Article 133 Use of the IMSOC in the case of animals and goods subject to certain official controls
1. In the case of animals or goods whose movements within the Union or placing on the market are subject to specific requirements or procedures established by the rules referred to in Article 1(2), the IMSOC shall enable the competent authorities at the place of dispatch and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning animals or goods being moved from one Member State to another and on official controls performed. 2. In the case of exported animals and goods for which Union rules apply in relation to the issuance of the export certificate, the IMSOC shall enable the competent authorities of the place of dispatch and other competent authorities responsible for performing official controls to exchange, in real time, data, information and documents concerning such animals and goods and the outcome of controls performed on those animals and goods. 3. In the case of animals or goods subject to the official controls referred to in Articles 44 to 64, the IMSOC shall: (a) enable the competent authorities at the border control posts and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning those animals and goods and on controls performed on those animals or goods; enable the competent authorities at the border control posts to share and exchange relevant data, information and documents with customs authorities and other authorities responsible for performing controls on animals or goods entering the Union from third countries, and with operators involved in entry procedures, in accordance with the rules adopted pursuant to Articles 15(4) and 75(2) and with other relevant Union rules; and (c) support and operate the procedures referred to in point (a) of Article 54(3) and in Article 65(6). 4. The IMSOC shall, for the purpose of this Article, integrate the existing Traces system.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 133 Use of the IMSOC in the case of animals and goods subject to certain official controls):
1. In the case of animals or goods whose movements within the Union or placing on the market are subject to specific requirements or procedures established by the rules referred to in Article 1(2), the IMSOC shall enable the competent authorities at the place of dispatch and other competent authorities responsible for performing official controls on those animals or goods to exchange, in real time, data, information and documents concerning animals or goods being moved from one Member State to another and on official controls performed. 2. In the case of exported animals and goods for which Union rules apply in relation to the issuance of the export certificate, the IMSOC shall enable the competent authorities of the place of dispatch and other competent authorities responsible for performing official controls to exchange, in real time, data, information and documents concerning such animals and goods and the outcome of controls performed on those animals and goods. 4. The IMSOC shall, for the purpose of this Article, integrate the existing Traces system.
Article 134 The functioning of the IMSOC
The Commission shall adopt implementing acts for the functioning of the IMSOC which lay down: (a) the technical specifications of the IMSOC and its system components, including the electronic data exchange mechanism for exchanges with existing national systems, identification of applicable standards, definition of message structures, data dictionaries, exchange of protocols and procedures; (b) the specific rules for the functioning of the IMSOC and of its system components to ensure protection of personal data and security of exchange of information; the specific rules for the functioning and use of the IMSOC and of its components, including the rules to update and create the necessary links between the systems referred to in point (e) of Article 132 and in Article 133(4); (d) contingency arrangements to be applied in the event of unavailability of any of the functionalities of the IMSOC; (e) the cases where, and the conditions under which, the third countries and international organisations concerned may be granted partial access to the functionalities of the IMSOC and the practical arrangements of such access; (f) the cases where, and the conditions under which, the data, information and documents are to be transmitted using the IMSOC; (g) the rules concerning an electronic system under which electronic certificates issued by the competent authorities of third countries are to be accepted by the competent authorities; and (h) the cases where, and the conditions under which, exemptions from the use of the IMSOC can be granted to occasional users. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 134 The functioning of the IMSOC):
The Commission shall adopt implementing acts for the functioning of the IMSOC which lay down: (a) the technical specifications of the IMSOC and its system components, including the electronic data exchange mechanism for exchanges with existing national systems, identification of applicable standards, definition of message structures, data dictionaries, exchange of protocols and procedures; (b) the specific rules for the functioning of the IMSOC and of its system components to ensure protection of personal data and security of exchange of information; (d) contingency arrangements to be applied in the event of unavailability of any of the functionalities of the IMSOC; (e) the cases where, and the conditions under which, the third countries and international organisations concerned may be granted partial access to the functionalities of the IMSOC and the practical arrangements of such access; (f) the cases where, and the conditions under which, the data, information and documents are to be transmitted using the IMSOC; (g) the rules concerning an electronic system under which electronic certificates issued by the competent authorities of third countries are to be accepted by the competent authorities; and (h) the cases where, and the conditions under which, exemptions from the use of the IMSOC can be granted to occasional users. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 135 Data protection
1. Directive 95/46/EC and Regulation (EC) No 45/2001 of the European Parliament and of the Council ( 17 ) shall apply to the extent that the information processed through the IMSOC contains personal data as defined in point (a) of Article 2 of Directive 95/46/EC and in point (a) of Article 2 of Regulation (EC) No 45/2001. 2. In relation to their responsibilities to transmit the relevant information to the IMSOC and the processing of any personal data that might result from that activity, the competent authorities of the Member States shall be regarded as controllers as defined in point (d) of Article 2 of Directive 95/46/EC. 3. In relation to its responsibility to manage the IMSOC and the processing of any personal data that might result from that activity, the Commission shall be regarded as controller as defined in point (d) of Article 2 of Regulation (EC) No 45/2001. 4. Member States may restrict the rights and obligations under Article 6(1), Article 10, Article 11(1) and Article 12 of Directive 95/46/EC as necessary to safeguard the interest referred to in points (d) and (f) of Article 13(1) of that Directive. 5. The Commission may restrict the rights and obligations under Article 4(1), Article 11, Article 12(1) and Articles 13 to 17 of Regulation (EC) No 45/2001 where such restriction constitutes a necessary measure to safeguard the interests referred to in points (a) and (e) of Article 20(1) of that Regulation during the period in which actions are being planned or performed to verify compliance with food or feed law or to ensure the enforcement of food or feed law in the specific case to which the information relates.
Article 136 Data security
Member States and the Commission shall ensure that the IMSOC complies with the rules on data security adopted by the Commission under Article 17 of Directive 95/46/EC and Article 22 of Regulation (EC) No 45/2001 respectively.
Article 137 General obligations of the competent authorities as regards enforcement action
1. When acting in accordance with this Chapter, the competent authorities shall give priority to action to be taken to eliminate or contain risks to human, animal and plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment. 2. In case of suspicion of non-compliance, the competent authorities shall perform an investigation in order to confirm or to eliminate that suspicion. 3. Where necessary, actions taken in accordance with paragraph 2 shall include: (a) the performance of intensified official controls on animals, goods and operators for an appropriate period; (b) the official detention of animals and goods and of any unauthorised substances or products as appropriate.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2019/6 1 , which enters into application on 28 January 2022, replaces the legal framework for veterinary medicinal products (“VMPs”) established by Directive 2001/82/EC and Regulation (EC) No 726/2004. Article 118(1) of Regulation (EU) 2019/6 provides that third country operators exporting animals and products of animal origin to the EU will have to respect the prohibition against using antimicrobials for growth promotion and yield increase (Article 107(2)), as well as the ban against using antimicrobials reserved for treatment of certain infections in humans (Article 37(5)) . Article 118(2) of Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts providing detailed rules on the application of the prohibitions referred to in Article 118. Regulation (EU) 2019/6 sets out the legal framework for the authorisation of veterinary medicinal products, whereas Article 118 of that Regulation by contrast applies to animals and products of animal origin. Unlike other legislation that lays down rules for animals and products of animal origin, Regulation (EU) 2019/6 does not contain any basic provisions on import conditions/requirements or on official controls of compliance of imports with these requirements. Import requirements and conditions (such as third country and establishment listing and certificates) for animals and for products of animal origin are laid down in relevant sectorial legislation, such as the Animal Health Law 2 , but may also be laid down on the basis of Regulation (EU) 2017/625 (‘the Official Controls Regulation’) 3 . For a third country to be included in a list of third countries authorised to export to the Union, it needs, for example, to provide guarantees that the animals and goods concerned comply with the Union’s requirements or with requirements equivalent thereto laid down in the relevant legislation. However, Article 1(4)(c) of the Official Controls Regulation states that that Regulation does not apply to official controls for the verification of compliance with Directive 2001/82/EC on veterinary medicinal products. When Regulation (EU) 2019/6 enters into application on 28 January 2022, the reference to Directive 2001/82/EC will in effect become a reference to that Regulation. 4 Article 1(4)(c) of the Official Controls Regulation excludes the entirety of Regulation (EU) 2019/6 from its scope. In the absence of relevant provisions in Regulation (EU) 2019/6 on official controls of compliance of imports with the requirements referred to in the preceding paragraph, i t would not be possible to implement and enforce Article 118 of Regulation (EU) 2019/6 properly without amending the Official Controls Regulation . The objective of this amendment is to modify Article 1(4)(c) of the Official Controls Regulation to include an exception to the above exclusion, integrating controls to verify compliance with Article 118 of Regulation (EU) 2019/6 into the scope of the Official Controls Regulation. This would mean that the Union’s official control system for animals and products of animal origin could be used to ensure compliance with the prohibitions in Article 118 of Regulation (EU) 2019/6. This would in turn make it possible to implement and enforce Article 118 properly. Article 123 of Regulation (EU) 2019/6, which was part of the Commission’s proposal, provides for controls of compliance with the Regulation by Member State competent authorities. However, these controls only apply to manufacturers and importers of VMPs and active substances (and other persons involved in the placing on the market and use of VMPs and active substances). To ensure that animals and products of animal origin imported into the Union comply with Article 118 of Regulation (EU) 2019/6, it is necessary to provide that controls of compliance with Article 118 are included into the scope of the Official Controls Regulation. Under its Farm to Fork Strategy, the EU has set the ambitious target of reducing by 50% its overall EU sales of antimicrobials used for farmed animals and in aquaculture by 2030. Building on the One Health approach, Regulation (EU) 2019/6 provides for a wide range of concrete measures that will apply to EU operators in order to enhance the fight against antimicrobial resistance (‘AMR’) and promote a more prudent and responsible use of antimicrobials in animals. As a leader in the global fight against AMR, the Union also has the responsibility to encourage the reduction of use and consumption of antimicrobials in third countries, in particular linked to imports from third countries, and has the duty to promote its vision of a more sustainable use of antimicrobials to help preserve their efficiency on the international stage. Article 118 of Regulation (EU) 2019/6 is a key element in the fight against AMR.
