Article 21 Specific rules on official controls and for action to be taken by the competent authorities in relation to the welfare requirements for animals
1. Official controls to verify compliance with the rules referred to in point (f) of Article 1(2) shall be performed at all relevant stages of production, processing and distribution along the agri-food chain. 2. Official controls to verify compliance with the rules laying down welfare requirements for animals in the event of their transport, in particular with Regulation (EC) No 1/2005, shall include: (a) in the case of long journeys between Member States and with third countries, official controls performed prior to the loading to check the fitness of the animals for transport; in the case of long journeys between Member States and with third countries, of domestic equidae other than registered equidae and domestic animals of the bovine, ovine, caprine and porcine species, and prior to those journeys: (i) official controls on journey logs to verify that the journey log is realistic and indicates compliance with Regulation (EC) No 1/2005; and (ii) official controls to verify that the transporter indicated in the journey log has a valid transporter authorisation, certificate of approval for the means of transport for long journeys and certificates of competence for drivers and attendants; at border control posts provided for in Article 59(1) and at exit points: (i) official controls on the fitness of the animals being transported and on the means of transport to verify compliance with Chapter II of Annex I to Regulation (EC) No 1/2005 and where applicable Chapter VI thereof; (ii) official controls to verify that transporters comply with applicable international agreements and have valid transporter authorisations and certificates of competence for drivers and attendants; and (iii) official controls to verify whether domestic equidae and domestic animals of bovine, ovine, caprine and porcine species have been or are to be transported over long journeys. 3. During the performance of official controls and other official activities, the competent authorities shall take the necessary measures to prevent or reduce to a minimum any delay between the loading of the animals and their departure, or during the transport. The competent authorities shall not detain animals during the transport unless it is strictly necessary for animal welfare or animal or human health reasons. If animals have to be detained during transport for more than two hours, the competent authorities shall ensure that appropriate arrangements are taken for their care and, where necessary, their feeding, watering, unloading and accommodation. 4. Where a non-compliance is established following the official controls referred to in point (b) of paragraph 2 and is not corrected by the organiser prior to the long journey, by making appropriate changes to the transport arrangements, the competent authorities shall prohibit that long journey. 5. Where, following the official controls referred to in point (c) of paragraph 2, the competent authorities establish that animals are not fit to complete the journey, they shall give the order that animals be unloaded, watered, fed and rested until fit to continue their journey. 6. A notification of non-compliance with the rules referred to in paragraph 1 of this Article for the purposes of Articles 105 and 106 shall be made: (a) to the Member States that granted the authorisation to the transporter; (b) where non-compliance with any such rule applicable to the means of transport is identified, to the Member State that granted the certificate of approval of the means of transport; (c) where non-compliance with any such rule applicable to drivers is identified, to the Member State that issued the driver’s certificate of competence. 7. 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. 8. 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 official controls to verify compliance with Union rules referred to in point (f) of Article 1(2). Those delegated acts shall take into account the animal welfare risk related to the farming activities and to the transport, slaughter and killing of animals, and shall lay down rules on: (a) specific requirements for the performance of such official controls to respond to the risk associated with different animal species and means of transport, and the need to prevent non-compliant practices and to limit the suffering of animals; 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); (c) the verification of animal welfare requirements at border control posts and at exit points and the minimum requirements applicable to those exit points; (d) specific criteria and conditions for the activation of the mechanisms of administrative assistance provided for in Articles 102 to 108; (e) the cases and conditions where official controls to verify compliance with animal welfare requirements may include the use of specific animal welfare indicators based on measurable performance criteria, and the design of such indicators on the basis of scientific and technical evidence. 9. The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements on official controls performed to verify compliance with the Union rules referred to in point (f) of Article 1(2) laying down animal welfare requirements and on action taken by the competent authorities following such official controls, regarding: (a) uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to the risk associated with different animal species and means of transport, and the need to prevent non-compliant practices and to limit the suffering of animals; and (b) the practical arrangements for keeping written records of official controls performed and their retention period. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 21 Specific rules on official controls and for action to be taken by the competent authorities in relation to the welfare requirements for animals):
1. Official controls to verify compliance with the rules referred to in point (f) of Article 1(2) shall be performed at all relevant stages of production, processing and distribution along the agri-food chain. 3. During the performance of official controls and other official activities, the competent authorities shall take the necessary measures to prevent or reduce to a minimum any delay between the loading of the animals and their departure, or during the transport. The competent authorities shall not detain animals during the transport unless it is strictly necessary for animal welfare or animal or human health reasons. If animals have to be detained during transport for more than two hours, the competent authorities shall ensure that appropriate arrangements are taken for their care and, where necessary, their feeding, watering, unloading and accommodation. 4. Where a non-compliance is established following the official controls referred to in point (b) of paragraph 2 and is not corrected by the organiser prior to the long journey, by making appropriate changes to the transport arrangements, the competent authorities shall prohibit that long journey. 5. Where, following the official controls referred to in point (c) of paragraph 2, the competent authorities establish that animals are not fit to complete the journey, they shall give the order that animals be unloaded, watered, fed and rested until fit to continue their journey. 7. 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. 9. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 22 Specific rules on official controls and for action taken by the competent authorities in relation to plant health
