Article 1 Subject matter and scope
1. This Regulation lays down rules for: (a) the performance of official controls and other official activities by the competent authorities of the Member States; (b) the financing of official controls; (c) the administrative assistance and cooperation between Member States in view of the correct application of the rules referred to in paragraph 2; (d) the performance of controls by the Commission in Member States and in third countries; (e) the adoption of conditions to be fulfilled with respect to animals and goods entering the Union from a third country; (f) the establishment of a computerised information system to manage information and data in relation to official controls. 2. This Regulation shall apply to the official controls performed for the verification of compliance with the rules, whether established at Union level or by the Member States, to apply Union legislation, in the areas of: (a) food and food safety, integrity and wholesomeness at any stage of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting consumer interests and information, and the manufacture and use of materials and articles intended to come into contact with food; (b) deliberate release into the environment of Genetically Modified Organisms (GMOs) for the purpose of food and feed production; (c) feed and feed safety at any stage of production, processing and distribution of feed and the use of feed, including rules aimed at ensuring fair practices in trade and protecting consumer health, interests and information; (d) animal health requirements; (e) prevention and minimisation of risks to human and animal health arising from animal by-products and derived products; (f) welfare requirements for animals; (g) protective measures against pests of plants; (h) requirements for the placing on the market and use of plant protection products and the sustainable use of pesticides, with the exception of pesticides application equipment; (i) organic production and labelling of organic products; (j) use and labelling of protected designations of origin, protected geographical indications and traditional specialities guaranteed. 3. This Regulation shall also apply to official controls performed for the verification of compliance with requirements laid down in the rules referred to in paragraph 2 where those requirements are applicable to animals and goods entering the Union or to be exported from the Union. 4. This Regulation shall not apply to official controls for the verification of compliance with: (b) Directive 2010/63/EU of the European Parliament and of the Council ( 1 ); (c) Directive 2001/82/EC of the European Parliament and of the Council ( 2 ). 5. Articles 4, 5, 6, 8, Article 12(2) and (3), Articles 15, 18 to 27, 31 to 34, 37 to 42 and 78, Articles 86 to 108, point (b) of Article 112, Article 130 and Articles 131 to 141 shall also apply to other official activities performed by the competent authorities in accordance with this Regulation or with the rules referred to in paragraph 2 of this Article.
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 1 Subject matter and scope):
3. This Regulation shall also apply to official controls performed for the verification of compliance with requirements laid down in the rules referred to in paragraph 2 where those requirements are applicable to animals and goods entering the Union or to be exported from the Union. 5. Articles 4, 5, 6, 8, Article 12(2) and (3), Articles 15, 18 to 27, 31 to 34, 37 to 42 and 78, Articles 86 to 108, point (b) of Article 112, Article 130 and Articles 131 to 141 shall also apply to other official activities performed by the competent authorities in accordance with this Regulation or with the rules referred to in paragraph 2 of this Article.
Article 2 Official controls and other official activities
1. For the purposes of this Regulation, ‘official controls’ means activities performed by the competent authorities, or by the delegated bodies or the natural persons to which certain official control tasks have been delegated in accordance with this Regulation, in order to verify: (a) compliance by the operators with this Regulation and with the rules referred to in Article 1(2); and (b) that animals or goods meet the requirements laid down in the rules referred to in Article 1(2), including for the issuance of an official certificate or official attestation. 2. For the purposes of this Regulation, ‘other official activities’ means activities, other than official controls, which are performed by the competent authorities, or by the delegated bodies or the natural persons to which certain other official activities have been delegated in accordance with this Regulation, and with the rules referred to in Article 1(2), including activities aimed at verifying the presence of animal diseases or pests of plants, preventing or containing the spread of such animal diseases or pests of plants, eradicating those animal diseases or pests of plants, granting authorisations or approvals, and issuing official certificates or official attestations.
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 2 Official controls and other official activities):
2. For the purposes of this Regulation, ‘other official activities’ means activities, other than official controls, which are performed by the competent authorities, or by the delegated bodies or the natural persons to which certain other official activities have been delegated in accordance with this Regulation, and with the rules referred to in Article 1(2), including activities aimed at verifying the presence of animal diseases or pests of plants, preventing or containing the spread of such animal diseases or pests of plants, eradicating those animal diseases or pests of plants, granting authorisations or approvals, and issuing official certificates or official attestations.
Article 3 Definitions
For the purposes of this Regulation, the following definitions apply: ‘food law’ means food law as defined in point (1) of Article 3 of Regulation (EC) No 178/2002; (2) ‘feed law’ means the laws, regulations and administrative provisions governing feed in general and feed safety in particular, whether at Union or national level at any stage of production, processing and distribution or use of feed; ‘competent authorities’ means: (a) the central authorities of a Member State responsible for the organisation of official controls and of other official activities, in accordance with this Regulation and the rules referred to in Article 1(2); (b) any other authority to which that responsibility has been conferred; (c) where appropriate, the corresponding authorities of a third country; (4) ‘organic control authority’ means a public administrative organisation for organic production and labelling of organic products of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Council Regulation (EC) No 834/2007 ( 3 ), including, where appropriate, the corresponding authority of a third country or operating in a third country; (5) ‘delegated body’ means a separate legal person to which the competent authorities have delegated certain official control tasks or certain tasks related to other official activities; (6) ‘control verification procedures’ means the arrangements put in place and actions performed by the competent authorities for the purpose of ensuring that official controls and other official activities are consistent and effective; (7) ‘control system’ means a system comprising the competent authorities and the resources, structures, arrangements and procedures set up in a Member State to ensure that official controls are performed in accordance with this Regulation and with the rules referred to in Articles 18 to 27; (8) ‘control plan’ means a description established by the competent authorities containing information on the structure and organisation of the official control system, and of its operation and the detailed planning of official controls to be performed, over a period of time, in each of the areas governed by the rules referred to in Article 1(2); ‘animals’ means animals as defined in point (1) of Article 4 of Regulation (EU) 2016/429; ‘animal disease’ means disease as defined in point (16) of Article 4 of Regulation (EU) 2016/429; (11) ‘goods’ means all that is subject to one or more of the rules referred to in Article 1(2), excluding animals; (12) ‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002; ‘feed’ means feed as defined in point (4) of Article 3 of Regulation (EC) No 178/2002; ‘animal by-products’ means animal by-products as defined in point (1) of Article 3 of Regulation (EC) No 1069/2009; ‘derived products’ means derived products as defined in point (2) of Article 3 of Regulation (EC) No 1069/2009; ‘plants’ means plants as defined in point (1) of Article 2 of Regulation (EU) 2016/2031; ‘pests of plants’ means pests as defined in Article 1(1) of Regulation (EU) 2016/2031; ‘plant protection products’ means plant protection products as referred to in Article 2(1) of Regulation (EC) No 1107/2009; (19) ‘products of animal origin’ means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council ( 4 ); ‘germinal products’ means germinal products as defined in point (28) of Article 4 of Regulation (EU) 2016/429; ‘plant products’ means plant products as defined in point (2) of Article 2 of Regulation (EU) 2016/2031; ‘other objects’ means other objects as defined in point (5) of Article 2 of Regulation (EU) 2016/2031; (23) ‘hazard’ means any agent or condition with the potential to have an adverse effect on human, animal or plant health, animal welfare or the environment; (24) ‘risk’ means a function of the probability of an adverse effect on human, animal or plant health, animal welfare or the environment and of the severity of that effect, consequential to a hazard; (25) ‘official certification’ means the procedure by which assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2) is provided by the competent authorities; ‘certifying officer’ means: (a) any official of the competent authorities authorised to sign official certificates by such authorities; or (b) any other natural person who is authorised by the competent authorities to sign official certificates in accordance with the rules referred to in Article 1(2); (27) ‘official certificate’ means a paper or electronic document