 25 to 64 (optional)

Household composition

HH_POP_65_MAX (optional)

Number of members of the household aged more than or equal to 65 (optional)

Household composition

HH_CHILD

Number of children under 16

Household composition

HH_CHILD_14_15

(optional)

Number of children aged from 14 to 15

(optional)

Household composition

HH_CHILD_5_13

(optional)

Number of children aged from 5 to 13 (optional)

Household composition

HH_CHILD_LE_4

(optional)

Number of children aged less than or equal to 4 (optional)

03.Labour market participation

– 5 collected variables,

– 3 optional variables

Main activity status (self-defined)

MAINSTAT

Main activity status (self-defined)

Elementary job characteristics

STAPRO

Status in employment in main job

Elementary job characteristics

NACE1D

(optional)

Economic activity of the local unit for main job

(optional)

Elementary job characteristics

ISCO2D

Occupation in main job

Elementary job characteristics

OCC_ICT

ICT professional or non-ICT professional

Elementary job characteristics

OCC_MAN

Manual worker or non-manual worker

Elementary job characteristics

EMPST_WKT

(optional)

Full- or part-time main job (self-defined)

(optional)

Duration of contract

EMPST_CONTR

(optional)

Permanency of main job

(optional)

04.Educational attainment and background

– 1 collected variable,

– 1 derived variable

Educational attainment level

ISCEDD

Educational attainment level (highest level of education successfully completed)

Educational attainment level

ISCED

Educational attainment level aggregated

5. Health: status and disability, access to, availability and use of health care and health determinants

– 1 collected variable

Elements of the Minimum European Health Module

GALI

Limitation in activities because of health problems

06. Income, consumption and elements of wealth, including debts

– 1 collected variable

Total monthly household income

HH_IQ5

Total average net current monthly income

07. Information society participation

– 119 collected variables

– 3 derived variables

– 14 optional variables

Access to ICT

IACC

Access of the household to the internet at home (by any device)

Use and frequency of use of ICT

IU

Most recent internet use, at any location, with any enabling device

Use and frequency of use of ICT

IFUS

Average frequency of internet use in the last 3 months

Internet activities

IUEM

Internet use in the last 3 months for private purpose for sending/receiving e-mails

Internet activities

IUPH1

Internet use in the last 3 months for private purpose for making calls (including video calls) over the internet

Internet activities

IUSNET

Internet use in the last 3 months for private purpose for participating in social networks (creating user profile, posting messages or other contributions)

Internet activities

IUCHAT1

Internet use in the last 3 months for private purpose for instant messaging (exchanging messages)

Internet activities

IUIF

Internet use in the last 3 months for private purpose for finding information about goods or services

Internet activities

IUNW1

Internet use in the last 3 months for private purpose for reading online news sites, newspapers or news magazines

Internet activities

IUPOL2

Internet use in the last 3 months for private purpose for expressing opinions on civic or political issues on websites or in social media

Internet activities

IUVOTE

Internet use in the last 3 months for private purpose for taking part in online consultations or voting to define civic or political issues (such as urban planning, signing a petition)

Internet activities

IUMUSS1

Internet use in the last 3 months for private purpose for listening to music (such as web radio, music streaming) or downloading music

Internet activities

IUSTV

Internet use in the last 3 months for private purpose for watching internet streamed TV (live or catch-up) from TV broadcasters (such as [national examples])

Internet activities

IUVOD

Internet use in the last 3 months for private purpose for watching Video on Demand from commercial services

Internet activities

IUVSS

Internet use in the last 3 months for private purpose for watching video content from sharing services

Internet activities

IUPDG

Internet use in the last 3 months for private purpose for playing or downloading games

Internet activities

IUPCAST

(optional)

Internet use in the last 3 months for private purpose for listening to podcasts or downloading podcasts

(optional)

Internet activities

IHIF

Internet use in the last 3 months for private purpose for seeking health-related information (such as about injuries, diseases, nutrition, improving health)

Internet activities

IUMAPP

Internet use in the last 3 months for private purpose for making an appointment with a practitioner via a website or app (such as of a hospital or a health care centre)

Internet activities

IUAPR

Internet use in the last 3 months for private purpose for accessing personal health records online

Internet activities

IUOHC

Internet use in the last 3 months for private purpose for using other health services via a website or app instead of having to go to the hospital or visit a doctor (such as by getting a prescription or a consultation online)

Internet activities

IUSELL

Internet use in the last 3 months for private purpose for selling goods or services via a website or app

Internet activities

IUBK

Internet use in the last 3 months for private purpose for internet banking (including mobile banking)

Internet activities

IUOLC

Internet use in the last 3 months for conducting learning activities for educational, professional or private purposes, by doing an online course

Internet activities

IUOLM

Internet use in the last 3 months for conducting learning activities for educational, professional or private purposes, by using online learning material other than a complete online course (such as video tutorials, webinars, electronic textbooks, learning apps or platforms)

Internet activities

IUOCIS1

Internet use in the last 3 months for conducting learning activities for educational, professional or private purposes, by communicating with educators or learners using audio or video online tools

Internet activities

IUOFE

Learning activities the respondent participated in, in the last 3 months, for formal education (e.g. school or university)

Internet activities

IUOW

Learning activities the respondent participated in, in the last 3 months, for professional/work-related purposes

Internet activities

IUOPP

Learning activities the respondent participated in, in the last 3 months, for private purpose

Interaction with public authorities

IGOVIP

Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in accessing by the respondent information about himself/herself stored by public authorities or public services

Interaction with public authorities

IGOVIDB

Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in accessing by the respondent information from public databases or registers (such as information about availability of books in public libraries, cadastral registers, enterprise registers)

Interaction with public authorities

IGOV12IF

Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in obtaining by the respondent information (e.g. about services, benefits, entitlements, laws, opening hours)

Interaction with public authorities

IGOVIX

Respondent has not accessed any personal records or databases nor obtained any information via a website or app of public authorities or public services for private purpose in the last 12 months

Interaction with public authorities

IGOV12FM

Downloading/printing official forms by the respondent from a website or app of public authorities or public services for private purpose in the last 12 months

Interaction with public authorities

IGOVAPR

Making an appointment or reservation by the respondent via a website or app with public authorities or public services (such as reservation of a book in a public library, appointment with a government servant or a state healthcare provider) for private purpose in the last 12 months

Interaction with public authorities

IGOVPOST

(Optional)

Receiving by the respondent any official communication or documents sent by public authorities via the respondent’s account on a website or app (name of the service, if applicable in the country) of public authorities or services (such as notifications of fines or invoices, letters; service of court summons, court documents, [national examples]) for private purpose in the last 12 months? Usage of email or SMS based information messages or notifications that a document is available should be excluded.(optional)

Interaction with public authorities

IGOVTAX1

Submitting the respondent’s own tax declaration via a website or app for private purpose in the last 12 months

Interaction with public authorities

IGOVODC

Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in requesting by the respondent official documents or certificates (such as graduation, birth, marriage, divorce, death, residence certificates, police or criminal records, [national examples])

Interaction with public authorities

IGOVBE

Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in requesting by the respondent benefits or entitlements (such as pension, unemployment, child allowance, enrolment in schools, universities, [national examples])

Interaction with public authorities

IGOVRCC

Activities via a website or app of public authorities or public services for private purpose in the last 12 months consisting in making by the respondent other requests, claims or complaints (such as reporting theft to the police, launching a legal complaint, requesting legal aid, initiating a civil claim procedure in front of a court, [national examples])

Interaction with public authorities

IRGOVNN

Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – respondent did not have to request any documents or to make any claims

Interaction with public authorities

IRGOVLS

Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – lack of skills or knowledge (e.g. respondent did not know how to use the website or app or it was too complicated to use)

Interaction with public authorities

IRGOVSEC

Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – concerns about the security of personal data or unwillingness to pay online (credit card fraud)

Interaction with public authorities

IRGOVEID

(Optional)

Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – lack of electronic signature, activated electronic identification (eID) or any other tool to use the eID (required for using the services) [national examples] (optional)

Interaction with public authorities

IRGOVOP

Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – another person did it on the respondent’s behalf (e.g. consultant, adviser, relative)

Interaction with public authorities

IRGOVOTH

Reasons for not requesting any official documents or not making any claims via a website or app of public authorities or public services in the last 12 months – other reason

Interaction with public authorities

IGOVANYS

Respondent has interacted with public authorities

Interaction with public authorities

IIGOVDU

Issues when using a website or app of public authorities or public services in the last 12 months –

website or app was difficult to use (e.g. it was not user-friendly, the wording was not clear, procedure was not well explained)

Interaction with public authorities

IIGOVTP

Issues when using a website or app of public authorities or public services in the last 12 months –

technical problems experienced when using website or app (e.g. long loading, website crashed)

Interaction with public authorities

IIGOVEID

(Optional)

Issues when using a website or app of public authorities or public services in the last 12 months –

problems in using the electronic signature or electronic identification (eID) (optional)

Interaction with public authorities

IIGOVPAY

(Optional)

Issues when using a website or app of public authorities or public services in the last 12 months – the respondent was not able to pay via the website or app (e.g. due to lack of access to the payment methods required) (optional)

Interaction with public authorities

IIGOVMOB

Issues when using a website or app of public authorities or public services in the last 12 months – the respondent was not able to access the service on smartphone or tablet (e.g. non compatible device version or non-available applications)

Interaction with public authorities

IIGOVOTH

Issues when using a website or app of public authorities or public services in the last 12 months –

other issue

Interaction with public authorities

IIGOVX

The respondent has not encountered any issues when using a website or app of public authorities or public services in the last 12 months

e-Commerce

IBUY

Last purchase or order of goods or services over the internet for private use

e-Commerce

BCLOT1

Internet use for buying clothes (including sport clothing), shoes or accessories (such as bags, jewellery) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BSPG

Internet use for buying sports goods (excluding sport clothing) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BCG

Internet use for buying children toys or childcare items (such as nappies, bottles, baby strollers) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BFURN1

Internet use for buying furniture, home accessories (such as carpets or curtains) or gardening products (such as tools, plants) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BMUSG

Internet use for buying music as CDs, vinyls etc. from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BFLMG

Internet use for buying films or series as DVDs, Blu-ray etc. from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BBOOKNLG

Internet use for buying printed books, magazines or newspapers from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BHARD1

Internet use for buying computers, tablets, mobile phones or accessories from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BEEQU1

Internet use for buying consumer electronics (such as TV-sets, stereos, cameras, sound bars or smart speakers, virtual assistants) or household appliances (such as washing machines) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BMED1

Internet use for buying medicine or dietary supplements such as vitamins (excluding online renewal of prescriptions) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BFDR

Internet use for buying deliveries from restaurants, fast-food chains, catering services from enterprises or private persons via a website or app for private use in the last 3 months

e-Commerce

BFDS

Internet use for buying food or beverages from stores or from meal-kits providers from enterprises or private persons via a website or app for private use in the last 3 months

e-Commerce

BCBW

Internet use for buying cosmetics, beauty or wellness products from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BCPH

Internet use for buying cleaning products or personal hygiene products (such as toothbrushes, handkerchiefs, washing detergents, cleaning cloths) from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BBMC

Internet use for buying bicycles, mopeds, cars, or other vehicles or their spare parts from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BOPG

Internet use for buying other physical goods from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BPG_ANY

Internet use for buying any of the listed physical goods from enterprises or private persons (including used goods) via a website or app for private use in the last 3 months

e-Commerce

BPG_DOM

Internet use for buying goods via a website or app in the last 3 months from national sellers (from enterprises or private persons)

e-Commerce

BPG_EU

Internet use for buying goods via a website or app in the last 3 months from sellers from other EU countries (from enterprises or private persons)

e-Commerce

BPG_WRLD

Internet use for buying goods via a website or app in the last 3 months from sellers from the rest of the world (from enterprises or private persons)

e-Commerce

BPG_UNK

Internet use for buying goods via a website or app in the last 3 months from sellers which country of origin is not known (from enterprises or private persons)

e-Commerce

BPG_PP

Goods bought from private persons via a website or app

e-Commerce

BMUSS

Internet use for buying or subscribing to music as a streaming service or downloads via a website or app for private use in the last 3 months

e-Commerce

BFLMS

Internet use for buying or subscribing to films or series as a streaming service or downloads via a website or app for private use in the last 3 months

e-Commerce

BBOOKNLS

Internet use for buying or subscribing to e-books, online-magazines or online-newspapers via a website or app for private use in the last 3 months

e-Commerce

BGAMES

Internet use for buying or subscribing to games online or as downloads for smartphones, tablets, computers or consoles via a website or app for private use in the last 3 months

e-Commerce

BSOFTS

Internet use for buying or subscribing to computer software or other software as downloads including upgrades via a website or app for private use in the last 3 months

e-Commerce

BHLFTS

Internet use for buying or subscribing to apps related to health or fitness (excluding free apps) via a website or app for private use in the last 3 months

e-Commerce

BAPP

Internet use for buying or subscribing to other apps (such as apps related to learning languages, travelling, weather) (excluding free apps) via a website or app for private use in the last 3 months

e-Commerce

BSTICK

Internet use for buying tickets to sports events via a website or app for private use in the last 3 months

e-Commerce

BCTICK

Internet use for buying tickets to cultural or other events (such as tickets to cinema, concerts, fairs) via a website or app for private use in the last 3 months

e-Commerce

BSIMC

Internet use for buying subscriptions to the internet or mobile phone connections via a website or app for private use in the last 3 months

e-Commerce

BSUTIL

Internet use for buying subscriptions to electricity, water or heating supply, waste disposal or similar services via a website or app for private use in the last 3 months

e-Commerce

BHHS

Internet use for buying household services (such as cleaning, babysitting, repair work, gardening) (also when bought from private persons) via a website or app for private use in the last 3 months

e-Commerce

BHHS_PP

Internet use for buying household services from private persons via a website or app for private use in the last 3 months

e-Commerce

BTPS_E

Internet use for buying transport services from a transport enterprise, such as local bus, flight or train ticket or taxi ride via a website or app for private use in the last 3 months

e-Commerce

BTPS_PP

Internet use for buying transport services from a private person via a website or app for private use in the last 3 months

e-Commerce

BRA_E

Internet use for renting accommodation from enterprises such as hotels or travel agencies via a website or app for private use in the last 3 months

e-Commerce

BRA_PP

Internet use for renting accommodation from a private person via a website or app for private use in the last 3 months

e-Commerce

BOTS (optional)

Internet use for buying any other services (excluding financial and insurance services) via a website or app for private use in the last 3 months

(optional)

e-Commerce

BFIN_IN1

Internet use for buying insurance policies, including travel insurance, also as a package together with for example a plane ticket, via a website or app for private purposes in the last 3 months

e-Commerce

BFIN_CR1

Internet use for taking a loan or mortgage or arranging credit from banks or other financial providers via a website or app for private purposes in the last 3 months

e-Commerce

BFIN_SH1

Internet use for buying or selling shares, bonds, units in funds or other financial assets via a website or app for private purposes in the last 3 months

Connection to the internet from anywhere

IOT_DEM

Use of internet-connected thermostat, utility meter, lights, plug-ins or other internet-connected solutions for energy management for the respondent’s home for private purposes

Connection to the internet from anywhere

IOT_DSEC

Use of internet-connected home alarm system, smoke detector, security cameras, door locks or other internet-connected security or safety solutions for the respondent’s home for private purposes

Connection to the internet from anywhere

IOT_DHA

Use of internet-connected home appliances such as robot vacuums, fridges, ovens, coffee machines for private purposes

Connection to the internet from anywhere

IOT_DVA

Use of a virtual assistant in the form of a smart speaker or of an app for private purposes

Connection to the internet from anywhere

IOT_DX

Respondent did not use any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes

Connection to the internet from anywhere

IOT_BDK

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – respondent did not know that such devices or systems exist

Connection to the internet from anywhere

IOT_BNN

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – respondent had no need to use those connected devices or systems

Connection to the internet from anywhere

IOT_BCST

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – costs too high

Connection to the internet from anywhere

IOT_BLC

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – lack of compatibility with other devices or systems

Connection to the internet from anywhere

IOT_BLSK

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – lack of skills to use those devices or systems

Connection to the internet from anywhere

IOT_BCPP

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – concerns about the privacy and protection of data about the respondent generated by those devices or systems

Connection to the internet from anywhere

IOT_BCSC

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – concerns about security (e.g. that the device or system will be hacked)

Connection to the internet from anywhere

IOT_BCSH

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – concerns about safety or health (e.g. that the use of the device or system could lead to an accident, injury or health problem)

Connection to the internet from anywhere

IOT_BOTH

Reasons for not using any of the internet-connected devices for energy management, security or safety solutions, home appliances or virtual assistants for private purposes – other reasons

Connection to the internet from anywhere

IOT_IUTV

Internet use on an internet-connected TV in the respondent’s home for private purposes

Connection to the internet from anywhere

IOT_IUGC

Internet use on an internet-connected game console in the respondent’s home for private purposes

Connection to the internet from anywhere

IOT_IUHA

Internet use on an internet-connected home audio system or smart speakers in the respondent’s home for private purposes

Connection to the internet from anywhere

IOT_DCS

Use of an internet-connected smart watch, fitness band, internet-connected goggles or headsets, safety- trackers, internet-connected accessories, internet-connected clothes or shoes for private purposes

Connection to the internet from anywhere

IOT_DHE

Use of internet-connected devices for monitoring blood pressure, sugar level, body weight (such as smart scales) or other internet-connected devices for health and medical care for private purposes

Connection to the internet from anywhere

IOT_DTOY

Use of toys connected to the internet, such as robot toys (including educational) or dolls for private purposes

Connection to the internet from anywhere

IOT_DCAR

Use of a car with built-in wireless internet connection for private purposes

Connection to the internet from anywhere

IOT_USE

Respondent used internet of things

Connection to the internet from anywhere

IOT_PSEC

Problems encountered with the mentioned internet-connected devices or systems – security or privacy problems (e.g. the device or system was hacked, problems with the protection of information about the respondent and his/her family generated by those devices or systems)

Connection to the internet from anywhere

IOT_PSHE

Problems encountered with the mentioned internet-connected devices or systems – safety or health problems (e.g. the use of the device or system lead to an accident, injury or health problem)

Connection to the internet from anywhere

IOT_PDU

Problems encountered with the mentioned internet-connected devices or systems – difficulties with using the device (e.g. setting-up, installing, connecting, pairing the device)

Connection to the internet from anywhere

IOT_POTH

Problems encountered with the mentioned internet-connected devices or systems – other problems (such as connection problems, support problems)

Connection to the internet from anywhere

IOT_PX

Respondent has not encountered any problem with the mentioned internet-connected devices or systems

Effect of use

ECO_DMOB

Way in which the respondent dealt with his/her mobile phone or smartphone that he/she replaced or no longer use

Effect of use

ECO_DLT

Way in which the respondent dealt with his/her laptop or tablet that he/she replaced or no longer use

Effect of use

ECO_DPC

Way in which the respondent dealt with his/her desktop computer that he/she replaced or no longer use

Effect of use

ECO_PP

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – price

(Optional)

Effect of use

ECO_PHD

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – hard drive characteristics (storage, speed), processor speed

(Optional)

Effect of use

ECO_PECD

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – eco-design of the device e.g. durable, upgradeable and reparable designs that require fewer materials; environmentally friendly materials used for packaging, etc.

(Optional)

Effect of use

ECO_PEG

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – possibility to extend the life span of the device by buying extra guarantee

(Optional)

Effect of use

ECO_PEE

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – energy efficiency of the device

(Optional)

Effect of use

ECO_PTBS

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – a take-back scheme offered by manufacturer or seller (i.e. the manufacturer or seller takes the device which becomes obsolete at no cost or offers discounts to the client to purchase another device)

(Optional)

Effect of use

ECO_PX

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – the respondent has not considered any of the mentioned characteristics

(Optional)

Effect of use

ECO_PBX

(Optional)

Characteristics considered as important by the respondent when he/she most recently bought a mobile or smartphone, tablet, laptop or desktop computer – the respondent never bought any of these devices

(Optional)

---

| 3.11.2021 | EN | Official Journal of the European Union | L 387/77 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/77

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1899

of 25 October 2021

entering a name in the register of protected designations of origin and protected geographical indications (‘Fertőd vidéki sárgarépa’ (PGI))

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Hungary’s application to register the name ‘Fertőd vidéki sárgarépa’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Hungary’s application to register the name ‘Fertőd vidéki sárgarépa’ was published in the Official Journal of the European Union (2).

| (2) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Fertőd vidéki sárgarépa’ should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Fertőd vidéki sárgarépa’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Fertőd vidéki sárgarépa’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.6. – Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 25 October 2021.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  
  OJ C 283, 15.7.2021, p. 12.