1. Official controls to verify compliance with the rules referred to in point (g) of Article 1(2) shall include official controls on pests, plants, plant products and other objects, and on professional operators and other persons subject to those rules. 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 official controls on plants, plant products and other objects in order to verify compliance with Union rules referred to in point (g) of Article 1(2) applicable to those goods and for action taken by the competent authorities following the performance of those official controls. Those delegated acts shall lay down rules on: specific requirements for the performance of such official controls on the introduction into and movement in the Union of particular plants, plant products, and other objects subject to the rules referred to in point (g) of Article 1(2), to respond to recognised hazards and risks to plant health in relation to specific plants, plant products and other objects of a particular origin or provenance; and 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). 3. The Commission shall, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of official controls on plants, plant products and other objects in order to verify compliance with Union rules referred to in point (g) of Article 1(2) applicable to those goods and for action taken by the competent authorities following such official controls on: (a) uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to recognised uniform hazards and risks to plant health in relation to specific plants, plant products and other objects of a particular origin or provenance; uniform frequency of official controls performed by competent authorities on operators authorised to issue plant passports in accordance with Article 84(1) of Regulation (EU) 2016/2031 having regard to whether those operators have implemented a pest risk management plan as referred to in Article 91 of that Regulation for the plants, plant products and other objects they produce; (c) uniform frequency of official controls performed by competent authorities on operators authorised to apply the mark referred to in Article 96(1) of Regulation (EU) 2016/2031 or to issue the official attestation referred to in point (a) of Article 99(2) of that Regulation. 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 22 Specific rules on official controls and for action taken by the competent authorities in relation to plant health):
1. Official controls to verify compliance with the rules referred to in point (g) of Article 1(2) shall include official controls on pests, plants, plant products and other objects, and on professional operators and other persons subject to those rules. 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 23 Specific rules on official controls and for action taken by the competent authorities in relation to GMOs for the purpose of food and feed production and genetically modified 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 such official controls. Those delegated acts shall take into account the need to ensure a minimum level of official controls to prevent practices that infringe the rules referred to in point (b) of Article 1(2), and lay down: specific requirements for the performance of official controls to respond to recognised uniform hazards and risks of: (i) the presence in the agri-food chain of GMOs for food and feed production and of genetically modified food and feed which have not been authorised in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003; 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). 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, taking into account the need to ensure a minimum level of official controls to prevent practices that infringe those rules regarding uniform minimum frequency of such official controls where a minimum level of official control is necessary to respond to recognised uniform hazards and risks of: (b) the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in point (e) of Article 13(2) of Directive 2001/18/EC and in point (b) of Article 5(5) and point (b) of Article 17(5) of Regulation (EC) No 1829/2003. 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 23 Specific rules on official controls and for action taken by the competent authorities in relation to GMOs for the purpose of food and feed production and genetically modified 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 24 Specific rules on official controls and for action taken by the competent authorities in relation to plant protection products
2. For the purpose of establishing the frequency of risk based official controls referred to in paragraph 1, competent authorities shall take into account also the following: results of relevant monitoring activities including those on pesticides residues carried out for the purpose of Article 32(2) of Regulation (EC) No 396/2005 and of Article 8 of Directive 2000/60/EC of the European Parliament and of the Council ( 10 ); (b) information on non-authorised plant protection products, including illegal trade of plant protection product, and results of relevant controls by the authorities referred to in Article 8 of Regulation (EU) No 649/2012 of the European Parliament and of the Council ( 11 ); and 3. 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 official controls referred to in paragraph 1 of this Article. Those delegated acts shall lay down rules on: (a) specific requirements for the performance of such official controls to respond to recognised uniform hazards and risks which might be posed by plant protection products, concerning the manufacture, placing on the market, entry into the Union, labelling, packaging, transport, storage and use of plant protection products to ensure their safe and sustainable use and to combat their illegal trade; and 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). 4. The Commission may, by means of implementing acts, lay down detailed rules on uniform practical arrangements for the performance of official controls on the products referred to in paragraph 1 regarding: (a) uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to recognised uniform hazards and risks which might be posed by plant protection products, concerning the manufacture, placing on the market, entry into the Union, labelling, packaging, transport, storage and use of plant protection products to ensure their safe and sustainable use and to combat their illegal trade; (b) the collection of information, monitoring and reporting on suspected poisonings from plant protection products; (c) the collection of information, and the monitoring of and reporting on non-authorised plant protection products including illegal trade of plant protection products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 5. 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 24 Specific rules on official controls and for action taken by the competent authorities in relation to plant protection products):
4. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 5. 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 25 Specific rules on official controls and other official activities for organic production and labelling of organic products
The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of official controls to verify compliance with the rules referred to in point (i) of Article 1(2), regarding: (a) specific requirements and additional content to that provided for in Article 110 to prepare the relevant parts of the MANCP provided for in Article 109(1), and specific additional content to the report provided for in Article 113; (b) specific responsibilities and tasks for the European Union reference centres in addition to those provided for in Article 98; (c) practical arrangements for activating the mechanisms of administrative assistance provided for in Articles 102 to 108, including the exchange of information concerning instances of non-compliance or the likelihood of non-compliance between competent authorities and delegated bodies; (d) the methods to be used for sampling and for laboratory analyses and tests, excluding any rules involving the setting of thresholds. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 26 Specific rules on official controls and other official activities performed by the competent authorities in relation to protected designations of origin, protected geographical indications and traditional specialities guaranteed
(a) ordering that certain activities of the operator be subject to systematic or increased official controls; (b) ordering the operator to increase the frequency of own controls; ordering the alteration of label in order to comply with the product specifications and the rules referred in point (j) of Article 1(2). 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 official controls to verify compliance with the rules referred to in point (j) of Article 1(2). Those delegated acts shall lay down rules on: (a) requirements, methods and techniques referred to in Articles 12 and 14 for official controls performed to verify compliance with product specifications and labelling requirements; specific methods and techniques referred to in Article 14 for the performance of official controls aimed at ensuring the traceability of goods and animals falling within the scope of the rules referred to in point (j) of Article 1(2) at all stages of production, preparation and distribution, and at providing assurances as to compliance with those rules; the cases where the competent authorities, in relation to specific non-compliances, are to take one or more of the actions and measures referred to in Article 138(1) and (2). 3. The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements for the performance of the official controls to verify compliance with the rules referred to in point (j) of Article 1(2) regarding: (a) specific practical arrangements for activating the mechanisms of administrative assistance provided for in Articles 102 to 108, including the exchange of information concerning instances of non-compliance or the likelihood of non-compliance between competent authorities and delegated bodies; and (b) specific reporting obligations of the delegated bodies. 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 26 Specific rules on official controls and other official activities performed by the competent authorities in relation to protected designations of origin, protected geographical indications and traditional specialities guaranteed):