signed by the certifying officer and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2); (28) ‘official attestation’ means any label, mark or other form of attestation issued by the operators under the supervision, through dedicated official controls, of the competent authorities or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in this Regulation or in the rules referred to in Article 1(2); (29) ‘operator’ means any natural or legal person subject to one or more of the obligations provided for in the rules referred to in Article 1(2); (30) ‘audit’ means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve the objectives; (31) ‘rating’ means a classification of operators based on an assessment of their conformity with rating criteria; (32) ‘official veterinarian’ means a veterinarian appointed by a competent authority, either as staff or otherwise, and appropriately qualified to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in Article 1(2); ‘official plant health officer’ means a natural person appointed by a competent authority, either as staff or otherwise, and appropriately trained to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in point (g) of Article 1(2); ‘long journey’ means a long journey as defined in point (m) of Article 2 of Regulation (EC) No 1/2005; (36) ‘pesticide application equipment’ means pesticide application equipment as defined in point (4) of Article 3 of Directive 2009/128/EC; ‘consignment’ means a number of animals or quantity of goods covered by the same official certificate, official attestation or any other document, conveyed by the same means of transport and coming from the same territory or third country, and, except for goods subject to the rules referred to in point (g) of Article 1(2), being of the same type, class or description; (38) ‘border control post’ means a place, and the facilities belonging to it, designated by a Member State for the performance of the official controls provided for in Article 47(1); (39) ‘exit point’ means a border control post or any other place designated by a Member State where animals, falling within the scope of Regulation (EC) No 1/2005, leave the customs territory of the Union; (42) ‘identity check’ means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, seals and means of transport, correspond to the information provided in the official certificates, official attestations and other documents accompanying it; (43) ‘physical check’ means a check on animals or goods and, as appropriate, checks on packaging, the means of transport, labelling and temperature, the sampling for analysis, testing or diagnosis and any other check necessary to verify compliance with the rules referred to in Article 1(2); ‘transit’ means movement from one third country to another third country passing under customs supervision through one of the territories listed in Annex I or from one of the territories listed in Annex I to another territory listed in Annex I after passing through the territory of a third country, except in relation to the rules referred to in point (g) of Article 1(2), for which it means one of the following; ‘supervision by the customs authorities’ means customs supervision as defined in point (27) of Article 5 of Regulation (EU) No 952/2013 of the European Parliament and of the Council ( 5 ); ‘control by the customs authorities’ means customs controls as defined in point (3) of Article 5 of Regulation (EU) No 952/2013; (47) ‘official detention’ means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators in accordance with the instructions and under the control of the competent authorities; (48) ‘journey log’ means the document set out in points 1 to 5 of Annex II to Regulation (EC) No 1/2005; (49) ‘official auxiliary’ means a representative of the competent authorities trained in accordance with the requirements established under Article 18 and employed to perform certain official control tasks or certain tasks related to other official activities; (51) ‘health mark’ means a mark applied after the official controls referred to in points (a) and (c) of Article 18(2) have been performed and which attests that the meat is fit for human consumption.
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 3 Definitions):
For the purposes of this Regulation, the following definitions apply: (2) ‘feed law’ means the laws, regulations and administrative provisions governing feed in general and feed safety in particular, whether at Union or national level at any stage of production, processing and distribution or use of feed; (4) ‘organic control authority’ means a public administrative organisation for organic production and labelling of organic products of a Member State to which the competent authorities have conferred, in whole or in part, their competences in relation to the application of Council Regulation (EC) No 834/2007 ( 3 ), including, where appropriate, the corresponding authority of a third country or operating in a third country; (5) ‘delegated body’ means a separate legal person to which the competent authorities have delegated certain official control tasks or certain tasks related to other official activities; (6) ‘control verification procedures’ means the arrangements put in place and actions performed by the competent authorities for the purpose of ensuring that official controls and other official activities are consistent and effective; (7) ‘control system’ means a system comprising the competent authorities and the resources, structures, arrangements and procedures set up in a Member State to ensure that official controls are performed in accordance with this Regulation and with the rules referred to in Articles 18 to 27; (8) ‘control plan’ means a description established by the competent authorities containing information on the structure and organisation of the official control system, and of its operation and the detailed planning of official controls to be performed, over a period of time, in each of the areas governed by the rules referred to in Article 1(2); (11) ‘goods’ means all that is subject to one or more of the rules referred to in Article 1(2), excluding animals; (12) ‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002; (19) ‘products of animal origin’ means products of animal origin as defined in point 8.1 of Annex I to Regulation (EC) No 853/2004 of the European Parliament and of the Council ( 4 ); (23) ‘hazard’ means any agent or condition with the potential to have an adverse effect on human, animal or plant health, animal welfare or the environment; (24) ‘risk’ means a function of the probability of an adverse effect on human, animal or plant health, animal welfare or the environment and of the severity of that effect, consequential to a hazard; (25) ‘official certification’ means the procedure by which assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2) is provided by the competent authorities; (27) ‘official certificate’ means a paper or electronic document signed by the certifying officer and providing assurance concerning compliance with one or more requirements laid down in the rules referred to in Article 1(2); (28) ‘official attestation’ means any label, mark or other form of attestation issued by the operators under the supervision, through dedicated official controls, of the competent authorities or by the competent authorities themselves, and providing assurance concerning compliance with one or more requirements laid down in this Regulation or in the rules referred to in Article 1(2); (29) ‘operator’ means any natural or legal person subject to one or more of the obligations provided for in the rules referred to in Article 1(2); (30) ‘audit’ means a systematic and independent examination to determine whether activities and the related results of such activities comply with planned arrangements and whether these arrangements are applied effectively and are suitable to achieve the objectives; (31) ‘rating’ means a classification of operators based on an assessment of their conformity with rating criteria; (32) ‘official veterinarian’ means a veterinarian appointed by a competent authority, either as staff or otherwise, and appropriately qualified to perform official controls and other official activities in accordance with this Regulation and the relevant rules referred to in Article 1(2); (36) ‘pesticide application equipment’ means pesticide application equipment as defined in point (4) of Article 3 of Directive 2009/128/EC; (38) ‘border control post’ means a place, and the facilities belonging to it, designated by a Member State for the performance of the official controls provided for in Article 47(1); (39) ‘exit point’ means a border control post or any other place designated by a Member State where animals, falling within the scope of Regulation (EC) No 1/2005, leave the customs territory of the Union; (42) ‘identity check’ means a visual inspection to verify that the content and the labelling of a consignment, including the marks on animals, seals and means of transport, correspond to the information provided in the official certificates, official attestations and other documents accompanying it; (43) ‘physical check’ means a check on animals or goods and, as appropriate, checks on packaging, the means of transport, labelling and temperature, the sampling for analysis, testing or diagnosis and any other check necessary to verify compliance with the rules referred to in Article 1(2); (47) ‘official detention’ means the procedure by which the competent authorities ensure that animals and goods subject to official controls are not moved or tampered with pending a decision on their destination; it includes storage by operators in accordance with the instructions and under the control of the competent authorities; (48) ‘journey log’ means the document set out in points 1 to 5 of Annex II to Regulation (EC) No 1/2005; (49) ‘official auxiliary’ means a representative of the competent authorities trained in accordance with the requirements established under Article 18 and employed to perform certain official control tasks or certain tasks related to other official activities; (51) ‘health mark’ means a mark applied after the official controls referred to in points (a) and (c) of Article 18(2) have been performed and which attests that the meat is fit for human consumption.
