Article 75 Cooperation between authorities in relation to consignments entering the Union from third countries
1. Competent authorities, customs authorities and other authorities of the Member States dealing with animals and goods entering the Union shall cooperate closely to ensure that the official controls on consignments of animals and goods entering the Union are performed in accordance with the requirements of this Regulation. For that purpose, competent authorities, customs authorities and other authorities shall: (a) ensure reciprocal access to information which is necessary for the organisation and conduct of their respective activities in relation to animals and goods entering the Union; and (b) ensure the timely exchange of such information, including via electronic means. 2. The Commission shall, by means of implementing acts, lay down rules on uniform cooperation arrangements that competent authorities, customs authorities and other authorities referred to in paragraph 1 are required to put in place to ensure: (a) access by competent authorities to the information necessary for the immediate and complete identification of the consignments of animals and goods entering the Union that are subject to official controls at a border control post in accordance with Article 47(1); (b) the reciprocal update, through exchanges of information or synchronisation of relevant data sets, of information gathered by competent authorities, customs authorities and other authorities on consignments of animals and goods entering the Union; and (c) the swift communication of decisions taken by such authorities on the basis of the information referred to in points (a) and (b). 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in the adoption of Regulation (EU) 2016/2031 of the European Parliament of the Council 1 (‘the Regulation’), which repealed and replaced Council Directive 2000/29/EC 2 .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 75 Cooperation between authorities in relation to consignments entering the Union from third countries):
1. Competent authorities, customs authorities and other authorities of the Member States dealing with animals and goods entering the Union shall cooperate closely to ensure that the official controls on consignments of animals and goods entering the Union are performed in accordance with the requirements of this Regulation. For that purpose, competent authorities, customs authorities and other authorities shall: (a) ensure reciprocal access to information which is necessary for the organisation and conduct of their respective activities in relation to animals and goods entering the Union; and (b) ensure the timely exchange of such information, including via electronic means. 2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 76 Cooperation between authorities in relation to consignments not subject to specific controls at borders
1. Paragraphs 2, 3, and 4 of this Article shall apply in the case of consignments of animals and goods other than those subject to controls at entry into the Union as required by Article 47(1) of this Regulation and for which a customs declaration for release for free circulation has been made in accordance with point 12 of Article 5 of Regulation (EU) No 952/2013 and Articles 158 to 202 of that Regulation. 2. Customs authorities shall suspend release for free circulation when they have reason to believe that the consignment may present a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, and immediately notify the competent authorities of such suspension. 3. A consignment whose release for free circulation has been suspended pursuant to paragraph 2 shall be released if, within three working days of the suspension of release, the competent authorities have not requested customs authorities to continue the suspension or have informed customs authorities that no risk is present. 4. Where the competent authorities consider that a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, is present; they shall request the customs authorities not to release the consignment for free circulation and to include the following statement on the commercial invoice accompanying the consignment and on any other relevant accompanying document or the relevant electronic equivalents: ‘Product presents a risk — release for free circulation not authorised — Regulation (EU) 2017/625 ’; (b) no other customs procedure shall be permitted without the consent of the competent authorities; and (c) Article 66(1), (3), (5) and (6), Articles 67, 68 and 69, Article 71(1) and (2) and Article 72(1) and (2) shall apply. 5. In the case of consignments of animals and goods other than those subject to controls at entry into the Union as required by Article 47(1) and for which no customs declaration for release for free circulation has been made, customs authorities, where they have reason to believe that the consignment may present a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, shall transmit all relevant information to the customs authorities in the Member States of final destination.
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 76 Cooperation between authorities in relation to consignments not subject to specific controls at borders):
1. Paragraphs 2, 3, and 4 of this Article shall apply in the case of consignments of animals and goods other than those subject to controls at entry into the Union as required by Article 47(1) of this Regulation and for which a customs declaration for release for free circulation has been made in accordance with point 12 of Article 5 of Regulation (EU) No 952/2013 and Articles 158 to 202 of that Regulation. 2. Customs authorities shall suspend release for free circulation when they have reason to believe that the consignment may present a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, and immediately notify the competent authorities of such suspension. 3. A consignment whose release for free circulation has been suspended pursuant to paragraph 2 shall be released if, within three working days of the suspension of release, the competent authorities have not requested customs authorities to continue the suspension or have informed customs authorities that no risk is present. 5. In the case of consignments of animals and goods other than those subject to controls at entry into the Union as required by Article 47(1) and for which no customs declaration for release for free circulation has been made, customs authorities, where they have reason to believe that the consignment may present a risk to human, animal or plant health, animal welfare or, as regards GMOs and plant protection products, also to the environment, shall transmit all relevant information to the customs authorities in the Member States of final destination.