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 27 Specific rules on official controls and for action taken by the competent authorities in cases of newly identified risks in relation to food and feed
(a) uniform specific requirements for the performance of official controls to respond to the specific hazards and risks which exist in relation to each category of food and feed and the different processes it undergoes; and (b) 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). 2. The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements on official controls performed on certain categories of food or feed to verify compliance with the rules referred to in points (a) to (e) of Article 1(2) to address newly identified risks which may arise through food or feed to human or animal health or, in relation to GMOs and plant protection products, also to the environment, or any such risks emerging from new patterns of production or consumption of food or feed, and which cannot be effectively addressed in the absence of such common rules regarding uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to the specific hazards and risks which exist in relation to each category of food and feed and the different processes it undergoes. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 3. On duly justified imperative grounds of urgency relating to cases of serious risks to human or animal health or to the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 27 Specific rules on official controls and for action taken by the competent authorities in cases of newly identified risks in relation to food and feed):
2. The Commission may, by means of implementing acts, lay down rules on uniform practical arrangements on official controls performed on certain categories of food or feed to verify compliance with the rules referred to in points (a) to (e) of Article 1(2) to address newly identified risks which may arise through food or feed to human or animal health or, in relation to GMOs and plant protection products, also to the environment, or any such risks emerging from new patterns of production or consumption of food or feed, and which cannot be effectively addressed in the absence of such common rules regarding uniform minimum frequency of such official controls, where a minimum level of official control is necessary to respond to the specific hazards and risks which exist in relation to each category of food and feed and the different processes it undergoes. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2). 3. On duly justified imperative grounds of urgency relating to cases of serious risks to human or animal health or to the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 145(3).
Article 28 Delegation by the competent authorities of certain official control tasks
1. Competent authorities may delegate certain official control tasks to one or more delegated bodies or natural persons in accordance with the conditions provided for in Articles 29 and 30 respectively. The competent authority shall ensure that the delegated body or natural person, to which such tasks have been delegated, have the powers needed to effectively perform these tasks. 2. Where a competent authority or a Member State decides to delegate certain official control tasks for the verification of compliance with the rules referred to in point (i) of Article 1(2) to one or more delegated bodies, it shall attribute a code number to each delegated body, and shall designate relevant authorities responsible for their approval and supervision.
Article 29 Conditions for delegating certain official control tasks to delegated bodies
The delegation of certain official control tasks to a delegated body referred to in Article 28(1) shall be in writing and shall comply with the following conditions: (a) the delegation contains a precise description of those official control tasks that the delegated body may perform, and the conditions under which it may perform those tasks; the delegated body: (i) has the expertise, equipment and infrastructure required to perform those official control tasks delegated to it; (ii) has a sufficient number of suitably qualified and experienced staff; (iii) is impartial and free from any conflict of interest and in particular is not in a situation which may, directly or indirectly, affect the impartiality of its professional conduct as regards the performance of those official control tasks delegated to it; (iv) works and is accredited in accordance with standards relevant to the delegated tasks in question, including standard EN ISO/IEC 17020 ‘Requirements for the operation of various types of bodies performing inspection’; (v) has sufficient powers to perform the official control tasks delegated to it; and (c) there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the delegated body.
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 29 Conditions for delegating certain official control tasks to delegated bodies):
The delegation of certain official control tasks to a delegated body referred to in Article 28(1) shall be in writing and shall comply with the following conditions: (a) the delegation contains a precise description of those official control tasks that the delegated body may perform, and the conditions under which it may perform those tasks; (c) there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the delegated body.
Article 30 Conditions for delegating certain official control tasks to natural persons
Competent authorities may delegate certain official control tasks to one or more natural persons, where the rules provided for in Articles 18 to 27 so allow. Such delegation shall be in writing and shall comply with the following conditions: (a) the delegation contains a precise description of those official control tasks that the natural persons may perform and the conditions under which the natural persons may perform those tasks; the natural persons: (i) have the expertise, equipment and infrastructure required to perform those official control tasks delegated to them; (ii) are suitably qualified and experienced; (iii) act impartially and are free from any conflict of interest as regards the exercise of those official control tasks delegated to them; and (c) there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the natural persons.
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 30 Conditions for delegating certain official control tasks to natural persons):
Competent authorities may delegate certain official control tasks to one or more natural persons, where the rules provided for in Articles 18 to 27 so allow. Such delegation shall be in writing and shall comply with the following conditions: (a) the delegation contains a precise description of those official control tasks that the natural persons may perform and the conditions under which the natural persons may perform those tasks; (c) there are arrangements in place ensuring efficient and effective coordination between the delegating competent authorities and the natural persons.
Article 31 Conditions for delegating certain tasks related to other official activities
1. The competent authorities may delegate certain tasks related to other official activities to one or more delegated bodies subject to compliance with the following conditions: (a) the rules referred to in Article 1(2) do not prohibit such delegation; and the conditions laid down in Article 29 are fulfilled with the exception of that laid down in point (b)(iv). 2. The competent authorities may delegate certain tasks related to other official activities to one or more natural persons subject to compliance with the following conditions: (a) the rules referred to in Article 1(2) allow such delegation; and (b) the conditions laid down in Article 30, applied mutatis mutandis , are fulfilled. 3. Competent authorities shall not delegate to a delegated body or to a natural person the decision concerning the tasks provided for in point (b) of Article 138(1) and in Article 138(2) and (3).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 31 Conditions for delegating certain tasks related to other official activities):
3. Competent authorities shall not delegate to a delegated body or to a natural person the decision concerning the tasks provided for in point (b) of Article 138(1) and in Article 138(2) and (3).