Article 4 Designation of competent authorities
1. For each of the areas governed by the rules referred to in Article 1(2), Member States shall designate the competent authority or authorities on which they confer the responsibility to organise or perform official controls and other official activities. 2. Where, for the same area, a Member State confers the responsibility to organise or perform official controls or other official activities on more than one competent authority, at national, regional or local level, or where the competent authorities designated in accordance with paragraph 1 are allowed by that designation to transfer specific responsibilities for official controls or other official activities to other public authorities, the Member State shall: (a) ensure efficient and effective coordination between all authorities involved, and the consistency and effectiveness of official controls or other official activities across its territory; and (b) designate a single authority, in conformity with Member States’ constitutional requirements, responsible for coordinating the cooperation and the contacts with the Commission and with other Member States in relation to the official controls and other official activities performed in each of the areas governed by the rules referred to in Article 1(2). 3. Competent authorities responsible for the verification of compliance with the rules referred to in point (i) of Article 1(2) may confer certain responsibilities related to official controls or other official activities to one or more organic control authorities. In such cases, they shall attribute a code number to each of them. 4. Member States shall ensure that the Commission is informed of the contact details and of any changes regarding: (a) the competent authorities designated in accordance with paragraph 1; (b) the single authorities designated in accordance with point (b) of paragraph 2; (c) the organic control authorities referred to in paragraph 3; (d) the delegated bodies referred to in Article 28(1). The information referred to in the first subparagraph shall also be made available by Member States to the public, including on the internet.
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 4 Designation of competent authorities):
1. For each of the areas governed by the rules referred to in Article 1(2), Member States shall designate the competent authority or authorities on which they confer the responsibility to organise or perform official controls and other official activities. 3. Competent authorities responsible for the verification of compliance with the rules referred to in point (i) of Article 1(2) may confer certain responsibilities related to official controls or other official activities to one or more organic control authorities. In such cases, they shall attribute a code number to each of them. The information referred to in the first subparagraph shall also be made available by Member States to the public, including on the internet.
Article 5 General obligations concerning the competent authorities and the organic control authorities
1. The competent authorities and the organic control authorities shall: (a) have procedures and/or arrangements in place to ensure the effectiveness and appropriateness of official controls and other official activities; (b) have procedures and/or arrangements in place to ensure the impartiality, quality and consistency of official controls and other official activities at all levels; (c) have procedures and/or arrangements in place to ensure that staff performing official controls and other official activities are free from any conflict of interest; (d) have, or have access to, an adequate laboratory capacity for analysis, testing and diagnosis; (e) have, or have access to, a sufficient number of suitably qualified and experienced staff so that official controls and other official activities can be performed efficiently and effectively; (f) have appropriate and properly maintained facilities and equipment to ensure that staff can perform official controls and other official activities efficiently and effectively; (g) have the legal powers to perform official controls and other official activities and to take the action provided for in this Regulation and in the rules referred to in Article 1(2); (h) have legal procedures in place in order to ensure that staff have access to the premises of, and documents kept by, operators so as to be able to accomplish their tasks properly; (i) have contingency plans in place, and be prepared to operate such plans in the event of an emergency, where appropriate, in accordance with the rules referred to in Article 1(2). 2. Any appointment of an official veterinarian shall be in writing and shall set out the official controls and the other official activities and related tasks for which the appointment has been made. Requirements imposed on staff of competent authorities that are provided for in this Regulation, including the requirement on freedom from any conflict of interest, shall apply to all official veterinarians. 3. Any appointment of an official plant health officer shall be in writing and shall set out the official controls and the other official activities and related tasks for which the appointment has been made. Requirements imposed on staff of competent authorities that are provided for in this Regulation, including the requirement on freedom from any conflict of interest, shall apply to all official plant health officers. 4. Staff performing official controls and other official activities shall: (a) receive, for their area of competence, appropriate training enabling them to undertake their duties competently and to perform official controls and other official activities in a consistent manner; (b) keep up-to-date in their area of competence and receive regular additional training as necessary; and (c) receive training in the subject matters set out in Chapter I of Annex II and on the obligations of the competent authorities resulting from this Regulation, as appropriate. Competent authorities, organic control authorities and delegated bodies shall develop and implement training programmes for the purpose of ensuring that staff performing official controls and other official activities receive the training referred to in points (a), (b) and (c). 5. When, within the services of a competent authority, more than one unit is competent to perform official controls or other official activities, efficient and effective coordination and cooperation shall be ensured between the different units.
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 5 General obligations concerning the competent authorities and the organic control authorities):
2. Any appointment of an official veterinarian shall be in writing and shall set out the official controls and the other official activities and related tasks for which the appointment has been made. Requirements imposed on staff of competent authorities that are provided for in this Regulation, including the requirement on freedom from any conflict of interest, shall apply to all official veterinarians. 3. Any appointment of an official plant health officer shall be in writing and shall set out the official controls and the other official activities and related tasks for which the appointment has been made. Requirements imposed on staff of competent authorities that are provided for in this Regulation, including the requirement on freedom from any conflict of interest, shall apply to all official plant health officers. 4. Competent authorities, organic control authorities and delegated bodies shall develop and implement training programmes for the purpose of ensuring that staff performing official controls and other official activities receive the training referred to in points (a), (b) and (c). 5. When, within the services of a competent authority, more than one unit is competent to perform official controls or other official activities, efficient and effective coordination and cooperation shall be ensured between the different units.
Article 6 Audits of the competent authorities
1. To ensure their compliance with this Regulation, the competent authorities shall carry out internal audits or have audits carried out on themselves and shall take appropriate measures in the light of the results of those audits. 2. The audits referred to in paragraph 1 shall be subject to independent scrutiny and carried out in a transparent manner.
Article 7 Right of appeal
The decisions taken by the competent authorities in accordance with Article 55, Article 66(3) and (6), Article 67, point (b) of Article 137(3), and Article 138(1) and (2), concerning natural or legal persons shall be subject to such persons’ right of appeal in accordance with national law. The right of appeal shall not affect the obligation of competent authorities to take prompt action to eliminate or contain the risks to human, animal or plant health, to animal welfare or, as regards GMOs and plant protection products, also to the environment, in accordance with this Regulation and with the rules referred to in Article 1(2).