Article 77 Rules for specific official controls and for measures to be taken following the performance of such controls
1. The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules for the performance of specific official controls and on measures in cases of non-compliance, to account for the specificities of the following categories of animals and goods or the arrangements for, and means of, their transport: consignments of fresh fishery products directly landed in ports designated by Member States in accordance with Article 5(1) of Council Regulation (EC) No 1005/2008 ( 16 ) from a fishing vessel flying a third country flag; (b) consignments of unskinned, furred wild game; consignments of the categories of goods referred to in point (b) of Article 47(1) which are delivered, with or without storage in a specially approved customs warehouses or in free zones, to vessels leaving the Union and intended for ship supply or consumption by the crew and passengers; (d) wood packaging material; (e) feed accompanying animals and intended for the feeding of those animals; (f) animals and goods ordered by sales through distance contracts and delivered from a third country to an address in the Union, and the notification requirements necessary to allow the proper performance of official controls; (g) plant products which, on account of their subsequent destination, may give rise to the risk of spreading infectious or contagious animal diseases; (i) goods entering the Union in bulk from a third country, irrespective of whether they all originate from that third country; (j) consignments of goods referred to in Article 47(1) coming from the territory of Croatia and transiting through the territory of Bosnia and Herzegovina at Neum (‘Neum corridor’) before re-entering the territory of Croatia via the points of entry at Klek or Zaton Doli; (k) animals and goods exempted from Article 47 in accordance with Article 48. 2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the conditions for monitoring the transport and arrival of consignments of certain animals and goods, from the border control post of arrival to the establishment at the place of destination in the Union, to the border control post at the place of destination or to the border control post of exit. 3. The Commission may, by means of implementing acts, lay down rules on: (a) model official certificates and rules for the issuance of such certificates; and (b) the format of documents that must accompany the categories of animals or goods referred to in paragraph 1. 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 77 Rules for specific official controls and for measures to be taken following the performance of such controls):
The Commission shall adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning rules for the performance of specific official controls and on measures in cases of non-compliance, to account for the specificities of the following categories of animals and goods or the arrangements for, and means of, their transport: consignments of fresh fishery products directly landed in ports designated by Member States in accordance with Article 5(1) of Council Regulation (EC) No 1005/2008 ( 16 ) from a fishing vessel flying a third country flag; (b) consignments of unskinned, furred wild game; consignments of the categories of goods referred to in point (b) of Article 47(1) which are delivered, with or without storage in a specially approved customs warehouses or in free zones, to vessels leaving the Union and intended for ship supply or consumption by the crew and passengers; (d) wood packaging material; (e) feed accompanying animals and intended for the feeding of those animals; (f) animals and goods ordered by sales through distance contracts and delivered from a third country to an address in the Union, and the notification requirements necessary to allow the proper performance of official controls; (g) plant products which, on account of their subsequent destination, may give rise to the risk of spreading infectious or contagious animal diseases; (i) goods entering the Union in bulk from a third country, irrespective of whether they all originate from that third country; (j) consignments of goods referred to in Article 47(1) coming from the territory of Croatia and transiting through the territory of Bosnia and Herzegovina at Neum (‘Neum corridor’) before re-entering the territory of Croatia via the points of entry at Klek or Zaton Doli; (k) animals and goods exempted from Article 47 in accordance with Article 48. 2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the conditions for monitoring the transport and arrival of consignments of certain animals and goods, from the border control post of arrival to the establishment at the place of destination in the Union, to the border control post at the place of destination or to the border control post of exit. 3. The Commission may, by means of implementing acts, lay down rules on: (a) model official certificates and rules for the issuance of such certificates; and (b) the format of documents that must accompany the categories of animals or goods referred to in paragraph 1. The Commission may, by means of implementing acts, lay down rules on: (a) model official certificates and rules for the issuance of such certificates; and (b) the format of documents that must accompany the categories of animals or goods referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 78 General rules
1. Member States shall ensure that adequate financial resources are available to provide the staff and other resources necessary for the competent authorities to perform official controls and other official activities. 2. This Chapter also applies in the case of delegation of certain official control tasks and other official activities in accordance with Articles 28 and 31.
Article 79 Mandatory fees or charges
(a) at the level of the cost calculated in accordance with Article 82(1); or (b) at the amounts provided for in Annex IV. 2. The competent authorities shall collect fees or charges to recover the costs they incur in relation to: (b) official controls performed at the request of the operator, to obtain the approval provided for in Article 10 of Regulation (EC) No 183/2005; official controls which were not originally planned, and which; (i) have become necessary following the detection of a case of non-compliance by the same operator, during an official control performed in accordance with this Regulation; and (ii) are performed to assess the extent and the impact of the case of non-compliance or to verify that the non-compliance has been remedied. official controls which were not originally planned, and which; (i) have become necessary following the detection of a case of non-compliance by the same operator, during an official control performed in accordance with this Regulation; and (ii) are performed to assess the extent and the impact of the case of non-compliance or to verify that the non-compliance has been remedied. 3. Notwithstanding paragraphs 1 and 2, Member States may, in relation to the activities referred to in Chapter II of Annex IV, on an objective and non-discriminatory basis, reduce the amount of the fees or charges, taking into account: (a) the interests of operators with a low throughput; (b) the traditional methods used for production, processing and distribution; (c) the needs of operators located in regions subject to specific geographical constraints; and (d) the operators’ record of compliance with the relevant rules referred to in Article 1(2) as ascertained through official controls. 4. Member States may decide that fees and charges calculated in accordance with point (b) of Article 82(1) shall not be collected below the amount at which, taking into account the cost of collection and the overall income expected from the fees and charges, the collection of that fee or charge would be uneconomical. 5. This Article shall not apply to official controls performed to verify compliance with the rules referred to in points (i) and (j) of 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 79 Mandatory fees or charges):
4. Member States may decide that fees and charges calculated in accordance with point (b) of Article 82(1) shall not be collected below the amount at which, taking into account the cost of collection and the overall income expected from the fees and charges, the collection of that fee or charge would be uneconomical. 5. This Article shall not apply to official controls performed to verify compliance with the rules referred to in points (i) and (j) of Article 1(2).
Article 80 Other fees or charges
Member States may collect fees or charges to cover the costs of official controls and other official activities other than those fees or charges referred to in Article 79, unless prohibited by the legislative provisions applicable in the areas governed by the rules referred to in Article 1(2).
Article 81 Costs
(a) the salaries of the staff, including support and administrative staff, involved in the performance of official controls, their social security, pension and insurance costs; (b) the cost of facilities and equipment, including maintenance and insurance costs and other associated costs; (c) the cost of consumables and tools; (d) the cost of services charged to the competent authorities by delegated bodies for official controls delegated to these delegated bodies; (e) the cost of training of the staff referred to in point (a), with the exclusion of the training necessary to obtain the qualification necessary to be employed by the competent authorities; (f) the cost of travel of the staff referred to in point (a), and associated subsistence costs; (g) the cost of sampling and of laboratory analysis, testing and diagnosis charged by official laboratories for those tasks.