Revised version (Article 137 General obligations of the competent authorities as regards enforcement action):
1. When acting in accordance with this Chapter, the competent authorities shall give priority to action to be taken to eliminate or contain risks to human, animal and plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment. 2. In case of suspicion of non-compliance, the competent authorities shall perform an investigation in order to confirm or to eliminate that suspicion. 3. Where necessary, actions taken in accordance with paragraph 2 shall include: (a) the performance of intensified official controls on animals, goods and operators for an appropriate period; (b) the official detention of animals and goods and of any unauthorised substances or products as appropriate. Where necessary, actions taken in accordance with paragraph 2 shall include: (a) the performance of intensified official controls on animals, goods and operators for an appropriate period; (b) the official detention of animals and goods and of any unauthorised substances or products as appropriate.
Article 138 Actions in the event of established non-compliance
1. Where the non-compliance is established, the competent authorities shall take: (a) any action necessary to determine the origin and extent of the non-compliance and to establish the operator’s responsibilities; and (b) appropriate measures to ensure that the operator concerned remedies the non-compliance and prevents further occurrences of such non-compliance. When deciding which measures to take, the competent authorities shall take account of the nature of that non-compliance and the operator’s past record with regard to compliance. 2. When acting in accordance with paragraph 1 of this Article, competent authorities shall take any measure they deem appropriate to ensure compliance with the rules referred to in Article 1(2), including, but not limited, to the following: (a) order or perform treatments on animals; (b) order the unloading, transfer to another means of transport, holding and care of animals, quarantine periods, the postponement of the slaughter of animals, and, if necessary, order that veterinary assistance be sought; (c) order treatments on goods, the alteration of labels or corrective information to be provided to consumers; (d) restrict or prohibit the placing on the market, the movement, the entry into the Union or the export of animals and goods; and prohibit their return to the Member State of dispatch or order their return to the Member State of dispatch; (e) order the operator to increase the frequency of own controls; (f) order certain activities of the operator concerned to be subject to increased or systematic official controls; (g) order the recall, withdrawal, removal and destruction of goods, authorising, where appropriate, the use of the goods for purposes other than those for which they were originally intended; (h) order the isolation or closure, for an appropriate period of time, of all or part of the business of the operator concerned, or its establishments, holdings or other premises; (i) order the cessation for an appropriate period of time of all or part of the activities of the operator concerned and, where relevant, of the internet sites it operates or employs; (j) order the suspension or withdrawal of the registration or approval of the establishment, plant, holding or means of transport concerned, of the authorisation of a transporter or of the certificate of competence of the driver; (k) order the slaughter or killing of animals provided that this is the most appropriate measure to safeguard human health as well as animal health and welfare. 3. The competent authorities shall provide the operator concerned, or its representative, with: (a) written notification of their decision concerning the action or measure to be taken in accordance with paragraphs 1 and 2, together with the reasons for that decision; and (b) information on any right of appeal against such decisions and on the applicable procedure and time limits with respect to such right of appeal. 4. All expenditure incurred under this Article shall be borne by the responsible operators. 5. The competent authorities, in the case of issuance of false or misleading official certificates or in the case of abuse of official certificates, shall take appropriate measures, including: (a) the temporary suspension of the certifying officer from its duties; (b) the withdrawal of the authorisation to sign official certificates; (c) any other measure to prevent a reoccurrence of the offences referred to in Article 89(2).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2019/6 1 , which enters into application on 28 January 2022, replaces the legal framework for veterinary medicinal products (“VMPs”) established by Directive 2001/82/EC and Regulation (EC) No 726/2004. Article 118(1) of Regulation (EU) 2019/6 provides that third country operators exporting animals and products of animal origin to the EU will have to respect the prohibition against using antimicrobials for growth promotion and yield increase (Article 107(2)), as well as the ban against using antimicrobials reserved for treatment of certain infections in humans (Article 37(5)) . Article 118(2) of Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts providing detailed rules on the application of the prohibitions referred to in Article 118. Regulation (EU) 2019/6 sets out the legal framework for the authorisation of veterinary medicinal products, whereas Article 118 of that Regulation by contrast applies to animals and products of animal origin. Unlike other legislation that lays down rules for animals and products of animal origin, Regulation (EU) 2019/6 does not contain any basic provisions on import conditions/requirements or on official controls of compliance of imports with these requirements. Import requirements and conditions (such as third country and establishment listing and certificates) for animals and for products of animal origin are laid down in relevant sectorial legislation, such as the Animal Health Law 2 , but may also be laid down on the basis of Regulation (EU) 2017/625 (‘the Official Controls Regulation’) 3 . For a third country to be included in a list of third countries authorised to export to the Union, it needs, for example, to provide guarantees that the animals and goods concerned comply with the Union’s requirements or with requirements equivalent thereto laid down in the relevant legislation. However, Article 1(4)(c) of the Official Controls Regulation states that that Regulation does not apply to official controls for the verification of compliance with Directive 2001/82/EC on veterinary medicinal products. When Regulation (EU) 2019/6 enters into application on 28 January 2022, the reference to Directive 2001/82/EC will in effect become a reference to that Regulation. 4 Article 1(4)(c) of the Official Controls Regulation excludes the entirety of Regulation (EU) 2019/6 from its scope. In the absence of relevant provisions in Regulation (EU) 2019/6 on official controls of compliance of imports with the requirements referred to in the preceding paragraph, i t would not be possible to implement and enforce Article 118 of Regulation (EU) 2019/6 properly without amending the Official Controls Regulation . The objective of this amendment is to modify Article 1(4)(c) of the Official Controls Regulation to include an exception to the above exclusion, integrating controls to verify compliance with Article 118 of Regulation (EU) 2019/6 into the scope of the Official Controls Regulation. This would mean that the Union’s official control system for animals and products of animal origin could be used to ensure compliance with the prohibitions in Article 118 of Regulation (EU) 2019/6. This would in turn make it possible to implement and enforce Article 118 properly. Article 123 of Regulation (EU) 2019/6, which was part of the Commission’s proposal, provides for controls of compliance with the Regulation by Member State competent authorities. However, these controls only apply to manufacturers and importers of VMPs and active substances (and other persons involved in the placing on the market and use of VMPs and active substances). To ensure that animals and products of animal origin imported into the Union comply with Article 118 of Regulation (EU) 2019/6, it is necessary to provide that controls of compliance with Article 118 are included into the scope of the Official Controls Regulation. Under its Farm to Fork Strategy, the EU has set the ambitious target of reducing by 50% its overall EU sales of antimicrobials used for farmed animals and in aquaculture by 2030. Building on the One Health approach, Regulation (EU) 2019/6 provides for a wide range of concrete measures that will apply to EU operators in order to enhance the fight against antimicrobial resistance (‘AMR’) and promote a more prudent and responsible use of antimicrobials in animals. As a leader in the global fight against AMR, the Union also has the responsibility to encourage the reduction of use and consumption of antimicrobials in third countries, in particular linked to imports from third countries, and has the duty to promote its vision of a more sustainable use of antimicrobials to help preserve their efficiency on the international stage. Article 118 of Regulation (EU) 2019/6 is a key element in the fight against AMR.