Article 32 Obligations of the delegated bodies and natural persons
Delegated bodies or natural persons to which certain official control tasks have been delegated in accordance with Article 28(1), or certain tasks related to other official activities have been delegated in accordance with Article 31, shall: (a) communicate the outcome of the official controls and other official activities performed by them to the delegating competent authorities on a regular basis and whenever those competent authorities so request; (b) immediately inform the delegating competent authorities whenever the outcome of the official controls indicate non-compliance or point to the likelihood of non-compliance, unless specific arrangements established between the competent authority and the delegated body or the natural person concerned provides otherwise; and (c) give competent authorities access to their premises and facilities and cooperate and provide assistance.
Article 33 Obligations of the delegating competent authorities
Competent authorities that have delegated certain official control tasks to delegated bodies or natural persons in accordance with Article 28(1), or certain tasks related to other official activities to delegated bodies or natural persons in accordance with Article 31, shall: organise audits or inspections of such bodies or persons, as necessary and avoiding duplication, taking into account any accreditation referred to in point (b)(iv) of Article 29; fully or partly withdraw the delegation without delay where: (i) there is evidence that such a delegated body or natural person is failing to properly perform the tasks delegated to it; (ii) the delegated body or the natural person fails to take appropriate and timely action to remedy the shortcomings identified; or (iii) the independence or impartiality of the delegated body or natural person has been shown to be compromised. This point shall be without prejudice to the competence of the competent authorities to withdraw the delegation for reasons other than those referred to in this Regulation.
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 33 Obligations of the delegating competent authorities):
Competent authorities that have delegated certain official control tasks to delegated bodies or natural persons in accordance with Article 28(1), or certain tasks related to other official activities to delegated bodies or natural persons in accordance with Article 31, shall:
Article 34 Methods used for sampling, analyses, tests and diagnoses
1. Methods used for sampling and for laboratory analyses, tests and diagnoses during official controls and other official activities shall comply with Union rules establishing those methods or the performance criteria for those methods. 2. In the absence of the Union rules as referred to in paragraph 1, and in the context of official controls and other official activities, official laboratories shall use one of the following methods according to the suitability for their specific analytical, testing and diagnostic needs: (a) available methods complying with relevant internationally recognised rules or protocols including those that the European Committee for Standardisation (CEN) has accepted; or relevant methods developed or recommended by the European Union reference laboratories and validated in accordance with internationally accepted scientific protocols; available methods complying with relevant internationally recognised rules or protocols including those that the European Committee for Standardisation (CEN) has accepted; or relevant methods developed or recommended by the European Union reference laboratories and validated in accordance with internationally accepted scientific protocols; (b) in the absence of the suitable rules or protocols, as referred to in point (a), methods which comply with relevant rules established at national level, or, if no such rules exist, relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or relevant methods developed and validated with inter or intra-laboratory methods validation studies in accordance with internationally accepted scientific protocols. in the absence of the suitable rules or protocols, as referred to in point (a), methods which comply with relevant rules established at national level, or, if no such rules exist, relevant methods developed or recommended by national reference laboratories and validated in accordance with internationally accepted scientific protocols; or relevant methods developed and validated with inter or intra-laboratory methods validation studies in accordance with internationally accepted scientific protocols. 3. Where laboratory analyses, tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2 of this Article exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 37(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols. 4. Wherever possible, methods used for laboratory analyses shall be characterised by the relevant criteria set out in Annex III. 5. Samples shall be taken, handled and labelled in such a way as to ensure their legal, scientific and technical validity. 6. The Commission may, by means of implementing acts, lay down rules on: (a) the methods to be used for sampling and for laboratory analyses, tests and diagnoses; (b) performance criteria, analysis, test or diagnosis parameters, measurement uncertainty and procedures for the validation of those methods; (c) the interpretation of analytical, testing and diagnostic results. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency. 
Revised version (Article 34 Methods used for sampling, analyses, tests and diagnoses):
1. Methods used for sampling and for laboratory analyses, tests and diagnoses during official controls and other official activities shall comply with Union rules establishing those methods or the performance criteria for those methods. 3. Where laboratory analyses, tests or diagnoses are urgently needed and none of the methods referred to in paragraphs 1 and 2 of this Article exists, the relevant national reference laboratory or, if no such national reference laboratory exists, any other laboratory designated in accordance with Article 37(1) may use methods other than those referred to in paragraphs 1 and 2 of this Article until the validation of an appropriate method in accordance with internationally accepted scientific protocols. 4. Wherever possible, methods used for laboratory analyses shall be characterised by the relevant criteria set out in Annex III. 5. Samples shall be taken, handled and labelled in such a way as to ensure their legal, scientific and technical validity. 6. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 35 Second expert opinion
1. The competent authorities shall ensure that operators, whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls, have the right to a second expert opinion, at the operator’s own expense. The right to a second expert opinion shall entitle the operator to request a documentary review of the sampling, analysis, test or diagnosis by another recognised and appropriately qualified expert. 2. Where relevant, appropriate and technically feasible, having regard in particular to the prevalence and distribution of the hazard in the animals or goods, to the perishability of the samples or the goods and to the amount of available substrate, the competent authorities shall: (a) when taking the sample, and if so requested by the operator, ensure that a sufficient quantity is taken to allow for a second expert opinion and for the review referred to in paragraph 3, should this prove necessary; or (b) where it is not possible to take a sufficient quantity as referred to in point (a), inform the operator thereof. This paragraph shall not apply when assessing the presence of quarantine pests in plants, plant products or other objects for the purpose of verifying compliance with the rules referred to in point (g) of Article 1(2). 3. Member States may decide that, where there is a dispute between the competent authorities and the operators that is based on the second expert opinion referred to in paragraph 1, the operators may request, at their own expense, the documentary review of the initial analysis, test or diagnosis and, where appropriate, another analysis, test or diagnosis by another official laboratory. 4. The application by the operator for a second expert opinion under paragraph 1 of this Article shall not affect the obligation of competent authorities to take prompt action to eliminate or contain the risks to human, animal and plant health, or 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).