Article 8 Confidentiality obligations of the competent authorities
1. Competent authorities shall ensure that, subject to paragraph 3, information acquired when performing their duties in the context of official controls and other official activities is not disclosed to third parties where, under national or Union legislation, that information is, by its nature, covered by professional secrecy. For that purpose, Member States shall ensure that appropriate confidentiality obligations are established for staff and other individuals employed during official controls and other official activities. 2. Paragraph 1 shall also apply to organic control authorities, delegated bodies and natural persons to which specific official control tasks have been delegated and to official laboratories. 3. Unless there is an overriding public interest in the disclosure of information covered by professional secrecy as referred to in paragraph 1, and without prejudice to situations where disclosure is required by Union or national legislation, such information shall include information whose disclosure would undermine: (a) the purpose of inspections, investigations or audits; (b) the protection of commercial interests of an operator or any other natural or legal person; or (c) the protection of court proceedings and legal advice. 4. The competent authorities, when determining whether there is an overriding public interest in the disclosure of information covered by professional secrecy as referred to in paragraph 1, shall take into account inter alia the possible risks to human, animal or plant health, or to the environment, and the nature, severity and extent of such risks. 5. The confidentiality obligations provided for in this Article shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators, provided, without prejudice to situations where disclosure is required by Union or national legislation, that the following conditions are met: (a) the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to its publication or release, taking into account the urgency of the situation; and (b) the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments.
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 8 Confidentiality obligations of the competent authorities):
1. Competent authorities shall ensure that, subject to paragraph 3, information acquired when performing their duties in the context of official controls and other official activities is not disclosed to third parties where, under national or Union legislation, that information is, by its nature, covered by professional secrecy. For that purpose, Member States shall ensure that appropriate confidentiality obligations are established for staff and other individuals employed during official controls and other official activities. 2. Paragraph 1 shall also apply to organic control authorities, delegated bodies and natural persons to which specific official control tasks have been delegated and to official laboratories. 3. Unless there is an overriding public interest in the disclosure of information covered by professional secrecy as referred to in paragraph 1, and without prejudice to situations where disclosure is required by Union or national legislation, such information shall include information whose disclosure would undermine: (a) the purpose of inspections, investigations or audits; (b) the protection of commercial interests of an operator or any other natural or legal person; or (c) the protection of court proceedings and legal advice. 4. The competent authorities, when determining whether there is an overriding public interest in the disclosure of information covered by professional secrecy as referred to in paragraph 1, shall take into account inter alia the possible risks to human, animal or plant health, or to the environment, and the nature, severity and extent of such risks. 5. The confidentiality obligations provided for in this Article shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators, provided, without prejudice to situations where disclosure is required by Union or national legislation, that the following conditions are met: (a) the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to its publication or release, taking into account the urgency of the situation; and (b) the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments. The confidentiality obligations provided for in this Article shall not prevent the competent authorities from publishing or making otherwise available to the public information about the outcome of official controls regarding individual operators, provided, without prejudice to situations where disclosure is required by Union or national legislation, that the following conditions are met: (a) the operator concerned is given the opportunity to comment on the information that the competent authority intends to publish or make otherwise available to the public, prior to its publication or release, taking into account the urgency of the situation; and (b) the information which is published or made otherwise available to the public takes into account the comments expressed by the operator concerned or is published or released together with such comments.
Article 9 General rules on official controls
1. Competent authorities shall perform official controls on all operators regularly, on a risk basis and with appropriate frequency, taking account of: identified risks associated with: (i) animals and goods; (ii) the activities under the control of operators; (iii) the location of the activities or operations of operators; (iv) the use of products, processes, materials or substances that may influence food safety, integrity and wholesomeness, or feed safety, animal health or animal welfare, plant health or, in the case of GMOs and plant protection products, that may also have an adverse impact on the environment; (b) any information indicating the likelihood that consumers might be misled, in particular as to the nature, identity, properties, composition, quantity, durability, country of origin or place of provenance, method of manufacture or production of food; (c) operators’ past record as regards the outcome of official controls performed on them and their compliance with the rules referred to in Article 1(2); (d) the reliability and results of own controls that have been performed by the operators, or by a third party at their request, including, where appropriate, private quality assurance schemes, for the purpose of ascertaining compliance with the rules referred to in Article 1(2); and (e) any information that might indicate non-compliance with the rules referred to in Article 1(2). 2. Competent authorities shall perform official controls regularly, with appropriate frequencies determined on a risk basis, to identify possible intentional violations of the rules referred to in Article 1(2), perpetrated through fraudulent or deceptive practices, and taking into account information regarding such violations shared through the mechanisms of administrative assistance provided for in Articles 102 to 108 and any other information pointing to the possibility of such violations. 3. Official controls that are performed prior to the placing on the market, or the movement of certain animals and goods in view of the issuance of the official certificates or official attestations required by the rules referred to in Article 1(2), as a condition for the placing on the market or the movement of the animals or goods shall be performed in accordance with both of the following: (a) the rules referred to in Article 1(2); (b) the applicable delegated and implementing acts adopted by the Commission in accordance with Articles 18 to 27. 4. Official controls shall be performed without prior notice, except where such notice is necessary and duly justified for the official control to be carried out. As regards official controls upon request from the operator, the competent authority may decide whether the official controls are to be performed with or without prior notice. Official controls with prior notice shall not preclude official controls without prior notice. 5. Official controls shall be performed as much as possible in such a manner that the administrative burden and operational disruption for operators are kept to the minimum necessary, but without this negatively affecting the effectiveness of those controls. 6. Competent authorities shall perform official controls in the same manner, while taking account of the need to adapt the controls to the specific situations, irrespective of whether the animals and goods concerned are: (a) available on the Union market, whether originating in the Member State where the official controls are performed or in another Member State; (b) to be exported from the Union; or (c) entering the Union. 7. To the extent strictly necessary for the organisation of the official controls, Member States of destination may require operators that have animals or goods delivered to them from another Member State to report the arrival of such animals or goods.
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 9 General rules on official controls):
2. Competent authorities shall perform official controls regularly, with appropriate frequencies determined on a risk basis, to identify possible intentional violations of the rules referred to in Article 1(2), perpetrated through fraudulent or deceptive practices, and taking into account information regarding such violations shared through the mechanisms of administrative assistance provided for in Articles 102 to 108 and any other information pointing to the possibility of such violations. 4. Official controls shall be performed without prior notice, except where such notice is necessary and duly justified for the official control to be carried out. As regards official controls upon request from the operator, the competent authority may decide whether the official controls are to be performed with or without prior notice. Official controls with prior notice shall not preclude official controls without prior notice. 5. Official controls shall be performed as much as possible in such a manner that the administrative burden and operational disruption for operators are kept to the minimum necessary, but without this negatively affecting the effectiveness of those controls. 7. To the extent strictly necessary for the organisation of the official controls, Member States of destination may require operators that have animals or goods delivered to them from another Member State to report the arrival of such animals or goods.