2

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

3

---

| 3.11.2021 | EN | Official Journal of the European Union | L 387/78 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/78

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1900

of 27 October 2021

amending Implementing Regulation (EU) 2019/1793 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), and in particular Article 53(1)(b) thereof,

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (2), and in particular Article 47(2)(b), Article 54(4)(a) and (b) and Article 90(a), (b) and (c) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2019/1793 (3) lays down rules on the temporary increase of official controls at the entry into the Union on certain food and feed of non-animal origin from certain third countries listed in Annex I to that Implementing Regulation, on special conditions governing the entry into the Union of certain food and feed from certain third countries due to the risk of contamination by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins, and microbiological contamination, listed in Annex II to that Implementing Regulation, and on the suspension of entry into the Union of certain food and feed from certain third countries, listed in Annex IIa to that Implementing Regulation. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) 2019/1793 (3) lays down rules on the temporary increase of official controls at the entry into the Union on certain food and feed of non-animal origin from certain third countries listed in Annex I to that Implementing Regulation, on special conditions governing the entry into the Union of certain food and feed from certain third countries due to the risk of contamination by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins, and microbiological contamination, listed in Annex II to that Implementing Regulation, and on the suspension of entry into the Union of certain food and feed from certain third countries, listed in Annex IIa to that Implementing Regulation.

| (2) | Since the term ‘compound food’ in Article 1(1)(b)(ii), Article 8, in Table 2 of Annex II and in Annex IV to Implementing Regulation (EU) 2019/1793 is not used with the same understanding as in other Union legislation, it is appropriate to replace this term by ‘food consisting of two or more ingredients’. |
| --- | --- |

(2)

Since the term ‘compound food’ in Article 1(1)(b)(ii), Article 8, in Table 2 of Annex II and in Annex IV to Implementing Regulation (EU) 2019/1793 is not used with the same understanding as in other Union legislation, it is appropriate to replace this term by ‘food consisting of two or more ingredients’.

| (3) | In order to ensure uniform understanding and application of Implementing Regulation (EU) 2019/1793, it is appropriate to add the definition of ‘country of origin’ to Article 2 of that Implementing Regulation. |
| --- | --- |

(3)

In order to ensure uniform understanding and application of Implementing Regulation (EU) 2019/1793, it is appropriate to add the definition of ‘country of origin’ to Article 2 of that Implementing Regulation.

| (4) | Article 12 of Implementing Regulation (EU) 2019/1793 provides that the lists set out in its Annexes I and II are to be reviewed at regular intervals not exceeding six months, in order to take into account new information related to risks and non-compliance with Union legislation. |
| --- | --- |

(4)

Article 12 of Implementing Regulation (EU) 2019/1793 provides that the lists set out in its Annexes I and II are to be reviewed at regular intervals not exceeding six months, in order to take into account new information related to risks and non-compliance with Union legislation.

| (5) | Annex IIa to Implementing Regulation (EU) 2019/1793 lists food and feed from certain third countries subject to suspension of entry into the Union, as referred to in Article 11a of that Regulation. |
| --- | --- |

(5)

Annex IIa to Implementing Regulation (EU) 2019/1793 lists food and feed from certain third countries subject to suspension of entry into the Union, as referred to in Article 11a of that Regulation.

| (6) | Given that Implementing Regulation (EU) 2019/1793 does not explicitly provide for a period of applicability of the emergency measures for the products listed in Annex IIa and considering that these measures are to be withdrawn or modified where new information related to risks and to non-compliance with Union legislation becomes available, the list set out in Annex IIa to this Regulation should also be regularly reviewed. It is therefore appropriate to amend Article 12 of Implementing Regulation (EU) 2019/1793. |
| --- | --- |

(6)

Given that Implementing Regulation (EU) 2019/1793 does not explicitly provide for a period of applicability of the emergency measures for the products listed in Annex IIa and considering that these measures are to be withdrawn or modified where new information related to risks and to non-compliance with Union legislation becomes available, the list set out in Annex IIa to this Regulation should also be regularly reviewed. It is therefore appropriate to amend Article 12 of Implementing Regulation (EU) 2019/1793.

| (7) | The occurrence and relevance of recent food incidents notified through the Rapid Alert System for Food and Feed (‘RASFF’), as established by Regulation (EC) No 178/2002, and information regarding official controls performed by Member States on food and feed of non-animal origin in the second semester of 2020 indicate that the lists set out in Annexes I and II to Implementing Regulation (EU) 2019/1793 should be amended in order to protect human health in the Union. |
| --- | --- |

(7)

The occurrence and relevance of recent food incidents notified through the Rapid Alert System for Food and Feed (‘RASFF’), as established by Regulation (EC) No 178/2002, and information regarding official controls performed by Member States on food and feed of non-animal origin in the second semester of 2020 indicate that the lists set out in Annexes I and II to Implementing Regulation (EU) 2019/1793 should be amended in order to protect human health in the Union.

| (8) | In particular, for consignments of lemons from Turkey, the data resulting from notifications in the RASFF and information regarding official controls performed by Member States indicate the emergence of new risks to human health, due to a possible contamination by pesticide residues, requiring an increased level of official controls. In addition, for consignments of groundnuts from Brazil, information regarding official controls performed by Member States indicate the emergence of new risks to human health, due to a possible contamination by pesticide residues, requiring an increased level of official controls. Entries on both of those commodities should therefore be included in Annex I to Implementing Regulation (EU) 2019/1793, with a frequency of identity and physical checks set at 20 %. |
| --- | --- |

(8)

In particular, for consignments of lemons from Turkey, the data resulting from notifications in the RASFF and information regarding official controls performed by Member States indicate the emergence of new risks to human health, due to a possible contamination by pesticide residues, requiring an increased level of official controls. In addition, for consignments of groundnuts from Brazil, information regarding official controls performed by Member States indicate the emergence of new risks to human health, due to a possible contamination by pesticide residues, requiring an increased level of official controls. Entries on both of those commodities should therefore be included in Annex I to Implementing Regulation (EU) 2019/1793, with a frequency of identity and physical checks set at 20 %.

| (9) | Due to the frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by pesticide residues detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, and due to the high number of notifications in the RASFF, it is appropriate to increase to 20 % the frequency of identity and physical checks to be performed on oranges, mandarins, clementines, wilkings and similar citrus hybrids, and sweet peppers and peppers of the genus Capsicum (other than sweet) from Turkey. |
| --- | --- |

(9)

Due to the frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by pesticide residues detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, and due to the high number of notifications in the RASFF, it is appropriate to increase to 20 % the frequency of identity and physical checks to be performed on oranges, mandarins, clementines, wilkings and similar citrus hybrids, and sweet peppers and peppers of the genus Capsicum (other than sweet) from Turkey.

| (10) | Due to the high frequency of non-compliance with the relevant requirements provided for in Union legislation with respect to contamination by pesticide residues detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, it is appropriate to increase to 50 % the frequency of identity and physical checks to be performed on jackfruit from Malaysia and on peppers of the genus Capsicum (other than sweet) from Uganda. |
| --- | --- |

(10)

Due to the high frequency of non-compliance with the relevant requirements provided for in Union legislation with respect to contamination by pesticide residues detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, it is appropriate to increase to 50 % the frequency of identity and physical checks to be performed on jackfruit from Malaysia and on peppers of the genus Capsicum (other than sweet) from Uganda.

| (11) | Due to notifications in the RASFF concerning contamination by residues of ethylene oxide, as regards certain consignments of okra from India, ethylene oxide should be added to the analysis to be performed on this commodity and the frequency of physical and identity checks for the presence of pesticide residues, including ethylene oxide, to be performed on okra from India at the Union borders, should be increased to 20 %. |
| --- | --- |

(11)

Due to notifications in the RASFF concerning contamination by residues of ethylene oxide, as regards certain consignments of okra from India, ethylene oxide should be added to the analysis to be performed on this commodity and the frequency of physical and identity checks for the presence of pesticide residues, including ethylene oxide, to be performed on okra from India at the Union borders, should be increased to 20 %.

| (12) | Due to the frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by aflatoxins detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, and due to the high number of notifications in the RASFF, it is appropriate to increase to 20 % the frequency of identity and physical checks to be performed on groundnuts from the United States. |
| --- | --- |

(12)

Due to the frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by aflatoxins detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, and due to the high number of notifications in the RASFF, it is appropriate to increase to 20 % the frequency of identity and physical checks to be performed on groundnuts from the United States.

| (13) | Due to the high frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by Salmonella detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, it is appropriate to increase to 50 % the frequency of identity and physical checks to be performed on Sesamum seeds from Sudan. |
| --- | --- |

(13)

Due to the high frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by Salmonella detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, it is appropriate to increase to 50 % the frequency of identity and physical checks to be performed on Sesamum seeds from Sudan.

| (14) | Due to the high frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by pesticide residues detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, it is appropriate to increase to 50 % the frequency of identity and physical checks to be performed on vine leaves from Turkey. |
| --- | --- |

(14)

Due to the high frequency of non-compliance with the relevant requirements provided for in Union legislation as regards contamination by pesticide residues detected during official controls performed by Member States in accordance with Implementing Regulation (EU) 2019/1793, it is appropriate to increase to 50 % the frequency of identity and physical checks to be performed on vine leaves from Turkey.

| (15) | For hazelnuts and products produced from hazelnuts from Georgia, the available information indicates a favourable trend of the degree of compliance with the relevant requirements provided for in Union legislation as regards contamination by aflatoxins. It is appropriate to decrease to 20 % the frequency of identity and physical checks to be performed on hazelnuts and products produced from hazelnuts from Georgia. Hazelnuts and products produced from hazelnuts from Turkey and from Azerbaijan are listed in Annex II to Implementing Regulation (EU) 2019/1793 due to risk of contamination by aflatoxins. For the purpose of ensuring consistency in mitigating risks, it is appropriate to amend the existing entry on hazelnuts and products produced from hazelnuts from Georgia to cover the same products as those originating from Turkey and from Azerbaijan. |
| --- | --- |

(15)

For hazelnuts and products produced from hazelnuts from Georgia, the available information indicates a favourable trend of the degree of compliance with the relevant requirements provided for in Union legislation as regards contamination by aflatoxins. It is appropriate to decrease to 20 % the frequency of identity and physical checks to be performed on hazelnuts and products produced from hazelnuts from Georgia. Hazelnuts and products produced from hazelnuts from Turkey and from Azerbaijan are listed in Annex II to Implementing Regulation (EU) 2019/1793 due to risk of contamination by aflatoxins. For the purpose of ensuring consistency in mitigating risks, it is appropriate to amend the existing entry on hazelnuts and products produced from hazelnuts from Georgia to cover the same products as those originating from Turkey and from Azerbaijan.

| (16) | Sesamum seeds from Ethiopia have been subject to an increased level of official controls due to the risk of contamination by Salmonella since January 2019. The official controls carried out on those foodstuffs by the Member States show a persistent high rate of non-compliance since the establishment of the increased level of official controls. Those results provide evidence that the entry of those foodstuffs into the Union constitutes a serious risk for human health. |
| --- | --- |

(16)

Sesamum seeds from Ethiopia have been subject to an increased level of official controls due to the risk of contamination by Salmonella since January 2019. The official controls carried out on those foodstuffs by the Member States show a persistent high rate of non-compliance since the establishment of the increased level of official controls. Those results provide evidence that the entry of those foodstuffs into the Union constitutes a serious risk for human health.

| (17) | It is therefore necessary, in addition to the increased level of official controls, to provide for special conditions in relation to Sesamum seeds from Ethiopia. In particular, all consignments of Sesamum seeds from Ethiopia should be accompanied by an official certificate stating that all results of sampling and analysis show the absence of Salmonella in 25 g as provided in Article 10(2)(d) of Implementing Regulation (EU) 2019/1793. The results of the sampling and analysis should be attached to that certificate. Therefore, the entry on Sesamum seeds from Ethiopia in Annex I to Implementing Regulation (EU) 2019/1793 should be deleted and an entry on those seeds should be inserted in Annex II to that Implementing Regulation. |
| --- | --- |

(17)

It is therefore necessary, in addition to the increased level of official controls, to provide for special conditions in relation to Sesamum seeds from Ethiopia. In particular, all consignments of Sesamum seeds from Ethiopia should be accompanied by an official certificate stating that all results of sampling and analysis show the absence of Salmonella in 25 g as provided in Article 10(2)(d) of Implementing Regulation (EU) 2019/1793. The results of the sampling and analysis should be attached to that certificate. Therefore, the entry on Sesamum seeds from Ethiopia in Annex I to Implementing Regulation (EU) 2019/1793 should be deleted and an entry on those seeds should be inserted in Annex II to that Implementing Regulation.

| (18) | Peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka have been subject to an increased level of official controls as regards the presence of aflatoxins since July 2017. The official controls carried out on these foodstuffs by the Member States show a persistent high rate of non-compliance since the establishment of the increased level of official controls. Those results provide evidence that the entry of those foodstuffs into the Union constitutes a serious risk for human health. |
| --- | --- |

(18)

Peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka have been subject to an increased level of official controls as regards the presence of aflatoxins since July 2017. The official controls carried out on these foodstuffs by the Member States show a persistent high rate of non-compliance since the establishment of the increased level of official controls. Those results provide evidence that the entry of those foodstuffs into the Union constitutes a serious risk for human health.

| (19) | It is therefore necessary, in addition to the increased level of official controls, to provide for special conditions for peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka. In particular, all consignments of that commodity from Sri Lanka should be accompanied by an official certificate stating that the products have been sampled and analysed for aflatoxins and all results show that the relevant maximum levels of aflatoxins have not been exceeded. The results of the sampling and analysis should be attached to that certificate. Therefore, the entry on peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka in Annex I to Implementing Regulation (EU) 2019/1793 should be deleted and an entry on those peppers should be inserted in Annex II to that Implementing Regulation. |
| --- | --- |

(19)

It is therefore necessary, in addition to the increased level of official controls, to provide for special conditions for peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka. In particular, all consignments of that commodity from Sri Lanka should be accompanied by an official certificate stating that the products have been sampled and analysed for aflatoxins and all results show that the relevant maximum levels of aflatoxins have not been exceeded. The results of the sampling and analysis should be attached to that certificate. Therefore, the entry on peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka in Annex I to Implementing Regulation (EU) 2019/1793 should be deleted and an entry on those peppers should be inserted in Annex II to that Implementing Regulation.

| (20) | As regards pistachios from the United States, listed in Annex I to Implementing Regulation (EU) 2019/1793 due to the risk of contamination by aflatoxins, the available information indicates an overall satisfactory degree of compliance with the relevant requirements provided for in Union legislation. Therefore, an increased level of official controls is no longer justified for this commodity and its entry in Annex I to Implementing Regulation (EU) 2019/1793 should be deleted. |
| --- | --- |

(20)

As regards pistachios from the United States, listed in Annex I to Implementing Regulation (EU) 2019/1793 due to the risk of contamination by aflatoxins, the available information indicates an overall satisfactory degree of compliance with the relevant requirements provided for in Union legislation. Therefore, an increased level of official controls is no longer justified for this commodity and its entry in Annex I to Implementing Regulation (EU) 2019/1793 should be deleted.

| (21) | In order to ensure efficient protection against potential health risks arising from contamination of groundnuts by aflatoxins, in the columns referring to ‘Food and feed (intended use)’ and ‘CN code’ in Table 1 of Annex II to Implementing Regulation (EU) 2019/1793, the terms ‘including mixtures’ and the CN codes for mixtures should be added in the rows referring to groundnuts (peanuts), otherwise prepared or preserved. |
| --- | --- |

(21)

In order to ensure efficient protection against potential health risks arising from contamination of groundnuts by aflatoxins, in the columns referring to ‘Food and feed (intended use)’ and ‘CN code’ in Table 1 of Annex II to Implementing Regulation (EU) 2019/1793, the terms ‘including mixtures’ and the CN codes for mixtures should be added in the rows referring to groundnuts (peanuts), otherwise prepared or preserved.

| (22) | It is appropriate to provide a transitional period for consignments of Sesamum seeds from Ethiopia and consignments of peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka, which are not accompanied by an official certificate, but which were already subject to official controls at the border control post in accordance with harmonised frequency rates for identity and physical checks in accordance with Implementing Regulation (EU) 2019/1793 before the amendment by this Regulation. |
| --- | --- |

(22)

It is appropriate to provide a transitional period for consignments of Sesamum seeds from Ethiopia and consignments of peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka, which are not accompanied by an official certificate, but which were already subject to official controls at the border control post in accordance with harmonised frequency rates for identity and physical checks in accordance with Implementing Regulation (EU) 2019/1793 before the amendment by this Regulation.

| (23) | Implementing Regulation (EU) 2019/1793 lays down requirements as regards the model official certificate for the entry into the Union of consignments of food and feed listed in Annex II to that Implementing Regulation. |
| --- | --- |

(23)

Implementing Regulation (EU) 2019/1793 lays down requirements as regards the model official certificate for the entry into the Union of consignments of food and feed listed in Annex II to that Implementing Regulation.

| (24) | To align the official certificates for the entry into the Union laid down in Commission Implementing Regulation (EU) 2020/2235 (4) for different categories of goods and to ensure consistency with the new certification requirements in the official certificates, it is appropriate to amend the model official certificate and the notes on the completion of that certificate set out in Annex IV to Implementing Regulation (EU) 2019/1793. |
| --- | --- |

(24)

To align the official certificates for the entry into the Union laid down in Commission Implementing Regulation (EU) 2020/2235 (4) for different categories of goods and to ensure consistency with the new certification requirements in the official certificates, it is appropriate to amend the model official certificate and the notes on the completion of that certificate set out in Annex IV to Implementing Regulation (EU) 2019/1793.

| (25) | In order to ensure consistency and clarity, it is appropriate to replace Annexes I, II, IIa, and IV to Implementing Regulation (EU) 2019/1793 in their entirety. |
| --- | --- |

(25)

In order to ensure consistency and clarity, it is appropriate to replace Annexes I, II, IIa, and IV to Implementing Regulation (EU) 2019/1793 in their entirety.

| (26) | Implementing Regulation (EU) 2019/1793 should therefore be amended accordingly. |
| --- | --- |

(26)

Implementing Regulation (EU) 2019/1793 should therefore be amended accordingly.

| (27) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(27)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Implementing Regulation (EU) 2019/1793

Implementing Regulation (EU) 2019/1793 is amended as follows:

| (1) | in Article 1, point (1)(b)(ii) is replaced by the following:






  ‘(ii) | consignments of food consisting of two or more ingredients, containing any of the food listed in Table 1 to Annex II due to the risk of contamination by aflatoxins in a quantity above 20 % of either a single product or as the sum of those products and falling within the CN codes laid down in Table 2 to that Annex;’; |
| --- | --- | --- |

(1)

in Article 1, point (1)(b)(ii) is replaced by the following:

‘(ii)

consignments of food consisting of two or more ingredients, containing any of the food listed in Table 1 to Annex II due to the risk of contamination by aflatoxins in a quantity above 20 % of either a single product or as the sum of those products and falling within the CN codes laid down in Table 2 to that Annex;’;

| (2) | in Article 2(1), the following point (c) is added:






  ‘(c) | “country of origin” means:






  (i) | the country where the goods originate from, were grown, harvested or produced, where food and feed is listed in the Annexes due to a possible risk of contamination by mycotoxins, including aflatoxins, or by plant toxins, or due to possible non-compliance with maximum allowed levels of pesticide residues; |
| --- | --- | --- | --- |

(2)

in Article 2(1), the following point (c) is added:

‘(c)

“country of origin” means:

(i)

the country where the goods originate from, were grown, harvested or produced, where food and feed is listed in the Annexes due to a possible risk of contamination by mycotoxins, including aflatoxins, or by plant toxins, or due to possible non-compliance with maximum allowed levels of pesticide residues;

| (ii) | the country where the goods were produced, manufactured or wrapped where food and feed is listed in the Annexes due to the risk of presence of Salmonella or due to other hazards than those specified in point (i).’; |
| --- | --- |

(ii)

the country where the goods were produced, manufactured or wrapped where food and feed is listed in the Annexes due to the risk of presence of Salmonella or due to other hazards than those specified in point (i).’;

Salmonella

| (3) | in Article 8, paragraphs 3 and 4 are replaced by the following:

  ‘3.   Food consisting of two or more ingredients listed in Table 2 to Annex II which contains products falling only under one entry in Table 1 to Annex II shall be subject to the overall frequency of identity and physical checks set out in Table 1 to Annex II for that entry.


  4.   Food consisting of two or more ingredients listed in Table 2 to Annex II which contains products falling under several entries for the same hazard in Table 1 to Annex II shall be subject to the highest overall frequency of identity and physical checks set out in Table 1 to Annex II for these entries.’; |
| --- | --- |

(3)

in Article 8, paragraphs 3 and 4 are replaced by the following:

‘3.   Food consisting of two or more ingredients listed in Table 2 to Annex II which contains products falling only under one entry in Table 1 to Annex II shall be subject to the overall frequency of identity and physical checks set out in Table 1 to Annex II for that entry.

4.   Food consisting of two or more ingredients listed in Table 2 to Annex II which contains products falling under several entries for the same hazard in Table 1 to Annex II shall be subject to the highest overall frequency of identity and physical checks set out in Table 1 to Annex II for these entries.’;

| (4) | Article 12 is replaced by the following:

  ‘Article 12
  Updates to Annexes
  The Commission shall review the lists set out in Annexes I, II and IIa on a regular basis not exceeding a period of six months, in order to take into account new information related to risks and non-compliance.’; |
| --- | --- |

(4)

Article 12 is replaced by the following:

‘Article 12

Updates to Annexes

The Commission shall review the lists set out in Annexes I, II and IIa on a regular basis not exceeding a period of six months, in order to take into account new information related to risks and non-compliance.’;

| (5) | Article 14 is replaced by the following:

  ‘Article 14
  Transitional period
  Consignments of Sesamum seeds from Ethiopia and consignments of peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka which are not accompanied by an official certificate and the results of sampling and analysis in accordance with this Regulation shall be accepted for entry into the Union until 13 January 2022.’; |
| --- | --- |

(5)

Article 14 is replaced by the following:

‘Article 14

Transitional period

Consignments of Sesamum seeds from Ethiopia and consignments of peppers of the genus Capsicum (sweet or other than sweet) from Sri Lanka which are not accompanied by an official certificate and the results of sampling and analysis in accordance with this Regulation shall be accepted for entry into the Union until 13 January 2022.’;

| (6) | Annexes I, II, IIa and IV are replaced by the text set out in the Annex to this Regulation. |
| --- | --- |

(6)

Annexes I, II, IIa and IV are replaced by the text set out in the Annex to this Regulation.

Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Official Journal of the European Union

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 October 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 31, 1.2.2002, p. 1.

1

(2)  
  OJ L 95, 7.4.2017, p. 1.

2

(3)  Commission Implementing Regulation (EU) 2019/1793 of 22 October 2019 on the temporary increase of official controls and emergency measures governing the entry into the Union of certain goods from certain third countries implementing Regulations (EU) 2017/625 and (EC) No 178/2002 of the European Parliament and of the Council and repealing Commission Regulations (EC) No 669/2009, (EU) No 884/2014, (EU) 2015/175, (EU) 2017/186 and (EU) 2018/1660 (OJ L 277, 29.10.2019, p. 89).

3

(4)  Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442, 30.12.2020, p. 1).