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 35 Second expert opinion):
1. The competent authorities shall ensure that operators, whose animals or goods are subject to sampling, analysis, test or diagnosis in the context of official controls, have the right to a second expert opinion, at the operator’s own expense. The right to a second expert opinion shall entitle the operator to request a documentary review of the sampling, analysis, test or diagnosis by another recognised and appropriately qualified expert. This paragraph shall not apply when assessing the presence of quarantine pests in plants, plant products or other objects for the purpose of verifying compliance with the rules referred to in point (g) of Article 1(2). 3. Member States may decide that, where there is a dispute between the competent authorities and the operators that is based on the second expert opinion referred to in paragraph 1, the operators may request, at their own expense, the documentary review of the initial analysis, test or diagnosis and, where appropriate, another analysis, test or diagnosis by another official laboratory. 4. The application by the operator for a second expert opinion under paragraph 1 of this Article shall not affect the obligation of competent authorities to take prompt action to eliminate or contain the risks to human, animal and plant health, or 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 36 Sampling of animals and goods offered for sale by means of distance communication
1. In the case of animals and goods offered for sale by means of distance communication, samples ordered from operators by the competent authorities without identifying themselves may be used for the purposes of an official control. 2. Competent authorities, once they are in possession of the samples, shall take all steps to ensure that the operators from whom these samples have been ordered in accordance with paragraph 1: (a) are informed that such samples have been taken in the context of an official control and, where appropriate, are analysed or tested for the purposes of such official control; and (b) where the samples referred to in that paragraph are analysed or tested, are able to exercise the right to a second expert opinion, as provided for in Article 35(1). 3. Paragraphs 1 and 2 shall apply to delegated bodies and natural persons to which certain official controls tasks 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 36 Sampling of animals and goods offered for sale by means of distance communication):
1. In the case of animals and goods offered for sale by means of distance communication, samples ordered from operators by the competent authorities without identifying themselves may be used for the purposes of an official control. 3. Paragraphs 1 and 2 shall apply to delegated bodies and natural persons to which certain official controls tasks have been delegated.
Article 37 Designation of official laboratories
1. The competent authorities shall designate official laboratories to carry out the laboratory analyses, tests and diagnoses on samples taken during official controls and other official activities, in the Member State in whose territory those competent authorities operate or in another Member State or a third country that is a Contracting Party to the Agreement on the European Economic Area. 2. Competent authorities may designate as an official laboratory a laboratory located in another Member State or third country that is a Contracting Party to the Agreement on the European Economic Area, subject to compliance with the following conditions: (a) appropriate arrangements are in place under which the competent authorities are enabled to perform the audits and inspections referred to in Article 39(1) or delegate the performance of such audits and inspections to the competent authorities of the Member State or third country that is a Contracting Party to the Agreement on the European Economic Area where the laboratory is located; and (b) that laboratory is already designated as an official laboratory by the competent authorities of the Member State on whose territory it is located. 3. The designation of an official laboratory shall be in writing and shall include a detailed description of: (a) the tasks that the laboratory carries out as an official laboratory; (b) the conditions under which it carries out the tasks referred to in point (a); and (c) the arrangements necessary to ensure efficient and effective coordination and collaboration between the laboratory and the competent authorities. 4. The competent authorities may only designate as an official laboratory a laboratory which: (a) has the expertise, equipment and infrastructure required to carry out analyses or tests or diagnoses on samples; (b) has a sufficient number of suitably qualified, trained and experienced staff; (c) ensures that the tasks conferred upon it as set out in paragraph 1 are performed impartially and which is free from any conflict of interest as regards the exercise of its tasks as an official laboratory; (d) can deliver in a timely manner the results of the analysis, test or diagnosis carried out on the samples taken during official controls and other official activities; and (e) operates in accordance with the standard EN ISO/IEC 17025 and is accredited in accordance with that standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008. 5. The scope of the accreditation of an official laboratory as referred to in point (e) of paragraph 4: (a) shall include those methods of laboratory analysis, test or diagnosis required to be used by the laboratory for analyses, tests or diagnoses, when it operates as an official laboratory; (b) may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods; (c) may be defined in a flexible manner, so as to allow the scope of accreditation to include modified versions of the methods used by the official laboratory when the accreditation was granted or new methods in addition to those methods, on the basis of the laboratory’s own validations without a specific assessment by the national accreditation body prior to the use of those modified or new methods. 6. Where no official laboratory designated in the Union or in a third country that is a Contracting Party to the Agreement on the European Economic Area in accordance with paragraph 1 has the expertise, equipment, infrastructure and staff necessary to perform new or particularly uncommon laboratory analyses, tests or diagnoses, the competent authorities may request a laboratory or diagnostic centre which does not comply with one or more of the requirements set out in paragraphs 3 and 4 to carry out those analyses, tests and diagnoses.