Article 10 Operators, processes and activities subject to official controls
1. To the extent necessary to ascertain compliance with the rules referred to in Article 1(2), competent authorities shall perform official controls on: (a) animals and goods at any stage of production, processing, distribution and use; (b) substances, materials or other objects which may influence the characteristics or health of animals and goods and their compliance with applicable requirements, at any stage of production, processing, distribution and use; (c) operators as regards activities, including the keeping of animals, equipment, means of transport, premises and other places under their control and their surroundings and on related documentation. 2. Without prejudice to the rules concerning existing lists or registers established on the basis of the rules referred to in Article 1(2), the competent authorities shall draw up and keep up-to-date a list of operators. Where such a list or register already exists for other purposes, it may also be used for the purposes of this Regulation. 3. The Commission shall adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the setting out of categories of operators to be exempted from the list of operators referred to in paragraph 2 of this Article where their inclusion in such a list would constitute a disproportionate administrative burden for them compared to the risk related to their activities.
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 10 Operators, processes and activities subject to official controls):
2. Without prejudice to the rules concerning existing lists or registers established on the basis of the rules referred to in Article 1(2), the competent authorities shall draw up and keep up-to-date a list of operators. Where such a list or register already exists for other purposes, it may also be used for the purposes of this Regulation. 3. The Commission shall adopt delegated acts in accordance with Article 144 to amend this Regulation concerning the setting out of categories of operators to be exempted from the list of operators referred to in paragraph 2 of this Article where their inclusion in such a list would constitute a disproportionate administrative burden for them compared to the risk related to their activities.
Article 11 Transparency of official controls
1. Competent authorities shall perform official controls with a high level of transparency and shall, at least once a year, make available to the public, including through publication on the internet, relevant information concerning the organisation and the performance of official controls. They shall also ensure the regular and timely publication of information on the following: (a) the type, number and outcome of official controls; (b) the type and number of cases of non-compliance detected; (c) the type and number of cases where measures were taken by the competent authorities in accordance with Article 138; and (d) the type and number of cases where the penalties referred to in Article 139 were imposed. 2. Competent authorities shall establish procedures to ensure that any inaccuracies in the information made available to the public are appropriately rectified. 3. Competent authorities may publish, or make otherwise available to the public, information about the rating of individual operators based on the outcome of one or more official controls, provided that the following conditions are met: (a) the rating criteria are objective, transparent and publicly available; and (b) appropriate arrangements are in place to ensure the fairness, consistency and transparency of the rating process.
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 11 Transparency of official controls):
1. Competent authorities shall perform official controls with a high level of transparency and shall, at least once a year, make available to the public, including through publication on the internet, relevant information concerning the organisation and the performance of official controls. They shall also ensure the regular and timely publication of information on the following: (a) the type, number and outcome of official controls; (b) the type and number of cases of non-compliance detected; (c) the type and number of cases where measures were taken by the competent authorities in accordance with Article 138; and (d) the type and number of cases where the penalties referred to in Article 139 were imposed. 2. Competent authorities shall establish procedures to ensure that any inaccuracies in the information made available to the public are appropriately rectified. 3. Competent authorities may publish, or make otherwise available to the public, information about the rating of individual operators based on the outcome of one or more official controls, provided that the following conditions are met: (a) the rating criteria are objective, transparent and publicly available; and (b) appropriate arrangements are in place to ensure the fairness, consistency and transparency of the rating process. Competent authorities may publish, or make otherwise available to the public, information about the rating of individual operators based on the outcome of one or more official controls, provided that the following conditions are met: (a) the rating criteria are objective, transparent and publicly available; and (b) appropriate arrangements are in place to ensure the fairness, consistency and transparency of the rating process.
Article 12 Documented control procedures
1. Competent authorities shall perform official controls in accordance with documented procedures. Those procedures shall cover the subject areas for control procedures set out in Chapter II of Annex II and shall contain instructions for staff performing official controls. 2. Competent authorities shall have control verification procedures in place. 3. Competent authorities shall: (a) take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings; and (b) update the documented procedures provided for in paragraph 1 as appropriate. 4. Paragraphs 1, 2 and 3 shall also apply to delegated bodies and organic control authorities.
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 12 Documented control procedures):
1. Competent authorities shall perform official controls in accordance with documented procedures. Those procedures shall cover the subject areas for control procedures set out in Chapter II of Annex II and shall contain instructions for staff performing official controls. 2. Competent authorities shall have control verification procedures in place. 3. Competent authorities shall: (a) take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings; and (b) update the documented procedures provided for in paragraph 1 as appropriate. Competent authorities shall: (a) take corrective actions in all cases where the procedures provided for in paragraph 2 identify shortcomings; and (b) update the documented procedures provided for in paragraph 1 as appropriate. 4. Paragraphs 1, 2 and 3 shall also apply to delegated bodies and organic control authorities.
Article 13 Written records of official controls
1. Competent authorities shall draw up written records of every official control that they perform. Those records may be on paper or in electronic form. Those records shall contain: (a) a description of the purpose of the official controls; (b) the control methods applied; (c) the outcome of the official controls; and (d) where appropriate, action that the competent authorities require the operator concerned to take as a result of their official controls. 2. Unless the purposes of judicial investigations or the protection of court proceedings require otherwise, the operators subject to an official control shall be provided upon request with a copy of the records provided for in paragraph 1, except where an official certificate or official attestation has been issued. The operator shall be promptly informed in writing by the competent authorities of any case of non-compliance identified through the official controls. 3. Where official controls require the continuous or regular presence of staff or representatives of the competent authorities on the operator’s premises, the records provided for in paragraph 1 shall be produced with a frequency that enables the competent authorities and the operator to be: (a) regularly informed of the level of compliance; and (b) promptly informed of any case of non-compliance identified through the official controls. 4. Paragraphs 1, 2 and 3 shall also apply to delegated bodies, organic control authorities and natural persons to which certain official control tasks have been delegated.
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 13 Written records of official controls):
1. Competent authorities shall draw up written records of every official control that they perform. Those records may be on paper or in electronic form. Those records shall contain: (a) a description of the purpose of the official controls; (b) the control methods applied; (c) the outcome of the official controls; and (d) where appropriate, action that the competent authorities require the operator concerned to take as a result of their official controls. 2. Unless the purposes of judicial investigations or the protection of court proceedings require otherwise, the operators subject to an official control shall be provided upon request with a copy of the records provided for in paragraph 1, except where an official certificate or official attestation has been issued. The operator shall be promptly informed in writing by the competent authorities of any case of non-compliance identified through the official controls. 3. Where official controls require the continuous or regular presence of staff or representatives of the competent authorities on the operator’s premises, the records provided for in paragraph 1 shall be produced with a frequency that enables the competent authorities and the operator to be: (a) regularly informed of the level of compliance; and (b) promptly informed of any case of non-compliance identified through the official controls. Where official controls require the continuous or regular presence of staff or representatives of the competent authorities on the operator’s premises, the records provided for in paragraph 1 shall be produced with a frequency that enables the competent authorities and the operator to be: (a) regularly informed of the level of compliance; and (b) promptly informed of any case of non-compliance identified through the official controls. 4. Paragraphs 1, 2 and 3 shall also apply to delegated bodies, organic control authorities and natural persons to which certain official control tasks have been delegated.