4

---

ANNEX

‘ANNEX I

Food and feed of non-animal origin from certain third countries subject to a temporary increase of official controls at border control posts and control points

| Row | Food and feed (intended use) | CN code
   (1) | TARIC sub-division | Country of origin | Hazard | Frequency of identity and physical checks (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 1 | — | Groundnuts (peanuts), in shell |

Row

Food and feed (intended use)

CN code
   (1)

TARIC sub-division

Country of origin

Hazard

Frequency of identity and physical checks (%)

1

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Bolivia (BO)

Aflatoxins

50

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(Food and feed)

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

2

| — | Black pepper (Piper nigrum) |
| --- | --- |

—

Black pepper (Piper nigrum)

(Food – neither crushed nor ground)

ex 0904 11 00

10

Brazil (BR)

Salmonella
   (2)

50

3

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Brazil (BR)

Aflatoxins

10

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98

Pesticide residues (3)

20

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(Food and feed)

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

4

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

China (CN)

Aflatoxins

10

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

5

Sweet peppers (Capsicum annuum)

(Food – crushed or ground)

ex 0904 22 00

11

China (CN)

Salmonella
   (6)

20

6

Tea, whether or not flavoured

(Food)

0902

China (CN)

Pesticide residues (3)
   (7)

20

7

Aubergines (Solanum melongena)

(Food – fresh or chilled)

0709 30 00

Dominican Republic (DO)

Pesticide residues (3)

20

8

| — | Sweet peppers (Capsicum annuum) |
| --- | --- |

—

Sweet peppers (Capsicum annuum)

| — | 0709 60 10 ;
  0710 80 51 |
| --- | --- |

—

0709 60 10 ;

0710 80 51

Dominican Republic (DO)

Pesticide residues (3)
   (8)

50

| — | Peppers of the genus Capsicum (other than sweet) |
| --- | --- |

—

Peppers of the genus Capsicum (other than sweet)

| — | ex 0709 60 99 ; |
| --- | --- |

—

ex 0709 60 99 ;

20

ex 0710 80 59

20

| — | Yardlong beans (Vigna unguiculata ssp. sesquipedalis, Vigna unguiculata ssp. unguiculata) |
| --- | --- |

—

Yardlong beans (Vigna unguiculata ssp. sesquipedalis, Vigna unguiculata ssp. unguiculata)

(Food – fresh, chilled or frozen)

| — | ex 0708 20 00 ; |
| --- | --- |

—

ex 0708 20 00 ;

10

ex 0710 22 00

10

9

| — | Sweet peppers (Capsicum annuum) |
| --- | --- |

—

Sweet peppers (Capsicum annuum)

| — | 0709 60 10 ;
  0710 80 51 |
| --- | --- |

—

0709 60 10 ;

0710 80 51

Egypt (EG)

Pesticide residues (3)
   (9)

20

| — | Peppers of the genus Capsicum (other than sweet) |
| --- | --- |

—

Peppers of the genus Capsicum (other than sweet)

(Food – fresh, chilled or frozen)

| — | ex 0709 60 99 ; |
| --- | --- |

—

ex 0709 60 99 ;

20

| | ex 0710 80 59 |
| --- | --- |

ex 0710 80 59

20

10

| — | Hazelnuts (Corylus sp.), in shell |
| --- | --- |

—

Hazelnuts (Corylus sp.), in shell

| — | 0802 21 00 |
| --- | --- |

—

0802 21 00

Georgia (GE)

Aflatoxins

20

| — | Hazelnuts (Corylus sp.), shelled |
| --- | --- |

—

Hazelnuts (Corylus sp.), shelled

| — | 0802 22 00 |
| --- | --- |

—

0802 22 00

| — | Mixtures of nuts or dried fruits containing hazelnuts |
| --- | --- |

—

Mixtures of nuts or dried fruits containing hazelnuts

| — | ex 0813 50 39 ; |
| --- | --- |

—

ex 0813 50 39 ;

70

| | ex 0813 50 91 ; |
| --- | --- |

ex 0813 50 91 ;

70

| | ex 0813 50 99 |
| --- | --- |

ex 0813 50 99

70

| — | Hazelnut paste |
| --- | --- |

—

Hazelnut paste

| — | ex 2007 10 10 ; |
| --- | --- |

—

ex 2007 10 10 ;

70

| | ex 2007 10 99 ; |
| --- | --- |

ex 2007 10 99 ;

40

| | ex 2007 99 39 ; |
| --- | --- |

ex 2007 99 39 ;

05; 06

| | ex 2007 99 50 ; |
| --- | --- |

ex 2007 99 50 ;

33

| | ex 2007 99 97 ; |
| --- | --- |

ex 2007 99 97 ;

23

| — | Hazelnuts, otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Hazelnuts, otherwise prepared or preserved, including mixtures

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

30

| | ex 2008 19 19 ; |
| --- | --- |

ex 2008 19 19 ;

30

| | ex 2008 19 92 ; |
| --- | --- |

ex 2008 19 92 ;

30

| | ex 2008 19 95 ; |
| --- | --- |

ex 2008 19 95 ;

20

| | ex 2008 19 99 ; |
| --- | --- |

ex 2008 19 99 ;

30

| | ex 2008 97 12 ; |
| --- | --- |

ex 2008 97 12 ;

15

| | ex 2008 97 14 ; |
| --- | --- |

ex 2008 97 14 ;

15

| | ex 2008 97 16 |
| --- | --- |

ex 2008 97 16

15

| | ex 2008 97 18 |
| --- | --- |

ex 2008 97 18

15

| | ex 2008 97 32 ; |
| --- | --- |

ex 2008 97 32 ;

15

| | ex 2008 97 34 ; |
| --- | --- |

ex 2008 97 34 ;

15

| | ex 2008 97 36 ; |
| --- | --- |

ex 2008 97 36 ;

15

| | ex 2008 97 38 ; |
| --- | --- |

ex 2008 97 38 ;

15

| | ex 2008 97 51 ; |
| --- | --- |

ex 2008 97 51 ;

15

| | ex 2008 97 59 ; |
| --- | --- |

ex 2008 97 59 ;

15

| | ex 2008 97 72 ; |
| --- | --- |

ex 2008 97 72 ;

15

| | ex 2008 97 74 ; |
| --- | --- |

ex 2008 97 74 ;

15

| | ex 2008 97 76 ; |
| --- | --- |

ex 2008 97 76 ;

15

| | ex 2008 97 78 ; |
| --- | --- |

ex 2008 97 78 ;

15

| | ex 2008 97 92 ; |
| --- | --- |

ex 2008 97 92 ;

15

| | ex 2008 97 93 ; |
| --- | --- |

ex 2008 97 93 ;

15

| | ex 2008 97 94 ; |
| --- | --- |

ex 2008 97 94 ;

15

| | ex 2008 97 96 ; |
| --- | --- |

ex 2008 97 96 ;

15

| | ex 2008 97 97 ; |
| --- | --- |

ex 2008 97 97 ;

15

| | ex 2008 97 98 ; |
| --- | --- |

ex 2008 97 98 ;

15

| — | Flour, meal and powder of hazelnuts |
| --- | --- |

—

Flour, meal and powder of hazelnuts

| — | ex 1106 30 90 |
| --- | --- |

—

ex 1106 30 90

40

| — | Hazelnut oil |
| --- | --- |

—

Hazelnut oil

(Food)

| — | ex 1515 90 99 |
| --- | --- |

—

ex 1515 90 99

20

11

Palm oil

(Food)

| | 1511 10 90 ; |
| --- | --- |

1511 10 90 ;

Ghana (GH)

Sudan dyes (10)

50

| | 1511 90 11 ; |
| --- | --- |

1511 90 11 ;

| | ex 1511 90 19 ; |
| --- | --- |

ex 1511 90 19 ;

90

| | 1511 90 99 |
| --- | --- |

1511 90 99

12

Curry leaves (Bergera/Murraya koenigii)

(Food – fresh, chilled, frozen or dried)

ex 1211 90 86

10

India (IN)

Pesticide residues (3)
   (11)

50

13

Okra

(Food – fresh, chilled or frozen)

| | ex 0709 99 90 ; |
| --- | --- |

ex 0709 99 90 ;

20

India (IN)

Pesticide residues (3)
   (12)
   (22)

20

| | ex 0710 80 95 |
| --- | --- |

ex 0710 80 95

30

14

Beans (Vigna spp., Phaseolus spp.)

(Food – fresh or chilled)

0708 20

Kenya (KE)

Pesticide residues (3)

10

15

Chinese celery (Apium graveolens)

(Food – fresh or chilled herb)

ex 0709 40 00

20

Cambodia (KH)

Pesticide residues (3)
   (13)

50

16

Yardlong beans (Vigna unguiculata ssp. sesquipedalis, Vigna unguiculata ssp. unguiculata)

(Food – fresh, chilled or frozen vegetables)

| | ex 0708 20 00 ; |
| --- | --- |

ex 0708 20 00 ;

10

Cambodia (KH)

Pesticide residues (3)
   (14)

50

| | ex 0710 22 00 |
| --- | --- |

ex 0710 22 00

10

17

Turnips (Brassica rapa ssp. rapa)

(Food – prepared or preserved by vinegar or acetic acid)

ex 2001 90 97

11; 19

Lebanon (LB)

Rhodamine B

50

18

Turnips (Brassica rapa ssp. rapa)

(Food – prepared or preserved by brine or citric acid, not frozen)

ex 2005 99 80

93

Lebanon (LB)

Rhodamine B

50

19

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Madagascar (MG)

Aflatoxins

50

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

20

Jackfruit (Artocarpus heterophyllus)

(Food – fresh)

ex 0810 90 20

20

Malaysia (MY)

Pesticide residues (3)

50

21

Sesamum seeds

(Food)

| — | 1207 40 90 |
| --- | --- |

—

1207 40 90

Nigeria (NG)

Salmonella
   (2)

50

| — | ex 2008 19 19 |
| --- | --- |

—

ex 2008 19 19

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

40

22

Spice mixes

(Food)

0910 91 10 ;

0910 91 90

Pakistan (PK)

Aflatoxins

50

23

Watermelon (Egusi, Citrullus spp.) seeds and derived products

(Food)

| | ex 1207 70 00 ; |
| --- | --- |

ex 1207 70 00 ;

10

Sierra Leone (SL)

Aflatoxins

50

| | ex 1208 90 00 ; |
| --- | --- |

ex 1208 90 00 ;

10

| | ex 2008 99 99 |
| --- | --- |

ex 2008 99 99

50

24

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Senegal (SN)

Aflatoxins

50

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| | Groundnut flours and meals |
| --- | --- |

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

25

Turnips (Brassica rapa ssp. rapa)

(Food – prepared or preserved by vinegar or acetic acid)

ex 2001 90 97

11; 19

Syria (SY)

Rhodamine B

50

26

Turnips (Brassica rapa ssp. rapa)

(Food – prepared or preserved by brine or citric acid, not frozen)

ex 2005 99 80

93

Syria (SY)

Rhodamine B

50

27

Peppers of the genus Capsicum (other than sweet)

(Food – fresh, chilled or frozen)

ex 0709 60 99 ;

20

Thailand (TH)

Pesticide residues (3)
   (15)

20

ex 0710 80 59

20

28

| — | Hazelnuts (Corylus sp.), in shell |
| --- | --- |

—

Hazelnuts (Corylus sp.), in shell

| — | 0802 21 00 |
| --- | --- |

—

0802 21 00

Turkey (TR)

Aflatoxins

5

| — | Hazelnuts (Corylus sp.), shelled |
| --- | --- |

—

Hazelnuts (Corylus sp.), shelled

| — | 0802 22 00 |
| --- | --- |

—

0802 22 00

| — | Mixtures of nuts or dried fruits containing hazelnuts |
| --- | --- |

—

Mixtures of nuts or dried fruits containing hazelnuts

| — | ex 0813 50 39 ; |
| --- | --- |

—

ex 0813 50 39 ;

70

| | ex 0813 50 91 ; |
| --- | --- |

ex 0813 50 91 ;

70

| | ex 0813 50 99 |
| --- | --- |

ex 0813 50 99

70

| — | Hazelnut paste |
| --- | --- |

—

Hazelnut paste

| — | ex 2007 10 10 ; |
| --- | --- |

—

ex 2007 10 10 ;

70

| | ex 2007 10 99 ; |
| --- | --- |

ex 2007 10 99 ;

40

| | ex 2007 99 39 ; |
| --- | --- |

ex 2007 99 39 ;

05; 06

| | ex 2007 99 50 ; |
| --- | --- |

ex 2007 99 50 ;

33

| | ex 2007 99 97 |
| --- | --- |

ex 2007 99 97

23

| — | Hazelnuts, otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Hazelnuts, otherwise prepared or preserved, including mixtures

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

30

| | ex 2008 19 19 ; |
| --- | --- |

ex 2008 19 19 ;

30

| | ex 2008 19 92 ; |
| --- | --- |

ex 2008 19 92 ;

30

| | ex 2008 19 95 ; |
| --- | --- |

ex 2008 19 95 ;

20

| | ex 2008 19 99 ; |
| --- | --- |

ex 2008 19 99 ;

30

| | ex 2008 97 12 ; |
| --- | --- |

ex 2008 97 12 ;

15

| | ex 2008 97 14 ; |
| --- | --- |

ex 2008 97 14 ;

15

| | ex 2008 97 16 ; |
| --- | --- |

ex 2008 97 16 ;

15

| | ex 2008 97 18 ; |
| --- | --- |

ex 2008 97 18 ;

15

| | ex 2008 97 32 ; |
| --- | --- |

ex 2008 97 32 ;

15

| | ex 2008 97 34 ; |
| --- | --- |

ex 2008 97 34 ;

15

| | ex 2008 97 36 ; |
| --- | --- |

ex 2008 97 36 ;

15

| | ex 2008 97 38 ; |
| --- | --- |

ex 2008 97 38 ;

15

| | ex 2008 97 51 ; |
| --- | --- |

ex 2008 97 51 ;

15

| | ex 2008 97 59 ; |
| --- | --- |

ex 2008 97 59 ;

15

| | ex 2008 97 72 ; |
| --- | --- |

ex 2008 97 72 ;

15

| | ex 2008 97 74 ; |
| --- | --- |

ex 2008 97 74 ;

15

| | ex 2008 97 76 ; |
| --- | --- |

ex 2008 97 76 ;

15

| | ex 2008 97 78 ; |
| --- | --- |

ex 2008 97 78 ;

15

| | ex 2008 97 92 ; |
| --- | --- |

ex 2008 97 92 ;

15

| | ex 2008 97 93 ; |
| --- | --- |

ex 2008 97 93 ;

15

| | ex 2008 97 94 ; |
| --- | --- |

ex 2008 97 94 ;

15

| | ex 2008 97 96 ; |
| --- | --- |

ex 2008 97 96 ;

15

| | ex 2008 97 97 ; |
| --- | --- |

ex 2008 97 97 ;

15

| | ex 2008 97 98 ; |
| --- | --- |

ex 2008 97 98 ;

15

| — | Flour, meal and powder of hazelnuts |
| --- | --- |

—

Flour, meal and powder of hazelnuts

| — | ex 1106 30 90 |
| --- | --- |

—

ex 1106 30 90

40

| — | Hazelnut oil |
| --- | --- |

—

Hazelnut oil

(Food)

| — | ex 1515 90 99 |
| --- | --- |

—

ex 1515 90 99

20

29

Lemons (Citrus limon, Citrus limonum)

(
  Food – fresh, chilled or dried
  )

| | 0805 50 10 |
| --- | --- |

0805 50 10

Turkey (TR)

Pesticide residues (3)

20

30

Mandarins (including tangerines and satsumas); clementines, wilkings and similar citrus hybrids

(Food – fresh or dried)

0805 21 ;

0805 22 ;

0805 29

Turkey (TR)

Pesticide residues (3)

20

31

Oranges

(Food – fresh or dried)

0805 10

Turkey (TR)

Pesticide residues (3)

20

32

Pomegranates

(Food – fresh or chilled)

ex 0810 90 75

30

Turkey (TR)

Pesticide residues (3)
   (16)

20

33

| — | Sweet peppers (Capsicum annuum) |
| --- | --- |

—

Sweet peppers (Capsicum annuum)

| — | 0709 60 10 ;
  0710 80 51 ; |
| --- | --- |

—

0709 60 10 ;

0710 80 51 ;

Turkey (TR)

Pesticide residues (3)
   (17)

20

| — | Peppers of the genus Capsicum (other than sweet) |
| --- | --- |

—

Peppers of the genus Capsicum (other than sweet)

(Food – fresh, chilled or frozen)

| — | ex 0709 60 99 ; |
| --- | --- |

—

ex 0709 60 99 ;

20

ex 0710 80 59

20

34

Unprocessed whole, ground, milled, cracked, chopped apricot kernels intended to be placed on the market for the final consumer (18)
   (19)

(Food)

ex 1212 99 95

20

Turkey (TR)

Cyanide

50

35

Peppers of the genus Capsicum (other than sweet)

(Food – fresh, chilled or frozen)

| | ex 0709 60 99 ; |
| --- | --- |

ex 0709 60 99 ;

20

Uganda (UG)

Pesticide residues (3)

50

| | ex 0710 80 59 |
| --- | --- |

ex 0710 80 59

20

36

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

United States (US)

Aflatoxins

20

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

37

| — | Dried apricots |
| --- | --- |

—

Dried apricots

| — | 0813 10 00 |
| --- | --- |

—

0813 10 00

Uzbekistan (UZ)

Sulphites (20)

50

| — | Apricots, otherwise prepared or preserved |
| --- | --- |

—

Apricots, otherwise prepared or preserved

(Food)

| — | 2008 50 |
| --- | --- |

—

2008 50

38

| — | Coriander leaves |
| --- | --- |

—

Coriander leaves

| — | ex 0709 99 90 |
| --- | --- |

—

ex 0709 99 90

72

Vietnam (VN)

Pesticide residues (3)
   (21)

50

| — | Basil (holy, sweet) |
| --- | --- |

—

Basil (holy, sweet)

| — | ex 1211 90 86 |
| --- | --- |

—

ex 1211 90 86

20

| — | Mint |
| --- | --- |

—

Mint

| — | ex 1211 90 86 |
| --- | --- |

—

ex 1211 90 86

30

| — | Parsley |
| --- | --- |

—

Parsley

(Food – fresh or chilled herbs)

| — | ex 0709 99 90 |
| --- | --- |

—

ex 0709 99 90

40

39

Okra

(Food – fresh, chilled or frozen)

| | ex 0709 99 90 ; |
| --- | --- |

ex 0709 99 90 ;

20

Vietnam (VN)

Pesticide residues (3)
   (21)

50

| | ex 0710 80 95 |
| --- | --- |

ex 0710 80 95

30

40

Peppers of the genus Capsicum (other than sweet)

(Food – fresh, chilled or frozen)

| | ex 0709 60 99 ; |
| --- | --- |

ex 0709 60 99 ;

20

Vietnam (VN)

Pesticide residues (3)
   (21)

50

| | ex 0710 80 59 |
| --- | --- |

ex 0710 80 59

20

ANNEX II

Food and feed from certain third countries subject to special conditions for the entry into the Union due to contamination risk by mycotoxins, including aflatoxins, pesticide residues, pentachlorophenol and dioxins, and to microbiological contamination

1.   Food and feed of non-animal origin referred to in Article 1(1)(b)(i)

| Row | Food and feed (intended use) | CN code
   (23) | TARIC sub-division | Country of origin | Hazard | Frequency of identity and physical checks (%) |
| --- | --- | --- | --- | --- | --- | --- |
| 1 | — | Groundnuts (peanuts), in shell |

Row

Food and feed (intended use)

CN code
   (23)

TARIC sub-division

Country of origin

Hazard

Frequency of identity and physical checks (%)

1

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Argentina (AR)

Aflatoxins

5

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved, including mixtures

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 ; |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98 ;

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

40

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

40

| — | ex 2008 19 19 ; |
| --- | --- |

—

ex 2008 19 19 ;

50

| — | ex 2008 19 92 ; |
| --- | --- |

—

ex 2008 19 92 ;

40

| — | ex 2008 19 93 ; |
| --- | --- |

—

ex 2008 19 93 ;

40

| — | ex 2008 19 95 ; |
| --- | --- |

—

ex 2008 19 95 ;

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

50

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

2

| — | Hazelnuts (Corylus sp.), in shell |
| --- | --- |

—

Hazelnuts (Corylus sp.), in shell

| — | 0802 21 00 |
| --- | --- |

—

0802 21 00

Azerbaijan (AZ)

Aflatoxins

20

| — | Hazelnuts (Corylus sp.), shelled |
| --- | --- |

—

Hazelnuts (Corylus sp.), shelled

| — | 0802 22 00 |
| --- | --- |

—

0802 22 00

| — | Mixtures of nuts or dried fruits containing hazelnuts |
| --- | --- |

—

Mixtures of nuts or dried fruits containing hazelnuts

| — | ex 0813 50 39 ; |
| --- | --- |

—

ex 0813 50 39 ;

70

| | ex 0813 50 91 ; |
| --- | --- |

ex 0813 50 91 ;

70

| | ex 0813 50 99 |
| --- | --- |

ex 0813 50 99

70

| — | Hazelnut paste |
| --- | --- |

—

Hazelnut paste

| — | ex 2007 10 10 ; |
| --- | --- |

—

ex 2007 10 10 ;

70

| | ex 2007 10 99 ; |
| --- | --- |

ex 2007 10 99 ;

40

| | ex 2007 99 39 ; |
| --- | --- |

ex 2007 99 39 ;

05; 06

| | ex 2007 99 50 ; |
| --- | --- |

ex 2007 99 50 ;

33

| | ex 2007 99 97 |
| --- | --- |

ex 2007 99 97

23

| — | Hazelnuts, otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Hazelnuts, otherwise prepared or preserved, including mixtures

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

30

| | ex 2008 19 19 ; |
| --- | --- |

ex 2008 19 19 ;

30

| | ex 2008 19 92 ; |
| --- | --- |

ex 2008 19 92 ;

30

| | ex 2008 19 95 ; |
| --- | --- |

ex 2008 19 95 ;

20

| | ex 2008 19 99 ; |
| --- | --- |

ex 2008 19 99 ;

30

| | ex 2008 97 12 ; |
| --- | --- |

ex 2008 97 12 ;

15

| | ex 2008 97 14 ; |
| --- | --- |

ex 2008 97 14 ;

15

| | ex 2008 97 16 ; |
| --- | --- |

ex 2008 97 16 ;

15

| | ex 2008 97 18 ; |
| --- | --- |

ex 2008 97 18 ;

15

| | ex 2008 97 32 ; |
| --- | --- |

ex 2008 97 32 ;

15

| | ex 2008 97 34 ; |
| --- | --- |

ex 2008 97 34 ;

15

| | ex 2008 97 36 ; |
| --- | --- |

ex 2008 97 36 ;

15

| | ex 2008 97 38 ; |
| --- | --- |

ex 2008 97 38 ;

15

| | ex 2008 97 51 ; |
| --- | --- |

ex 2008 97 51 ;

15

| | ex 2008 97 59 ; |
| --- | --- |

ex 2008 97 59 ;

15

| | ex 2008 97 72 ; |
| --- | --- |

ex 2008 97 72 ;

15

| | ex 2008 97 74 ; |
| --- | --- |

ex 2008 97 74 ;

15

| | ex 2008 97 76 ; |
| --- | --- |

ex 2008 97 76 ;

15

| | ex 2008 97 78 ; |
| --- | --- |

ex 2008 97 78 ;

15

| | ex 2008 97 92 ; |
| --- | --- |

ex 2008 97 92 ;

15

| | ex 2008 97 93 ; |
| --- | --- |

ex 2008 97 93 ;

15

| | ex 2008 97 94 ; |
| --- | --- |

ex 2008 97 94 ;

15

| | ex 2008 97 96 ; |
| --- | --- |

ex 2008 97 96 ;

15

| | ex 2008 97 97 ; |
| --- | --- |

ex 2008 97 97 ;

15

| | ex 2008 97 98 ; |
| --- | --- |

ex 2008 97 98 ;

15

| — | Flour, meal and powder of hazelnuts |
| --- | --- |

—

Flour, meal and powder of hazelnuts

| — | ex 1106 30 90 |
| --- | --- |

—

ex 1106 30 90

40

| — | Hazelnut oil |
| --- | --- |

—

Hazelnut oil

(Food)

| — | ex 1515 90 99 |
| --- | --- |

—

ex 1515 90 99

20

3

| — | Foodstuffs containing or consisting of betel leaves (Piper betle) |
| --- | --- |

—

Foodstuffs containing or consisting of betel leaves (Piper betle)

(Food)

ex 1404 90 00  (32)

10

Bangladesh (BD)

Salmonella
   (28)

50

4

| — | Brazil nuts in shell |
| --- | --- |

—

Brazil nuts in shell

| — | 0801 21 00 |
| --- | --- |

—

0801 21 00

Brazil (BR)

Aflatoxins

50

| — | Mixtures of nuts or dried fruits containing Brazil nuts in shell |
| --- | --- |

—

Mixtures of nuts or dried fruits containing Brazil nuts in shell

(Food)

| — | ex 0813 50 31 ; |
| --- | --- |

—

ex 0813 50 31 ;

20

| | ex 0813 50 39 ; |
| --- | --- |

ex 0813 50 39 ;

20

| | ex 0813 50 91 ; |
| --- | --- |

ex 0813 50 91 ;

20

| | ex 0813 50 99 |
| --- | --- |

ex 0813 50 99

20

5

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Egypt (EG)

Aflatoxins

20

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved, including mixtures

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 ; |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98 ;

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

40

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

40

| — | ex 2008 19 19 ; |
| --- | --- |

—

ex 2008 19 19 ;

50

| — | ex 2008 19 92 ; |
| --- | --- |

—

ex 2008 19 92 ;

40

| — | ex 2008 19 93 ; |
| --- | --- |

—

ex 2008 19 93 ;

40

| — | ex 2008 19 95 ; |
| --- | --- |

—

ex 2008 19 95 ;

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

50

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

6

| — | Pepper of the genus Piper; dried or crushed or ground fruit of the genus Capsicum or of the genus Pimenta |
| --- | --- |

—

Pepper of the genus Piper; dried or crushed or ground fruit of the genus Capsicum or of the genus Pimenta

| — | 0904 |
| --- | --- |

—

0904

Ethiopia (ET)

Aflatoxins

50

| — | Ginger, saffron, turmeric (curcuma), thyme, bay leaves, curry and other spices |
| --- | --- |

—

Ginger, saffron, turmeric (curcuma), thyme, bay leaves, curry and other spices

(Food – dried spices)

| — | 0910 |
| --- | --- |

—

0910

7

Sesamum seeds

(Food)

| — | 1207 40 90 |
| --- | --- |

—

1207 40 90

Ethiopia (ET)

Salmonella
   (28)

50

| — | ex 2008 19 19 |
| --- | --- |

—

ex 2008 19 19

40

| | ex 2008 19 99 |
| --- | --- |

ex 2008 19 99

40

8

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Ghana (GH)

Aflatoxins

50

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved, including mixtures

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 ; |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98 ;

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

40

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

40

| — | ex 2008 19 19 ; |
| --- | --- |

—

ex 2008 19 19 ;

50

| — | ex 2008 19 92 ; |
| --- | --- |

—

ex 2008 19 92 ;

40

| — | ex 2008 19 93 ; |
| --- | --- |

—

ex 2008 19 93 ;

40

| — | ex 2008 19 95 ; |
| --- | --- |

—

ex 2008 19 95 ;

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

50

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

9

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Gambia (GM)

Aflatoxins

50

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved, including mixtures

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 ; |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98 ;

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

40

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

40

| — | ex 2008 19 19 ; |
| --- | --- |

—

ex 2008 19 19 ;

50

| — | ex 2008 19 92 ; |
| --- | --- |

—

ex 2008 19 92 ;

40

| — | ex 2008 19 93 ; |
| --- | --- |

—

ex 2008 19 93 ;

40

| — | ex 2008 19 95 ; |
| --- | --- |

—

ex 2008 19 95 ;

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

50

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

10

Nutmeg (Myristica fragrans)

(Food – dried spices)

| | 0908 11 00 ; |
| --- | --- |

0908 11 00 ;

| | 0908 12 00 |
| --- | --- |

0908 12 00

Indonesia (ID)

Aflatoxins

20

11

Betel leaves (Piper betle L.)