Article 82 Calculation of fees or charges
(a) at a flat-rate on the basis of the overall costs of official controls borne by the competent authorities over a given period of time, and applied to all operators irrespective of whether any official control is performed during the reference period in relation to each operator charged; in establishing the level of the fees to be charged for each sector, activity and category of operators, the competent authorities shall take into consideration the impact that the type and the size of the activity concerned, and the relevant risk factors, have on the distribution of the overall costs of those official controls; or (b) on the basis of the calculation of the actual costs of each individual official control, and applied to the operators subject to such official control. 2. Travel costs as referred to in point (f) of Article 81 shall be considered for the calculation of the fees or charges referred to in point (a) of Article 79(1) and in Article 79(2) in a manner that does not discriminate between operators on the basis of the distance of their premises from the location of the competent authorities. 3. Where fees or charges are calculated in accordance with point (a) of paragraph 1, the fees or charges collected by competent authorities shall not exceed the overall costs incurred for the official controls performed over the period of time referred to therein. 4. Where fees or charges are calculated in accordance with point (b) of paragraph 1, they shall not exceed the actual cost of the official control performed.
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 82 Calculation of fees or charges):
2. Travel costs as referred to in point (f) of Article 81 shall be considered for the calculation of the fees or charges referred to in point (a) of Article 79(1) and in Article 79(2) in a manner that does not discriminate between operators on the basis of the distance of their premises from the location of the competent authorities. 3. Where fees or charges are calculated in accordance with point (a) of paragraph 1, the fees or charges collected by competent authorities shall not exceed the overall costs incurred for the official controls performed over the period of time referred to therein. 4. Where fees or charges are calculated in accordance with point (b) of paragraph 1, they shall not exceed the actual cost of the official control performed.
Article 83 Collection and application of fees or charges
1. An operator shall only be charged with a fee or charge for an official control and for another official activity performed on the basis of a complaint if that control leads to the confirmation of non-compliance. 2. Fees or charges collected in accordance with Articles 79 and 80 shall not be directly or indirectly refunded, unless unduly collected. 3. Member States may decide that fees or charges shall be collected by authorities other than the competent authorities or by delegated bodies.
Article 84 Payment of fees or charges
1. The competent authorities shall ensure that the operators receive, upon request, proof of payment of fees or charges in the event that the operators do not otherwise have access to such proof. 2. Fees or charges collected in accordance with Article 79(1) shall be paid by the operator responsible for the consignment or its representative.
Article 85 Transparency
1. Member States shall ensure a high level of transparency on: (i) the method and data used to establish these fees or charges; (ii) the amount of the fees or charges, applied to each category of operators and for each category of official controls or other official activities; (iii) the breakdown of the costs, as referred to in Article 81; (b) the identity of the authorities or bodies responsible for the collection of the fees or charges. 2. Each competent authority shall make available to the public the information referred to in paragraph 1 of this Article for each reference period and the costs to the competent authority for which a fee or charge is due in accordance with point (a) of Article 79(1), Article 79(2) and Article 80. 3. Member States shall consult relevant stakeholders on the general methods used to calculate the fees or charges provided for in point (a) of Article 79(1), Article 79(2) and Article 80.
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 85 Transparency):
2. Each competent authority shall make available to the public the information referred to in paragraph 1 of this Article for each reference period and the costs to the competent authority for which a fee or charge is due in accordance with point (a) of Article 79(1), Article 79(2) and Article 80. 3. Member States shall consult relevant stakeholders on the general methods used to calculate the fees or charges provided for in point (a) of Article 79(1), Article 79(2) and Article 80.
Article 86 General requirements concerning official certification
1. Official certification shall result in the issuance of: (a) official certificates; or (b) official attestations in the cases provided for in the rules referred to in Article 1(2). 2. Where the competent authorities delegate certain tasks related to the issuance of official certificates or official attestations, or to the official supervision referred to in Article 91(1), such delegation shall comply with Articles 28 to 33.
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 86 General requirements concerning official certification):
2. Where the competent authorities delegate certain tasks related to the issuance of official certificates or official attestations, or to the official supervision referred to in Article 91(1), such delegation shall comply with Articles 28 to 33.
Article 87 Official certificates
Articles 88, 89 and 90 shall apply: (a) when the rules referred to in Article 1(2) require the issuance of an official certificate; and (b) to official certificates which are necessary for the purposes of exporting consignments of animals and goods to third countries or which are requested from the competent authority of a Member State of dispatch by the competent authority of a Member State of destination in respect of consignments of animals and goods which are to be exported to third countries.
Article 88 Signature and issuance of official certificates
1. Official certificates shall be issued by the competent authorities. 2. Competent authorities shall designate the certifying officers who are authorised to sign official certificates and shall ensure that these officers: (a) are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified; and (b) have received appropriate training on the rules with which compliance is certified by an official certificate and on the technical assessment of compliance with those rules as well as with the relevant rules laid down in this Regulation. 3. Official certificates shall be signed by the certifying officer and issued on one of the following grounds: direct knowledge by the certifying officer of up-to-date facts and data relevant for the certification that is obtained through: (i) an official control; or (ii) the acquisition of another official certificate issued by the competent authorities; direct knowledge by the certifying officer of up-to-date facts and data relevant for the certification that is obtained through: (i) an official control; or (ii) the acquisition of another official certificate issued by the competent authorities; (b) facts and data relevant for the certification, knowledge of which was ascertained by another person authorised for that purpose by, and acting under the control of, the competent authorities, provided that the certifying officer can verify the accuracy of such facts and data; (c) facts and data relevant for the certification which were obtained from the operators’ own control systems, complemented and confirmed by results from regular official controls, where the certifying officer is thus satisfied that the conditions for issuing the official certificate are met. 4. Official certificates shall be signed by the certifying officer and issued only on the basis of point (a) of paragraph 3 of this Article when rules referred to in Article 1(2) so require.