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 37 Designation of official laboratories):
1. The competent authorities shall designate official laboratories to carry out the laboratory analyses, tests and diagnoses on samples taken during official controls and other official activities, in the Member State in whose territory those competent authorities operate or in another Member State or a third country that is a Contracting Party to the Agreement on the European Economic Area. 6. Where no official laboratory designated in the Union or in a third country that is a Contracting Party to the Agreement on the European Economic Area in accordance with paragraph 1 has the expertise, equipment, infrastructure and staff necessary to perform new or particularly uncommon laboratory analyses, tests or diagnoses, the competent authorities may request a laboratory or diagnostic centre which does not comply with one or more of the requirements set out in paragraphs 3 and 4 to carry out those analyses, tests and diagnoses.
Article 38 Obligations of official laboratories
1. Where the results of an analysis, test or diagnosis carried out on samples taken during official controls or other official activities indicate a risk to human, animal or plant health, or, as regards GMOs and plant protection products, also to the environment, or point to the likelihood of non-compliance, official laboratories shall inform immediately the competent authorities which designated them for that analysis, test or diagnosis and, where relevant, delegated bodies or natural persons to which tasks have been delegated. However, specific arrangements between the competent authorities, delegated bodies or natural persons to which tasks have been delegated and the official laboratories may specify that this information is not required to be provided immediately. 2. Upon request by the European Union reference laboratory or national reference laboratory, official laboratories shall take part in inter-laboratory comparative tests or proficiency tests that are organised for the analyses, tests or diagnoses they perform as official laboratories. 3. Official laboratories shall, upon request of the competent authorities, make available to the public the names of the methods used for analyses, tests or diagnoses performed in the context of official controls and other official activities. 4. Official laboratories shall indicate, at the request of the competent authorities, together with the results, the method used for each analysis, testing or diagnosis, performed in the context of official controls and other official activities.
Article 39 Audits of official laboratories
2. The competent authorities shall immediately withdraw the designation of an official laboratory, either completely or for certain tasks, where it fails to take appropriate and timely remedial action following the results of an audit provided for in paragraph 1 which disclose any of the following: it no longer complies with the conditions provided for in Article 37(4) and (5); (b) it does not comply with the obligations provided for in Article 38; (c) it is underperforming at inter-laboratory comparative tests referred to in Article 38(2).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal Legislation on protective measures against pests of plants or plant products has been established at Union level since the 1970s. That legislation has been of major importance for the protection of the agriculture, the landscape and the environment in the Union. The first evaluation and revision of the Union phytosanitary policy took place between 2008 and 2016 and resulted in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 . Th e Regulation is currently the basic legal framework for the U nion plant health policy. Article 50 and Article 79(6) of the Regulation prescribed that the Commission submits, by the end of 2021, to the European Parliament and the Council reports on the enforcement and effectiveness of the import measures, and the experience gained by operators from the extension of the plant passport to all plants for planting (‘the reports submitted in accordance with Article 50 and Article 79(6)’). The Commission submitted those reports on 10 December 2021. The report on import measures concluded that it could be considered that those import measures, as well the inclusion of the plant health controls within the scope of Regulation (EU) 2017/625 of the European Parliament and of the Council 3 have contributed towards achieving the objectives to enhance the phytosanitary protection of the Union and to increase proactive action against pests in compliance with the rules of the International Plant Protection Convention ( IPPC) through risk-based and transparent approaches. The report on the extension of the plant passport system to all plants for planting concluded that that extension has contributed towards achieving the objectives of the Regulation. More specifically it contributed to increased effectiveness of the protection against quarantine pests, improved preparedness for the identification of new plant pests of Union concern, improved understanding and awareness on the part of relevant stakeholders concerning the plant health importance, and increased possibility to identify pests. The reports identified areas for further discussion to enhance the effectiveness and practical implementation of the rules for plant health but also for official controls. Those discussions took place in 2022 with the Member States’ Chief Plant Health Officers, as well as with Union associations relevant to plant health. They led to the conclusion that certain improvements of the system were needed, which were only possible by amending the Regulation. Those improvements refer to the need for (i) declarations on the phytosanitary certificate for regulated non-quarantine pests (RNQPs), (ii) reporting the non-compliances with the RNQP rules in the electronic notification notification system (Information Management System for Official Controls – IMSOC), (iii) procedural rules for the submission and examination of non-EU countries’ requests for temporary derogations from import prohibitions, (iv) procedures for identifying and listing of high-risk plants and (v) rationalising the obligation to attach a plant passport to certain plants. Further improvements were identified through elements deriving from the experience gained by the Commission during the first 5 years of the application of the Regulation, with regard to (i) measures against pests qualifying as quarantine pests but not yet fully assessed, (ii) the need for autonomous acts for adopting temporary derogations from import prohibitions, and special import requirements, (iii) the need for setting temporary import requirements for the introduction into the Union of palnts, plant products or other objects which have been removed from the list of high risk plants but for which the phytosanitary risk has not been fully assesed, (iv) setting out requirements for third countries’ equivalence, and (v) the alternative official attestations. Finally, certain reporting elements were identified as falling under the scope of the Commission’s commitment to rationalise the reporting obligations of Member States and professional operators on the basis of its Communication on ‘ Long-term competitiveness of the EU: looking beyond 2030’ 4 . Rationalisation of the reporting obligations As regards the rationalisiation of reporting obligations, the Commission has taken a horizontal initiative. In its Communication on ‘Long-term competitiveness of the EU: looking beyond 2030’, it stressed the importance of a regulatory system that ensures that objectives are reached at minimum costs. It has committed therefore to a fresh push to rationalise and simplify reporting requirements, with the ultimate aim to reduce such burdens by 25%, without undermining the related policy objectives. Its overall objectives are summarised as follows: (a) to improve legal certainty and clarity for competent authorities and professional operators, both in the Union and in third countries; (b) to increase transparency, flexibility and consistency of the Union regulatory procedures; (c) to contribute through digitalisation, to the rationalisation of reporting obligations and the administrative tasks linked to them . Reporting requirements play a key role in ensuring correct enforcement and proper monitoring of legislation. Their costs are overall largely offset by the benefit they bring, in particular in monitoring and ensuring compliance with key policy measures. Reporting requirements can however also impose disproportionate burden on stakeholders, particularly affecting SMEs and micro-companies. Their cumulation over time can result in redundant, duplicating or obsolete obligations, inefficient frequency and timing, or inadequate methods of collection. The proposal thus aims also at rationalising reporting obligations by a combination of measures: – removal of reports which are not necessary any longer; – digitalisation of transmission of information; – reduction of frequency of reporting requirements The reporting requirements concern public authorities and, in certain cases, indirectly, professional operators. According to the proposed amendments, certain reporting obligations are removed, while others are digitalised or are requested with reduced frequency.