(Food)

ex 1404 90 00

10

India (IN)

Salmonella
   (24)

10

12

Peppers of the genus Capsicum (sweet or other than sweet)

(Food – dried, roasted, crushed or ground)

| | 0904 21 10 ; |
| --- | --- |

0904 21 10 ;

India (IN)

Aflatoxins

20

| | ex 0904 22 00 ; |
| --- | --- |

ex 0904 22 00 ;

11; 19

| | ex 0904 21 90 ; |
| --- | --- |

ex 0904 21 90 ;

20

| | ex 2005 99 10 ; |
| --- | --- |

ex 2005 99 10 ;

10; 90

| | ex 2005 99 80 |
| --- | --- |

ex 2005 99 80

94

13

Nutmeg (Myristica fragrans)

(Food – dried spices)

0908 11 00 ;

0908 12 00

India (IN)

Aflatoxins

20

14

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

India (IN)

Aflatoxins

50

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved, including mixtures

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 ; |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98 ;

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

40

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

40

| — | ex 2008 19 19 ; |
| --- | --- |

—

ex 2008 19 19 ;

50

| — | ex 2008 19 92 ; |
| --- | --- |

—

ex 2008 19 92 ;

40

| — | ex 2008 19 93 ; |
| --- | --- |

—

ex 2008 19 93 ;

40

| — | ex 2008 19 95 ; |
| --- | --- |

—

ex 2008 19 95 ;

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

50

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

15

Guar gum

(Food and feed)

ex 1302 32 90

10

India (IN)

Pentachlorophenol and dioxins (25)

5

16

Peppers of the genus Capsicum (other than sweet)

(Food – fresh, chilled or frozen)

| | ex 0709 60 99 ; |
| --- | --- |

ex 0709 60 99 ;

20

India (IN)

Pesticide residues (26)
   (27)

10

| | ex 0710 80 59 |
| --- | --- |

ex 0710 80 59

20

17

Sesamum seeds

(Food and feed)

| — | 1207 40 90 |
| --- | --- |

—

1207 40 90

India (IN)

Salmonella
   (28)

Pesticide residues (26)
   (33)

20

50

| — | ex 2008 19 19 |
| --- | --- |

—

ex 2008 19 19

40

| | ex 2008 19 99 |
| --- | --- |

ex 2008 19 99

40

18

| — | Pistachios, in shell |
| --- | --- |

—

Pistachios, in shell

| — | 0802 51 00 |
| --- | --- |

—

0802 51 00

Iran (IR)

Aflatoxins

50

| — | Pistachios, shelled |
| --- | --- |

—

Pistachios, shelled

| — | 0802 52 00 |
| --- | --- |

—

0802 52 00

| — | Mixtures of nuts or dried fruits containing pistachios |
| --- | --- |

—

Mixtures of nuts or dried fruits containing pistachios

| — | ex 0813 50 39 ; |
| --- | --- |

—

ex 0813 50 39 ;

60

| | ex 0813 50 91 ; |
| --- | --- |

ex 0813 50 91 ;

60

| | ex 0813 50 99 |
| --- | --- |

ex 0813 50 99

60

| — | Pistachio paste |
| --- | --- |

—

Pistachio paste

| — | ex 2007 10 10 ; |
| --- | --- |

—

ex 2007 10 10 ;

60

| | ex 2007 10 99 ; |
| --- | --- |

ex 2007 10 99 ;

30

| | ex 2007 99 39 ; |
| --- | --- |

ex 2007 99 39 ;

03; 04

| | ex 2007 99 50 ; |
| --- | --- |

ex 2007 99 50 ;

32

| | ex 2007 99 97 |
| --- | --- |

ex 2007 99 97

22

| — | Pistachios, prepared or preserved, including mixtures |
| --- | --- |

—

Pistachios, prepared or preserved, including mixtures

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

20

| | ex 2008 19 93 ; |
| --- | --- |

ex 2008 19 93 ;

20

| | ex 2008 97 12 ; |
| --- | --- |

ex 2008 97 12 ;

19

| | ex 2008 97 14 ; |
| --- | --- |

ex 2008 97 14 ;

19

| | ex 2008 97 16 ; |
| --- | --- |

ex 2008 97 16 ;

19

| | ex 2008 97 18 ; |
| --- | --- |

ex 2008 97 18 ;

19

| | ex 2008 97 32 ; |
| --- | --- |

ex 2008 97 32 ;

19

| | ex 2008 97 34 ; |
| --- | --- |

ex 2008 97 34 ;

19

| | ex 2008 97 36 ; |
| --- | --- |

ex 2008 97 36 ;

19

| | ex 2008 97 38 ; |
| --- | --- |

ex 2008 97 38 ;

19

| | ex 2008 97 51 ; |
| --- | --- |

ex 2008 97 51 ;

19

| | ex 2008 97 59 ; |
| --- | --- |

ex 2008 97 59 ;

19

| | ex 2008 97 72 ; |
| --- | --- |

ex 2008 97 72 ;

19

| | ex 2008 97 74 ; |
| --- | --- |

ex 2008 97 74 ;

19

| | ex 2008 97 76 ; |
| --- | --- |

ex 2008 97 76 ;

19

| | ex 2008 97 78 ; |
| --- | --- |

ex 2008 97 78 ;

19

| | ex 2008 97 92 ; |
| --- | --- |

ex 2008 97 92 ;

19

| | ex 2008 97 93 ; |
| --- | --- |

ex 2008 97 93 ;

19

| | ex 2008 97 94 ; |
| --- | --- |

ex 2008 97 94 ;

19

| | ex 2008 97 96 ; |
| --- | --- |

ex 2008 97 96 ;

19

| | ex 2008 97 97 ; |
| --- | --- |

ex 2008 97 97 ;

19

| | ex 2008 97 98 |
| --- | --- |

ex 2008 97 98

19

| — | Flour, meal and powder of pistachios |
| --- | --- |

—

Flour, meal and powder of pistachios

(Food)

| — | ex 1106 30 90 |
| --- | --- |

—

ex 1106 30 90

50

19

Peppers of the genus Capsicum

(sweet or other than sweet)

(Food – dried, roasted, crushed or ground)

| | 0904 21 10 ; |
| --- | --- |

0904 21 10 ;

Sri Lanka (LK)

Aflatoxins

50

| | ex 0904 21 90 ; |
| --- | --- |

ex 0904 21 90 ;

20

| | ex 0904 22 00 ; |
| --- | --- |

ex 0904 22 00 ;

11; 19

| | ex 2005 99 10 ; |
| --- | --- |

ex 2005 99 10 ;

10; 90

| | ex 2005 99 80 |
| --- | --- |

ex 2005 99 80

94

20

Watermelon (Egusi, Citrullus spp.) seeds and derived products

(Food)

| | ex 1207 70 00 ; |
| --- | --- |

ex 1207 70 00 ;

10

Nigeria (NG)

Aflatoxins

50

| | ex 1208 90 00 ; |
| --- | --- |

ex 1208 90 00 ;

10

| | ex 2008 99 99 |
| --- | --- |

ex 2008 99 99

50

21

Peppers of the genus Capsicum (other than sweet)

(Food – fresh, chilled or frozen)

| | ex 0709 60 99 ; |
| --- | --- |

ex 0709 60 99 ;

20

Pakistan (PK)

Pesticide residues (26)

20

| | ex 0710 80 59 |
| --- | --- |

ex 0710 80 59

20

22

| — | Groundnuts (peanuts), in shell |
| --- | --- |

—

Groundnuts (peanuts), in shell

| — | 1202 41 00 |
| --- | --- |

—

1202 41 00

Sudan (SD)

Aflatoxins

50

| — | Groundnuts (peanuts), shelled |
| --- | --- |

—

Groundnuts (peanuts), shelled

| — | 1202 42 00 |
| --- | --- |

—

1202 42 00

| — | Peanut butter |
| --- | --- |

—

Peanut butter

| — | 2008 11 10 |
| --- | --- |

—

2008 11 10

| — | Groundnuts (peanuts), otherwise prepared or preserved, including mixtures |
| --- | --- |

—

Groundnuts (peanuts), otherwise prepared or preserved, including mixtures

| — | 2008 11 91 ;
  2008 11 96 ;
  2008 11 98 ; |
| --- | --- |

—

2008 11 91 ;

2008 11 96 ;

2008 11 98 ;

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

40

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

40

| — | ex 2008 19 19 ; |
| --- | --- |

—

ex 2008 19 19 ;

50

| — | ex 2008 19 92 ; |
| --- | --- |

—

ex 2008 19 92 ;

40

| — | ex 2008 19 93 ; |
| --- | --- |

—

ex 2008 19 93 ;

40

| — | ex 2008 19 95 ; |
| --- | --- |

—

ex 2008 19 95 ;

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

50

| — | Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil |
| --- | --- |

—

Oilcake and other solid residues, whether or not ground or in the form of pellets, resulting from the extraction of groundnut oil

| — | 2305 00 00 |
| --- | --- |

—

2305 00 00

| — | Groundnut flours and meals |
| --- | --- |

—

Groundnut flours and meals

(
  Food and feed
  )

| — | ex 1208 90 00 |
| --- | --- |

—

ex 1208 90 00

20

23

Sesamum seeds

(Food)

| — | 1207 40 90 |
| --- | --- |

—

1207 40 90

Sudan (SD)

Salmonella
   (28)

50

| — | ex 2008 19 19 |
| --- | --- |

—

ex 2008 19 19

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

40

24

| — | Dried figs |
| --- | --- |

—

Dried figs

| — | 0804 20 90 |
| --- | --- |

—

0804 20 90

Turkey (TR)

Aflatoxins

20

| — | Mixtures of nuts or dried fruits containing figs |
| --- | --- |

—

Mixtures of nuts or dried fruits containing figs

| — | ex 0813 50 99 |
| --- | --- |

—

ex 0813 50 99

50

| — | Dried fig paste |
| --- | --- |

—

Dried fig paste

| — | ex 2007 10 10 ; |
| --- | --- |

—

ex 2007 10 10 ;

50

| | ex 2007 10 99 ; |
| --- | --- |

ex 2007 10 99 ;

20

| | ex 2007 99 39 ; |
| --- | --- |

ex 2007 99 39 ;

01; 02

| | ex 2007 99 50 ; |
| --- | --- |

ex 2007 99 50 ;

31

| | ex 2007 99 97 |
| --- | --- |

ex 2007 99 97

21

| — | Dried figs, prepared or preserved, including mixtures |
| --- | --- |

—

Dried figs, prepared or preserved, including mixtures

| — | ex 2008 19 12 ; |
| --- | --- |

—

ex 2008 19 12 ;

11

| | ex 2008 19 14 ; |
| --- | --- |

ex 2008 19 14 ;

11

| | ex 2008 97 16 ; |
| --- | --- |

ex 2008 97 16 ;

11

| | ex 2008 97 18 ; |
| --- | --- |

ex 2008 97 18 ;

11

| | ex 2008 97 32 ; |
| --- | --- |

ex 2008 97 32 ;

11

| | ex 2008 97 34 ; |
| --- | --- |

ex 2008 97 34 ;

11

| | ex 2008 97 36 ; |
| --- | --- |

ex 2008 97 36 ;

11

| | ex 2008 97 38 ; |
| --- | --- |

ex 2008 97 38 ;

11

| | ex 2008 97 51 ; |
| --- | --- |

ex 2008 97 51 ;

11

| | ex 2008 97 59 ; |
| --- | --- |

ex 2008 97 59 ;

11

| | ex 2008 97 72 ; |
| --- | --- |

ex 2008 97 72 ;

11

| | ex 2008 97 74 ; |
| --- | --- |

ex 2008 97 74 ;

11

| | ex 2008 97 76 ; |
| --- | --- |

ex 2008 97 76 ;

11

| | ex 2008 97 78 ; |
| --- | --- |

ex 2008 97 78 ;

11

| | ex 2008 97 92 ; |
| --- | --- |

ex 2008 97 92 ;

11

| | ex 2008 97 93 ; |
| --- | --- |

ex 2008 97 93 ;

11

| | ex 2008 97 94 ; |
| --- | --- |

ex 2008 97 94 ;

11

| | ex 2008 97 96 ; |
| --- | --- |

ex 2008 97 96 ;

11

| | ex 2008 97 97 ; |
| --- | --- |

ex 2008 97 97 ;

11

| | ex 2008 97 98 ; |
| --- | --- |

ex 2008 97 98 ;

11

| | ex 2008 99 28 ; |
| --- | --- |

ex 2008 99 28 ;

10

| | ex 2008 99 34 ; |
| --- | --- |

ex 2008 99 34 ;

10

| | ex 2008 99 37 ; |
| --- | --- |

ex 2008 99 37 ;

10

| | ex 2008 99 40 ; |
| --- | --- |

ex 2008 99 40 ;

10

| | ex 2008 99 49 ; |
| --- | --- |

ex 2008 99 49 ;

60

| | ex 2008 99 67 ; |
| --- | --- |

ex 2008 99 67 ;

95

| | ex 2008 99 99 |
| --- | --- |

ex 2008 99 99

60

| — | Flour, meal and powder of dried figs


  (Food) |
| --- | --- |

—

Flour, meal and powder of dried figs

(Food)

| — | ex 1106 30 90 |
| --- | --- |

—

ex 1106 30 90

60

25

| — | Pistachios, in shell |
| --- | --- |

—

Pistachios, in shell

| — | 0802 51 00 |
| --- | --- |

—

0802 51 00

Turkey (TR)

Aflatoxins

50

| — | Pistachios, shelled |
| --- | --- |

—

Pistachios, shelled

| — | 0802 52 00 |
| --- | --- |

—

0802 52 00

| — | Mixtures of nuts or dried fruits containing pistachios |
| --- | --- |

—

Mixtures of nuts or dried fruits containing pistachios

| — | ex 0813 50 39 ; |
| --- | --- |

—

ex 0813 50 39 ;

60

| | ex 0813 50 91 ; |
| --- | --- |

ex 0813 50 91 ;

60

| | ex 0813 50 99 |
| --- | --- |

ex 0813 50 99

60

| — | Pistachio paste |
| --- | --- |

—

Pistachio paste

| — | ex 2007 10 10 ; |
| --- | --- |

—

ex 2007 10 10 ;

60

| | ex 2007 10 99 ; |
| --- | --- |

ex 2007 10 99 ;

30

| | ex 2007 99 39 ; |
| --- | --- |

ex 2007 99 39 ;

03; 04

| | ex 2007 99 50 ; |
| --- | --- |

ex 2007 99 50 ;

32

| | ex 2007 99 97 |
| --- | --- |

ex 2007 99 97

22

| — | Pistachios, prepared or preserved, including mixtures |
| --- | --- |

—

Pistachios, prepared or preserved, including mixtures

| — | ex 2008 19 13 ; |
| --- | --- |

—

ex 2008 19 13 ;

20

| | ex 2008 19 93 ; |
| --- | --- |

ex 2008 19 93 ;

20

| | ex 2008 97 12 |
| --- | --- |

ex 2008 97 12

19

| | ex 2008 97 14 ; |
| --- | --- |

ex 2008 97 14 ;

19

| | ex 2008 97 16 ; |
| --- | --- |

ex 2008 97 16 ;

19

| | ex 2008 97 18 ; |
| --- | --- |

ex 2008 97 18 ;

19

| | ex 2008 97 32 ; |
| --- | --- |

ex 2008 97 32 ;

19

| | ex 2008 97 34 ; |
| --- | --- |

ex 2008 97 34 ;

19

| | ex 2008 97 36 ; |
| --- | --- |

ex 2008 97 36 ;

19

| | ex 2008 97 38 ; |
| --- | --- |

ex 2008 97 38 ;

19

| | ex 2008 97 51 ; |
| --- | --- |

ex 2008 97 51 ;

19

| | ex 2008 97 59 ; |
| --- | --- |

ex 2008 97 59 ;

19

| | ex 2008 97 72 ; |
| --- | --- |

ex 2008 97 72 ;

19

| | ex 2008 97 74 ; |
| --- | --- |

ex 2008 97 74 ;

19

| | ex 2008 97 76 ; |
| --- | --- |

ex 2008 97 76 ;

19

| | ex 2008 97 78 ; |
| --- | --- |

ex 2008 97 78 ;

19

| | ex 2008 97 92 ; |
| --- | --- |

ex 2008 97 92 ;

19

| | ex 2008 97 93 ; |
| --- | --- |

ex 2008 97 93 ;

19

| | ex 2008 97 94 ; |
| --- | --- |

ex 2008 97 94 ;

19

| | ex 2008 97 96 ; |
| --- | --- |

ex 2008 97 96 ;

19

| | ex 2008 97 97 ; |
| --- | --- |

ex 2008 97 97 ;

19

| | ex 2008 97 98 |
| --- | --- |

ex 2008 97 98

19

| — | Flour, meal and powder of pistachios |
| --- | --- |

—

Flour, meal and powder of pistachios

(Food)

| — | ex 1106 30 90 |
| --- | --- |

—

ex 1106 30 90

50

26

Vine leaves

(Food)

ex 2008 99 99

11; 19

Turkey (TR)

Pesticide residues (26)
   (29)

50

27

Sesamum seeds

(Food)

| — | 1207 40 90 |
| --- | --- |

—

1207 40 90

Uganda (UG)

Salmonella
   (28)

20

| — | ex 2008 19 19 |
| --- | --- |

—

ex 2008 19 19

40

| — | ex 2008 19 99 |
| --- | --- |

—

ex 2008 19 99

40

28

Pitahaya (dragon fruit)

(Food – fresh or chilled)

ex 0810 90 20

10

Vietnam (VN)

Pesticide residues (26)
   (30)

10

2.   Food referred to in Article 1(1)(b)(ii)

| Row | Food consisting of two or more ingredients, containing any of the individual products listed in the table in point 1 of this Annex due to risk of contamination by aflatoxins in a quantity above 20 % of either a single product or as the sum of products listed |
| --- | --- |
| | CN code
   (34) | Description
   (35) |
| 1 | ex 1704 90 | Sugar confectionery (including white chocolate), not containing cocoa, other than chewing gum, whether or not sugar-coated |
| 2 | ex 1806 | Chocolate and other food preparations containing cocoa |
| 3 | ex 1905 | Bread, pastry, cakes, biscuits and other bakers’ wares, whether or not containing cocoa, communion wafers, empty cachets of a kind suitable for pharmaceutical use, sealing wafers, rice paper and similar products |

Row

Food consisting of two or more ingredients, containing any of the individual products listed in the table in point 1 of this Annex due to risk of contamination by aflatoxins in a quantity above 20 % of either a single product or as the sum of products listed

CN code
   (34)

Description
   (35)

1

ex 1704 90

Sugar confectionery (including white chocolate), not containing cocoa, other than chewing gum, whether or not sugar-coated

2

ex 1806

Chocolate and other food preparations containing cocoa

3

ex 1905

Bread, pastry, cakes, biscuits and other bakers’ wares, whether or not containing cocoa, communion wafers, empty cachets of a kind suitable for pharmaceutical use, sealing wafers, rice paper and similar products

ANNEX IIa

Food and feed from certain third countries subject to suspension of entry into the Union referred to in Article 11a

| Row | Food and feed


  (intended use) | CN code | TARIC sub-division | Country of origin | Hazard |
| --- | --- | --- | --- | --- | --- |
| 1 | — | Foodstuffs consisting of dried beans |

Row

Food and feed

(intended use)

CN code

TARIC sub-division

Country of origin

Hazard

1

—

Foodstuffs consisting of dried beans

(Food)

| — | 0713 35 00 |
| --- | --- |

—

0713 35 00

| — | 0713 39 00 |
| --- | --- |

—

0713 39 00

| — | 0713 90 00 |
| --- | --- |

—

0713 90 00

Nigeria (NG)

Pesticide residues

ANNEX IV

MODEL OFFICIAL CERTIFICATE REFERRED TO IN ARTICLE 11 OF COMMISSION IMPLEMENTING REGULATION (EU) 2019/1793 FOR THE ENTRY INTO THE UNION OF CERTAIN FOOD OR FEED

Image 9

Image 10

Image 11

Image 12

NOTES FOR THE COMPLETION OF THE MODEL OFFICIAL CERTIFICATE REFERRED TO IN ARTICLE 11 OF COMMISSION IMPLEMENTING REGULATION (EU) 2019/1793 FOR THE ENTRY INTO THE UNION OF CERTAIN FOOD OR FEED

General

To positively select any option, please tick or mark the relevant box with a cross (X).