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 88 Signature and issuance of official certificates):
1. Official certificates shall be issued by the competent authorities. 2. Competent authorities shall designate the certifying officers who are authorised to sign official certificates and shall ensure that these officers: (a) are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified; and (b) have received appropriate training on the rules with which compliance is certified by an official certificate and on the technical assessment of compliance with those rules as well as with the relevant rules laid down in this Regulation. Competent authorities shall designate the certifying officers who are authorised to sign official certificates and shall ensure that these officers: (a) are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified; and (b) have received appropriate training on the rules with which compliance is certified by an official certificate and on the technical assessment of compliance with those rules as well as with the relevant rules laid down in this Regulation. 3. Official certificates shall be signed by the certifying officer and issued on one of the following grounds: direct knowledge by the certifying officer of up-to-date facts and data relevant for the certification that is obtained through: (i) an official control; or (ii) the acquisition of another official certificate issued by the competent authorities; direct knowledge by the certifying officer of up-to-date facts and data relevant for the certification that is obtained through: (i) an official control; or (ii) the acquisition of another official certificate issued by the competent authorities; (b) facts and data relevant for the certification, knowledge of which was ascertained by another person authorised for that purpose by, and acting under the control of, the competent authorities, provided that the certifying officer can verify the accuracy of such facts and data; (c) facts and data relevant for the certification which were obtained from the operators’ own control systems, complemented and confirmed by results from regular official controls, where the certifying officer is thus satisfied that the conditions for issuing the official certificate are met. 4. Official certificates shall be signed by the certifying officer and issued only on the basis of point (a) of paragraph 3 of this Article when rules referred to in Article 1(2) so require.
Article 89 Guarantees of reliability for official certificates
1. Official certificates shall: (a) bear a unique code; (b) not be signed by the certifying officer where they are blank or incomplete; (c) be drawn up in one or more of the official languages of the institutions of the Union understood by the certifying officer and, where relevant, in one of the official languages of the Member State of destination; (d) be authentic and accurate; (e) allow for the identification of the person who signed them and the date of issue; and (f) allow the easy verification of the links between the certificate, the issuing authority and the consignment, lot or individual animal or good covered by the certificate. 2. The competent authorities shall take all appropriate measures to prevent the issuance of false or misleading official certificates or the abuse of official certificates.
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 89 Guarantees of reliability for official certificates):
2. The competent authorities shall take all appropriate measures to prevent the issuance of false or misleading official certificates or the abuse of official certificates.
Article 90 Implementing powers concerning official certificates
The Commission may, by means of implementing acts, lay down rules for the uniform application of Articles 88 and 89 concerning: (a) model official certificates and rules for the issuance of such certificates, where requirements are not laid down in the rules referred to in Article 1(2); (b) the mechanisms and technical arrangements to ensure the issuance of accurate and reliable official certificates, and prevent risk of fraud; (c) the procedures to be followed in the case of withdrawals of official certificates and for the issuance of replacement certificates; (d) rules for the production of certified copies of official certificates; (e) the format of documents that must accompany animals and goods after official controls have been performed; (f) rules for the issuance of electronic certificates and for the use of electronic signatures. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 91 Official attestations
1. When this Regulation or the rules referred to in Article 1(2) require the issuance of official attestations by the operators under the official supervision of the competent authorities, or by the competent authorities themselves, paragraphs 2, 3 and 4 of this Article shall apply. 2. Official attestations shall: (a) be authentic and accurate; (b) be drawn up in one or more of the official languages of the institutions of the Union and, where relevant, in one of the official languages of the Member State of destination; and (c) where they relate to a consignment or a lot, allow the verification of the link between the official attestation and that consignment or lot. 3. Competent authorities shall ensure that the staff performing official controls to supervise the issuance of official attestations or, where the official attestations are issued by the competent authorities, the staff involved in the issuance of those official attestations: (a) are impartial, free from any conflict of interest, and in particular are not in a situation which may, directly or indirectly, affect the impartiality of their professional conduct in relation to what is being certified by the official attestations; and have received appropriate training on: (i) the rules with which compliance is certified by the official attestations and on the technical assessment of compliance with those rules; (ii) the relevant rules laid down in this Regulation. have received appropriate training on: (i) the rules with which compliance is certified by the official attestations and on the technical assessment of compliance with those rules; (ii) the relevant rules laid down in this Regulation. 4. Competent authorities shall perform regular official controls to verify that: (a) the operators issuing the attestations comply with the conditions laid down in the rules referred to in Article 1(2); and (b) the attestation is issued on the basis of relevant, correct and verifiable facts and data.
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 91 Official attestations):
1. When this Regulation or the rules referred to in Article 1(2) require the issuance of official attestations by the operators under the official supervision of the competent authorities, or by the competent authorities themselves, paragraphs 2, 3 and 4 of this Article shall apply.
Article 92 Decision to establish a European Union reference laboratory
1. In the areas governed by the rules referred to in Article 1(2), a European Union reference laboratory shall be established where the effectiveness of official controls and other official activities also depends on the quality, uniformity and reliability of: (a) the methods of analysis, test or diagnosis employed by the official laboratories designated in accordance with Article 37(1); and (b) the results of the analyses, tests and diagnoses performed by those official laboratories. 2. A European Union reference laboratory shall be established where there is a recognised need to promote uniform practices in relation to the development or use of the methods referred to in point (a) of paragraph 1. 3. The Commission shall review regularly the mandate and operation of the European Union reference laboratories. 4. The Commission shall supplement this Regulation by adopting the decision to establish a European Union reference laboratory by means of a delegated act in accordance with Article 144.