Article 14 Methods and techniques for official controls
Official control methods and techniques shall include the following as appropriate: (a) an examination of the controls that operators have put in place and of the results obtained; an inspection of: (i) equipment, means of transport, premises and other places under their control and their surroundings; (ii) animals and goods, including semi-finished goods, raw materials, ingredients, processing aids and other products used for the preparation and production of goods or for feeding or treating animals; (iii) cleaning and maintenance products and processes; (iv) traceability, labelling, presentation, advertising and relevant packaging materials including materials intended to come into contact with food; (c) controls on the hygiene conditions in the operators’ premises; (d) an assessment of procedures on good manufacturing practices, good hygiene practices, good farming practices, and of procedures based on the principles of hazard analysis critical control points (HACCP); (e) an examination of documents, traceability records and other records which may be relevant to the assessment of compliance with the rules referred to in Article 1(2), including, where appropriate, documents accompanying food, feed and any substance or material entering or leaving an establishment; (f) interviews with operators and with their staff; (g) the verification of measurements taken by the operator and other test results; (h) sampling, analysis, diagnosis and tests; (i) audits of operators; (j) any other activity required to identify cases of non-compliance.
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 14 Methods and techniques for official controls):
Official control methods and techniques shall include the following as appropriate: (a) an examination of the controls that operators have put in place and of the results obtained; (c) controls on the hygiene conditions in the operators’ premises; (d) an assessment of procedures on good manufacturing practices, good hygiene practices, good farming practices, and of procedures based on the principles of hazard analysis critical control points (HACCP); (e) an examination of documents, traceability records and other records which may be relevant to the assessment of compliance with the rules referred to in Article 1(2), including, where appropriate, documents accompanying food, feed and any substance or material entering or leaving an establishment; (f) interviews with operators and with their staff; (g) the verification of measurements taken by the operator and other test results; (h) sampling, analysis, diagnosis and tests; (i) audits of operators; (j) any other activity required to identify cases of non-compliance.
Article 15 Obligations of operators
1. To the extent that this is necessary for the performance of official controls or of other official activities, operators shall, where required by the competent authorities, give staff of the competent authorities access to: (a) the equipment, means of transport, premises and other places under their control and their surroundings; (b) their computerised information management systems; (c) the animals and goods under their control; (d) their documents and any other relevant information. 2. During official controls and other official activities, operators shall assist and cooperate with the staff of the competent authorities and organic control authorities in the accomplishment of their tasks. 3. The operator responsible for a consignment entering the Union shall, in addition to the obligations set out in paragraphs 1 and 2, make available, on paper or in electronic form, and without delay, all information concerning the animals and goods. 4. The Commission may, by means of implementing acts, lay down rules on the cooperation and exchange of information between operators and competent authorities related to the arrival and unloading of the animals and goods referred to in Article 47(1) where it is necessary to ensure their complete identification and the efficient performance of official controls on such animals and goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 5. For the purpose of Article 10(2) and subject to Article 10(3), operators shall provide the competent authorities with at least the following updated details: (a) their name and legal form; and (b) the specific activities they carry out, including activities undertaken by means of distance communication, and the places under their control. 6. The obligations of operators set out in this Article shall also apply in cases where official controls and other official activities are performed by official veterinarians, official plant health officers, delegated bodies, control authorities and natural persons to which certain official control tasks or certain tasks related to other official activities have been delegated.
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 15 Obligations of operators):
2. During official controls and other official activities, operators shall assist and cooperate with the staff of the competent authorities and organic control authorities in the accomplishment of their tasks. 3. The operator responsible for a consignment entering the Union shall, in addition to the obligations set out in paragraphs 1 and 2, make available, on paper or in electronic form, and without delay, all information concerning the animals and goods. 4. The Commission may, by means of implementing acts, lay down rules on the cooperation and exchange of information between operators and competent authorities related to the arrival and unloading of the animals and goods referred to in Article 47(1) where it is necessary to ensure their complete identification and the efficient performance of official controls on such animals and goods. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 6. The obligations of operators set out in this Article shall also apply in cases where official controls and other official activities are performed by official veterinarians, official plant health officers, delegated bodies, control authorities and natural persons to which certain official control tasks or certain tasks related to other official activities have been delegated.
Article 16 Additional requirements
1. In the areas governed by the rules provided for in this Section, those rules shall apply in addition to the other rules set out in this Regulation. 2. When adopting delegated acts and implementing acts provided for in this Section, the Commission shall take into account the following: the experience gained by competent authorities and food and feed business operators when applying the procedures referred to in Article 5 of Regulation (EC) No 852/2004 of the European Parliament and of the Council ( 7 ) and Article 6 of Regulation (EC) No 183/2005 of the European Parliament and of the Council ( 8 ); (b) scientific and technological developments; (c) consumer expectations with regard to food composition and changes in patterns of consumption of food; (d) risks to human and animal health and plant health associated with animals and goods; and (e) information on possible intentional violations perpetrated through fraudulent or deceptive practices. 3. When adopting delegated acts and implementing acts provided for in this Section, and insofar as this does not prevent the achievement of the objectives pursued by the rules referred to in Article 1(2), the Commission shall also take into account the following: (a) the need to facilitate the application of the delegated acts and implementing acts, taking into account the nature and the size of small businesses; (b) the need to enable the continued use of traditional methods at any stage of production, processing or distribution of food, and the production of traditional foods; and (c) the needs of operators situated in regions that are subject to specific geographical constraints.
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 16 Additional requirements):
1. In the areas governed by the rules provided for in this Section, those rules shall apply in addition to the other rules set out in this Regulation.
Article 17 Specific definitions
For the purpose of Article 18: (a) ‘under the responsibility of the official veterinarian’ means that the official veterinarian assigns the performance of an action to an official auxiliary; (b) ‘under the supervision of the official veterinarian’ means that an action is performed by an official auxiliary under the responsibility of the official veterinarian and the official veterinarian is present on the premises during the time necessary to perform that action; (c) ‘ante-mortem inspection’ means the verification, prior to slaughtering activities, of human and animal health and animal welfare requirements, including, where appropriate, the clinical examination of each individual animal, and the verification of the food chain information as referred to in Section III of Annex II to Regulation (EC) No 853/2004; ‘post-mortem inspection’ means the verification in the slaughterhouse or game-handling establishment of compliance with requirements applicable to: (i) carcases as defined in point 1.9 of Annex I to Regulation (EC) No 853/2004 and offal as defined in point 1.11 of that Annex, for the purpose of deciding if the meat is fit for human consumption, (ii) safe removal of specified risk material, and (iii) the health and welfare of the animals.