Only one of the options may be selected in boxes I.18, I.20.

Select among points II.2.1, II.2.2, II.2.3 and II.2.4, the point(s) corresponding to the category of product and the hazard(s) for which the certification is given.

Unless otherwise indicated, all boxes are compulsory.

If the consignee, the entry border control post (BCP) or the transport details (that is to say, the means and date) change after the certificate has been issued, the operator responsible for the consignment must advise the competent authority of the Member State of entry. Such a change shall not result in a request for a replacement certificate.

In case the certificate is submitted in the information management system for official controls (IMSOC), the following applies:

| — | the statements which are not relevant are crossed out, |
| --- | --- |

—

the statements which are not relevant are crossed out,

| — | the entries or boxes specified in Part I constitute the data dictionaries for the electronic version of the official certificate, |
| --- | --- |

—

the entries or boxes specified in Part I constitute the data dictionaries for the electronic version of the official certificate,

| — | the sequences of boxes in Part I of the model official certificate and the size and shape of those boxes are indicative, |
| --- | --- |

—

the sequences of boxes in Part I of the model official certificate and the size and shape of those boxes are indicative,

| — | where a stamp is required, its electronic equivalent is an electronic seal. |
| --- | --- |

—

where a stamp is required, its electronic equivalent is an electronic seal.

In case the official certificate is not submitted in the IMSOC, the statements which are not relevant must be crossed out, initialled and stamped by the certifying officer, or completely removed from the certificate.

| PART I – DESCRIPTION OF CONSIGNMENT |
| --- |
| Box | Description |
| | Country |
| | Indicate the name of the third country issuing the certificate. |
| I.1 | Consignor/Exporter |
| | Indicate the name and address, country and ISO country code (36), of the natural or legal person dispatching the consignment. This person shall be established in a third country, except for the re-entry of consignments originating in the Union. |
| I.2 | Certificate reference |
| | Indicate the unique alphanumeric code assigned by the competent authority of the third country. This box is not compulsory for certificates submitted in the IMSOC. Repeated in box II.a |
| I.2a | IMSOC reference |
| | This is the unique alphanumeric code assigned by the IMSOC. Repeated in box II.b
  This box shall not be completed if the certificate is not submitted in the IMSOC. |
| I.3 | Central competent authority |
| | Indicate the name of the central authority in the third country issuing the certificate. |
| I.4 | Local competent authority |
| | Indicate, if applicable, the name of the local authority in the third country issuing the certificate. |
| I.5 | Consignee/Importer |
| | Indicate the name and address of the natural or legal person to whom the consignment is destined in the Member State of destination. |
| I.6 | Operator responsible for the consignment |
| | Indicate the name and address, country and ISO country code, of the natural or legal person in the Member State in charge of the consignment when presented at the Border Control Post (BCP) who makes the necessary declarations to the competent authorities as the importer or on behalf of the importer. This operator may be the same as indicated in box I.5.
  This box is optional. |
| I.7 | Country of origin |
| | Indicate the name and ISO country code of the country where the goods originate from, were grown, harvested or produced for food and feed listed in the Annexes due to a possible risk of contamination by mycotoxins, including aflatoxins, or by plant toxins, or due to possible non-compliance with the maximum allowed levels of pesticide residues.
  Indicate the name and ISO country code of the country where the goods were produced, manufactured or wrapped for food and feed listed in the Annexes due to the risk of presence of Salmonella or due to other hazards than those specified in the first paragraph. |
| I.8 | Region of origin |
| | Not applicable. |
| I.9 | Country of destination |
| | Indicate the name and ISO country code of Member State of destination of the products. |
| I.10 | Region of destination |
| | Not applicable. |
| I.11 | Place of dispatch |
| | Indicate the name and address, country and ISO country code of the establishment(s) from where the products come from. Where required by Union legislation, indicate its registration or approval number.
  For other products: any unit of a company in the food or feed sector. Only the establishment shipping the products is to be named.
  In the case of trade involving more than one third country (triangular trade), the place of dispatch is the last third-country establishment of the export chain from which the final consignment is transported to the Union. |
| I.12 | Place of destination |
| | Indicate the name and address, country and ISO country code, of the place where the consignment is being delivered for final unloading. Where applicable, also indicate the registration or approval number of the establishment of destination. |
| I.13 | Place of loading |
| | Not applicable. |
| I.14 | Date and time of departure |
| | Indicate the date when the means of transport departs (aircraft, vessel, railway or road vehicle). |
| I.15 | Means of transport |
| | Select one or more of the following means of transport for goods leaving the country of dispatch, and indicate its identification:






  — | aircraft (indicate the flight number); |

PART I – DESCRIPTION OF CONSIGNMENT

Box

Description

Country

Indicate the name of the third country issuing the certificate.

I.1

Consignor/Exporter

Indicate the name and address, country and ISO country code (36), of the natural or legal person dispatching the consignment. This person shall be established in a third country, except for the re-entry of consignments originating in the Union.

I.2

Certificate reference

Indicate the unique alphanumeric code assigned by the competent authority of the third country. This box is not compulsory for certificates submitted in the IMSOC. Repeated in box II.a

I.2a

IMSOC reference

This is the unique alphanumeric code assigned by the IMSOC. Repeated in box II.b

This box shall not be completed if the certificate is not submitted in the IMSOC.

I.3

Central competent authority

Indicate the name of the central authority in the third country issuing the certificate.

I.4

Local competent authority

Indicate, if applicable, the name of the local authority in the third country issuing the certificate.

I.5

Consignee/Importer

Indicate the name and address of the natural or legal person to whom the consignment is destined in the Member State of destination.

I.6

Operator responsible for the consignment

Indicate the name and address, country and ISO country code, of the natural or legal person in the Member State in charge of the consignment when presented at the Border Control Post (BCP) who makes the necessary declarations to the competent authorities as the importer or on behalf of the importer. This operator may be the same as indicated in box I.5.

This box is optional.

I.7

Country of origin

Indicate the name and ISO country code of the country where the goods originate from, were grown, harvested or produced for food and feed listed in the Annexes due to a possible risk of contamination by mycotoxins, including aflatoxins, or by plant toxins, or due to possible non-compliance with the maximum allowed levels of pesticide residues.

Indicate the name and ISO country code of the country where the goods were produced, manufactured or wrapped for food and feed listed in the Annexes due to the risk of presence of Salmonella or due to other hazards than those specified in the first paragraph.

I.8

Region of origin

Not applicable.

I.9

Country of destination

Indicate the name and ISO country code of Member State of destination of the products.

I.10

Region of destination

Not applicable.

I.11

Place of dispatch

Indicate the name and address, country and ISO country code of the establishment(s) from where the products come from. Where required by Union legislation, indicate its registration or approval number.

For other products: any unit of a company in the food or feed sector. Only the establishment shipping the products is to be named.

In the case of trade involving more than one third country (triangular trade), the place of dispatch is the last third-country establishment of the export chain from which the final consignment is transported to the Union.

I.12

Place of destination

Indicate the name and address, country and ISO country code, of the place where the consignment is being delivered for final unloading. Where applicable, also indicate the registration or approval number of the establishment of destination.

I.13

Place of loading

Not applicable.

I.14

Date and time of departure

Indicate the date when the means of transport departs (aircraft, vessel, railway or road vehicle).

I.15

Means of transport

Select one or more of the following means of transport for goods leaving the country of dispatch, and indicate its identification:

—

aircraft (indicate the flight number);

| — | vessel (indicate the vessel name and number); |
| --- | --- |

—

vessel (indicate the vessel name and number);

| — | railway (indicate the train identity and wagon number); |
| --- | --- |

—

railway (indicate the train identity and wagon number);

| — | road vehicle (indicate the registration number with trailer number, if applicable). |
| --- | --- |

—

road vehicle (indicate the registration number with trailer number, if applicable).

In the case of a ferry, tick “vessel” and identify the road vehicle(s) with registration number (with trailer number, if applicable), in addition to the name and number of the scheduled ferry.

I.16

Entry Border Control Post

Indicate the name of the BCP of entry into the Union for certificates not submitted in the IMSOC or select the name of the BCP of entry into the Union and its unique alphanumeric code assigned by the IMSOC.

I.17

Accompanying documents

Indicate the type of required document: analytical report/results of sampling and analyses referred to in Article 10 of Implementing Regulation (EU) 2019/1793, and indicate the unique code of required accompanying documents and country of issue.

Other documents: indicate the type and reference number of document when a consignment is accompanied by other documents such as commercial documents (for example, the airway bill number, the bill of lading number or the commercial number of the train or road vehicle).

I.18

Transport conditions

Indicate the category of required temperature during the transport of products (ambient, chilled, frozen).

I.19

Container number/Seal number

Where applicable, indicate the container number and seal number (more than one possible).

The container number must be provided if the goods are transported in closed containers.

Only the official seal number must be stated. An official seal applies if a seal is affixed to the container, truck or rail wagon under the supervision of the competent authority issuing the certificate.

I.20

Certified as or for

Select the intended use of goods as specified in the relevant Union legislation:

Feedstuffs: concerns only products intended for animal feed.

Products for human consumption: concerns only products intended for human consumption for which an official certificate is required by Union legislation.

I.21

For transit

Not applicable.

I.22

For internal market

Tick this box where consignments are intended to be placed on the Union market.

I.23

For re-entry

Not applicable.

I.24

Total number of packages

Indicate the total number of packages in the consignment, where appropriate:

In the case of bulk consignments, this box is optional.

I.25

Total quantity

Not applicable.

I.26

Total net weight/gross weight (kg)

The total net weight is the mass of goods themselves, without immediate containers or any packaging. It is automatically calculated by the IMSOC on the basis of the information entered in box I.27. The declared net weight of glazed food shall be exclusive of the glaze.

Indicate the total gross weight, i.e. the aggregate mass of the goods, plus immediate containers and all their packaging, but excluding transport containers and other transport equipment.

I.27

Description of consignment

Indicate the relevant Harmonised System (HS) code and the title defined by the World Customs Organisation as referred to in Council Regulation (EEC) No 2658/87 (37). This customs description shall be supplemented, if necessary, by additional information required to classify the products. In addition, state any specific requirements relating to the nature/processing of the products as defined in the relevant Union legislation.

Indicate the species, and approval number of establishments when applicable together with ISO country code, number of packages, type of packaging, batch number, and net weight. Tick “final consumer” where products are packaged for final consumers.

Species: indicate the scientific name or as defined in accordance with Union legislation.

Type of packaging: identify the type of packaging according to the definition given in Recommendation No 21 (38) of UN/CEFACT (United Nations Centre for Trade Facilitation and Electronic Business).

| PART II – Certification |
| --- |
| Box | Description |
| | Country |
| | Indicate the name of the third country issuing the certificate. |
| | Certificate model |
| | This box refers to the specific title of each model of certificate. |
| II | Health information |
| | This box refers to the specific Union health requirements applicable to the nature of the products and as defined in the equivalence agreements with certain third countries or in other Union legislation, such as that for certification. |
| II.2a | Certificate reference |
| | This is the unique alphanumeric code indicated in box I.2. |
| II.2b | IMSOC reference |
| | This is the unique alphanumeric code indicated in box I.2a |
| | Certifying officer |
| | This box refers to the signature of the certifying officer as defined in point (26) of Article 3 of Regulation (EU) 2017/625.
  Indicate the name in capital letters, qualification and title, where applicable, of the signatory, and the name and original stamp of the competent authority the signatory is attached to and date of signature. |

PART II – Certification

Box

Description

Country

Indicate the name of the third country issuing the certificate.

Certificate model

This box refers to the specific title of each model of certificate.

II

Health information

This box refers to the specific Union health requirements applicable to the nature of the products and as defined in the equivalence agreements with certain third countries or in other Union legislation, such as that for certification.

II.2a

Certificate reference

This is the unique alphanumeric code indicated in box I.2.

II.2b

IMSOC reference

This is the unique alphanumeric code indicated in box I.2a

Certifying officer

This box refers to the signature of the certifying officer as defined in point (26) of Article 3 of Regulation (EU) 2017/625.

Indicate the name in capital letters, qualification and title, where applicable, of the signatory, and the name and original stamp of the competent authority the signatory is attached to and date of signature.

---

(1)  Where only certain products under any CN code are required to be examined, the CN code is marked “ex”.

1

(2)  The sampling and the analyses shall be performed in accordance with the sampling procedures and the analytical reference methods set out in point 1(a) of Annex III.

2

(3)  Residues of at least those pesticides listed in the control programme adopted in accordance with Article 29(2) of Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1) that can be analysed with multi-residue methods based on GC-MS and LC-MS (pesticides to be monitored in/on products of plant origin only).

3

(4)  Residues of Amitraz.

4

(5)  Residues of Nicotine.

5

(6)  The sampling and the analyses shall be performed in accordance with the sampling procedures and the analytical reference methods set out in point 1(b) of Annex III.

6

(7)  Residues of Tolfenpyrad.

7

(8)  Residues of Amitraz (amitraz including the metabolites containing the 2,4 -dimethylaniline moiety expressed as amitraz), Diafenthiuron, Dicofol (sum of p, p’ and o,p’ isomers) and Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram).

8

(9)  Residues of Dicofol (sum of p, p’ and o,p’ isomers), Dinotefuran, Folpet, Prochloraz (sum of prochloraz and its metabolites containing the 2,4,6-Trichlorophenol moiety expressed as prochloraz), Thiophanate-methyl and Triforine.

9

(10)  For the purposes of this Annex, “Sudan dyes” refers to the following chemical substances: (i) Sudan I (CAS Number 842-07-9); (ii) Sudan II (CAS Number 3118-97-6); (iii) Sudan III (CAS Number 85-86-9); (iv) Scarlet Red; or Sudan IV (CAS Number 85-83-6).

10

(11)  Residues of Acephate.

11

(12)  Residues of Diafenthiuron.

12

(13)  Residues of Phenthoate.

13

(14)  Residues of Chlorbufam.

14

(15)  Residues of Formetanate (sum of formetanate and its salts expressed as formetanate (hydrochloride)), Prothiofos and Triforine.

15

(16)  Residues of Prochloraz.

16

(17)  Residues of Diafenthiuron, Formetanate (sum of formetanate and its salts expressed as formetanate (hydrochloride)) and Thiophanate-methyl.

17

(18)  
  “Unprocessed products” as defined in Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).

18

(19)  
  “Placing on the market” and “final consumer” as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

19

(20)  Reference methods: EN 1988-1:1998, EN 1988-2:1998 or ISO 5522:1981.

20

(21)  Residues of Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram), Phenthoate and Quinalphos.

21

(22)  Residues of Ethylene Oxide (sum of ethylene oxide and 2-chloro-ethanol, expressed as ethylene oxide).

22

(23)  Where only certain products under any CN code are required to be examined, the CN code is marked “ex”.

23

(24)  The sampling and the analyses shall be performed in accordance with the sampling procedures and the analytical reference methods set out in point 1(b) of Annex III.

24

(25)  The analytical report referred to in Article 10(3) shall be issued by a laboratory accredited in accordance with EN ISO/IEC 17025 for the analysis of pentachlorophenol (PCP) in food and feed.

25

The analytical report shall indicate:

| (a) | the results of sampling and analysis for the presence of PCP, performed by the competent authorities of the country of origin or of the country where the consignment is consigned from if that country is different from the country of origin; |
| --- | --- |

(a)

the results of sampling and analysis for the presence of PCP, performed by the competent authorities of the country of origin or of the country where the consignment is consigned from if that country is different from the country of origin;

| (b) | the measurement uncertainty of the analytical result; |
| --- | --- |

(b)

the measurement uncertainty of the analytical result;

| (c) | the limit of detection (LOD) of the analytical method; and |
| --- | --- |

(c)

the limit of detection (LOD) of the analytical method; and

| (d) | the limit of quantification (LOQ) of the analytical method. |
| --- | --- |

(d)

the limit of quantification (LOQ) of the analytical method.

The extraction before analysis shall be performed with an acidified solvent. The analysis shall be carried out according to the modified version of the QuEChERS method as set out on the websites of the European Union Reference Laboratories for Residues of Pesticides or according to an equally reliable method.

(26)  Residues of at least those pesticides listed in the control programme adopted in accordance with Article 29(2) of Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1) that can be analysed with multi-residue methods based on GC-MS and LC-MS (pesticides to be monitored in/on products of plant origin only).

26

(27)  Residues of Carbofuran.

27

(28)  The sampling and the analyses shall be performed in accordance with the sampling procedures and the analytical reference methods set out in point 1(a) of Annex III.

28

(29)  Residues of Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram) and Metrafenone.

29

(30)  Residues of Dithiocarbamates (dithiocarbamates expressed as CS2, including maneb, mancozeb, metiram, propineb, thiram and ziram), Phenthoate and Quinalphos.

30

(31)  The description of the goods is as laid down in the description column of the CN in Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

31

(32)  Foodstuffs containing or consisting of betel leaves (Piper betle) including, but not limited to, those declared under CN code 1404 90 00.

32

Piper betle

(33)  Residues of Ethylene Oxide (sum of ethylene oxide and 2-chloro-ethanol, expressed as ethylene oxide).

33

(34)  Where only certain products under any CN code are required to be examined, the CN code is marked “ex”.

34

(35)  The description of the goods is as laid down in the description column of the CN in Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

35

(36)  International standard two-letter code for a country in accordance with the ISO 3166 alpha-2 international standard; http://www.iso.org/iso/country_codes/iso-3166-1_decoding_table.htm

36

(37)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

37

(38)  Last version: www.unece.org/uncefact/codelistrecs.html

38

---

| 3.11.2021 | EN | Official Journal of the European Union | L 387/110 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/110

---

COMMISSION REGULATION (EU) 2021/1901

of 29 October 2021

implementing Regulation (EC) No 1338/2008 of the European Parliament and of the Council as regards statistics on health care expenditure and financing

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1338/2008 of the European Parliament and of the Council of 16 December 2008 on Community statistics on public health and health and safety at work (1), and in particular Article 9(1) and Annex II, point (d), thereof,

Whereas:

| (1) | It follows from Regulation (EC) No 1338/2008 that the data and metadata on health care expenditure and financing should be set out by implementing measures. |
| --- | --- |

(1)

It follows from Regulation (EC) No 1338/2008 that the data and metadata on health care expenditure and financing should be set out by implementing measures.

| (2) | In accordance with Article 6(2) of Regulation (EC) No 1338/2008, the Commission carried out a cost-benefit analysis, taking into account the benefits of the availability of data on health care expenditure and financing. Variables on health care expenditure and financing should be collected to ensure the availability of EU-wide data for decisions relating to health and social policy. |
| --- | --- |

(2)

In accordance with Article 6(2) of Regulation (EC) No 1338/2008, the Commission carried out a cost-benefit analysis, taking into account the benefits of the availability of data on health care expenditure and financing. Variables on health care expenditure and financing should be collected to ensure the availability of EU-wide data for decisions relating to health and social policy.

| (3) | The Commission (Eurostat) produced jointly with the Organisation for Economic Cooperation and Development and the World Health Organization a statistical reference manual, the System of Health Accounts 2011 (2), to ensure relevance and comparability of the data. This manual, which sets out the concepts, the definitions and the methods for data processing relating to health care expenditure and financing should form the basis for the detailed questionnaire together with the guidelines accompanying the joint annual data collection exercise. |
| --- | --- |

(3)

The Commission (Eurostat) produced jointly with the Organisation for Economic Cooperation and Development and the World Health Organization a statistical reference manual, the System of Health Accounts 2011 (2), to ensure relevance and comparability of the data. This manual, which sets out the concepts, the definitions and the methods for data processing relating to health care expenditure and financing should form the basis for the detailed questionnaire together with the guidelines accompanying the joint annual data collection exercise.

| (4) | The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee established by Article 7 of Regulation (EC) No 223/2009 of the European Parliament and of the Council (3), |
| --- | --- |

(4)

The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee established by Article 7 of Regulation (EC) No 223/2009 of the European Parliament and of the Council (3),

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation lays down rules for the development and production of European statistics in the area of health care expenditure and financing, one of the subjects for statistics on health care listed in Annex II to Regulation (EC) No 1338/2008.

Article 2

For the purpose of this Regulation, the definitions set out in Annex I shall apply.

Article 3

Member States shall provide data for the areas and at the level of aggregation specified in Annex II.

Article 4

1.   Member States shall provide the required data and the associated standard reference metadata on an annual basis. The reference period shall be the calendar year. The first reference year shall be 2021.

2.   Data and reference metadata for the reference year N shall be transmitted by 30 April N+2.

3.   Data and reference metadata shall be provided to the Commission (Eurostat) using the single entry point services, or be made available for retrieval by the Commission (Eurostat) by electronic means.

Article 5

Member States shall provide the necessary reference metadata, in particular concerning:

| (a) | the data sources and their coverage; |
| --- | --- |

(a)

the data sources and their coverage;

| (b) | the compilation methods used; |
| --- | --- |

(b)

the compilation methods used;

| (c) | information on features of national health care expenditure and financing specific to the Member States and deviations from the definitions listed in Annex I; |
| --- | --- |

(c)

information on features of national health care expenditure and financing specific to the Member States and deviations from the definitions listed in Annex I;

| (d) | references to national legislation where it forms the basis for health care expenditure and financing; |
| --- | --- |

(d)

references to national legislation where it forms the basis for health care expenditure and financing;

| (e) | information on any changes to the statistical concepts mentioned in Annex I. |
| --- | --- |

(e)

information on any changes to the statistical concepts mentioned in Annex I.

Article 6

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 October 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 354, 31.12.2008, p. 70.

1

(2)  OECD, Eurostat and World Health Organization, A System of Health Accounts 2011

2

(3)  Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

3

---

ANNEX I

Definitions

1.

‘Health care’ means all activities with the primary purpose of improving, maintaining and preventing the deterioration of the health status of persons and mitigating the consequences of ill-health through the application of qualified health knowledge;

2.

‘Current expenditure on health care’ means the final consumption expenditure of resident units on health care goods and services, including the health care goods and services provided directly to individual persons as well as collective health care services;

3.

‘Health care functions’ means the type of need that health care goods and services aim to satisfy or the kind of health objective pursued;

4.

‘Inpatient curative and rehabilitative care’: ‘Inpatient care’ means the treatment and/or care provided in a health care facility to patients formally admitted and requiring an overnight stay; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

5.

‘Day curative and rehabilitative care’: ‘Day care’ means the planned medical and paramedical services delivered in a health care facility to patients who have been formally admitted for diagnosis, treatment or other types of health care and are discharged on the same day; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

6.

‘Outpatient curative and rehabilitative care’: ‘Outpatient care’ means the medical and ancillary services delivered in a health care facility to a patient who is not formally admitted and does not stay overnight; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

7.

‘Home-based curative and rehabilitative care’: ‘Home-based care’ means the medical, ancillary and nursing services that are consumed by patients at their home and involve the providers’ physical presence; ‘Curative care’ means the health care services during which the principal intent is to relieve symptoms or to reduce the severity of an illness or injury, or to protect against its exacerbation or complication that could threaten life or normal function; ‘Rehabilitative care’ means the services to stabilise, improve or restore impaired body functions and structures, compensate for the absence or loss of body functions and structures, improve activities and participation and prevent impairments, medical complications and risks;

8.