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 92 Decision to establish a European Union reference laboratory):
2. A European Union reference laboratory shall be established where there is a recognised need to promote uniform practices in relation to the development or use of the methods referred to in point (a) of paragraph 1. 3. The Commission shall review regularly the mandate and operation of the European Union reference laboratories. 4. The Commission shall supplement this Regulation by adopting the decision to establish a European Union reference laboratory by means of a delegated act in accordance with Article 144.
Article 93 Designation of European Union reference laboratories
1. The Commission shall, by means of implementing acts, designate European Union reference laboratories in the cases where a decision has been taken to establish such a laboratory in accordance with Article 92. 2. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time and with a minimum period of five years, or reviewed regularly. 3. European Union reference laboratories shall: operate in accordance with standard EN ISO/IEC 17025 and be accredited in accordance with that standard by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008. The scope of that accreditation: (i) shall include all the methods of laboratory analysis, test or diagnosis required to be used by the laboratory when it operates as a European Union reference laboratory; (ii) may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods; (iii) may be defined in a flexible manner, so as to allow the scope of the accreditation to include modified versions of the methods used by the European Union reference 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, prior to the use of those modified or new methods, by the national accreditation body of the Member State where the European Union reference laboratory is located; (b) be impartial, free from any conflict of interest, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as European Union reference laboratories; (c) have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques applied in their area of competence, and support staff as appropriate; (d) possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them; (e) ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work; (f) be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and (g) where relevant, be equipped to comply with relevant biosecurity standards. 5. By way of derogation from paragraphs 1 and 2 of this Article, the laboratories referred to in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 and the first paragraph of the Article 21 of Regulation (EC) No 1831/2003 shall be the European Union reference laboratories having the responsibilities and performing the tasks referred to in Article 94 of this Regulation in the areas respectively of: (a) GMOs and genetically modified food and feed; and (b) feed additives. 6. The confidentiality obligations of staff, referred to in Article 8, shall apply mutatis mutandis to staff of the European Union reference laboratories.
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 93 Designation of European Union reference laboratories):
1. The Commission shall, by means of implementing acts, designate European Union reference laboratories in the cases where a decision has been taken to establish such a laboratory in accordance with Article 92. 2. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time and with a minimum period of five years, or reviewed regularly. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time and with a minimum period of five years, or reviewed regularly. 3. European Union reference laboratories shall: operate in accordance with standard EN ISO/IEC 17025 and be accredited in accordance with that standard by a national accreditation body, operating in accordance with Regulation (EC) No 765/2008. The scope of that accreditation: (i) shall include all the methods of laboratory analysis, test or diagnosis required to be used by the laboratory when it operates as a European Union reference laboratory; (ii) may comprise one or more methods of laboratory analysis, test or diagnosis or groups of methods; (iii) may be defined in a flexible manner, so as to allow the scope of the accreditation to include modified versions of the methods used by the European Union reference 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, prior to the use of those modified or new methods, by the national accreditation body of the Member State where the European Union reference laboratory is located; (b) be impartial, free from any conflict of interest, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as European Union reference laboratories; (c) have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques applied in their area of competence, and support staff as appropriate; (d) possess, or have access to, the infrastructure, equipment and products necessary to carry out the tasks assigned to them; (e) ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work; (f) be equipped, or have access to, the necessary equipment to perform their tasks in emergency situations; and (g) where relevant, be equipped to comply with relevant biosecurity standards. By way of derogation from paragraphs 1 and 2 of this Article, the laboratories referred to in the first paragraph of Article 32 of Regulation (EC) No 1829/2003 and the first paragraph of the Article 21 of Regulation (EC) No 1831/2003 shall be the European Union reference laboratories having the responsibilities and performing the tasks referred to in Article 94 of this Regulation in the areas respectively of: (a) GMOs and genetically modified food and feed; and (b) feed additives. 6. The confidentiality obligations of staff, referred to in Article 8, shall apply mutatis mutandis to staff of the European Union reference laboratories.
Article 94 Responsibilities and tasks of European Union reference laboratories
1. European Union reference laboratories shall contribute to the improvement and harmonisation of methods of analysis, test or diagnosis to be used by official laboratories designated in accordance with Article 37(1) and of the analytical, testing and diagnostic data generated by them. 2. European Union reference laboratories designated in accordance with Article 93(1) shall be responsible for the following tasks insofar as they are included in the reference laboratories’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014: (a) providing national reference laboratories with details and guidance on the methods of laboratory analysis, testing or diagnosis, including reference methods; (b) providing reference materials to national reference laboratories; (c) coordinating the application by the national reference laboratories and, if necessary, by other official laboratories of the methods referred to in point (a), in particular, by organising regular inter-laboratory comparative testing or proficiency tests and by ensuring appropriate follow-up of such comparative testing or proficiency tests in accordance, where available, with internationally accepted protocols, and informing the Commission and the Member States of the results and follow-up to the inter-laboratory comparative testing or proficiency tests; (d) coordinating practical arrangements necessary to apply new methods of laboratory analysis, testing or diagnosis, and informing national reference laboratories of advances in this field; (e) conducting training courses for staff from national reference laboratories and, if needed, from other official laboratories, as well as of experts from third countries; (f) providing scientific and technical assistance to the Commission within the scope of their mission; (g) providing information on relevant national, Union and international research activities to national reference laboratories; (h) collaborating within the scope of their mission with laboratories in third countries and with the European Food Safety Authority (EFSA), the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC); (i) assisting actively in the diagnosis of outbreaks in Member States of foodborne, zoonotic or animal diseases, or of pests of plants, by carrying out confirmatory diagnosis, characterisation and taxonomic or epizootic studies on pathogen isolates or pest specimens; (j) coordinating or performing tests for the verification of the quality of reagents and lots of reagents used for the diagnosis of foodborne, zoonotic or animal diseases and pests of plants; where relevant for their area of competence, establishing and maintaining: (i) reference collections of pests of plants and/or reference strains of pathogenic agents; (ii) reference collections of materials intended to come into contact with food used to calibrate analytical equipment and provide samples thereof to national reference laboratories; (iii) up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents; and (l) where relevant for their area of competence, cooperate among themselves and with the Commission, as appropriate, to develop methods of analysis, testing or diagnosis of high standards. As regards point (i) of point (k), the European Union reference laboratory may establish and maintain those reference collections and reference strains by contractual outsourcing to other official laboratories and to scientific organisations. 3. European Union reference laboratories shall publish the list of the national reference laboratories designated by the Member States in accordance with Article 100(1).