Revised version (Article 138 Actions in the event of established non-compliance):
1. Where the non-compliance is established, the competent authorities shall take: (a) any action necessary to determine the origin and extent of the non-compliance and to establish the operator’s responsibilities; and (b) appropriate measures to ensure that the operator concerned remedies the non-compliance and prevents further occurrences of such non-compliance. Where the non-compliance is established, the competent authorities shall take: (a) any action necessary to determine the origin and extent of the non-compliance and to establish the operator’s responsibilities; and (b) appropriate measures to ensure that the operator concerned remedies the non-compliance and prevents further occurrences of such non-compliance. When deciding which measures to take, the competent authorities shall take account of the nature of that non-compliance and the operator’s past record with regard to compliance. When acting in accordance with paragraph 1 of this Article, competent authorities shall take any measure they deem appropriate to ensure compliance with the rules referred to in Article 1(2), including, but not limited, to the following: (a) order or perform treatments on animals; (b) order the unloading, transfer to another means of transport, holding and care of animals, quarantine periods, the postponement of the slaughter of animals, and, if necessary, order that veterinary assistance be sought; (c) order treatments on goods, the alteration of labels or corrective information to be provided to consumers; (d) restrict or prohibit the placing on the market, the movement, the entry into the Union or the export of animals and goods; and prohibit their return to the Member State of dispatch or order their return to the Member State of dispatch; (e) order the operator to increase the frequency of own controls; (f) order certain activities of the operator concerned to be subject to increased or systematic official controls; (g) order the recall, withdrawal, removal and destruction of goods, authorising, where appropriate, the use of the goods for purposes other than those for which they were originally intended; (h) order the isolation or closure, for an appropriate period of time, of all or part of the business of the operator concerned, or its establishments, holdings or other premises; (i) order the cessation for an appropriate period of time of all or part of the activities of the operator concerned and, where relevant, of the internet sites it operates or employs; (j) order the suspension or withdrawal of the registration or approval of the establishment, plant, holding or means of transport concerned, of the authorisation of a transporter or of the certificate of competence of the driver; (k) order the slaughter or killing of animals provided that this is the most appropriate measure to safeguard human health as well as animal health and welfare. 3. The competent authorities shall provide the operator concerned, or its representative, with: (a) written notification of their decision concerning the action or measure to be taken in accordance with paragraphs 1 and 2, together with the reasons for that decision; and (b) information on any right of appeal against such decisions and on the applicable procedure and time limits with respect to such right of appeal. The competent authorities shall provide the operator concerned, or its representative, with: (a) written notification of their decision concerning the action or measure to be taken in accordance with paragraphs 1 and 2, together with the reasons for that decision; and (b) information on any right of appeal against such decisions and on the applicable procedure and time limits with respect to such right of appeal. 4. All expenditure incurred under this Article shall be borne by the responsible operators. The competent authorities, in the case of issuance of false or misleading official certificates or in the case of abuse of official certificates, shall take appropriate measures, including: (a) the temporary suspension of the certifying officer from its duties; (b) the withdrawal of the authorisation to sign official certificates; (c) any other measure to prevent a reoccurrence of the offences referred to in Article 89(2).
Article 139 Penalties
1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by 14 December 2019, notify those provisions to the Commission and shall notify it without delay of any subsequent amendment affecting them. 2. Member States shall ensure that financial penalties for violations of this Regulation and of the rules referred to in Article 1(2), perpetrated through fraudulent or deceptive practices, reflect, in accordance with national law, at least either the economic advantage for the operator or, as appropriate, a percentage of the operator's turnover.
Article 140 Reporting of infringements
1. Member States shall ensure that competent authorities have effective mechanisms to enable reporting of actual or potential infringements of this Regulation. 2. The mechanisms referred to in paragraph 1 shall include at least: (a) procedures for the receipt of reports of infringements and their follow-up; (b) appropriate protection for persons reporting an infringement against retaliation, discrimination or other types of unfair treatment; and (c) protection of personal data of the person reporting an infringement in accordance with Union and national law.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 140 Reporting of infringements):
1. Member States shall ensure that competent authorities have effective mechanisms to enable reporting of actual or potential infringements of this Regulation.
Article 141 Serious disruption in a Member State's control system
1. Where the Commission has evidence of a serious disruption in a Member State’s control system and such disruption may constitute a widespread risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, or result in a widespread infringement of the rules referred to in Article 1(2), it shall, by means of implementing acts, adopt one or more of the following measures, to be applied until such disruption is eliminated: (a) the prohibition to make available on the market or to transport, move or otherwise handle certain animals or goods concerned by the disruption in the control system; (b) special conditions for the activities, animals or goods referred to in point (a); (c) the suspension of the operation of official controls in border control posts or other control points concerned by the disruption in the official control system or the withdrawal of such border control posts or other control points; (d) other appropriate temporary measures necessary to contain that risk until the disruption in the control system is eliminated. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 2. The measures referred to in paragraph 1 shall be adopted only where the Member State concerned has not corrected the situation upon request and within the appropriate time limit set by the Commission. 3. On duly justified imperative grounds of urgency relating to human and animal health or, as regards GMOs and plant protection products, also to the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 141 Serious disruption in a Member State's control system):
1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 2. The measures referred to in paragraph 1 shall be adopted only where the Member State concerned has not corrected the situation upon request and within the appropriate time limit set by the Commission. 3. On duly justified imperative grounds of urgency relating to human and animal health or, as regards GMOs and plant protection products, also to the protection of the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).
Article 142 Amendment of Annexes and references to European standards
1. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning amendments to Annexes II and III, in order to take into account changes to the rules referred to in Article 1(2), technical progress and scientific developments. 2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the references to the European standards referred to in point (b)(iv) of Article 29, point (e) of Article 37(4) and point (a) of Article 93(3), in the event that CEN amends those standards.
Article 143 Data protection
1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member States pursuant to this Regulation. 2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission pursuant to this Regulation.
Article 144 Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) shall be conferred on the Commission for a period of five years from 28 April 2017. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Articles 18(7) and 21(8), Article 41, Articles 45(4) and 47(3), Article 48, Article 50(4), Article 51, and Articles 53(1), 62(3), 64(2) and (5), 77(1) and (2), 92(4), 99(2), 100(6), 101(2), 126(1), 142(1) and (2), 149(2), 150(3), 154(3), 155(3) and 165(3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 145 Committee procedure
1. The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002, except in respect of Articles 25 and 26 of this Regulation for which the Commission shall be assisted respectively by the committees established pursuant to Regulation (EC) No 834/2007 and to Regulation (EU) No 1151/2012. Those committees shall be committees within the meaning of Regulation (EU) No 182/2011. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply. 3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.
Article 146 Repeals
1. Regulations (EC) No 854/2004 and (EC) No 882/2004, Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Decision 92/438/EEC, are repealed with effect from 14 December 2019. 2. References to the repealed acts shall be construed as references to this Regulation and shall be read in accordance with the correlation tables in Annex V.