‘Inpatient long-term care (health)’: ‘Inpatient care’ means the treatment and/or care provided in a health care facility to patients formally admitted and requiring an overnight stay; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

9.

‘Day long-term care (health)’: ‘Day care’ means the planned medical and paramedical services delivered in a health care facility to patients who have been formally admitted for diagnosis, treatment or other types of health care and are discharged on the same day; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

10.

‘Outpatient long-term care (health)’: ‘Outpatient care’ means the medical and ancillary services delivered in a health care facility to a patient who is not formally admitted and does not stay overnight; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

11.

‘Home-based long-term care (health)’: ‘Home-based care’ means the medical, ancillary and nursing services that are consumed by patients at their home and involve the providers’ physical presence; ‘Long-term care (health)’ means a range of medical or nursing care and personal care services providing help with activities of daily living that are consumed with the primary goal of alleviating pain and suffering and reducing or managing the deterioration in health status in patients with a degree of long-term dependency;

12.

‘Ancillary services (non-specified by function)’ means the health care or long-term care related services non-specified by function and non-specified by mode of provision, which the patient consumes directly, in particular during an independent contact with the health system and that are not integral part of a care service package, such as laboratory or imaging services or patient transportation and emergency rescue;

13.

‘Pharmaceuticals and other medical non-durable goods (non-specified by function)’ means pharmaceutical products and non-durable medical goods intended for use in the diagnosis, cure, mitigation or treatment of disease, including prescribed medicines and over-the-counter drugs, where the function and mode of provision are not specified;

14.

‘Therapeutic appliances and other medical goods (non-specified by function)’ means medical durable goods including orthotic devices that support or correct deformities and/or abnormalities of the human body, orthopaedic appliances, prostheses or artificial extensions that replace a missing body part, and other prosthetic devices including implants which replace or supplement the functionality of a missing biological structure and medico-technical devices, where the function and the mode of provision are not specified;

15.

‘Preventive care’ means any measure that aims to avoid or reduce the number or the severity of injuries and diseases, their sequelae and complications;

16.

‘Governance and health system and financing administration’ means services that focus on the health system rather than direct health care, direct and support health system functioning, and are considered to be collective, as they are not allocated to specific individuals but benefit all health system users;

17.

‘Other health care services not elsewhere classified (n.e.c.)’ includes any other health care services not classified in HC.1 to HC.7;

18.

‘Health care financing schemes’ means types of financing arrangements through which people obtain health services, including both direct payments by households for services and goods and third-party financing arrangements;

19.

‘Government schemes’ means health care financing schemes whose characteristics are determined by law or by the government and where a separate budget is set for the programme and a government unit that has an overall responsibility for it;

20.

‘Social health insurance schemes’ means a financing arrangement to ensure access to health care for specific population groups through mandatory participation determined by law or by the government, and eligibility based on the payment of health insurance contributions by or on behalf of the individuals concerned;

21.

‘Compulsory private insurance schemes’ means a financing arrangement to ensure access to health care for specific population groups through mandatory participation determined by law or by the government and eligibility based upon the purchase of a health insurance policy;

22.

‘Voluntary health insurance schemes’ means schemes based upon the purchase of a health insurance policy, which is not made compulsory by government and where insurance premiums may be directly or indirectly subsidised by the government;

23.

‘Non-profit institutions financing schemes’ means non-compulsory financing arrangements and programmes with non-contributory benefit entitlement that are based on donations from the general public, the government or corporations;

24.

‘Enterprise financing schemes’ means primarily arrangements where enterprises directly provide or finance health services for their employees without the involvement of an insurance-type scheme;

25.

‘Household out-of-pocket payment’ means a direct payment for health care goods and services from the household primary income or savings, where the payment is made by the user at the time of the purchase of goods or the use of the services;

26.

‘Rest of the world financing schemes’ means financial arrangements involving or managed by institutional units that are resident abroad, but who collect, pool resources and purchase health care goods and services on behalf of residents, without transiting their funds through a resident scheme;

27.

‘Health care providers’ means the organisations and actors that deliver health care goods and services as their primary activity, as well as those for which health care provision is only one among a number of activities;

28.

‘Hospitals’ means the licensed establishments that are primarily engaged in providing medical, diagnostic and treatment services that include physician, nursing and other health services to inpatients and the specialised accommodation services required by inpatients and which may also provide day care, outpatient and home health care services;

29.

‘Residential long-term care facilities’ means establishments that are primarily engaged in providing residential long-term care that combines nursing, supervisory or other types of care as required by the residents, where a significant part of the production process and the care provided is a mix of health and social services with the health services being largely at the level of nursing care in combination with personal care services;

30.

‘Providers of ambulatory health care’ means establishments that are primarily engaged in providing health care services directly to outpatients who do not require inpatient services, including both offices of general medical practitioners and medical specialists and establishments specialising in the treatment of day-cases and in the delivery of home care services;

31.

‘Providers of ancillary services’ means establishments that provide specific ancillary type of services directly to outpatients under the supervision of health professionals and not covered within the episode of treatment by hospitals, nursing care facilities, ambulatory care providers or other providers;

32.

‘Retailers and other providers of medical goods’ means establishments whose primary activity is the retail sale of medical goods to the general public for individual or household consumption or utilisation, including fitting and repair done in combination with sale;

33.

‘Providers of preventive care’ means organisations that primarily provide collective preventive programmes and campaigns/public health programmes for specific groups of individuals or the population-at-large, such as health promotion and protection agencies or public health institutes as well as specialised establishments providing primary preventive care as their principal activity;

34.

‘Providers of health care system administration and financing’ means establishments that are primarily engaged in the regulation of the activities of agencies that provide health care and in the overall administration of the health care sector, including the administration of health financing;

35.

‘Rest of the economy’ means other resident health care providers not elsewhere classified, including households as providers of personal home health services to family members, in cases where they correspond to social transfer payments granted for this purpose as well as all other industries that offer health care as a secondary activity;

36.

‘Rest of the world’ means all non-resident units providing health care goods and services as well as those involved in health-related activities.

---

ANNEX II

Subjects to be covered and their characteristics, cross-classification data and breakdowns

| (1) | Cross-classification current expenditure on health care by health care functions (HC) and financing schemes (HF)

  All data shall be transmitted in millions of national currency. | Financing schemes | HF.1.1 | HF.1.2.1 | HF.1.2.2 | HF.2.1 | HF.2.2 | HF.2.3 | HF.3 | HF.4 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Health care functions | | Government schemes | Social health insurance schemes | Compulsory private insurance schemes | Voluntary health insurance schemes | Non-profit institutions financing schemes | Enterprise financing schemes | Household out-of-pocket payment | Rest of the world financing schemes | Current expenditure on health care


  HF.1-HF.4 |
| HC.1.1; HC.2.1 | Inpatient curative and rehabilitative care | | | | | | | | | |
| HC.1.2; HC.2.2 | Day curative and rehabilitative care | | | | | | | | | |
| HC.1.3; HC.2.3 | Outpatient curative and rehabilitative care | | | | | | | | | |
| HC.1.4; HC.2.4 | Home-based curative and rehabilitative care | | | | | | | | | |
| HC.3.1 | Inpatient long-term care (health) | | | | | | | | | |
| HC.3.2 | Day long-term care (health) | | | | | | | | | |
| HC.3.3 | Outpatient long-term care (health) | | | | | | | | | |
| HC.3.4 | Home-based long-term care (health) | | | | | | | | | |
| HC.4 | Ancillary services (non-specified by function) | | | | | | | | | |
| HC.5.1 | Pharmaceuticals and other medical non-durable goods (non-specified by function) | | | | | | | | | |
| HC.5.2 | Therapeutic appliances and other medical goods (non-specified by function) | | | | | | | | | |
| HC.6 | Preventive care | | | | | | | | | |
| HC.7 | Governance and health system and financing administration | | | | | | | | | |
| HC.9 | Other health care services not elsewhere classified (n.e.c.) | | | | | | | | | |
| | Current expenditure on health care


  HC.1-HC.9 | | | | | | | | | |

(1)

Cross-classification current expenditure on health care by health care functions (HC) and financing schemes (HF)

All data shall be transmitted in millions of national currency.

Financing schemes

HF.1.1

HF.1.2.1

HF.1.2.2

HF.2.1

HF.2.2

HF.2.3

HF.3

HF.4

Health care functions

Government schemes

Social health insurance schemes

Compulsory private insurance schemes

Voluntary health insurance schemes

Non-profit institutions financing schemes

Enterprise financing schemes

Household out-of-pocket payment

Rest of the world financing schemes

Current expenditure on health care

HF.1-HF.4

HC.1.1; HC.2.1

Inpatient curative and rehabilitative care

HC.1.2; HC.2.2

Day curative and rehabilitative care

HC.1.3; HC.2.3

Outpatient curative and rehabilitative care

HC.1.4; HC.2.4

Home-based curative and rehabilitative care

HC.3.1

Inpatient long-term care (health)

HC.3.2

Day long-term care (health)

HC.3.3

Outpatient long-term care (health)

HC.3.4

Home-based long-term care (health)

HC.4

Ancillary services (non-specified by function)

HC.5.1

Pharmaceuticals and other medical non-durable goods (non-specified by function)

HC.5.2

Therapeutic appliances and other medical goods (non-specified by function)

HC.6

Preventive care

HC.7

Governance and health system and financing administration

HC.9

Other health care services not elsewhere classified (n.e.c.)

Current expenditure on health care

HC.1-HC.9

| (2) | Cross-classification current expenditure on health care by health care functions (HC) and health care providers (HP)

  All data shall be transmitted in millions of national currency. | Health care providers | HP.1 | HP.2 | HP.3 | HP.4 | HP.5 | HP.6 | HP.7 | HP.8 | HP.9 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Health care functions | | Hospitals | Residential long-term care facilities | Providers of ambulatory health care | Providers of ancillary services | Retailers and other providers of medical goods | Providers of preventive care | Providers of health care system administration and financing | Rest of the economy | Rest of the world | Current expenditure on health care


  HP.1-HP.9 |
| HC.1.1; HC.2.1 | Inpatient curative and rehabilitative care | | | | | | | | | | |
| HC.1.2; HC.2.2 | Day curative and rehabilitative care | | | | | | | | | | |
| HC.1.3; HC.2.3 | Outpatient curative and rehabilitative care | | | | | | | | | | |
| HC.1.4; HC.2.4 | Home-based curative and rehabilitative care | | | | | | | | | | |
| HC.3.1 | Inpatient long-term care (health) | | | | | | | | | | |
| HC.3.2 | Day long-term care (health) | | | | | | | | | | |
| HC.3.3 | Outpatient long-term care (health) | | | | | | | | | | |
| HC.3.4 | Home-based long-term care (health) | | | | | | | | | | |
| HC.4 | Ancillary services (non-specified by function) | | | | | | | | | | |
| HC.5.1 | Pharmaceuticals and other medical non-durable goods (non-specified by function) | | | | | | | | | | |
| HC.5.2 | Therapeutic appliances and other medical goods (non-specified by function) | | | | | | | | | | |
| HC.6 | Preventive care | | | | | | | | | | |
| HC.7 | Governance and health system and financing administration | | | | | | | | | | |
| HC.9 | Other health care services not elsewhere classified (n.e.c.) | | | | | | | | | | |
| | Current expenditure on health care


  HC.1-HC.9 | | | | | | | | | | |

(2)

Cross-classification current expenditure on health care by health care functions (HC) and health care providers (HP)

All data shall be transmitted in millions of national currency.

Health care providers

HP.1

HP.2

HP.3

HP.4

HP.5

HP.6

HP.7

HP.8

HP.9

Health care functions

Hospitals

Residential long-term care facilities

Providers of ambulatory health care

Providers of ancillary services

Retailers and other providers of medical goods

Providers of preventive care

Providers of health care system administration and financing

Rest of the economy

Rest of the world

Current expenditure on health care

HP.1-HP.9

HC.1.1; HC.2.1

Inpatient curative and rehabilitative care

HC.1.2; HC.2.2

Day curative and rehabilitative care

HC.1.3; HC.2.3

Outpatient curative and rehabilitative care

HC.1.4; HC.2.4

Home-based curative and rehabilitative care

HC.3.1

Inpatient long-term care (health)

HC.3.2

Day long-term care (health)

HC.3.3

Outpatient long-term care (health)

HC.3.4

Home-based long-term care (health)

HC.4

Ancillary services (non-specified by function)

HC.5.1

Pharmaceuticals and other medical non-durable goods (non-specified by function)

HC.5.2

Therapeutic appliances and other medical goods (non-specified by function)

HC.6

Preventive care

HC.7

Governance and health system and financing administration

HC.9

Other health care services not elsewhere classified (n.e.c.)

Current expenditure on health care

HC.1-HC.9

| (3) | Cross-classification current expenditure on health care by health care providers (HP) and financing schemes (HF)

  All data shall be transmitted in millions of national currency. | Financing schemes | HF.1.1 | HF.1.2.1 | HF.1.2.2 | HF.2.1 | HF.2.2 | HF.2.3 | HF.3 | HF.4 | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Health care providers | | Government schemes | Social health insurance schemes | Compulsory private insurance schemes | Voluntary health insurance schemes | Non-profit institutions financing schemes | Enterprise financing schemes | Household out-of-pocket payment | Rest of the world financing schemes (non-resident) | Current expenditure on health care


  HF.1-HF.4 |
| HP.1 | Hospitals | | | | | | | | | |
| HP.2 | Residential long-term care facilities | | | | | | | | | |
| HP.3 | Providers of ambulatory health care | | | | | | | | | |
| HP.4 | Providers of ancillary services | | | | | | | | | |
| HP.5 | Retailers and other providers of medical goods | | | | | | | | | |
| HP.6 | Providers of preventive care | | | | | | | | | |
| HP.7 | Providers of health care system administration and financing | | | | | | | | | |
| HP.8 | Rest of the economy | | | | | | | | | |
| HP.9 | Rest of the world | | | | | | | | | |
| | Current expenditure on health care


  HP.1-HP.9 | | | | | | | | | |

(3)

Cross-classification current expenditure on health care by health care providers (HP) and financing schemes (HF)

All data shall be transmitted in millions of national currency.

Financing schemes

HF.1.1

HF.1.2.1

HF.1.2.2

HF.2.1

HF.2.2

HF.2.3

HF.3

HF.4

Health care providers

Government schemes

Social health insurance schemes

Compulsory private insurance schemes

Voluntary health insurance schemes

Non-profit institutions financing schemes

Enterprise financing schemes

Household out-of-pocket payment

Rest of the world financing schemes (non-resident)

Current expenditure on health care

HF.1-HF.4

HP.1

Hospitals

HP.2

Residential long-term care facilities

HP.3

Providers of ambulatory health care

HP.4

Providers of ancillary services

HP.5

Retailers and other providers of medical goods

HP.6

Providers of preventive care

HP.7

Providers of health care system administration and financing

HP.8

Rest of the economy

HP.9

Rest of the world

Current expenditure on health care

HP.1-HP.9

---

| 3.11.2021 | EN | Official Journal of the European Union | L 387/120 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/120

---

COMMISSION REGULATION (EU) 2021/1902

of 29 October 2021

amending Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 15(1) and the fourth subparagraph of Article 15(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) provides for a harmonised classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on a scientific assessment by the Risk Assessment Committee of the European Chemicals Agency. The substances are classified as CMR substances of category 1A, CMR substances of category 1B or CMR substances of category 2 depending on the level of evidence of their CMR properties. |
| --- | --- |

(1)

Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2) provides for a harmonised classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on a scientific assessment by the Risk Assessment Committee of the European Chemicals Agency. The substances are classified as CMR substances of category 1A, CMR substances of category 1B or CMR substances of category 2 depending on the level of evidence of their CMR properties.

| (2) | Article 15 of Regulation (EC) No 1223/2009 provides that substances which have been classified as CMR substances of category 1A, category 1B or category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CMR substances) are to be prohibited from use in cosmetic products. A CMR substance may however be used in cosmetic products where the conditions laid down in the second sentence of Article 15(1) of Regulation (EC) No 1223/2009 or in the second subparagraph of Article 15(2) of that Regulation are fulfilled. |
| --- | --- |

(2)

Article 15 of Regulation (EC) No 1223/2009 provides that substances which have been classified as CMR substances of category 1A, category 1B or category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CMR substances) are to be prohibited from use in cosmetic products. A CMR substance may however be used in cosmetic products where the conditions laid down in the second sentence of Article 15(1) of Regulation (EC) No 1223/2009 or in the second subparagraph of Article 15(2) of that Regulation are fulfilled.

| (3) | In order to uniformly implement the prohibition of CMR substances within the internal market, to ensure legal certainty in particular for economic operators and national competent authorities, and to ensure a high level of protection of human health, all CMR substances should be included in the list of prohibited substances in Annex II to Regulation (EC) No 1223/2009 and, where relevant, deleted from the lists of restricted or allowed substances in Annexes III to VI to that Regulation. Where the conditions laid down in the second sentence of Article 15(1) of Regulation (EC) No 1223/2009 or the second subparagraph of Article 15(2) of that Regulation are fulfilled, the lists of restricted or allowed substances in Annexes III to VI to that Regulation should be amended accordingly. |
| --- | --- |

(3)

In order to uniformly implement the prohibition of CMR substances within the internal market, to ensure legal certainty in particular for economic operators and national competent authorities, and to ensure a high level of protection of human health, all CMR substances should be included in the list of prohibited substances in Annex II to Regulation (EC) No 1223/2009 and, where relevant, deleted from the lists of restricted or allowed substances in Annexes III to VI to that Regulation. Where the conditions laid down in the second sentence of Article 15(1) of Regulation (EC) No 1223/2009 or the second subparagraph of Article 15(2) of that Regulation are fulfilled, the lists of restricted or allowed substances in Annexes III to VI to that Regulation should be amended accordingly.

| (4) | This Regulation covers the substances classified as CMR substances by Delegated Regulation (EU) 2020/1182 (3), which will apply from 1 March 2022. |
| --- | --- |

(4)

This Regulation covers the substances classified as CMR substances by Delegated Regulation (EU) 2020/1182 (3), which will apply from 1 March 2022.

| (5) | With regard to the substance (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc, with the International Nomenclature of Cosmetic Ingredients name Zinc Pyrithione, which has been classified as a CMR substance of category 1B (Toxic for Reproduction), a request for an exception under the second subparagraph of Article 15(2) was submitted on 11 April 2019 concerning use as an anti-dandruff ingredient in rinse-off hair products in a concentration of up to 1 %. No request for an exception has been made for any other use of Zinc Pyrithione. |
| --- | --- |

(5)

With regard to the substance (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc, with the International Nomenclature of Cosmetic Ingredients name Zinc Pyrithione, which has been classified as a CMR substance of category 1B (Toxic for Reproduction), a request for an exception under the second subparagraph of Article 15(2) was submitted on 11 April 2019 concerning use as an anti-dandruff ingredient in rinse-off hair products in a concentration of up to 1 %. No request for an exception has been made for any other use of Zinc Pyrithione.

| (6) | Zinc Pyrithione is currently listed in entry 8 of Annex V to Regulation (EC) No 1223/2009 as an allowed preservative in rinse-off hair products in a concentration of up to 1 % and in other rinse-off products that are not oral hygiene products in a concentration of up to 0,5 %. Zinc Pyrithione is also listed in entry 101 of Annex III to Regulation (EC) No 1223/2009 as a restricted substance only allowed, when used for purposes other than preservative, in leave-on hair products in a concentration of up to 0,1 %. |
| --- | --- |

(6)

Zinc Pyrithione is currently listed in entry 8 of Annex V to Regulation (EC) No 1223/2009 as an allowed preservative in rinse-off hair products in a concentration of up to 1 % and in other rinse-off products that are not oral hygiene products in a concentration of up to 0,5 %. Zinc Pyrithione is also listed in entry 101 of Annex III to Regulation (EC) No 1223/2009 as a restricted substance only allowed, when used for purposes other than preservative, in leave-on hair products in a concentration of up to 0,1 %.

| (7) | In accordance with the second subparagraph of Article 15(2) of Regulation (EC) No 1223/2009, CMR substances of category 1A or 1B may be used in cosmetic products by way of exception where certain conditions are fulfilled, including the conditions that no suitable alternative substances are available, as documented in an analysis of alternatives, and that the substance has been evaluated and found safe by the Scientific Committee on Consumer Safety (SCCS). |
| --- | --- |

(7)

In accordance with the second subparagraph of Article 15(2) of Regulation (EC) No 1223/2009, CMR substances of category 1A or 1B may be used in cosmetic products by way of exception where certain conditions are fulfilled, including the conditions that no suitable alternative substances are available, as documented in an analysis of alternatives, and that the substance has been evaluated and found safe by the Scientific Committee on Consumer Safety (SCCS).

| (8) | The SCCS concluded in its opinion of 3-4 March 2020 (4) that Zinc Pyrithione can be considered safe when used as an anti-dandruff ingredient in rinse-off hair products up to a maximum concentration of 1 %. However, since it has not been established that there are no suitable alternative substances available with regard to anti-dandruff ingredients in rinse-off hair products, Zinc Pyrithione should be deleted from the list of restricted substances in Annex III to Regulation (EC) No 1223/2009 and from the list of preservatives allowed in cosmetic products in Annex V to that Regulation. It should also be added to the list of substances prohibited in cosmetic products in Annex II to Regulation (EC) No 1223/2009. |
| --- | --- |

(8)

The SCCS concluded in its opinion of 3-4 March 2020 (4) that Zinc Pyrithione can be considered safe when used as an anti-dandruff ingredient in rinse-off hair products up to a maximum concentration of 1 %. However, since it has not been established that there are no suitable alternative substances available with regard to anti-dandruff ingredients in rinse-off hair products, Zinc Pyrithione should be deleted from the list of restricted substances in Annex III to Regulation (EC) No 1223/2009 and from the list of preservatives allowed in cosmetic products in Annex V to that Regulation. It should also be added to the list of substances prohibited in cosmetic products in Annex II to Regulation (EC) No 1223/2009.

| (9) | With regard to all substances other than Zinc Pyrithione, which were classified as CMR substances pursuant to Regulation (EC) No 1272/2008 by Delegated Regulation (EU) 2020/1182, no request for use in cosmetic products by way of exception has been submitted. Consequently, the CMR substances that are not already listed in Annex II to Regulation (EC) No 1223/2009 should be added to the list of substances prohibited in cosmetic products in that Annex. |
| --- | --- |

(9)

With regard to all substances other than Zinc Pyrithione, which were classified as CMR substances pursuant to Regulation (EC) No 1272/2008 by Delegated Regulation (EU) 2020/1182, no request for use in cosmetic products by way of exception has been submitted. Consequently, the CMR substances that are not already listed in Annex II to Regulation (EC) No 1223/2009 should be added to the list of substances prohibited in cosmetic products in that Annex.

| (10) | Regulation (EC) No 1223/2009 should therefore be amended accordingly. |
| --- | --- |

(10)

Regulation (EC) No 1223/2009 should therefore be amended accordingly.

| (11) | The amendments to Regulation (EC) No 1223/2009 are based on the classifications of the relevant substances as CMR substances by Delegated Regulation (EU) 2020/1182 and should therefore apply from the same date as those classifications. |
| --- | --- |

(11)

The amendments to Regulation (EC) No 1223/2009 are based on the classifications of the relevant substances as CMR substances by Delegated Regulation (EU) 2020/1182 and should therefore apply from the same date as those classifications.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products, |
| --- | --- |

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II, III and V to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 March 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 October 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 342, 22.12.2009, p. 59.