Article 40 Derogations from the condition for the mandatory accreditation for certain official laboratories
1. By way of derogation from point (e) of Article 37(4), competent authorities may designate the following as official laboratories irrespective of whether they fulfil the condition provided for in that point: laboratories: (i) whose sole activity is the detection of Trichinella in meat; (ii) that only use the methods of detection of Trichinella referred to in Article 6 of Commission Implementing Regulation (EU) 2015/1375 ( 13 ); that carry out the detection of Trichinella under the supervision of the competent authorities or of an official laboratory designated in accordance with Article 37(1) and accredited in accordance with the standard EN ISO/IEC 17025 for the use of the methods referred to in point (ii) of this point; and (iv) that participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories for the methods they use for the detection of Trichinella ; laboratories which only carry out analyses, tests or diagnoses in the context of other official activities, provided that they: (ii) carry out the analyses, tests or diagnoses under the supervision of the competent authorities or of the national reference laboratories in relation to the methods they use; (iii) participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories in relation to the methods they use; and (iv) have a quality assurance system in place to ensure sound and reliable results from the methods for laboratory analysis, test and diagnosis used. 2. Where the methods used by the laboratories referred to in point (b) of paragraph 1 of this Article require confirmation of the result of the laboratory analysis, test or diagnosis, the confirmatory laboratory analysis, test or diagnosis shall be carried out by an official laboratory which complies with the requirements set out in point (e) of Article 37(4). 3. The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.
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 40 Derogations from the condition for the mandatory accreditation for certain official laboratories):
2. Where the methods used by the laboratories referred to in point (b) of paragraph 1 of this Article require confirmation of the result of the laboratory analysis, test or diagnosis, the confirmatory laboratory analysis, test or diagnosis shall be carried out by an official laboratory which complies with the requirements set out in point (e) of Article 37(4). 3. The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.
Article 41 Powers to adopt derogations from the condition for the mandatory accreditation of all the methods of laboratory analysis, test and diagnosis used by official laboratories
(a) they operate and are accredited in accordance with the standard EN ISO/IEC 17025 for the use of one or more methods which are similar to and representative of the other methods they use; and (b) they make regular and significant use of the methods for which they have obtained the accreditation referred to in point (a) of this Article; except, as regards the area governed by the rules referred to in point (g) of Article 1(2), where a validated method for the detection of the particular pests of plants referred to in Article 34(1) and (2) does not exist.
Article 42 Temporary derogations from the conditions of the mandatory accreditation for official laboratories
(a) when the use of that method is newly required by Union rules; (b) when changes to a method in use require a new accreditation or an extension of the scope of the accreditation obtained by the official laboratory; or (c) in cases where the need for the use of the method results from an emergency situation or an emerging risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment. 2. The temporary designation referred to in paragraph 1 shall be subject to the following conditions: (a) the official laboratory is already accredited in accordance with the standard EN ISO/IEC 17025 for the use of a method which is similar to the one not included within the scope of its accreditation; (b) a quality assurance system is in place in the official laboratory to ensure sound and reliable results by using a method which is not included within the scope of the existing accreditation; (c) the analyses, tests or diagnoses are carried out under the supervision of the competent authorities or the national reference laboratory for that method. 3. The temporary designation provided for in paragraph 1 shall not exceed a period of one year. It may be renewed once for a further period of one year. 4. The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.
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 42 Temporary derogations from the conditions of the mandatory accreditation for official laboratories):
3. The temporary designation provided for in paragraph 1 shall not exceed a period of one year. It may be renewed once for a further period of one year. 4. The official laboratories designated in accordance with paragraph 1 shall be located in the Member States in whose territory the competent authorities which have designated them are located.
Article 43 Official controls on animals and goods entering the Union
Official controls on animals and goods entering the Union shall be organised on a risk basis. In relation to animals and goods referred to in Articles 47 and 48, such official controls shall be performed in accordance with Articles 47 to 64.
Article 44 Official controls on animals and goods other than those subject to official controls at border control posts under Section II
1. To ascertain compliance with the rules referred to in Article 1(2), the competent authorities shall perform official controls regularly, on a risk basis and with appropriate frequency, on animals and goods entering the Union and to which Articles 47 and 48 do not apply. 2. On animals and goods referred to in paragraph 1 the appropriate frequency of the official controls shall be determined, taking into account: (a) the risks to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, associated with different types of animals and goods; (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 goods; the history of compliance with the requirements established by the rules referred to in Article 1(2) applicable to the animals or goods concerned: (i) of the third country and establishment of origin or place of production, as appropriate; (ii) of the exporter; (iii) of the operator responsible for the consignment; (d) the controls that have already been performed on the animals and goods concerned; and (e) the guarantees that the competent authorities of the third country of origin have given with regard to compliance of the animals and goods with the requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto. 3. The official controls provided for in paragraph 1 shall be performed at an appropriate place within the customs territory of the Union, including: (a) the point of entry into the Union; (b) a border control post; (c) the point of release for free circulation in the Union; (d) the warehouses and the premises of the operator responsible for the consignment; (e) the place of destination. 4. Notwithstanding paragraphs 1 and 3, the competent authorities at border control posts and other points of entry into the Union shall perform official controls on the following whenever they have reason to believe that their entry into the Union may pose a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment: (a) means of transport, including where empty; and (b) packaging, including pallets. 5. The competent authorities may also perform official controls on goods that are placed under one of the customs procedures defined in point (16)(a), (b) and (c) of Article 5 of Regulation (EU) No 952/2013 and in a temporary storage defined in point (17) of Article 5 of that Regulation.