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 17 Specific definitions):
For the purpose of Article 18: (a) ‘under the responsibility of the official veterinarian’ means that the official veterinarian assigns the performance of an action to an official auxiliary; (b) ‘under the supervision of the official veterinarian’ means that an action is performed by an official auxiliary under the responsibility of the official veterinarian and the official veterinarian is present on the premises during the time necessary to perform that action; (c) ‘ante-mortem inspection’ means the verification, prior to slaughtering activities, of human and animal health and animal welfare requirements, including, where appropriate, the clinical examination of each individual animal, and the verification of the food chain information as referred to in Section III of Annex II to Regulation (EC) No 853/2004;
Article 18 Specific rules on official controls and for action taken by the competent authorities in relation to the production of products of animal origin intended for human consumption
2. The official controls referred to in paragraph 1 performed in relation to the production of meat shall include: (a) the ante-mortem inspection performed in the slaughterhouse by an official veterinarian who may, as regards pre-selection of animals, be assisted by official auxiliaries trained for that purpose; (b) by way of derogation from point (a), as regards poultry and lagomorphs, the ante-mortem inspection performed by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian; (c) the post-mortem inspection performed by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian; the other official controls performed in slaughterhouses, cutting plants and game-handling establishments, by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian, to verify compliance with the requirements applicable to: (i) the hygiene of meat production; (ii) the presence of residues of veterinary medicinal products and contaminants in products of animal origin intended for human consumption; (iii) audits of good hygiene practices and procedures based on HACCP principles; laboratory tests to detect the presence of zoonotic agents and animal diseases and to verify compliance with the microbiological criterion as defined in point (b) of Article 2 of Commission Regulation (EC) No 2073/2005 ( 9 ); (v) the handling and disposal of animal by-products and of specified risk material; (vi) the health and welfare of the animals. 3. The competent authority may, on the basis of a risk analysis, allow slaughterhouse staff to assist in the performance of tasks relating to the official controls referred to in paragraph 2 in establishments slaughtering poultry or lagomorphs, or, in establishments slaughtering animals of other species, to carry out specific sampling and testing tasks relating to such controls, on condition that staff: (a) act independently from the production staff of the slaughterhouse; (b) have undergone appropriate training to carry out these tasks; and (c) carry out these tasks in the presence and following the instructions of the official veterinarian or of the official auxiliary. 4. Where the official controls referred to in points (a) and (c) of paragraph 2 have not identified any shortcoming that would make the meat unfit for human consumption, the health mark shall be applied to domestic ungulates, farmed game mammals other than lagomorphs, and large wild game, by the official veterinarian, under the supervision of the official veterinarian, under the responsibility of the official veterinarian, or, in compliance with the conditions laid down in paragraph 3, by the slaughterhouse staff. 5. The official veterinarian shall remain responsible for the decisions taken following official controls provided for in paragraphs 2 and 4, even if the performance of an action is assigned by him or her to the official auxiliary. 6. For the purpose of the official controls referred to in paragraph 1 performed in relation to live bivalve molluscs, the competent authorities shall classify production and relaying areas. 7. The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning specific rules for the performance of the official controls referred to in paragraphs 2 to 6 of this Article on: (a) criteria and conditions to determine, by way of derogation from point (a) of paragraph 2, when the ante-mortem inspection in certain slaughterhouses may be performed under the supervision or under the responsibility of an official veterinarian, provided that the derogations do not affect the achievement of the objectives of this Regulation; (b) criteria and conditions to determine, as regards poultry and lagomorphs, when sufficient guarantees are met for the official controls to be performed under the responsibility of an official veterinarian in regard to the ante-mortem inspections referred to in point (b) of paragraph 2; (c) criteria and conditions to determine, by way of derogation from point (a) of paragraph 2, when the ante-mortem inspection may be performed outside the slaughterhouse in case of emergency slaughter; criteria and conditions to determine, by way of derogation from points (a) and (b) of paragraph 2, when the ante-mortem inspection may be performed at the holding of provenance; criteria and conditions to determine when sufficient guarantees are met for the official controls to be performed under the responsibility of an official veterinarian with regard to the post-mortem inspection and auditing activities referred to in points (c) and (d) of paragraph 2; (f) criteria and conditions to determine, by way of derogation from point (c) of paragraph 2, when, in case of emergency slaughter, the post-mortem inspection is to be performed by the official veterinarian; (g) criteria and conditions to determine, in relation to Pectinidae , marine gastropods and Holothuroidea , by way of derogation from paragraph 6, when production and relaying areas are not to be classified; (h) specific derogations in respect to Rangifer tarandus tarandus , Lagopus lagopus and Lagopus mutus , in order to allow the continuation of longstanding local and traditional customs and practices, provided that the derogations do not affect the achievement of the objectives of this Regulation; (i) criteria and conditions to determine, by way of derogation from point (d) of paragraph 2, when the official controls in cutting plants may be performed by staff designated by the competent authorities for that purpose and appropriately trained; (j) specific minimum requirements for the staff of the competent authorities and for official veterinarian and official auxiliary in order to ensure an adequate performance of their tasks provided for in this Article, including specific minimum training requirements; (k) appropriate minimum training requirements for the slaughterhouse staff assisting in the performance of tasks relating to official controls and other official activities in accordance with paragraph 3. 8. The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of the official controls referred to in this Article regarding: (a) specific requirements for the performance of official controls and the uniform minimum frequency of those official controls, having regard to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes, where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks which might be posed by products of animal origin; (b) the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs; the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Articles 137(2) and 138(2); (e) the technical requirements of the health mark and the practical arrangements for its application; (f) specific requirements for the performance of official controls and the uniform minimum frequency for those official controls on raw milk, milk products and fishery products, where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks they might pose. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 9. While complying with the objectives of this Regulation and in particular as regards food safety requirements, the Member States may adopt national measures implementing pilot projects limited in time and extent, to evaluate alternative practical arrangements for the performance of official controls on the production of meat. Those national measures shall be notified in accordance with the procedure laid down in Articles 5 and 6 of Directive (EU) 2015/1535. The outcome of the evaluation conducted through the pilot projects shall be communicated to the Commission as soon as available. 10. For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.