1

(2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

2

(3)  Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 261, 11.8.2020, p. 2).

3

(4)  SCCS Opinion on Zinc Pyrithione (ZPT) (CAS No 13463-41-7) – Submission III - SCCS/1614/19.

4

---

ANNEX

Annexes II, III and V to Regulation (EC) No 1223/2009 are amended as follows:

| (1) | in Annex II, the following entries are added:








  Reference number | Substance identification |
| --- | --- | --- |
| Chemical name/INN | CAS number | EC number |
| a | b | c | d |
| ‘1658 | Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) | 409-21-2
  308076-74-6 | 206-991-8 |
| 1659 | Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane | 1067-53-4 | 213-934-0 |
| 1660 | Dioctyltin dilaurate; [1]
  stannane, dioctyl-, bis (coco acyloxy) derivs. [2] | 3648-18-8 [1]
  91648- 39-4 [2] | 222-883-3 [1]
  293-901-5 [2] |
| 1661 | Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene | 191-30-0 | 205-886-4 |
| 1662 | Ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1- (1H-1,2,4-triazol-1-ylmethyl)cyclopentanol | 125225-28-7
  115850-69-6
  115937-89-8 | - |
| 1663 | Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme | 143-24-8 | 205-594-7 |
| 1664 | Paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl- 2-(1H-1,2,4-triazol-1- yl)pentan-3-ol | 76738-62-0 | - |
| 1665 | 2,2-bis(bromomethyl) propane-1,3-diol | 3296-90-0 | 221-967-7 |
| 1666 | 2-(4-tert-butylbenzyl) propionaldehyde | 80-54-6 | 201-289-8 |
| 1667 | Diisooctyl phthalate | 27554-26-3 | 248-523-5 |
| 1668 | 2-methoxyethyl acrylate | 3121-61-7 | 221-499-3 |
| 1669 | Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]
  if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w | 70161-44-3 | 274-357-8 |
| 1670 | Pyrithione zinc; (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc | 13463-41-7 | 236-671-3 |
| 1671 | Flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one | 61213-25-0 | 262-661-3 |
| 1672 | 3-(difluoromethyl)-1- methyl-N-(3',4',5'-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad | 907204-31-3 | - |
| 1673 | N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] | 924-42-5 | 213-103-2 |
| 1674 | 5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2'- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen | 494793-67-8 | - |
| 1675 | Iprovalicarb (ISO); isopropyl [(2S)-3- methyl-1-{[1-(4- methylphenyl)ethyl] amino}-1-oxobutan-2- yl]carbamate | 140923-17-7 | - |
| 1676 | Dichlorodioctylstannane | 3542-36-7 | 222-583-2 |
| 1677 | Mesotrione (ISO); 2-[4-(methylsulfonyl)- 2-nitrobenzoyl]-1,3- cyclohexanedione | 104206-82-8 | - |
| 1678 | Hymexazol (ISO); 3-hydroxy-5-methylisoxazole | 10004-44-1 | 233-000-6 |
| 1679 | Imiprothrin (ISO); reaction mass of: [2,4- dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-trans-chrysanthemate | 72963-72-5 | 428-790-6 |
| 1680 | Bis(α,α-dimethylbenzyl) peroxide | 80-43-3; | 201-279-3’ |

(1)

in Annex II, the following entries are added:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

‘1658

Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1)

409-21-2

308076-74-6

206-991-8

1659

Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane

1067-53-4

213-934-0

1660

Dioctyltin dilaurate; [1]

stannane, dioctyl-, bis (coco acyloxy) derivs. [2]

3648-18-8 [1]

91648- 39-4 [2]

222-883-3 [1]

293-901-5 [2]

1661

Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene

191-30-0

205-886-4

1662

Ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1- (1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

125225-28-7

115850-69-6

115937-89-8

-

1663

Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme

143-24-8

205-594-7

1664

Paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl- 2-(1H-1,2,4-triazol-1- yl)pentan-3-ol

76738-62-0

-

1665

2,2-bis(bromomethyl) propane-1,3-diol

3296-90-0

221-967-7

1666

2-(4-tert-butylbenzyl) propionaldehyde

80-54-6

201-289-8

1667

Diisooctyl phthalate

27554-26-3

248-523-5

1668

2-methoxyethyl acrylate

3121-61-7

221-499-3

1669

Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]

if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w

70161-44-3

274-357-8

1670

Pyrithione zinc; (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc

13463-41-7

236-671-3

1671

Flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one

61213-25-0

262-661-3

1672

3-(difluoromethyl)-1- methyl-N-(3',4',5'-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad

907204-31-3

-

1673

N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]

924-42-5

213-103-2

1674

5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2'- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen

494793-67-8

-

1675

Iprovalicarb (ISO); isopropyl [(2S)-3- methyl-1-{[1-(4- methylphenyl)ethyl] amino}-1-oxobutan-2- yl]carbamate

140923-17-7

-

1676

Dichlorodioctylstannane

3542-36-7

222-583-2

1677

Mesotrione (ISO); 2-[4-(methylsulfonyl)- 2-nitrobenzoyl]-1,3- cyclohexanedione

104206-82-8

-

1678

Hymexazol (ISO); 3-hydroxy-5-methylisoxazole

10004-44-1

233-000-6

1679

Imiprothrin (ISO); reaction mass of: [2,4- dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-trans-chrysanthemate

72963-72-5

428-790-6

1680

Bis(α,α-dimethylbenzyl) peroxide

80-43-3;

201-279-3’

| (2) | in Annex III is amended as follows:






  (a) | entry 24 is replaced by the following:













  Reference number | Substance identification | Restrictions | Wording of conditions of use and warnings |
| --- | --- | --- | --- | --- | --- |
| Chemical Name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other |
| a | b | c | d | e | f | g | h | i |
| ‘24 | Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (Annex II, entry X) | Zinc acetate,
  zinc chloride, zinc gluconate, zinc glutamate | | | | 1 % (as zinc)’ | | |

(2)

in Annex III is amended as follows:

(a)

entry 24 is replaced by the following:

Reference number

Substance identification

Restrictions

Wording of conditions of use and warnings

Chemical Name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, Body parts

Maximum concentration in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

‘24

Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (Annex II, entry X)

Zinc acetate,

zinc chloride, zinc gluconate, zinc glutamate

1 % (as zinc)’

| (b) | entries 83 and 101 are deleted; |
| --- | --- |

(b)

entries 83 and 101 are deleted;

| (3) | Annex V is amended as follows:






  (a) | entry 8 is deleted; |
| --- | --- | --- |

(3)

Annex V is amended as follows:

(a)

entry 8 is deleted;

| (b) | entry 51 is replaced by the following:













  Reference number | Substance identification | Conditions | Wording of conditions of use and warnings |
| --- | --- | --- | --- | --- |
| Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other |
| a | b | c | d | e | f | g | h | i |
| ‘51 | Sodium hydroxymethylamino acetate | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | | 0,5 % | Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0,1 % w/w’ | |

(b)

entry 51 is replaced by the following:

Reference number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, Body parts

Maximum concentration in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

‘51

Sodium hydroxymethylamino acetate

Sodium Hydroxymethylglycinate

70161-44-3

274-357-8

0,5 %

Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0,1 % w/w’

---

| 3.11.2021 | EN | Official Journal of the European Union | L 387/126 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/126

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1903

of 29 October 2021

amending Implementing Regulation (EU) 2018/764 on the fees and charges payable to the European Union Agency for Railways and their conditions of payment

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (1), and in particular Article 80(1) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2018/764 (2) sets out the fees and charges payable to the European Union Agency for Railways (‘the Agency’) for the performance of certain activities and the provision of other services referred to in Regulation (EU) 2016/796. |
| --- | --- |

(1)

Commission Implementing Regulation (EU) 2018/764 (2) sets out the fees and charges payable to the European Union Agency for Railways (‘the Agency’) for the performance of certain activities and the provision of other services referred to in Regulation (EU) 2016/796.

| (2) | While the larger part of costs generated by the activities of the Agency is covered by the EU budget, Article 80(2), first subparagraph of Regulation (EU) 2016/796 requires the Agency to levy fees and charges for the issuing of vehicle (type) authorisations, single safety certificates and European rail traffic management system (‘ERTMS’) approvals, as well as the provision of other services. Pursuant to Article 80(3) of Regulation (EU) 2016/796, the amount of the fees and charges is to be fixed at such a level as to ensure that the revenue in respect thereof is sufficient to cover the full cost of the tasks performed and services provided by the Agency. |
| --- | --- |

(2)

While the larger part of costs generated by the activities of the Agency is covered by the EU budget, Article 80(2), first subparagraph of Regulation (EU) 2016/796 requires the Agency to levy fees and charges for the issuing of vehicle (type) authorisations, single safety certificates and European rail traffic management system (‘ERTMS’) approvals, as well as the provision of other services. Pursuant to Article 80(3) of Regulation (EU) 2016/796, the amount of the fees and charges is to be fixed at such a level as to ensure that the revenue in respect thereof is sufficient to cover the full cost of the tasks performed and services provided by the Agency.

| (3) | Pursuant to Article 10 of Implementing Regulation (EU) 2018/764, the Commission is to assess the regime for fees and charges once every financial year. This assessment is to be based on the Agency’s previous financial results assessment and its estimate of future expenditure and revenue. Based on the assessment of financial results and forecasts of the Agency, the Commission is to revise fees and charges, if necessary. The Commission is to review the Regulation with a view to the progressive introduction of fixed fees by 16 June 2022 at the latest. |
| --- | --- |

(3)

Pursuant to Article 10 of Implementing Regulation (EU) 2018/764, the Commission is to assess the regime for fees and charges once every financial year. This assessment is to be based on the Agency’s previous financial results assessment and its estimate of future expenditure and revenue. Based on the assessment of financial results and forecasts of the Agency, the Commission is to revise fees and charges, if necessary. The Commission is to review the Regulation with a view to the progressive introduction of fixed fees by 16 June 2022 at the latest.

| (4) | In 2018, when Implementing Regulation (EU) 2018/764 was adopted, there was a lack of reliable financial data since Agency had not yet started to process applications. Since 2019, the Agency’s annual reports referred to in Article 51(1), point (a) of Regulation (EU) 2016/796 establish that, in exercising its role as the Union authority responsible for the certification and authorisation tasks referred to in Articles 14, 20, 21 and 22 of Regulation (EU) 2016/796, the Agency experiences a significant and recurrent negative imbalance in its budget. This imbalance results from the insufficient level of fees and charges levied in accordance with Article 80(2) of Regulation (EU) 2016/796 to compensate the costs linked to the processing of applications and the provision of services. |
| --- | --- |

(4)

In 2018, when Implementing Regulation (EU) 2018/764 was adopted, there was a lack of reliable financial data since Agency had not yet started to process applications. Since 2019, the Agency’s annual reports referred to in Article 51(1), point (a) of Regulation (EU) 2016/796 establish that, in exercising its role as the Union authority responsible for the certification and authorisation tasks referred to in Articles 14, 20, 21 and 22 of Regulation (EU) 2016/796, the Agency experiences a significant and recurrent negative imbalance in its budget. This imbalance results from the insufficient level of fees and charges levied in accordance with Article 80(2) of Regulation (EU) 2016/796 to compensate the costs linked to the processing of applications and the provision of services.

| (5) | In order for the Agency to cover costs for processing applications, the Union budget had to partly cover these costs. Moreover, in order to balance its budget, the Agency had to severely reduce the activities other than those that are financed by fees and charges. According to the Agency’s yearly single programming documents, forecasting for 2021 and 2022 implies a similar financial situation in the future. A revision of the Agency’s fees and charges regime is therefore necessary. |
| --- | --- |

(5)

In order for the Agency to cover costs for processing applications, the Union budget had to partly cover these costs. Moreover, in order to balance its budget, the Agency had to severely reduce the activities other than those that are financed by fees and charges. According to the Agency’s yearly single programming documents, forecasting for 2021 and 2022 implies a similar financial situation in the future. A revision of the Agency’s fees and charges regime is therefore necessary.

| (6) | It appears necessary to increase the hourly rate, which is currently lower than the hourly cost incurred by the Agency in delivering decisions to applicants for authorisations, certificates and approvals. The rates defined in Implementing Regulation (EU) 2018/764 should be therefore revised to cover the annual cost incurred by the Agency for processing application and for rendering available the one-stop shop (‘OSS’) to all applicants addressing the Agency for European vehicle authorisations, single safety certificates and ERTMS project approvals. |
| --- | --- |

(6)

It appears necessary to increase the hourly rate, which is currently lower than the hourly cost incurred by the Agency in delivering decisions to applicants for authorisations, certificates and approvals. The rates defined in Implementing Regulation (EU) 2018/764 should be therefore revised to cover the annual cost incurred by the Agency for processing application and for rendering available the one-stop shop (‘OSS’) to all applicants addressing the Agency for European vehicle authorisations, single safety certificates and ERTMS project approvals.

| (7) | The Agency has been levying fees and charges exclusively at an hourly rate calculated on the basis of the time dedicated to deliver its decisions and provide its services. A fixed fees regime should be introduced to further reduce the administrative burden and to enhance the predictability of the envisaged cost per application for the benefit of all parties involved. Moreover, since 2019, the Agency has gained experience and established a sufficiently robust methodology for calculating average cost for processing individual applications. Fixed fees should therefore apply to the processing of applications concerning a vehicle or a series of vehicles considered to be in conformity with a previously authorised vehicle type pursuant to Article 25(1) of Directive (EU) 2016/797 of the European Parliament and of the Council (3). |
| --- | --- |

(7)

The Agency has been levying fees and charges exclusively at an hourly rate calculated on the basis of the time dedicated to deliver its decisions and provide its services. A fixed fees regime should be introduced to further reduce the administrative burden and to enhance the predictability of the envisaged cost per application for the benefit of all parties involved. Moreover, since 2019, the Agency has gained experience and established a sufficiently robust methodology for calculating average cost for processing individual applications. Fixed fees should therefore apply to the processing of applications concerning a vehicle or a series of vehicles considered to be in conformity with a previously authorised vehicle type pursuant to Article 25(1) of Directive (EU) 2016/797 of the European Parliament and of the Council (3).

| (8) | The free of charge OSS generates considerable maintenance and development costs. Fees should therefore also be paid for the use of OSS when the addressee of applications submitted to the OSS is the Agency. Fees should be paid by applicants on fixed rates, depending on the impact of applications on the OSS’s facility in terms of documents uploaded and stored, functionalities exploited and exchanges held as well as in proportion to the overall estimated cost of the relevant decision. Moreover, where the application for a conformity to vehicle type is submitted to the Agency, the fee for using the OSS should become an integral part of the overall fee for delivering vehicle authorisations subject to fixed fees. |
| --- | --- |

(8)

The free of charge OSS generates considerable maintenance and development costs. Fees should therefore also be paid for the use of OSS when the addressee of applications submitted to the OSS is the Agency. Fees should be paid by applicants on fixed rates, depending on the impact of applications on the OSS’s facility in terms of documents uploaded and stored, functionalities exploited and exchanges held as well as in proportion to the overall estimated cost of the relevant decision. Moreover, where the application for a conformity to vehicle type is submitted to the Agency, the fee for using the OSS should become an integral part of the overall fee for delivering vehicle authorisations subject to fixed fees.

| (9) | Fees and charges should reflect the specific situation of micro, small and medium-sized enterprises. A specific reduction should be therefore applied. |
| --- | --- |

(9)

Fees and charges should reflect the specific situation of micro, small and medium-sized enterprises. A specific reduction should be therefore applied.

| (10) | All criteria and methodology for defining the level of fees and charges are based on the principle that the revenue in respect thereof should cover the full cost of the services provided, avoiding a deficit or a significant accumulation of surplus, in accordance with Article 80(3), first subparagraph of Regulation (EU) 2016/796. |
| --- | --- |

(10)

All criteria and methodology for defining the level of fees and charges are based on the principle that the revenue in respect thereof should cover the full cost of the services provided, avoiding a deficit or a significant accumulation of surplus, in accordance with Article 80(3), first subparagraph of Regulation (EU) 2016/796.

| (11) | Experience in applying Implementing Regulation (EU) 2018/764 has shown that the conditions of payment of fees and charges should be modernised and adjusted to mitigate the risk of failure to pay by applicants whose financial ability is at risk and applicants established in third countries, against whom the Agency lacks adequate legal enforcement safeguards. It is appropriate that the Agency should invoice the payable amounts early in the application process, in order to reduce the risk of late payment or failure to pay. It shall grant online payment options. |
| --- | --- |

(11)

Experience in applying Implementing Regulation (EU) 2018/764 has shown that the conditions of payment of fees and charges should be modernised and adjusted to mitigate the risk of failure to pay by applicants whose financial ability is at risk and applicants established in third countries, against whom the Agency lacks adequate legal enforcement safeguards. It is appropriate that the Agency should invoice the payable amounts early in the application process, in order to reduce the risk of late payment or failure to pay. It shall grant online payment options.

| (12) | Since fees and charges largely reflect the Agency’s expenditure for staff and associated direct expenditure related to the activities referred to in Article 80(2) of Regulation (EU) 2016/796, the relevant amounts should be indexed by the Agency once every financial year to take into account the inflation rate and the annual update of the remuneration of the Agency’s staff, based on reliable data. |
| --- | --- |

(12)

Since fees and charges largely reflect the Agency’s expenditure for staff and associated direct expenditure related to the activities referred to in Article 80(2) of Regulation (EU) 2016/796, the relevant amounts should be indexed by the Agency once every financial year to take into account the inflation rate and the annual update of the remuneration of the Agency’s staff, based on reliable data.

| (13) | The Agency’s should fully embrace cost efficiency and therefore, continuously attempt to improve processes applied to deliver the tasks imposed on it under Regulation (EU) 2016/796, and in particular match the scope of tasks and resources available. In doing so it should realise a truly Single European Rail Area and should take account of the EU rail policy goals for more sustainable and smart mobility as well as an innovative, safe, strong and fully interoperable rail sector. |
| --- | --- |

(13)

The Agency’s should fully embrace cost efficiency and therefore, continuously attempt to improve processes applied to deliver the tasks imposed on it under Regulation (EU) 2016/796, and in particular match the scope of tasks and resources available. In doing so it should realise a truly Single European Rail Area and should take account of the EU rail policy goals for more sustainable and smart mobility as well as an innovative, safe, strong and fully interoperable rail sector.

| (14) | Implementing Regulation (EU) 2018/764 should therefore be amended accordingly. |
| --- | --- |

(14)

Implementing Regulation (EU) 2018/764 should therefore be amended accordingly.

| (15) | The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 51 of Directive (EU) 2016/797, |
| --- | --- |

(15)

The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 51 of Directive (EU) 2016/797,

HAS ADOPTED THIS REGULATION:

Article 1

Implementing Regulation (EU) 2018/764 is amended as follows:

| (1) | in Article 1, paragraph 1 is replaced by the following:

  ‘1.   This Regulation lays down the fees and charges payable to the European Union Agency for Railways (‘the Agency’) for the processing of applications pursuant to Articles 14, 20, 21, and 22 of Regulation (EU) 2016/796, including for the use by an applicant of the one-stop shop (‘OSS’) provided for in Article 12 of that Regulation for the submission of applications to the Agency), and for the provision of other services in accordance with the objectives for which the Agency has been established. It also specifies the method to be used for calculating those fees and charges and conditions for payment.’; |
| --- | --- |

(1)

in Article 1, paragraph 1 is replaced by the following:

‘1.   This Regulation lays down the fees and charges payable to the European Union Agency for Railways (‘the Agency’) for the processing of applications pursuant to Articles 14, 20, 21, and 22 of Regulation (EU) 2016/796, including for the use by an applicant of the one-stop shop (‘OSS’) provided for in Article 12 of that Regulation for the submission of applications to the Agency), and for the provision of other services in accordance with the objectives for which the Agency has been established. It also specifies the method to be used for calculating those fees and charges and conditions for payment.’;

| (2) | Article 2 is replaced by the following:

  ‘Article 2
  Types of fees and charges levied by the Agency

  1.   The Agency shall levy fees:






  (a) | for the submission of applications through the OSS to the Agency, if those are not included in the fixed fees for the processing of applications; |
| --- | --- | --- |

(2)

Article 2 is replaced by the following:

‘Article 2

Types of fees and charges levied by the Agency

1.   The Agency shall levy fees:

(a)

for the submission of applications through the OSS to the Agency, if those are not included in the fixed fees for the processing of applications;

| (b) | for the processing of applications submitted to the Agency, including for the issuing of estimates referred to in Article 4 or where an application is subsequently withdrawn by the applicant; |
| --- | --- |

(b)

for the processing of applications submitted to the Agency, including for the issuing of estimates referred to in Article 4 or where an application is subsequently withdrawn by the applicant;

| (c) | where the Agency renews, restricts, amends or reviews a decision issued in accordance with Directive (EU) 2016/798 or Directive (EU) 2016/797. |
| --- | --- |

(c)

where the Agency renews, restricts, amends or reviews a decision issued in accordance with Directive (EU) 2016/798 or Directive (EU) 2016/797.

The Agency may levy fees where it revokes an authorisation for placing on the market due to a subsequently established non-compliance with essential requirements of a vehicle in use or a vehicle type in accordance with Article 26 of Directive (EU) 2016/797, or because a holder of a single safety certificate no longer satisfies the conditions for the certification in accordance with Article 17(5) and (6) of Directive 2016/798.

2.   The applications referred to in paragraph 1, first subparagraph, points (a) and (b), shall cover:

| (a) | authorisations for the placing on the market of vehicles and of vehicle types in accordance with Article 20 and 21 of Regulation (EU) 2016/796 other than those specified in point (b) of this paragraph; |
| --- | --- |

(a)

authorisations for the placing on the market of vehicles and of vehicle types in accordance with Article 20 and 21 of Regulation (EU) 2016/796 other than those specified in point (b) of this paragraph;

| (b) | authorisations for the placing on the market of a vehicle or a series of vehicles which is in conformity with an authorised vehicle type pursuant to Article 25(1) of Directive (EU) 2016/797; |
| --- | --- |

(b)

authorisations for the placing on the market of a vehicle or a series of vehicles which is in conformity with an authorised vehicle type pursuant to Article 25(1) of Directive (EU) 2016/797;

| (c) | single safety certificates in accordance with Article 14 of Regulation (EU) 2016/796; |
| --- | --- |

(c)

single safety certificates in accordance with Article 14 of Regulation (EU) 2016/796;

| (d) | decisions for approval of the interoperability compliance of an ERTMS track-side equipment solution with the relevant TSI in accordance with Article 22 of Regulation (EU) 2016/796; |
| --- | --- |

(d)

decisions for approval of the interoperability compliance of an ERTMS track-side equipment solution with the relevant TSI in accordance with Article 22 of Regulation (EU) 2016/796;

| (e) | pre-engagement applications in accordance with Article 22 of Commission Implementing Regulation (EU) 2018/545 and Articles 2(3) and 4(5) of Commission Implementing Regulation 2018/763; |
| --- | --- |

(e)

pre-engagement applications in accordance with Article 22 of Commission Implementing Regulation (EU) 2018/545 and Articles 2(3) and 4(5) of Commission Implementing Regulation 2018/763;

| (f) | appeals referred to in Article 58 of Regulation (EU) 2016/796 in accordance with Article 7 of this Regulation. |
| --- | --- |

(f)

appeals referred to in Article 58 of Regulation (EU) 2016/796 in accordance with Article 7 of this Regulation.