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 94 Responsibilities and tasks of European Union reference laboratories):
1. European Union reference laboratories shall contribute to the improvement and harmonisation of methods of analysis, test or diagnosis to be used by official laboratories designated in accordance with Article 37(1) and of the analytical, testing and diagnostic data generated by them. As regards point (i) of point (k), the European Union reference laboratory may establish and maintain those reference collections and reference strains by contractual outsourcing to other official laboratories and to scientific organisations. 3. European Union reference laboratories shall publish the list of the national reference laboratories designated by the Member States in accordance with Article 100(1).
Article 95 Designation of European Union reference centres for animal welfare
1. The Commission shall, by means of implementing acts, designate European Union reference centres for animal welfare that shall support the activities of the Commission and of the Member States in relation to the application of the rules referred to in point (f) of Article 1(2). 2. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time or reviewed regularly. 3. European Union reference centres for animal welfare shall: (a) act impartially as regards the exercise of their tasks as European Union reference centres; (b) possess a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal genetics, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals; (c) have suitably qualified staff with adequate training in the areas referred to in point (b) and in ethical issues related to animals and support staff as appropriate; (d) possess, or have access to, the infrastructure, the equipment and products necessary to carry out the tasks assigned to them; and (e) ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest developments in research at national, Union and international level, including studies performed and actions undertaken by other European Union reference centres for animal welfare, in those areas are taken into account in their work.
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 95 Designation of European Union reference centres for animal welfare):
1. The Commission shall, by means of implementing acts, designate European Union reference centres for animal welfare that shall support the activities of the Commission and of the Member States in relation to the application of the rules referred to in point (f) of Article 1(2). 2. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time or reviewed regularly. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time or reviewed regularly. 3. European Union reference centres for animal welfare shall: (a) act impartially as regards the exercise of their tasks as European Union reference centres; (b) possess a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal genetics, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals; (c) have suitably qualified staff with adequate training in the areas referred to in point (b) and in ethical issues related to animals and support staff as appropriate; (d) possess, or have access to, the infrastructure, the equipment and products necessary to carry out the tasks assigned to them; and (e) ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest developments in research at national, Union and international level, including studies performed and actions undertaken by other European Union reference centres for animal welfare, in those areas are taken into account in their work.
Article 96 Responsibilities and tasks of European Union reference centres for animal welfare
The European Union reference centres for animal welfare shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014: providing scientific and technical expertise within the scope of their mission including, where appropriate in the form of coordinated assistance, to relevant national support networks and bodies in the area governed by the rules referred to in point (f) of Article 1(2); providing scientific and technical expertise for the development and application of the animal welfare indicators referred to in point (e) of Article 21(8); (c) developing or coordinating the development of methods for the assessment of the level of welfare of animals and of methods for the improvement of the welfare of animals; (d) carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes; (e) conducting training courses for staff of the national scientific support networks or bodies referred to in point (a), for staff of the competent authorities and for experts from third countries; and (f) disseminating research findings and technical innovations and collaborating with Union research bodies in the fields within the scope of their mission.
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 96 Responsibilities and tasks of European Union reference centres for animal welfare):
The European Union reference centres for animal welfare shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014: (c) developing or coordinating the development of methods for the assessment of the level of welfare of animals and of methods for the improvement of the welfare of animals; (d) carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes; (e) conducting training courses for staff of the national scientific support networks or bodies referred to in point (a), for staff of the competent authorities and for experts from third countries; and (f) disseminating research findings and technical innovations and collaborating with Union research bodies in the fields within the scope of their mission.
Article 97 Designation of European Union reference centres for the authenticity and integrity of the agri-food chain
1. The Commission may, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission and of the Member States to prevent, detect and combat violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices. 2. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time or reviewed regularly. 3. European Union reference centres for the authenticity and integrity of the agri-food chain shall: (a) act impartially as regards the exercise of their tasks as European Union reference centres; possess a high level of scientific and technical expertise in the areas governed by the rules referred to in Article 1(2) and in applied forensic science in those areas, in order to have the ability to carry out or coordinate research at the highest level on the authenticity and integrity of goods and to develop, apply and validate the methods to be used for the detection of violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices; (c) have suitably qualified staff with adequate training in the areas referred to in point (b) and the necessary support staff; (d) possess, or have access to, the infrastructure, the equipment and the products necessary to carry out the tasks assigned to them; and (e) ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest research developments at national, Union and international level in those areas are taken into account in their work.
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 97 Designation of European Union reference centres for the authenticity and integrity of the agri-food chain):
1. The Commission may, by means of implementing acts, designate European Union reference centres that shall support the activities of the Commission and of the Member States to prevent, detect and combat violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices. 2. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time or reviewed regularly. The designations provided for in paragraph 1 shall: (a) follow a public selection process; and (b) be limited in time or reviewed regularly. 3. European Union reference centres for the authenticity and integrity of the agri-food chain shall: (a) act impartially as regards the exercise of their tasks as European Union reference centres; possess a high level of scientific and technical expertise in the areas governed by the rules referred to in Article 1(2) and in applied forensic science in those areas, in order to have the ability to carry out or coordinate research at the highest level on the authenticity and integrity of goods and to develop, apply and validate the methods to be used for the detection of violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices; (c) have suitably qualified staff with adequate training in the areas referred to in point (b) and the necessary support staff; (d) possess, or have access to, the infrastructure, the equipment and the products necessary to carry out the tasks assigned to them; and (e) ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest research developments at national, Union and international level in those areas are taken into account in their work.