Article 147 Relation with Regulation (EC) No 882/2004
The designation of each of the European Union reference laboratories referred to in Annex VII to Regulation (EC) No 882/2004 shall remain effective until a designation of a European Union reference laboratory in the same area takes place in accordance with Article 93 of this Regulation.
Article 148 Relation with Regulations (EC) No 852/2004 and (EC) No 853/2004 regarding approval of food business establishments
1. Competent authorities shall establish procedures for food business operators to follow when applying for the approval of their establishments in accordance with Regulations (EC) No 852/2004 and (EC) No 853/2004. 2. Upon receipt of an application for approval from a food business operator, the competent authority shall make an on-site visit. 3. The competent authority shall approve an establishment for the activities concerned only if the food business operator has demonstrated that it complies with the relevant requirements of food law. 4. The competent authority may grant conditional approval if it appears that the establishment meets all the infrastructure and equipment requirements. It shall grant full approval only if it appears from a new official control of the establishment, carried out within three months of granting conditional approval, that the establishment meets the other relevant requirements of food law. If clear progress has been made but the establishment still does not meet all of the relevant requirements, the competent authority may prolong the conditional approval. However, conditional approval shall not exceed a total of six months, except in the case of factory and freezer vessels flying the flag of Member States, for which such conditional approval shall not exceed a total of 12 months. 5. The competent authority shall keep the approval of establishments under review when carrying out official controls.
Article 149 Transitional measures related to the repeals of Directives 91/496/EEC and 97/78/EC
The relevant provisions of Directives 91/496/EEC and 97/78/EC which govern matters referred to in point (b) of Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58 of this Regulation shall apply instead of the corresponding provisions of this Regulation until 13 December 2019. The relevant provisions of Directive 97/78/EC which govern matters referred to in point (a) of Article 47(2) of this Regulation related to composite products shall continue to apply instead of that corresponding provision until 20 April 2021. 2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 1 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2019/6 1 , which enters into application on 28 January 2022, replaces the legal framework for veterinary medicinal products (“VMPs”) established by Directive 2001/82/EC and Regulation (EC) No 726/2004. Article 118(1) of Regulation (EU) 2019/6 provides that third country operators exporting animals and products of animal origin to the EU will have to respect the prohibition against using antimicrobials for growth promotion and yield increase (Article 107(2)), as well as the ban against using antimicrobials reserved for treatment of certain infections in humans (Article 37(5)) . Article 118(2) of Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts providing detailed rules on the application of the prohibitions referred to in Article 118. Regulation (EU) 2019/6 sets out the legal framework for the authorisation of veterinary medicinal products, whereas Article 118 of that Regulation by contrast applies to animals and products of animal origin. Unlike other legislation that lays down rules for animals and products of animal origin, Regulation (EU) 2019/6 does not contain any basic provisions on import conditions/requirements or on official controls of compliance of imports with these requirements. Import requirements and conditions (such as third country and establishment listing and certificates) for animals and for products of animal origin are laid down in relevant sectorial legislation, such as the Animal Health Law 2 , but may also be laid down on the basis of Regulation (EU) 2017/625 (‘the Official Controls Regulation’) 3 . For a third country to be included in a list of third countries authorised to export to the Union, it needs, for example, to provide guarantees that the animals and goods concerned comply with the Union’s requirements or with requirements equivalent thereto laid down in the relevant legislation. However, Article 1(4)(c) of the Official Controls Regulation states that that Regulation does not apply to official controls for the verification of compliance with Directive 2001/82/EC on veterinary medicinal products. When Regulation (EU) 2019/6 enters into application on 28 January 2022, the reference to Directive 2001/82/EC will in effect become a reference to that Regulation. 4 Article 1(4)(c) of the Official Controls Regulation excludes the entirety of Regulation (EU) 2019/6 from its scope. In the absence of relevant provisions in Regulation (EU) 2019/6 on official controls of compliance of imports with the requirements referred to in the preceding paragraph, i t would not be possible to implement and enforce Article 118 of Regulation (EU) 2019/6 properly without amending the Official Controls Regulation . The objective of this amendment is to modify Article 1(4)(c) of the Official Controls Regulation to include an exception to the above exclusion, integrating controls to verify compliance with Article 118 of Regulation (EU) 2019/6 into the scope of the Official Controls Regulation. This would mean that the Union’s official control system for animals and products of animal origin could be used to ensure compliance with the prohibitions in Article 118 of Regulation (EU) 2019/6. This would in turn make it possible to implement and enforce Article 118 properly. Article 123 of Regulation (EU) 2019/6, which was part of the Commission’s proposal, provides for controls of compliance with the Regulation by Member State competent authorities. However, these controls only apply to manufacturers and importers of VMPs and active substances (and other persons involved in the placing on the market and use of VMPs and active substances). To ensure that animals and products of animal origin imported into the Union comply with Article 118 of Regulation (EU) 2019/6, it is necessary to provide that controls of compliance with Article 118 are included into the scope of the Official Controls Regulation. Under its Farm to Fork Strategy, the EU has set the ambitious target of reducing by 50% its overall EU sales of antimicrobials used for farmed animals and in aquaculture by 2030. Building on the One Health approach, Regulation (EU) 2019/6 provides for a wide range of concrete measures that will apply to EU operators in order to enhance the fight against antimicrobial resistance (‘AMR’) and promote a more prudent and responsible use of antimicrobials in animals. As a leader in the global fight against AMR, the Union also has the responsibility to encourage the reduction of use and consumption of antimicrobials in third countries, in particular linked to imports from third countries, and has the duty to promote its vision of a more sustainable use of antimicrobials to help preserve their efficiency on the international stage. Article 118 of Regulation (EU) 2019/6 is a key element in the fight against AMR.
Revised version (Article 149 Transitional measures related to the repeals of Directives 91/496/EEC and 97/78/EC):
1. The relevant provisions of Directives 91/496/EEC and 97/78/EC which govern matters referred to in point (b) of Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58 of this Regulation shall apply instead of the corresponding provisions of this Regulation until 13 December 2019. The relevant provisions of Directive 97/78/EC which govern matters referred to in point (a) of Article 47(2) of this Regulation related to composite products shall continue to apply instead of that corresponding provision until 20 April 2021. The relevant provisions of Directives 91/496/EEC and 97/78/EC which govern matters referred to in point (b) of Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58 of this Regulation shall apply instead of the corresponding provisions of this Regulation until 13 December 2019. The relevant provisions of Directive 97/78/EC which govern matters referred to in point (a) of Article 47(2) of this Regulation related to composite products shall continue to apply instead of that corresponding provision until 20 April 2021. 2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 1 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), point (a) of Article 53(1), Article 54(1) and (3), and point (a) of Article 58.
Article 150 Transitional measures related to the repeal of Directive 96/23/EC
1. Competent authorities shall continue to perform the official controls necessary to detect the presence of the substances and groups of residues listed in Annex I to Directive 96/23/EC, in accordance with Annexes II, III and IV to that Directive, instead of the corresponding provisions of this Regulation, until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article. 2. Article 29(1) and (2) of Directive 96/23/EC shall continue to apply instead of the corresponding provisions of this Regulation until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article. 3. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the earlier date referred to in paragraphs 1 and 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Articles 19 and 112.