3.   The Agency shall levy charges for the provision of services other than those referred to in paragraph 1, requested by an applicant or any other person or entity.

4.   The Agency shall publish a list of services on its website.’;

| (3) | Article 3 is replaced by the following:

  ‘Article 3
  Calculation of fees, charges and fixed fees levied by the Agency

  1.   The amount of fees for the use of the OSS for submitting to the Agency applications referred to in Article 2(2), points (a), (c), (d) and (e) shall be a fixed amount specified in table A of point 2 of the Annex. That fixed fee shall be due for payment at the time of the submission of the application.


  2.   The amount of fees for processing applications referred to in Article 2(2), points (a), (c), (d) and (e), including for performing the activities referred to in Article 2(1), first subparagraph, point (c) and second subparagraph, shall be the total of the following:






  (a) | the number of hours spent by Agency staff and external experts, on the processing of the application multiplied by the hourly rate of the Agency specified in point 1 of the Annex; |
| --- | --- | --- |

(3)

Article 3 is replaced by the following:

‘Article 3

Calculation of fees, charges and fixed fees levied by the Agency

1.   The amount of fees for the use of the OSS for submitting to the Agency applications referred to in Article 2(2), points (a), (c), (d) and (e) shall be a fixed amount specified in table A of point 2 of the Annex. That fixed fee shall be due for payment at the time of the submission of the application.

2.   The amount of fees for processing applications referred to in Article 2(2), points (a), (c), (d) and (e), including for performing the activities referred to in Article 2(1), first subparagraph, point (c) and second subparagraph, shall be the total of the following:

(a)

the number of hours spent by Agency staff and external experts, on the processing of the application multiplied by the hourly rate of the Agency specified in point 1 of the Annex;

| (b) | the amount of fees levied by the Agency shall be supplemented by the relevant amount submitted by the national safety authorities (‘NSAs’) resulting from the cost for processing of the national part of the application. |
| --- | --- |

(b)

the amount of fees levied by the Agency shall be supplemented by the relevant amount submitted by the national safety authorities (‘NSAs’) resulting from the cost for processing of the national part of the application.

3.   The amount of fees for the submission and processing of respective applications and the issuing of authorisations referred to in Article 2(2), point (b) shall be a fixed amount specified in table B of point 3 of the Annex and includes the fee for using the OSS fee referred to in paragraph 1. That fixed fee shall be due for payment at the time of the submission of the application.

4.   The amount of charges for services referred to in Article 2(3) shall be the number of hours spent by Agency staff and external experts multiplied by the hourly rate of the Agency specified in point 1 of the Annex.

5.   At the request of the applicant, a 20 % reduction of the amount levied by the Agency for an application shall apply in case of micro, small or medium-sized enterprise. Such a request shall be made at application when fixed fees apply, and at the latest before the Agency issues an invoice in all other cases.

For the purposes of this Regulation, micro, small or medium-sized enterprise means an autonomous railway undertaking, infrastructure manager or manufacturer, established or having its seat in a member country of the European Economic Area and meeting the conditions laid down in Commission Recommendation 2003/361/EC (4).

The applicant shall provide evidence through the OSS proving that it qualifies as a micro, small or medium-sized enterprise. The Agency shall assess the evidence provided and decide to refuse the request for the status as micro, small or medium-sized enterprise in case of doubt or lack of justification.’;

| (4) | Article 5 is amended as follows:






  (a) | paragraph 1 is replaced by the following:

  ‘1.   The Agency shall issue an invoice for the fees and charges due, within 30 calendar days of the date:






  (a) | of its decision, except in case of decisions covered by the fixed fee regime or subject to Article 6(3); |
| --- | --- | --- | --- |

(4)

Article 5 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘1.   The Agency shall issue an invoice for the fees and charges due, within 30 calendar days of the date:

(a)

of its decision, except in case of decisions covered by the fixed fee regime or subject to Article 6(3);

| (b) | of the decision of Board of Appeal; |
| --- | --- |

(b)

of the decision of Board of Appeal;

| (c) | when the service rendered ended; |
| --- | --- |

(c)

when the service rendered ended;

| (d) | of withdrawal of an application; |
| --- | --- |

(d)

of withdrawal of an application;

| (e) | of any other event leading to cessation of processing of an application;
  With regard to fixed fees that become due for payment at the time of the submission of the application as referred to in Article 3(1) and (3) prior to the Agency’s processing the application, the Agency may agree a different due date with individual applicants, as well as enter into a special arrangement for invoicing.’; |
| --- | --- |

(e)

of any other event leading to cessation of processing of an application;

With regard to fixed fees that become due for payment at the time of the submission of the application as referred to in Article 3(1) and (3) prior to the Agency’s processing the application, the Agency may agree a different due date with individual applicants, as well as enter into a special arrangement for invoicing.’;

| (b) | paragraph 2 is replaced by the following:

  ‘2.   The invoice shall provide the following elements, where applicable:






  (a) | differentiation between fees or charges; |
| --- | --- | --- |

(b)

paragraph 2 is replaced by the following:

‘2.   The invoice shall provide the following elements, where applicable:

(a)

differentiation between fees or charges;

| (b) | amounts subject to fixed fees; |
| --- | --- |

(b)

amounts subject to fixed fees;

| (c) | where no fixed fees apply, the number of hours spent under the Agency’s responsibility and the hourly rate applied; |
| --- | --- |

(c)

where no fixed fees apply, the number of hours spent under the Agency’s responsibility and the hourly rate applied;

| (d) | where relevant, the costs charged by the NSA responsible. These shall be specified in relation to tasks and time spent or in form of fixed rates applied by the NSA to the processing of the national part of the application.’; |
| --- | --- |

(d)

where relevant, the costs charged by the NSA responsible. These shall be specified in relation to tasks and time spent or in form of fixed rates applied by the NSA to the processing of the national part of the application.’;

| (c) | the following paragraph 4a is inserted:

  ‘4a.   Where Article 6(3) applies to applicants, the Agency shall have the right to issue payment notices requiring partial payment for the parts of the application already processed. In the absence of the requested payment within a timeframe set by the Agency but not less than 10 calendar days, the Agency may suspend the processing of the application and inform the applicant thereof. The Agency shall resume the processing of the application in case the requested payment is made within 20 calendar days following the notification of the suspension. In the absence of the payment within 20 calendar days following the notification of the suspension, the Agency has the right to reject the application.’; |
| --- | --- |

(c)

the following paragraph 4a is inserted:

‘4a.   Where Article 6(3) applies to applicants, the Agency shall have the right to issue payment notices requiring partial payment for the parts of the application already processed. In the absence of the requested payment within a timeframe set by the Agency but not less than 10 calendar days, the Agency may suspend the processing of the application and inform the applicant thereof. The Agency shall resume the processing of the application in case the requested payment is made within 20 calendar days following the notification of the suspension. In the absence of the payment within 20 calendar days following the notification of the suspension, the Agency has the right to reject the application.’;

| (d) | paragraph 9 is replaced by the following:

  ‘9.   Where the applicant is a micro, small or medium-sized enterprise, the Agency shall take into account requests for a reasonable extension of the time limit for payment and payment by instalments.’; |
| --- | --- |

(d)

paragraph 9 is replaced by the following:

‘9.   Where the applicant is a micro, small or medium-sized enterprise, the Agency shall take into account requests for a reasonable extension of the time limit for payment and payment by instalments.’;

| (5) | Article 6 is amended as follows:






  (a) | paragraph 1 is replaced by the following:

  ‘1.   In the absence of payment of the amounts due, the Agency may charge interest for each additional calendar day for which payment is delayed and shall apply the rules on recovery provided for in Part one, Title IV, Chapter 6, Section 5 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, as applied to European agencies, in particular its Article 101, and in the financial rules of the Agency adopted in accordance with Article 66 of Regulation (EU) 2016/796.’; |
| --- | --- | --- |

(5)

Article 6 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘1.   In the absence of payment of the amounts due, the Agency may charge interest for each additional calendar day for which payment is delayed and shall apply the rules on recovery provided for in Part one, Title IV, Chapter 6, Section 5 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council, as applied to European agencies, in particular its Article 101, and in the financial rules of the Agency adopted in accordance with Article 66 of Regulation (EU) 2016/796.’;

| (b) | paragraph 3 is replaced by the following:

  ‘3.   Where the Agency has evidence that the applicant’s financial ability is at risk or where the applicant is not established or does not have its seat in a member country of the European Economic Area it may require the applicant to provide a bank guarantee or secured deposit within 15 days following receipt of the application. Where the applicant fails to do so, the Agency may reject its application.’; |
| --- | --- |

(b)

paragraph 3 is replaced by the following:

‘3.   Where the Agency has evidence that the applicant’s financial ability is at risk or where the applicant is not established or does not have its seat in a member country of the European Economic Area it may require the applicant to provide a bank guarantee or secured deposit within 15 days following receipt of the application. Where the applicant fails to do so, the Agency may reject its application.’;

| (c) | paragraph 4 is replaced by the following:

  ‘4.   Without prejudice to paragraph 1, the Agency may reject a new application or suspend the processing of an ongoing application, where the applicant or its legal successor has not fulfilled its payment obligations arising out of previous authorisation, certification or approval tasks or services performed by the Agency, unless the applicant pays all amounts due. In case an ongoing application is to be suspended the procedure referred to in Article 5, paragraph 4a shall apply accordingly.’; |
| --- | --- |

(c)

paragraph 4 is replaced by the following:

‘4.   Without prejudice to paragraph 1, the Agency may reject a new application or suspend the processing of an ongoing application, where the applicant or its legal successor has not fulfilled its payment obligations arising out of previous authorisation, certification or approval tasks or services performed by the Agency, unless the applicant pays all amounts due. In case an ongoing application is to be suspended the procedure referred to in Article 5, paragraph 4a shall apply accordingly.’;

| (6) | Article 8 is amended as follows:






  (a) | paragraph 1 is replaced by the following:

  ‘1.   The Agency shall publish the hourly rate and fixed rates referred to in Article 3 on its website.’; |
| --- | --- | --- |

(6)

Article 8 is amended as follows:

(a)

paragraph 1 is replaced by the following:

‘1.   The Agency shall publish the hourly rate and fixed rates referred to in Article 3 on its website.’;

| (b) | paragraph 2 is replaced by the following:

  ‘2.   The NSA shall publish on its website the rates relevant for establishing the costs charged to the Agency referred to in Article 3(2), point (b). Where the NSA applies a fixed rate it shall specify to which authorisation and certification case the fixed rate will apply. The NSA shall provide the Agency with a link to its website containing information on its fees and charges.’; |
| --- | --- |

(b)

paragraph 2 is replaced by the following:

‘2.   The NSA shall publish on its website the rates relevant for establishing the costs charged to the Agency referred to in Article 3(2), point (b). Where the NSA applies a fixed rate it shall specify to which authorisation and certification case the fixed rate will apply. The NSA shall provide the Agency with a link to its website containing information on its fees and charges.’;

| (7) | Article 10 is amended as follows:






  (a) | the following paragraph 1a is inserted:

  ‘1a.   Amounts referred to in the Annex shall be indexed by the Agency, for the first time in 2023 and once every financial year thereafter, with effect from 1 January, based on






  (a) | the annual update of the remuneration and pensions of the officials and other servants of the European Union and the correction coefficients applied thereto as published in the Official Journal of the European Union, in accordance with a calculation method to be agreed by the Agency’s Management Board, and based on the relevant annual financial data used in the Agency’s Single Programming Document and its Consolidated Annual Activity reports; and/or |
| --- | --- | --- | --- |

(7)

Article 10 is amended as follows:

(a)

the following paragraph 1a is inserted:

‘1a.   Amounts referred to in the Annex shall be indexed by the Agency, for the first time in 2023 and once every financial year thereafter, with effect from 1 January, based on

(a)

the annual update of the remuneration and pensions of the officials and other servants of the European Union and the correction coefficients applied thereto as published in the Official Journal of the European Union, in accordance with a calculation method to be agreed by the Agency’s Management Board, and based on the relevant annual financial data used in the Agency’s Single Programming Document and its Consolidated Annual Activity reports; and/or

| (b) | the inflation rate in the Union, in accordance with the method set out in point 4 of the Annex.’; |
| --- | --- |

(b)

the inflation rate in the Union, in accordance with the method set out in point 4 of the Annex.’;

| (b) | paragraph 3 is replaced by the following:

  ‘3.   In light of the information provided by the Agency in its annual reports this Regulation shall be reviewed at the latest by 16 June 2024 with a view to the progressive introduction of further fixed fees.’. |
| --- | --- |

(b)

paragraph 3 is replaced by the following:

‘3.   In light of the information provided by the Agency in its annual reports this Regulation shall be reviewed at the latest by 16 June 2024 with a view to the progressive introduction of further fixed fees.’.

Article 2

The text set out in the Annex to this Regulation is added as an Annex to Implementing Regulation (EU) 2018/764.

Article 3

In respect of applications submitted before the entry into force of this Regulation, Article 1, point (3) shall not apply.

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 October 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 138, 26.5.2016, p. 1.

1

(2)  Commission Implementing Regulation (EU) 2018/764 of 2 May 2018 on the fees and charges payable to the European Union Agency for Railways and their conditions of payment (OJ L 129, 25.5.2018, p. 68).

2

(3)  Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).

3

(4)  Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

4

---

ANNEX

| 1. | The Agency shall apply an hourly rate of EUR 239. |
| --- | --- |

1.

The Agency shall apply an hourly rate of EUR 239.

| 2. | The fixed fees to be paid to the Agency for the use of the one-stop shop (OSS) shall be as follows:

  Table A | OSS Cost group | Amount
  (EUR) |
| --- | --- | --- | --- |
| Submission of an application to the Agency for: |
| 1. | A single safety certificate | 400 |
| 2. | A vehicle type authorisation | 400 |
| 3. | A vehicle authorisation other than an authorisation in conformity to type | 400 |
| 4. | An ERTMS trackside approval | 400 |
| 5. | A pre-engagement process | 400 |

2.

The fixed fees to be paid to the Agency for the use of the one-stop shop (OSS) shall be as follows:

Table A

OSS Cost group

Amount
  (EUR)

Submission of an application to the Agency for:

1.

A single safety certificate

400

2.

A vehicle type authorisation

400

3.

A vehicle authorisation other than an authorisation in conformity to type

400

4.

An ERTMS trackside approval

400

5.

A pre-engagement process

400

| 3. | The fixed fees for the submission and processing of applications for the placing on the market of a vehicle, or a series of vehicles, which are in conformity with an authorised vehicle type shall be as follows:

  Table B | Cost group | Amount
  (EUR) |
| --- | --- | --- | --- |
| Submission to and processing by the Agency of an application for a decision authorising vehicles in conformity to type: |
| 1. | freight wagons and all vehicles referred to in point 2 of the Annex to Commission Regulation (EU) No 321/2013 (1) | 775 |
| 2. | (a) | thermal or electric traction units; |

3.

The fixed fees for the submission and processing of applications for the placing on the market of a vehicle, or a series of vehicles, which are in conformity with an authorised vehicle type shall be as follows:

Table B

Cost group

Amount
  (EUR)

Submission to and processing by the Agency of an application for a decision authorising vehicles in conformity to type:

1.

freight wagons and all vehicles referred to in point 2 of the Annex to Commission Regulation (EU) No 321/2013 (1)

775

2.

(a)

thermal or electric traction units;

| (b) | passenger carriages; |
| --- | --- |

(b)

passenger carriages;

| (c) | mobile railway infrastructure construction and maintenance equipment |
| --- | --- |

(c)

mobile railway infrastructure construction and maintenance equipment

970

3.

self-propelling thermal or electric trains

1 115

| 4. | The annual inflation rate referred to in Article 10(1a) is established as follows:






  Annual inflation rate to be used: | ‘Eurostat HICP (All items) – European Union all countries’ (2015 = 100) Percentage change/12 months average |
| --- | --- | --- |
| Value of the rate to be taken into account: | Value of the rate 3 months prior to the implementation of the indexation |

4.

The annual inflation rate referred to in Article 10(1a) is established as follows:

Annual inflation rate to be used:

‘Eurostat HICP (All items) – European Union all countries’ (2015 = 100) Percentage change/12 months average

Value of the rate to be taken into account:

Value of the rate 3 months prior to the implementation of the indexation

---

(1)  Commission Regulation (EU) No 321/2013 of 13 March 2013 concerning the technical specification for interoperability relating to the subsystem ‘rolling stock – freight wagons’ of the rail system in the European Union and repealing Decision 2006/861/EC (OJ L 104, 12.4.2013, p. 1).

---

| 3.11.2021 | EN | Official Journal of the European Union | L 387/133 |
| --- | --- | --- | --- |

3.11.2021

EN

Official Journal of the European Union

L 387/133

---

COMMISSION IMPLEMENTING REGULATION (EU) 2021/1904

of 29 October 2021

adopting the design of a common logo for the retail of veterinary medicinal products at a distance

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (1), and in particular Article 104(7) thereof,

Whereas:

| (1) | Persons permitted to supply veterinary medicinal products in accordance with Article 103 of Regulation (EU) 2019/6 may offer such products for sale at a distance under certain conditions. A common logo, which includes a hyperlink to the relevant Member State competent authority’s list of retailers permitted to offer veterinary medicinal products for sale at a distance, is to be adopted with the purpose of assisting the public in finding out whether a website offering such products for sale at a distance is legally entitled to do so. |
| --- | --- |

(1)

Persons permitted to supply veterinary medicinal products in accordance with Article 103 of Regulation (EU) 2019/6 may offer such products for sale at a distance under certain conditions. A common logo, which includes a hyperlink to the relevant Member State competent authority’s list of retailers permitted to offer veterinary medicinal products for sale at a distance, is to be adopted with the purpose of assisting the public in finding out whether a website offering such products for sale at a distance is legally entitled to do so.

| (2) | The design of the common logo for the supply of veterinary medicinal products at a distance is to include both a graphic design and a hyperlink to the list of retailers permitted to offer veterinary medicinal products for sale at a distance on the website of the competent authority of the relevant Member State. |
| --- | --- |

(2)

The design of the common logo for the supply of veterinary medicinal products at a distance is to include both a graphic design and a hyperlink to the list of retailers permitted to offer veterinary medicinal products for sale at a distance on the website of the competent authority of the relevant Member State.

| (3) | In accordance with the majority opinions of the Member States expressed at the Standing Committee on Veterinary Medicinal Products’ meeting of 2 December 2019, and a targeted consultation of stakeholders by email on 26 November 2019, the common logo should be modelled on the equivalent logo for medicinal products for human use (2). This logo has proven to be effective in practice by allowing the public to verify that a retailer is legally entitled to sell medicinal products on line. In order to distinguish the graphic design from the existing logo for medicinal products for human use, a different colour should be used and the letters ‘vet’, standing for veterinary, should be added. |
| --- | --- |

(3)

In accordance with the majority opinions of the Member States expressed at the Standing Committee on Veterinary Medicinal Products’ meeting of 2 December 2019, and a targeted consultation of stakeholders by email on 26 November 2019, the common logo should be modelled on the equivalent logo for medicinal products for human use (2). This logo has proven to be effective in practice by allowing the public to verify that a retailer is legally entitled to sell medicinal products on line. In order to distinguish the graphic design from the existing logo for medicinal products for human use, a different colour should be used and the letters ‘vet’, standing for veterinary, should be added.

| (4) | This Regulation should apply from 28 January 2022 in accordance with Article 153(1) of Regulation (EU) 2019/6. |
| --- | --- |

(4)

This Regulation should apply from 28 January 2022 in accordance with Article 153(1) of Regulation (EU) 2019/6.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

The design of the common logo referred to in Article 104(6) of Regulation (EU) 2019/6 shall follow the model set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 28 January 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 October 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 4, 7.1.2019, p. 43.

1

(2)  Commission Implementing Regulation (EU) No 699/2014 of 24 June 2014 on the design of the common logo to identify persons offering medicinal products for sale at a distance to the public and the technical, electronic and cryptographic requirements for verification of its authenticity (OJ L 184, 25.6.2014, p. 5).

2

---

ANNEX

| (1) | The model for the common logo referred to in Article 1 is the following: |
| --- | --- |

(1)

The model for the common logo referred to in Article 1 is the following:

Image 13

| (2) | The reference colours are:
  PANTONE 647 CMYK 88/50/12/0 RGB 63/107/162; PANTONE 2925 CMYK 78/28/0/0 RGB 78/138/224; PANTONE 2905 CMYK 45/10/0/0 RGB 159/195/239; PANTONE 421 CMYK 13/11/8/26 RGB 204/204/204. |
| --- | --- |

(2)

The reference colours are:

PANTONE 647 CMYK 88/50/12/0 RGB 63/107/162; PANTONE 2925 CMYK 78/28/0/0 RGB 78/138/224; PANTONE 2905 CMYK 45/10/0/0 RGB 159/195/239; PANTONE 421 CMYK 13/11/8/26 RGB 204/204/204.

| (3) | The national flag of the Member State where the retailer supplying veterinary medicinal products to the public at a distance by means of information society services is established shall be inserted in the white rectangle in the middle (left side) of the common logo. |
| --- | --- |

(3)

The national flag of the Member State where the retailer supplying veterinary medicinal products to the public at a distance by means of information society services is established shall be inserted in the white rectangle in the middle (left side) of the common logo.

| (4) | The language of the text in the common logo shall be established by the Member State where the retailer supplying veterinary medicinal products to the public at a distance by means of information society services is established. |
| --- | --- |

(4)

The language of the text in the common logo shall be established by the Member State where the retailer supplying veterinary medicinal products to the public at a distance by means of information society services is established.

| (5) | The common logo shall have a minimum width size of 90 pixel. |
| --- | --- |

(5)

The common logo shall have a minimum width size of 90 pixel.

| (6) | The common logo shall be static. |
| --- | --- |

(6)

The common logo shall be static.

| (7) | If the logo is used on a coloured background that makes it difficult to discern, a delimiting outer line around the logo can be used to improve contrast with the background colour. |
| --- | --- |

(7)

If the logo is used on a coloured background that makes it difficult to discern, a delimiting outer line around the logo can be used to improve contrast with the background colour.

Image 14

| (8) | The hyperlink, mentioned in Article 104(5)(c) of Regulation (EU) 2019/6, between the website of the retailer permitted to supply veterinary medicinal products at a distance to the public by means of information society services and the website providing the national list mentioned in Article 104(8)(c) of the Regulation, shall be fixed and reciprocal. |
| --- | --- |

(8)

The hyperlink, mentioned in Article 104(5)(c) of Regulation (EU) 2019/6, between the website of the retailer permitted to supply veterinary medicinal products at a distance to the public by means of information society services and the website providing the national list mentioned in Article 104(8)(c) of the Regulation, shall be fixed and reciprocal.

---