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 44 Official controls on animals and goods other than those subject to official controls at border control posts under Section II):
1. To ascertain compliance with the rules referred to in Article 1(2), the competent authorities shall perform official controls regularly, on a risk basis and with appropriate frequency, on animals and goods entering the Union and to which Articles 47 and 48 do not apply. On animals and goods referred to in paragraph 1 the appropriate frequency of the official controls shall be determined, taking into account: (a) the risks to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, associated with different types of animals and goods; (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 goods; the history of compliance with the requirements established by the rules referred to in Article 1(2) applicable to the animals or goods concerned: (i) of the third country and establishment of origin or place of production, as appropriate; (ii) of the exporter; (iii) of the operator responsible for the consignment; (d) the controls that have already been performed on the animals and goods concerned; and (e) the guarantees that the competent authorities of the third country of origin have given with regard to compliance of the animals and goods with the requirements established by the rules referred to in Article 1(2) or with requirements recognised to be at least equivalent thereto. The official controls provided for in paragraph 1 shall be performed at an appropriate place within the customs territory of the Union, including: (a) the point of entry into the Union; (b) a border control post; (c) the point of release for free circulation in the Union; (d) the warehouses and the premises of the operator responsible for the consignment; (e) the place of destination. 4. Notwithstanding paragraphs 1 and 3, the competent authorities at border control posts and other points of entry into the Union shall perform official controls on the following whenever they have reason to believe that their entry into the Union may pose a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment: (a) means of transport, including where empty; and (b) packaging, including pallets. Notwithstanding paragraphs 1 and 3, the competent authorities at border control posts and other points of entry into the Union shall perform official controls on the following whenever they have reason to believe that their entry into the Union may pose a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment: (a) means of transport, including where empty; and (b) packaging, including pallets. 5. The competent authorities may also perform official controls on goods that are placed under one of the customs procedures defined in point (16)(a), (b) and (c) of Article 5 of Regulation (EU) No 952/2013 and in a temporary storage defined in point (17) of Article 5 of that Regulation.
Article 45 Types of official controls on animals and goods other than those subject to official controls at border control posts under Section II
1. Where official controls are performed in accordance with Article 44(1), they shall: (a) always include a documentary check; and (b) include identity checks and physical checks depending on the risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment. 2. The competent authorities shall carry out the physical checks referred to in point (b) of paragraph 1 under appropriate conditions allowing investigations to be conducted properly. 3. Where the documentary checks, identity checks or physical checks referred to in paragraph 1 of this Article show that animals and goods do not comply with the rules referred to in Article 1(2), Article 66(1), (3) and (5), Articles 67, 68, and 69, Article 71(1) and (2), Article 72(1) and (2), Articles 137 and 138 shall apply. 4. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union.
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 45 Types of official controls on animals and goods other than those subject to official controls at border control posts under Section II):
2. The competent authorities shall carry out the physical checks referred to in point (b) of paragraph 1 under appropriate conditions allowing investigations to be conducted properly. 3. Where the documentary checks, identity checks or physical checks referred to in paragraph 1 of this Article show that animals and goods do not comply with the rules referred to in Article 1(2), Article 66(1), (3) and (5), Articles 67, 68, and 69, Article 71(1) and (2), Article 72(1) and (2), Articles 137 and 138 shall apply. 4. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the cases where and the conditions under which competent authorities may request operators to notify the arrival of certain goods entering the Union.
Article 46 Samples taken on animals and goods other than those subject to official controls at border control posts under Section II
1. Where samples on animals and goods are taken, the competent authorities shall, without prejudice to Articles 34 to 42: (a) inform the operators concerned and, where appropriate, the customs authorities; and (b) decide whether the animals or goods need to be detained pending the results of the analysis, test or diagnosis carried out, or whether they can be released provided that the traceability of the animals or goods is ensured. 2. The Commission shall, by means of implementing acts: (a) establish the procedures necessary to ensure the traceability of the animals or goods referred to in point (b) of paragraph 1; and (b) identify the documents that must accompany the animals or goods referred to in paragraph 1 when samples have been taken by the competent authorities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Amendment rationale: CONTEXT OF THE PROPOSAL Reasons for and objectives of the proposal 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 46 Samples taken on animals and goods other than those subject to official controls at border control posts under Section II):
1. Where samples on animals and goods are taken, the competent authorities shall, without prejudice to Articles 34 to 42: (a) inform the operators concerned and, where appropriate, the customs authorities; and (b) decide whether the animals or goods need to be detained pending the results of the analysis, test or diagnosis carried out, or whether they can be released provided that the traceability of the animals or goods is ensured. Where samples on animals and goods are taken, the competent authorities shall, without prejudice to Articles 34 to 42: (a) inform the operators concerned and, where appropriate, the customs authorities; and (b) decide whether the animals or goods need to be detained pending the results of the analysis, test or diagnosis carried out, or whether they can be released provided that the traceability of the animals or goods is ensured. The Commission shall, by means of implementing acts: (a) establish the procedures necessary to ensure the traceability of the animals or goods referred to in point (b) of paragraph 1; and (b) identify the documents that must accompany the animals or goods referred to in paragraph 1 when samples have been taken by the competent authorities. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).