Article 151 Amendments to Directive 98/58/EC
Directive 98/58/EC is amended as follows: Article 2, point (3) is replaced by the following: ‘3. “competent authorities” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *1 ) ‘3. Article 6 is amended as follows: (a) paragraph 1 is deleted; paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’; (c) in paragraph 3, point (a) is deleted; (3) Article 7 is deleted.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 152 Amendments to Directive 1999/74/EC
Directive 1999/74/EC is amended as follows: Article 8 is amended as follows: (a) paragraph 1 is deleted; paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of these reports to the Member States.’; (c) in paragraph 3, point (a) is deleted; (2) Article 9 is deleted.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 154 Amendments to Regulation (EC) No 1/2005 and related transitional measures
1. Regulation (EC) No 1/2005 is amended as follows: Article 2 is amended as follows: point (d) is replaced by the following: ‘(d) “border inspection post” means a border control post as defined in Article 3(38) of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *2 ); point (f) is replaced the following: ‘(f) “competent authority” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 ’; point (i) is replaced by the following: ‘(i) “exit point” means an exit point as defined in Article 3(39) of Regulation (EU) 2017/625 ’; point (p) is replaced by the following: ‘(p) “official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation (EU) 2017/625 ’. (2) Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 are deleted. Article 27 is amended as follows: (a) paragraph 1 is deleted; (b) paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried by the competent authority to verify compliance with the requirements of this Regulation. The report shall be accompanied by an analysis of the major deficiencies detected and an action plan to address them.’; Article 27 is amended as follows: (a) paragraph 1 is deleted; paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried by the competent authority to verify compliance with the requirements of this Regulation. The report shall be accompanied by an analysis of the major deficiencies detected and an action plan to address them.’; (4) Article 28 is deleted. 2. Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 of Regulation (EC) No 1/2005 shall continue to apply, instead of the corresponding provisions of this Regulation, until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article. 3. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 21.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 154 Amendments to Regulation (EC) No 1/2005 and related transitional measures):
2. Articles 14, 15, 16 and 21, Article 22(2), and Articles 23, 24 and 26 of Regulation (EC) No 1/2005 shall continue to apply, instead of the corresponding provisions of this Regulation, until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article. 3. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 21.
Article 155 Amendments to Regulation (EC) No 396/2005 and related transitional measures
1. Articles 26 and 27, Article 28(1) and (2) and Article 30 of Regulation (EC) No 396/2005 are deleted. 2. Article 26, Article 27(1) and Article 30 of Regulation (EC) No 396/2005 shall continue to apply instead of the corresponding provisions of this Regulation until 14 December 2022 or an earlier date to be determined in the delegated act adopted in accordance with paragraph 3 of this Article. 3. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. That date shall be the date of application of the corresponding rules to be established pursuant to the delegated or implementing acts provided for in Article 19.
Article 156 Amendments to Directive 2007/43/EC
Directive 2007/43/EC is amended as follows: ‘(c) “competent authorities” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *3 ); “official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation (EU) 2017/625 ; Article 7 is amended as follows: (a) paragraph 1 is deleted; (b) paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’. Article 7 is amended as follows: (a) paragraph 1 is deleted; paragraph 2 is replaced by the following: ‘2. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 157 Amendments to Directive 2008/119/EC
Directive 2008/119/EC is amended as follows: In Article 2, point (2) is replaced by the following: ‘2. “competent authorities” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *4 ). ‘2. Article 7 is amended as follows: (a) paragraphs 1 and 2 are deleted; (b) paragraph 3 is replaced by the following: ‘3. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’; Article 7 is amended as follows: (a) paragraphs 1 and 2 are deleted; paragraph 3 is replaced by the following: ‘3. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’; (3) Article 9 is deleted.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 158 Amendments to Directive 2008/120/EC
Directive 2008/120/EC is amended as follows: In Article 2, point (10) is replaced by the following: ‘10. “competent authorities” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *5 ). ‘10. Article 8 is amended as follows: (a) paragraphs 1 and 2 are deleted; (b) paragraph 3 is replaced by the following: ‘3. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’; Article 8 is amended as follows: (a) paragraphs 1 and 2 are deleted; paragraph 3 is replaced by the following: ‘3. Member States shall submit to the Commission by 31 August each year an annual report for the previous year on the inspections carried out by the competent authority to check compliance with the requirements of this Directive. The report shall be accompanied by an analysis of the most serious findings of non–compliance and a national action plan to prevent or decrease their occurrence for the forthcoming years. The Commission shall submit summaries of those reports to the Member States.’; (3) Article 10 is deleted.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 159 Amendments to Regulation (EC) No 1099/2009
Regulation (EC) No 1099/2009 is amended as follows: In Article 2, point (q) is replaced by the following: ‘(q) “competent authorities” means competent authorities as defined in point (3) of Article 3 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *6 ). (2) Article 22 is deleted.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 160 Amendments to Regulation (EC) No 1069/2009
Regulation (EC) No 1069/2009 is amended as follows: Article 3 is amended as follows: point (10) is replaced by the following: ‘10. “competent authority” means competent authorities as defined in point (3) of Article 3 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *7 ). ‘10. point (15) is replaced by the following: ‘15. “transit” means transit as defined in Article 3(44) of Regulation (EU) 2017/625 .’; ‘15. (2) Articles 45, 49 and 50 are deleted.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 161 Amendments to Regulation (EC) No 1107/2009
Regulation (EC) No 1107/2009 is amended as follows: Article 68 is amended as follows: (a) the first paragraph is replaced by the following: ‘Member States shall submit to the Commission by 31 August each year a report, for the previous year, on the scope and the outcome of the official controls performed in order to verify compliance with this Regulation’; (b) the second and third paragraphs are deleted. Article 68 is amended as follows: the first paragraph is replaced by the following: ‘Member States shall submit to the Commission by 31 August each year a report, for the previous year, on the scope and the outcome of the official controls performed in order to verify compliance with this Regulation’; (b) the second and third paragraphs are deleted. (2) point (n) of Article 78(1) is deleted.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 162 Amendments to Regulation (EU) No 1151/2012
Regulation (EU) No 1151/2012 is amended as follows: Article 36 is amended as follows: (a) the heading is replaced by the following: ‘Content of official controls’; (b) paragraphs 1 and 2 are deleted; in paragraph 3, the introductory phrase is replaced by the following: ‘3. Official controls performed in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council ( *8 ) shall cover: Article 37 is amended as follows: in paragraph 1, the first subparagraph is replaced by the following: ‘1. In respect of protected designations of origin, protected geographical indications and traditional specialities guaranteed that designate products originating within the Union, verification of compliance with the product specification, before placing the product on the market, shall be carried out by: (a) the competent authorities designated in accordance with Article 4 of Regulation (EU) 2017/625 ; or delegated bodies as defined in Article 3(5) of Regulation (EU) 2017/625 .’; (b) in paragraph 3, the first subparagraph is deleted; (c) in paragraph 4, the words ‘paragraphs 1 and 2’ are replaced by the words: ‘paragraph 2’; (3) Article 38 is deleted; (4) Article 39 is replaced by the following: ‘Article 39 Delegated bodies performing controls in third countries The delegated bodies performing controls in the third countries referred to in paragraph 2(b) of Article 37 shall be accredited to the relevant harmonised standard for “Conformity assessment- Requirements for bodies certifying products, processes and services”. These delegated bodies may be accredited either by a national accreditation body outside the Union, in accordance with Regulation (EC) No 765/2008, or by an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum.’. Article 39 is replaced by the following: 
‘Article 39
Delegated bodies performing controls in third countries
The delegated bodies performing controls in the third countries referred to in paragraph 2(b) of Article 37 shall be accredited to the relevant harmonised standard for “Conformity assessment- Requirements for bodies certifying products, processes and services”. These delegated bodies may be accredited either by a national accreditation body outside the Union, in accordance with Regulation (EC) No 765/2008, or by an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum.’.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 162 Amendments to Regulation (EU) No 1151/2012):
Regulation (EU) No 1151/2012 is amended as follows: (3) Article 38 is deleted; (4) Article 39 is replaced by the following: ‘Article 39 Delegated bodies performing controls in third countries The delegated bodies performing controls in the third countries referred to in paragraph 2(b) of Article 37 shall be accredited to the relevant harmonised standard for “Conformity assessment- Requirements for bodies certifying products, processes and services”. These delegated bodies may be accredited either by a national accreditation body outside the Union, in accordance with Regulation (EC) No 765/2008, or by an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum.’.