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 18 Specific rules on official controls and for action taken by the competent authorities in relation to the production of products of animal origin intended for human consumption):
The official controls referred to in paragraph 1 performed in relation to the production of meat shall include: (a) the ante-mortem inspection performed in the slaughterhouse by an official veterinarian who may, as regards pre-selection of animals, be assisted by official auxiliaries trained for that purpose; (b) by way of derogation from point (a), as regards poultry and lagomorphs, the ante-mortem inspection performed by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian; (c) the post-mortem inspection performed by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian; the other official controls performed in slaughterhouses, cutting plants and game-handling establishments, by an official veterinarian, under the supervision of the official veterinarian or, where sufficient guarantees are in place, under the responsibility of the official veterinarian, to verify compliance with the requirements applicable to: (i) the hygiene of meat production; (ii) the presence of residues of veterinary medicinal products and contaminants in products of animal origin intended for human consumption; (iii) audits of good hygiene practices and procedures based on HACCP principles; laboratory tests to detect the presence of zoonotic agents and animal diseases and to verify compliance with the microbiological criterion as defined in point (b) of Article 2 of Commission Regulation (EC) No 2073/2005 ( 9 ); (v) the handling and disposal of animal by-products and of specified risk material; (vi) the health and welfare of the animals. The competent authority may, on the basis of a risk analysis, allow slaughterhouse staff to assist in the performance of tasks relating to the official controls referred to in paragraph 2 in establishments slaughtering poultry or lagomorphs, or, in establishments slaughtering animals of other species, to carry out specific sampling and testing tasks relating to such controls, on condition that staff: (a) act independently from the production staff of the slaughterhouse; (b) have undergone appropriate training to carry out these tasks; and (c) carry out these tasks in the presence and following the instructions of the official veterinarian or of the official auxiliary. 4. Where the official controls referred to in points (a) and (c) of paragraph 2 have not identified any shortcoming that would make the meat unfit for human consumption, the health mark shall be applied to domestic ungulates, farmed game mammals other than lagomorphs, and large wild game, by the official veterinarian, under the supervision of the official veterinarian, under the responsibility of the official veterinarian, or, in compliance with the conditions laid down in paragraph 3, by the slaughterhouse staff. 5. The official veterinarian shall remain responsible for the decisions taken following official controls provided for in paragraphs 2 and 4, even if the performance of an action is assigned by him or her to the official auxiliary. 6. For the purposes of official controls referred to in paragraph 1 performed in relation to live bivalve molluscs, echinoderms, tunicates and marine gastropods, the competent authorities shall classify production and relaying areas. The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning specific rules for the performance of the official controls referred to in paragraphs 2 to 6 of this Article on: (a) criteria and conditions to determine, by way of derogation from point (a) of paragraph 2, when the ante-mortem inspection in certain slaughterhouses may be performed under the supervision or under the responsibility of an official veterinarian, provided that the derogations do not affect the achievement of the objectives of this Regulation; (b) criteria and conditions to determine, as regards poultry and lagomorphs, when sufficient guarantees are met for the official controls to be performed under the responsibility of an official veterinarian in regard to the ante-mortem inspections referred to in point (b) of paragraph 2; (c) criteria and conditions to determine, by way of derogation from point (a) of paragraph 2, when the ante-mortem inspection may be performed outside the slaughterhouse in case of emergency slaughter; criteria and conditions to determine, by way of derogation from points (a) and (b) of paragraph 2, when the ante-mortem inspection may be performed at the holding of provenance; criteria and conditions to determine when sufficient guarantees are met for the official controls to be performed under the responsibility of an official veterinarian with regard to the post-mortem inspection and auditing activities referred to in points (c) and (d) of paragraph 2; (f) criteria and conditions to determine, by way of derogation from point (c) of paragraph 2, when, in case of emergency slaughter, the post-mortem inspection is to be performed by the official veterinarian; criteria and conditions to determine, by way of derogation from paragraph 6, when production and relaying areas are not to be classified in relation to: (i) Pectinidae; and (ii) where they are not filter feeders: echinoderms and marine gastropods; criteria and conditions to determine, by way of derogation from paragraph 6, when production and relaying areas are not to be classified in relation to: (i) Pectinidae; and (ii) where they are not filter feeders: echinoderms and marine gastropods; (h) specific derogations in respect to Rangifer tarandus tarandus , Lagopus lagopus and Lagopus mutus , in order to allow the continuation of longstanding local and traditional customs and practices, provided that the derogations do not affect the achievement of the objectives of this Regulation; (i) criteria and conditions to determine, by way of derogation from point (d) of paragraph 2, when the official controls in cutting plants may be performed by staff designated by the competent authorities for that purpose and appropriately trained; (j) specific minimum requirements for the staff of the competent authorities and for official veterinarian and official auxiliary in order to ensure an adequate performance of their tasks provided for in this Article, including specific minimum training requirements; (k) appropriate minimum training requirements for the slaughterhouse staff assisting in the performance of tasks relating to official controls and other official activities in accordance with paragraph 3. The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of the official controls referred to in this Article regarding: (a) specific requirements for the performance of official controls and the uniform minimum frequency of those official controls, having regard to the specific hazards and risks which exist in relation to each product of animal origin and the different processes it undergoes, where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks which might be posed by products of animal origin; (b) the conditions for the classification and monitoring of classified production and relaying areas for live bivalve molluscs, echinoderms, tunicates and marine gastropods; the cases where the competent authorities in relation to specific non-compliances are to take one or more of the measures referred to in Articles 137(2) and 138(2); (e) the technical requirements of the health mark and the practical arrangements for its application; (f) specific requirements for the performance of official controls and the uniform minimum frequency for those official controls on raw milk, milk products and fishery products, where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks they might pose. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 9. While complying with the objectives of this Regulation and in particular as regards food safety requirements, the Member States may adopt national measures implementing pilot projects limited in time and extent, to evaluate alternative practical arrangements for the performance of official controls on the production of meat. Those national measures shall be notified in accordance with the procedure laid down in Articles 5 and 6 of Directive (EU) 2015/1535. The outcome of the evaluation conducted through the pilot projects shall be communicated to the Commission as soon as available. 10. For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.
Article 19 Specific rules on official controls and for action taken by the competent authorities in relation to the residues of relevant substances in food and feed
2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation by laying down rules for the performance of the official controls referred to in paragraph 1 of this Article and for action to be taken by the competent authorities following those official controls. Those delegated acts shall lay down rules on: the cases where the competent authorities in relation to non-compliance or suspicion thereof are to take one or more of the measures referred to in Articles 137(2) and 138(2); (c) the cases where the competent authorities in relation to non-compliance or suspicion thereof of animals and goods from third countries are to take one or more of the measures referred to Articles 65 to 72. 3. The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of the official controls referred to in paragraph 1 and for action to be taken by the competent authorities following those official controls, regarding: (a) uniform minimum frequency of such official controls, having regard to the hazards and risks related to substances referred to in paragraph 1; (b) specific additional arrangements and specific additional content to those provided for in Article 110, for the preparation of the relevant parts of the multi-annual national control plan (MANCP) provided for in Article 109(1); (c) specific practical arrangements for the activation of the mechanism of administrative assistance provided for in Articles 102 to 108. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 4. For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.
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 19 Specific rules on official controls and for action taken by the competent authorities in relation to the residues of relevant substances in food and feed):
3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 4. For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.
Article 20 Specific rules on official controls and for action taken by the competent authorities in relation to animals, products of animal origin, germinal products, animal by-products and derived products
2. (a) specific requirements for the performance of official controls on animals, products of animal origin and germinal products to respond to recognised hazards and risks to human and animal health by means of official controls performed to verify compliance with disease prevention and control measures laid down in accordance with the rules referred to in point (d) of Article 1(2); specific requirements for the performance of official controls on animal by-products and derived products to respond to specific hazards and risks to human and animal health by means of official controls performed to verify compliance with the rules referred to in point (e) of Article 1(2); the cases where the competent authorities in relation to non-compliance or suspicion thereof are to take one or more of the measures referred to in Articles 137(2) and 138(2). 3. The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of official controls referred to in paragraph 1 regarding: uniform minimum frequency of such official controls on animals, products of animal origin and germinal products where a minimum level of official controls is necessary to respond to recognised uniform hazards and risks to human and animal health by means of official controls performed to verify compliance with disease prevention and control measures laid down in accordance with the rules referred to in point (d) of Article 1(2); and (b) uniform minimum frequency of such official controls on animal-by-products and derived products where a minimum level of official controls is necessary to respond to specific hazards and risks to human and animal health by means of official controls performed to verify compliance with the rules referred to in point (e) of Article 1(2). Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 4. For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.
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 20 Specific rules on official controls and for action taken by the competent authorities in relation to animals, products of animal origin, germinal products, animal by-products and derived products):
3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 4. For the purpose of Article 30, the delegation of certain official control tasks, referred to in this Article, to one or more natural persons shall be allowed.