Article 98 Responsibilities and tasks of European Union reference centres for the authenticity and integrity of the agri-food chain
The European Union reference centres for the authenticity and integrity of the agri-food chain shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmes that have been established in conformity with the objectives and priorities of the relevant work programmes adopted by the Commission in accordance with Article 36 of Regulation (EU) No 652/2014: (a) providing specialised knowledge in relation to the authenticity and integrity of the agri-food chain and to the methods for detecting violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices, in relation to the forensic science applied to the areas governed by these rules; (b) providing specific analyses designed to identify the segments of the agri-food chain that are potentially subject to violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices and helping to develop specific official control techniques and protocols; (d) where necessary, establishing and maintaining collections or databases of authenticated reference materials, to be used to detect violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices; and (e) disseminating research findings and technical innovations in the fields within the scope of their mission.
Article 99 Obligations of the Commission
1. The Commission shall publish and update, whenever necessary, the list of: (a) European Union reference laboratories provided for in Article 93; (b) European Union reference centres for animal welfare provided for in Article 95; (c) European Union reference centres for the authenticity and integrity of the agri-food chain provided for in Article 97. (a) by means of an implementing act, withdraw the designation of that laboratory or centre; or (b) take any other appropriate measure.
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 100 Designation of national reference laboratories
1. Member States shall designate one or more national reference laboratories for each European Union reference laboratory designated in accordance with Article 93(1). Member States may designate a national reference laboratory also in the cases where there is no corresponding European Union reference laboratory. A Member State may designate a laboratory situated in another Member State or in a third country that is a Contracting Party to the Agreement on the European Economic Area. A single laboratory may be designated as a national reference laboratory for more than one Member State. 3. National reference laboratories shall: (a) be impartial, free from any conflict of interests, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as national reference laboratories; (b) have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques in their area of competence, and support staff as appropriate; (c) possess, or have access to, the infrastructure, equipment and products needed to carry out the tasks assigned to them; (d) ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at national, Union and international level are taken into account in their work; (e) be equipped with, or have access to, the necessary equipment to perform their tasks in emergency situations; and (f) where relevant, be equipped to comply with relevant biosecurity standards. 4. Member States shall: (a) communicate the name and address of each national reference laboratory to the Commission, the relevant European Union reference laboratory and other Member States; (b) make the information referred to in point (a) available to the public; and (c) update the information referred to in point (a) whenever necessary. 5. Member States that have more than one national reference laboratory for a European Union reference laboratory shall ensure that such laboratories work closely together, so as to ensure efficient coordination between them, with other national laboratories and with the European Union reference laboratory. 6. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of requirements for national reference laboratories in addition to those laid down in paragraphs 2 and 3 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional requirements adopted in accordance with Article 99(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 100 Designation of national reference laboratories):
1. Member States shall designate one or more national reference laboratories for each European Union reference laboratory designated in accordance with Article 93(1). Member States may designate a national reference laboratory also in the cases where there is no corresponding European Union reference laboratory. A Member State may designate a laboratory situated in another Member State or in a third country that is a Contracting Party to the Agreement on the European Economic Area. A single laboratory may be designated as a national reference laboratory for more than one Member State. 5. Member States that have more than one national reference laboratory for a European Union reference laboratory shall ensure that such laboratories work closely together, so as to ensure efficient coordination between them, with other national laboratories and with the European Union reference laboratory. 6. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of requirements for national reference laboratories in addition to those laid down in paragraphs 2 and 3 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional requirements adopted in accordance with Article 99(2).
Article 101 Responsibilities and tasks of national reference laboratories
1. National reference laboratories shall, in their area of competence: (a) collaborate with the European Union reference laboratories, and participate in training courses and in inter-laboratory comparative tests organised by these laboratories; (b) coordinate the activities of official laboratories designated in accordance with Article 37(1) with a view of harmonising and improving the methods of laboratory analysis, test or diagnosis and their use; (c) where appropriate, organise inter-laboratory comparative testing or proficiency tests between official laboratories, ensure an appropriate follow-up of such tests and inform the competent authorities of the results of such tests and follow-up; (d) ensure the dissemination to the competent authorities and official laboratories of information that the European Union reference laboratory supplies; (e) provide within the scope of their mission scientific and technical assistance to the competent authorities for the implementation of MANCPs referred to in Article 109 and of coordinated control programmes adopted in accordance with Article 112; (f) where relevant, validate the reagents and lots of reagents, establish and maintain up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents; (g) where necessary, conduct training courses for the staff of official laboratories designated under Article 37(1); and (h) assist actively the Member State having designated them in the diagnosis of outbreaks of foodborne, zoonotic or animal diseases or of pests of plants and in case of non-compliance of consignments, by carrying out confirmatory diagnoses, characterisation and epizootic or taxonomic studies on pathogen isolates or pest specimens. 2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of responsibilities and tasks for national reference laboratories in addition to those provided for in paragraph 1 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional responsibilities and tasks adopted in accordance with Article 99(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 101 Responsibilities and tasks of national reference laboratories):
2. The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of responsibilities and tasks for national reference laboratories in addition to those provided for in paragraph 1 of this Article. Such delegated acts shall be limited to ensuring coherence with any additional responsibilities and tasks adopted in accordance with Article 99(2).