Article 163 Amendments to Regulation (EU) No 652/2014
Regulation (EU) No 652/2014 is amended as follows: Article 30(1) is replaced by the following: ‘1. To cover the costs they incur to implement the work programmes approved by the Commission, grants may be awarded to: the European Union reference laboratories referred to in Article 93 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *9 ) and to the European Union reference centres referred to in Article 29 of Regulation (EU) 2016/1012 of the European Parliament and of the Council ( *10 ); (b) the European Union reference centres for animal welfare referred to in Article 95 of Regulation (EU) 2017/625 ; (c) the European Union reference centres for the authenticity and integrity of the agri-food chain referred to in Article 97 of Regulation (EU) 2017/625 . (2) the following Article is inserted: ‘Article 30a Accreditation of national reference laboratories for plant health 1. Grants may be awarded to the national reference laboratories referred to in Article 100 of Regulation (EU) 2017/625 for costs incurred for obtaining accreditation according to the standard EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories” for the use of methods of laboratory analysis, test and diagnosis to verify compliance with the rules on protective measures against pests of plants. 2. Grants may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.’. the following Article is inserted: 
‘Article 30a
Accreditation of national reference laboratories for plant health
1. Grants may be awarded to the national reference laboratories referred to in Article 100 of Regulation (EU) 2017/625 for costs incurred for obtaining accreditation according to the standard EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories” for the use of methods of laboratory analysis, test and diagnosis to verify compliance with the rules on protective measures against pests of plants.
2. Grants may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.’.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2019/6 1 , which enters into application on 28 January 2022, replaces the legal framework for veterinary medicinal products (“VMPs”) established by Directive 2001/82/EC and Regulation (EC) No 726/2004. Article 118(1) of Regulation (EU) 2019/6 provides that third country operators exporting animals and products of animal origin to the EU will have to respect the prohibition against using antimicrobials for growth promotion and yield increase (Article 107(2)), as well as the ban against using antimicrobials reserved for treatment of certain infections in humans (Article 37(5)) . Article 118(2) of Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts providing detailed rules on the application of the prohibitions referred to in Article 118. Regulation (EU) 2019/6 sets out the legal framework for the authorisation of veterinary medicinal products, whereas Article 118 of that Regulation by contrast applies to animals and products of animal origin. Unlike other legislation that lays down rules for animals and products of animal origin, Regulation (EU) 2019/6 does not contain any basic provisions on import conditions/requirements or on official controls of compliance of imports with these requirements. Import requirements and conditions (such as third country and establishment listing and certificates) for animals and for products of animal origin are laid down in relevant sectorial legislation, such as the Animal Health Law 2 , but may also be laid down on the basis of Regulation (EU) 2017/625 (‘the Official Controls Regulation’) 3 . For a third country to be included in a list of third countries authorised to export to the Union, it needs, for example, to provide guarantees that the animals and goods concerned comply with the Union’s requirements or with requirements equivalent thereto laid down in the relevant legislation. However, Article 1(4)(c) of the Official Controls Regulation states that that Regulation does not apply to official controls for the verification of compliance with Directive 2001/82/EC on veterinary medicinal products. When Regulation (EU) 2019/6 enters into application on 28 January 2022, the reference to Directive 2001/82/EC will in effect become a reference to that Regulation. 4 Article 1(4)(c) of the Official Controls Regulation excludes the entirety of Regulation (EU) 2019/6 from its scope. In the absence of relevant provisions in Regulation (EU) 2019/6 on official controls of compliance of imports with the requirements referred to in the preceding paragraph, i t would not be possible to implement and enforce Article 118 of Regulation (EU) 2019/6 properly without amending the Official Controls Regulation . The objective of this amendment is to modify Article 1(4)(c) of the Official Controls Regulation to include an exception to the above exclusion, integrating controls to verify compliance with Article 118 of Regulation (EU) 2019/6 into the scope of the Official Controls Regulation. This would mean that the Union’s official control system for animals and products of animal origin could be used to ensure compliance with the prohibitions in Article 118 of Regulation (EU) 2019/6. This would in turn make it possible to implement and enforce Article 118 properly. Article 123 of Regulation (EU) 2019/6, which was part of the Commission’s proposal, provides for controls of compliance with the Regulation by Member State competent authorities. However, these controls only apply to manufacturers and importers of VMPs and active substances (and other persons involved in the placing on the market and use of VMPs and active substances). To ensure that animals and products of animal origin imported into the Union comply with Article 118 of Regulation (EU) 2019/6, it is necessary to provide that controls of compliance with Article 118 are included into the scope of the Official Controls Regulation. Under its Farm to Fork Strategy, the EU has set the ambitious target of reducing by 50% its overall EU sales of antimicrobials used for farmed animals and in aquaculture by 2030. Building on the One Health approach, Regulation (EU) 2019/6 provides for a wide range of concrete measures that will apply to EU operators in order to enhance the fight against antimicrobial resistance (‘AMR’) and promote a more prudent and responsible use of antimicrobials in animals. As a leader in the global fight against AMR, the Union also has the responsibility to encourage the reduction of use and consumption of antimicrobials in third countries, in particular linked to imports from third countries, and has the duty to promote its vision of a more sustainable use of antimicrobials to help preserve their efficiency on the international stage. Article 118 of Regulation (EU) 2019/6 is a key element in the fight against AMR.
Revised version (Article 163 Amendments to Regulation (EU) No 652/2014):
Regulation (EU) No 652/2014 is amended as follows: Article 30(1) is replaced by the following: To cover the costs they incur to implement the work programmes approved by the Commission, grants may be awarded to: the European Union reference laboratories referred to in Article 93 of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *9 ) and to the European Union reference centres referred to in Article 29 of Regulation (EU) 2016/1012 of the European Parliament and of the Council ( *10 ); (b) the European Union reference centres for animal welfare referred to in Article 95 of Regulation (EU) 2017/625 ; (c) the European Union reference centres for the authenticity and integrity of the agri-food chain referred to in Article 97 of Regulation (EU) 2017/625 . (2) the following Article is inserted: ‘Article 30a Accreditation of national reference laboratories for plant health 1. Grants may be awarded to the national reference laboratories referred to in Article 100 of Regulation (EU) 2017/625 for costs incurred for obtaining accreditation according to the standard EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories” for the use of methods of laboratory analysis, test and diagnosis to verify compliance with the rules on protective measures against pests of plants. 2. Grants may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.’. the following Article is inserted: 
‘Article 30a
Accreditation of national reference laboratories for plant health
1. Grants may be awarded to the national reference laboratories referred to in Article 100 of Regulation (EU) 2017/625 for costs incurred for obtaining accreditation according to the standard EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories” for the use of methods of laboratory analysis, test and diagnosis to verify compliance with the rules on protective measures against pests of plants.
Grants may be awarded to the national reference laboratories referred to in Article 100 of Regulation (EU) 2017/625 for costs incurred for obtaining accreditation according to the standard EN ISO/IEC 17025 on “General requirements for the competence of testing and calibration laboratories” for the use of methods of laboratory analysis, test and diagnosis to verify compliance with the rules on protective measures against pests of plants.
2. Grants may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.’.
Grants may be awarded to a single national reference laboratory in each Member State for each European Union reference laboratory for plant health, up to three years after the designation of that European Union reference laboratory.’.
Article 164 Amendments to Regulation (EU) 2016/429 and related transitional provisions
1. Regulation (EU) 2016/429 is amended as follows: Article 4 is amended as follows: point (33) is replaced by the following: ‘(33) “official control” means any form of control performed in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council ( *11 ); ‘(33) point (51) is replaced by the following: ‘(51) “Traces” means a system component integrated into the IMSOC as referred to in Articles 131 to 136 of Regulation (EU) 2017/625 ;’; ‘(51) point (53) is replaced by the following: ‘(53) “official veterinarian” means an official veterinarian as defined in Article 3(32) of Regulation (EU) 2017/625 ;’; point (55) is replaced by the following: ‘(55) “competent authority” means the central veterinary authority of a Member State responsible for the organisation of official controls and any other official activities in accordance with this Regulation and Regulation (EU) 2017/625 , or any other authority to which that responsibility has been delegated;’; ‘(55) in Article 229, paragraph (2) is replaced by the following: ‘2. The operators responsible for the consignment in question shall present consignments of animals, germinal products and products of animal origin from third countries or territories for the purposes of official control as provided for in Article 47 of Regulation (EU) 2017/625 .’; (3) Article 281 is deleted. 2. The following provisions shall continue to apply in relation to the matters governed by Regulation (EU) 2016/429, until the date of application of that Regulation: (a) Article 9 of Directive 89/662/EEC; (b) Article 10 of Directive 90/425/EEC; (d) Article 22(1), (3), (4), (5), (6) and (7) of Directive 97/78/EC. 3. Having regard to Article 14 of Regulation (EU) 2016/429 and notwithstanding the date of application provided for in that Regulation, for the purpose of Article 31(2) of this Regulation, the condition for its application shall be considered to be fulfilled already from 14 December 2019.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 164 Amendments to Regulation (EU) 2016/429 and related transitional provisions):
3. Having regard to Article 14 of Regulation (EU) 2016/429 and notwithstanding the date of application provided for in that Regulation, for the purpose of Article 31(2) of this Regulation, the condition for its application shall be considered to be fulfilled already from 14 December 2019.