Article 102 General rules
1. The competent authorities in the Member States concerned shall provide each other with administrative assistance in accordance with Articles 104 to 107, in order to ensure the correct application of the rules referred to in Article 1(2) in cases which have relevance in more than one Member State. 2. Administrative assistance shall include, where appropriate, and, by agreement between the competent authorities concerned, participation by the competent authorities of a Member State in on-the-spot official controls that the competent authorities of another Member State perform. 3. This Title shall be without prejudice to national law: (a) applicable to the release of documents and information that are the object of, or related to, judicial investigations and court proceedings, including criminal investigations; and (b) aimed at the protection of natural or legal persons’ commercial interests. 4. Member States shall take measures to facilitate the transmission, from other law enforcement authorities, public prosecutors and judicial authorities, to the competent authorities, of information on possible non-compliance with the rules referred to in Article 1(2) which is relevant for the application of this Title and which may constitute: (a) a risk to human, animal or plant health, or to animal welfare, or, as regards GMOs and plant protection products, also to the environment; or (b) a possible violation of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices. 5. All communications between competent authorities in accordance with Articles 104 to 107 shall be in writing, on paper or in electronic form. 6. In order to streamline and simplify communication exchanges, the Commission shall, by means of implementing acts, establish a standard format for: (a) the requests for assistance provided for in Article 104(1); and (b) the communication of common and recurrent notifications and responses. 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 102 General rules):
1. The competent authorities in the Member States concerned shall provide each other with administrative assistance in accordance with Articles 104 to 107, in order to ensure the correct application of the rules referred to in Article 1(2) in cases which have relevance in more than one Member State. 2. Administrative assistance shall include, where appropriate, and, by agreement between the competent authorities concerned, participation by the competent authorities of a Member State in on-the-spot official controls that the competent authorities of another Member State perform. 3. This Title shall be without prejudice to national law: (a) applicable to the release of documents and information that are the object of, or related to, judicial investigations and court proceedings, including criminal investigations; and (b) aimed at the protection of natural or legal persons’ commercial interests. This Title shall be without prejudice to national law: (a) applicable to the release of documents and information that are the object of, or related to, judicial investigations and court proceedings, including criminal investigations; and (b) aimed at the protection of natural or legal persons’ commercial interests. 4. Member States shall take measures to facilitate the transmission, from other law enforcement authorities, public prosecutors and judicial authorities, to the competent authorities, of information on possible non-compliance with the rules referred to in Article 1(2) which is relevant for the application of this Title and which may constitute: (a) a risk to human, animal or plant health, or to animal welfare, or, as regards GMOs and plant protection products, also to the environment; or (b) a possible violation of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices. 5. All communications between competent authorities in accordance with Articles 104 to 107 shall be in writing, on paper or in electronic form. In order to streamline and simplify communication exchanges, the Commission shall, by means of implementing acts, establish a standard format for: (a) the requests for assistance provided for in Article 104(1); and (b) the communication of common and recurrent notifications and responses. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 103 Liaison bodies
1. Each Member State shall designate one or more liaison bodies acting as contact points responsible for facilitating the exchange of communications between competent authorities in accordance with Articles 104 to 107. 2. The designation of liaison bodies shall not preclude direct contacts, exchange of information or cooperation between the staff of competent authorities in different Member States. 3. Member States shall communicate to the Commission and other Member States the contact details of their liaison bodies designated in accordance with paragraph 1, and any subsequent modification of those details. 4. The Commission shall publish and update on its website the list of liaison bodies communicated to it by the Member States in accordance with paragraph 3. 5. All requests for assistance pursuant to Article 104(1), and notifications and communications pursuant to Articles 105, 106 and 107 shall be transmitted by a liaison body to its correspondent in the Member State to which the request or the notification is addressed. 6. The Commission shall, by means of implementing acts, establish the specifications of the technical tools and the procedures for communication between liaison bodies designated in accordance with paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 145(2).
Article 104 Assistance on request
1. Where the competent authorities in a Member State consider that, for the performance of official controls or for the effective follow-up to such controls in their territory, they require data or information from the competent authorities of another Member State, they shall issue a reasoned request for administrative assistance to the competent authorities of that Member State. The requested competent authorities shall: (a) acknowledge receipt of the request without delay; (b) where the requesting competent authority so specifies, indicate within ten working days from the date of receipt of the request, the estimated time necessary to provide an informed response to the request; and (c) perform official controls or investigations necessary to provide the requesting competent authorities without delay with all necessary information and documents to enable them to take informed decisions and verify compliance with Union rules within their jurisdiction. 2. Documents may be transmitted in their original form or copies may be provided. 3. By agreement between the requesting competent authorities and the requested competent authorities, staff designated by the former may be present during the official controls and investigations referred to in point (c) of paragraph 1 performed by the requested competent authorities. In such cases the staff of the requesting competent authorities shall: (a) at all times be able to produce written authority stating their identity and their official capacity; (b) be granted access by the operator to the same premises and documents as the staff of the requested competent authorities, through their intermediary, and for the sole purpose of the administrative enquiry being carried out; and (c) not, on their own initiative, exercise the powers of enquiry conferred on officials of the requested competent authorities.
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 104 Assistance on request):
2. Documents may be transmitted in their original form or copies may be provided. 3. By agreement between the requesting competent authorities and the requested competent authorities, staff designated by the former may be present during the official controls and investigations referred to in point (c) of paragraph 1 performed by the requested competent authorities. In such cases the staff of the requesting competent authorities shall: (a) at all times be able to produce written authority stating their identity and their official capacity; (b) be granted access by the operator to the same premises and documents as the staff of the requested competent authorities, through their intermediary, and for the sole purpose of the administrative enquiry being carried out; and (c) not, on their own initiative, exercise the powers of enquiry conferred on officials of the requested competent authorities.