Article 165 Amendments to Regulation (EU) 2016/2031 and related transitional provisions
1. Regulation (EU) 2016/2031 is amended as follows: Article 2, point (6) is replaced by the following: ‘(6) “competent authority” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *12 ); Article 10 is replaced by the following: ‘Article 10 Official confirmation by the competent authorities of the presence of a Union quarantine pest Where a competent authority suspects, or has received evidence concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within the Union territory, it shall immediately take any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation (EU) 2017/625 (“to officially confirm”), whether that pest is present or not. Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of that pest. The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.’; Article 10 is replaced by the following: 
‘Article 10
Official confirmation by the competent authorities of the presence of a Union quarantine pest
Where a competent authority suspects, or has received evidence concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within the Union territory, it shall immediately take any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation (EU) 2017/625 (“to officially confirm”), whether that pest is present or not.
Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of that pest.
The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.’; in Article 11, the second paragraph is replaced by the following: ‘Notifications under the first paragraph shall be made by the single authority, as referred to in Article 4(2) of Regulation (EU) 2017/625 , of the Member State concerned and through the electronic notification system referred to in Article 103.’; in Article 25(2), point (a) is replaced by the following: in Article 41, paragraph 4 is replaced by the following: ‘4. In the event that plants, plant products or other objects have been introduced into, or moved within, the Union territory in violation of paragraph 1 of this Article, Member States shall adopt the necessary measures, as referred to in Article 66(3) of Regulation (EU) 2017/625 , and shall notify the Commission and other Member States through the electronic notification system referred to in Article 103. Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.’; in Article 41, paragraph 4 is replaced by the following: ‘4. In the event that plants, plant products or other objects have been introduced into, or moved within, the Union territory in violation of paragraph 1 of this Article, Member States shall adopt the necessary measures, as referred to in Article 66(3) of Regulation (EU) 2017/625 , and shall notify the Commission and other Member States through the electronic notification system referred to in Article 103. Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.’; in Article 44, paragraph 2 is replaced by the following: in Article 49(6), the third subparagraph is replaced by the following: in Article 76, paragraphs 4 and 5 are replaced by the following: ‘4. In the case of a third country which is not a contracting party to the IPPC, the competent authority shall only accept the phytosanitary certificates issued by the authorities which are competent in accordance with the national rules of that third country and notified to the Commission. The Commission shall inform the Member States and the operators, through the electronic notification system referred to in Article 103, in accordance with point (a) of Article 132 of Regulation (EU) 2017/625 , of the notifications received. The Commission is empowered to adopt delegated acts, in accordance with Article 105, to supplement this Regulation concerning the conditions for acceptance referred to in the first subparagraph of this paragraph, to ensure the reliability of those certificates. 5. Electronic phytosanitary certificates shall only be accepted when provided through, or in electronic exchange with, the IMSOC referred to in Article 131(1) of Regulation (EU) 2017/625 .’; in Article 77(1), the first subparagraph is replaced by the following: in Article 91(1), the second subparagraph is replaced by the following: in Article 94(1), the first subparagraph is replaced by the following: in Article 100, paragraph 5 is replaced by the following: ‘5. Electronic phytosanitary certificates for export shall be provided through, or in electronic exchange with, the IMSOC.’; in Article 101, paragraph 6 is replaced by the following: ‘6. Electronic phytosanitary certificates for re-export shall be provided through, or in electronic exchange with, the IMSOC.’; in Article 102, paragraph 4 is replaced by the following: ‘4. The pre-export certificate shall accompany the plants, plant products and other objects concerned during their movement within the Union territory, unless the information contained in it is exchanged between the Member States concerned through, or in electronic exchange with, the IMSOC.’; (15) Article 103 is replaced by the following: ‘Article 103 Establishment of electronic notification system The Commission shall establish an electronic system for the submission of notifications by the Member States. That system shall be connected to, and compatible with, the IMSOC.’; Article 103 is replaced by the following: 
‘Article 103
Establishment of electronic notification system
The Commission shall establish an electronic system for the submission of notifications by the Member States.
That system shall be connected to, and compatible with, the IMSOC.’; in Article 109, paragraph 1 is replaced by the following: ‘Directive 2000/29/EC is repealed, without prejudice to Article 165(2), (3) and (4) of Regulation (EU) 2017/625 .’. In relation to matters governed by Directive 2000/29/EC, Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), and point (a) of Article 58 of this Regulation shall apply from 15 December 2019 instead of the relevant provisions of that Directive, which shall cease to be applicable as of the same date. The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by points (a) of Article 53(1) of this Regulation instead of that latter provision until 13 December 2020. The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by Article 54(1) and (3) of this Regulation instead of these latter provisions until 13 December 2022. 3. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. 4. Without prejudice to paragraphs 2 and 3 of this Article and the date of application provided for in Article 167(1), the Commission shall adopt the delegated acts referred to in points (a) and (e) of Article 53(1), as regards goods referred to in point (c) of Article 47(1), at the latest 12 months before their date of application.
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Regulation (EU) 2019/6 1 , which enters into application on 28 January 2022, replaces the legal framework for veterinary medicinal products (“VMPs”) established by Directive 2001/82/EC and Regulation (EC) No 726/2004. Article 118(1) of Regulation (EU) 2019/6 provides that third country operators exporting animals and products of animal origin to the EU will have to respect the prohibition against using antimicrobials for growth promotion and yield increase (Article 107(2)), as well as the ban against using antimicrobials reserved for treatment of certain infections in humans (Article 37(5)) . Article 118(2) of Regulation (EU) 2019/6 empowers the Commission to adopt delegated acts providing detailed rules on the application of the prohibitions referred to in Article 118. Regulation (EU) 2019/6 sets out the legal framework for the authorisation of veterinary medicinal products, whereas Article 118 of that Regulation by contrast applies to animals and products of animal origin. Unlike other legislation that lays down rules for animals and products of animal origin, Regulation (EU) 2019/6 does not contain any basic provisions on import conditions/requirements or on official controls of compliance of imports with these requirements. Import requirements and conditions (such as third country and establishment listing and certificates) for animals and for products of animal origin are laid down in relevant sectorial legislation, such as the Animal Health Law 2 , but may also be laid down on the basis of Regulation (EU) 2017/625 (‘the Official Controls Regulation’) 3 . For a third country to be included in a list of third countries authorised to export to the Union, it needs, for example, to provide guarantees that the animals and goods concerned comply with the Union’s requirements or with requirements equivalent thereto laid down in the relevant legislation. However, Article 1(4)(c) of the Official Controls Regulation states that that Regulation does not apply to official controls for the verification of compliance with Directive 2001/82/EC on veterinary medicinal products. When Regulation (EU) 2019/6 enters into application on 28 January 2022, the reference to Directive 2001/82/EC will in effect become a reference to that Regulation. 4 Article 1(4)(c) of the Official Controls Regulation excludes the entirety of Regulation (EU) 2019/6 from its scope. In the absence of relevant provisions in Regulation (EU) 2019/6 on official controls of compliance of imports with the requirements referred to in the preceding paragraph, i t would not be possible to implement and enforce Article 118 of Regulation (EU) 2019/6 properly without amending the Official Controls Regulation . The objective of this amendment is to modify Article 1(4)(c) of the Official Controls Regulation to include an exception to the above exclusion, integrating controls to verify compliance with Article 118 of Regulation (EU) 2019/6 into the scope of the Official Controls Regulation. This would mean that the Union’s official control system for animals and products of animal origin could be used to ensure compliance with the prohibitions in Article 118 of Regulation (EU) 2019/6. This would in turn make it possible to implement and enforce Article 118 properly. Article 123 of Regulation (EU) 2019/6, which was part of the Commission’s proposal, provides for controls of compliance with the Regulation by Member State competent authorities. However, these controls only apply to manufacturers and importers of VMPs and active substances (and other persons involved in the placing on the market and use of VMPs and active substances). To ensure that animals and products of animal origin imported into the Union comply with Article 118 of Regulation (EU) 2019/6, it is necessary to provide that controls of compliance with Article 118 are included into the scope of the Official Controls Regulation. Under its Farm to Fork Strategy, the EU has set the ambitious target of reducing by 50% its overall EU sales of antimicrobials used for farmed animals and in aquaculture by 2030. Building on the One Health approach, Regulation (EU) 2019/6 provides for a wide range of concrete measures that will apply to EU operators in order to enhance the fight against antimicrobial resistance (‘AMR’) and promote a more prudent and responsible use of antimicrobials in animals. As a leader in the global fight against AMR, the Union also has the responsibility to encourage the reduction of use and consumption of antimicrobials in third countries, in particular linked to imports from third countries, and has the duty to promote its vision of a more sustainable use of antimicrobials to help preserve their efficiency on the international stage. Article 118 of Regulation (EU) 2019/6 is a key element in the fight against AMR.
Revised version (Article 165 Amendments to Regulation (EU) 2016/2031 and related transitional provisions):
1. Regulation (EU) 2016/2031 is amended as follows: Article 2, point (6) is replaced by the following: ‘(6) “competent authority” means competent authorities as defined in Article 3(3) of Regulation (EU) 2017/625 of the European Parliament and of the Council ( *12 ); Article 10 is replaced by the following: ‘Article 10 Official confirmation by the competent authorities of the presence of a Union quarantine pest Where a competent authority suspects, or has received evidence concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within the Union territory, it shall immediately take any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation (EU) 2017/625 (“to officially confirm”), whether that pest is present or not. Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of that pest. The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.’; Article 10 is replaced by the following: 
‘Article 10
Official confirmation by the competent authorities of the presence of a Union quarantine pest
Where a competent authority suspects, or has received evidence concerning, the presence of a Union quarantine pest, or a pest subject to measures adopted pursuant to Article 30(1), in a part of the territory of the respective Member State where that pest was previously not known to be present, or in a consignment of plants, plant products or other objects introduced into, intended to be introduced into, or moved within the Union territory, it shall immediately take any measures necessary to confirm on the basis of a diagnosis of an official laboratory as referred to in Article 37 of Regulation (EU) 2017/625 (“to officially confirm”), whether that pest is present or not.
Pending the official confirmation of the presence of that pest, the Member States concerned shall, where applicable, take phytosanitary measures to eliminate the risk of spread of that pest.
The suspicion or evidence referred to in the first paragraph of this Article may be based on any information received pursuant to Articles 14 and 15, or from any other source.’; in Article 11, the second paragraph is replaced by the following: ‘Notifications under the first paragraph shall be made by the single authority, as referred to in Article 4(2) of Regulation (EU) 2017/625 , of the Member State concerned and through the electronic notification system referred to in Article 103.’; in Article 25(2), point (a) is replaced by the following: in Article 41, paragraph 4 is replaced by the following: ‘4. In the event that plants, plant products or other objects have been introduced into, or moved within, the Union territory in violation of paragraph 1 of this Article, Member States shall adopt the necessary measures, as referred to in Article 66(3) of Regulation (EU) 2017/625 , and shall notify the Commission and other Member States through the electronic notification system referred to in Article 103. Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.’; in Article 41, paragraph 4 is replaced by the following: ‘4. In the event that plants, plant products or other objects have been introduced into, or moved within, the Union territory in violation of paragraph 1 of this Article, Member States shall adopt the necessary measures, as referred to in Article 66(3) of Regulation (EU) 2017/625 , and shall notify the Commission and other Member States through the electronic notification system referred to in Article 103. Where applicable, that notification shall also be made to the third country from which the plants, plant products or other objects were introduced into the Union territory.’; in Article 44, paragraph 2 is replaced by the following: in Article 49(6), the third subparagraph is replaced by the following: in Article 76, paragraphs 4 and 5 are replaced by the following: ‘4. In the case of a third country which is not a contracting party to the IPPC, the competent authority shall only accept the phytosanitary certificates issued by the authorities which are competent in accordance with the national rules of that third country and notified to the Commission. The Commission shall inform the Member States and the operators, through the electronic notification system referred to in Article 103, in accordance with point (a) of Article 132 of Regulation (EU) 2017/625 , of the notifications received. The Commission is empowered to adopt delegated acts, in accordance with Article 105, to supplement this Regulation concerning the conditions for acceptance referred to in the first subparagraph of this paragraph, to ensure the reliability of those certificates. 5. Electronic phytosanitary certificates shall only be accepted when provided through, or in electronic exchange with, the IMSOC referred to in Article 131(1) of Regulation (EU) 2017/625 .’; in Article 77(1), the first subparagraph is replaced by the following: in Article 91(1), the second subparagraph is replaced by the following: in Article 94(1), the first subparagraph is replaced by the following: in Article 100, paragraph 5 is replaced by the following: ‘5. Electronic phytosanitary certificates for export shall be provided through, or in electronic exchange with, the IMSOC.’; in Article 101, paragraph 6 is replaced by the following: ‘6. Electronic phytosanitary certificates for re-export shall be provided through, or in electronic exchange with, the IMSOC.’; in Article 102, paragraph 4 is replaced by the following: ‘4. The pre-export certificate shall accompany the plants, plant products and other objects concerned during their movement within the Union territory, unless the information contained in it is exchanged between the Member States concerned through, or in electronic exchange with, the IMSOC.’; (15) Article 103 is replaced by the following: ‘Article 103 Establishment of electronic notification system The Commission shall establish an electronic system for the submission of notifications by the Member States. That system shall be connected to, and compatible with, the IMSOC.’; Article 103 is replaced by the following: 
‘Article 103
Establishment of electronic notification system
The Commission shall establish an electronic system for the submission of notifications by the Member States.
That system shall be connected to, and compatible with, the IMSOC.’; in Article 109, paragraph 1 is replaced by the following: ‘Directive 2000/29/EC is repealed, without prejudice to Article 165(2), (3) and (4) of Regulation (EU) 2017/625 .’. 2. In relation to matters governed by Directive 2000/29/EC, Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), and point (a) of Article 58 of this Regulation shall apply from 15 December 2019 instead of the relevant provisions of that Directive, which shall cease to be applicable as of the same date. The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by points (a) of Article 53(1) of this Regulation instead of that latter provision until 13 December 2020. The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by Article 54(1) and (3) of this Regulation instead of these latter provisions until 13 December 2022. In relation to matters governed by Directive 2000/29/EC, Article 47(2), Article 48, points (b), (c) and (d) of Article 51(1), and point (a) of Article 58 of this Regulation shall apply from 15 December 2019 instead of the relevant provisions of that Directive, which shall cease to be applicable as of the same date. The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by points (a) of Article 53(1) of this Regulation instead of that latter provision until 13 December 2020. The relevant provisions of Directive 2000/29/EC shall continue to apply in relation to the matters governed by Article 54(1) and (3) of this Regulation instead of these latter provisions until 13 December 2022. 3. The Commission is empowered to adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the date referred to in paragraph 2 of this Article. 4. Without prejudice to paragraphs 2 and 3 of this Article and the date of application provided for in Article 167(1), the Commission shall adopt the delegated acts referred to in points (a) and (e) of Article 53(1), as regards goods referred to in point (c) of Article 47(1), at the latest 12 months before their date of application.
Article 166 Transitional measures for the adoption of delegated and implementing acts
Without prejudice to the dates of application referred to in Article 167 and transitional provisions provided for in this Chapter, the Commission is empowered to adopt delegated and implementing acts provided for in this Regulation as from 28 April 2017. Such acts shall apply from the date of application in accordance with Article 167, without prejudice to any transitional rules provided for in this Chapter.