Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation (Text with EEA relevance)

For the purpose of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, this Regulation lays down the following: (a) the annual uniform minimum sampling frequency as part of official controls, having regard to the hazards and risks related to the substances concerned; (b) specific additional arrangements and specific additional content for the Member States’ multi-annual national control plan (‘MANCP’), in addition to those provided for in Article 110 of Regulation (EU) 2017/625.

For the purposes of this Regulation, the definitions in Regulation (EC) No 178/2002, Commission Delegated Regulation (EU) 2019/2090 , Implementing Regulation (EU) 2021/808 and Delegated Regulation (EU) 2022/1644 apply.

Member States shall ensure that the part of the MANCP concerning the performance of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof in live animals and products of animal origin contains the following: (a) a ‘national risk-based control plan for production in the Member States’, as set out in Article 4; (b) a ‘national randomised surveillance plan for production in the Member States’ as set out in Article 5; (c) a ‘national risk-based control plan for third-country imports’ as set out in Article 6.

Member States shall prepare a national risk-based control plan for substances in groups A and B of Annex I to Delegated Regulation (EU) 2022/1644 to verify compliance of food-producing animals and products of animal origin produced in the Member States with Union legislation governing the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof and the applicable maximum residue limits (‘MRL’) and maximum levels (‘ML’) in food. The national risk-based control plan for production in the Member States shall contain the following: (a) the list of combinations of substances and species, products and matrices in accordance with Annex II to Delegated Regulation (EU) 2022/1644; (b) the sampling strategy as decided by the Member State in accordance with Annex III to Delegated Regulation (EU) 2022/1644; (c) the actual sampling frequencies as decided by the Member State taking into account the annual minimum control frequencies laid down in Annex I; (d) the analytical methods to be used and their performance characteristics; (e) the detailed information referred to in Article 7(1) and (2). Pursuant to Article 111(2) of Regulation (EU) 2017/625, during the course of the execution of the MANCP, Member States shall review the national risk-based plan for production in the Member States to take account of illegal treatments identified, in particular, through the surveillance plan.

Member States shall prepare a national randomised surveillance plan for the control of production in the Member States, ensuring random monitoring for a wide range of substances. The national randomised surveillance plan for production in each Member State shall contain the following: (a) the list of combinations of substances and species, products and matrices in accordance with Annex IV to Delegated Regulation (EU) 2022/1644; (b) the sampling strategy as decided by the Member State set out in accordance with Annex V to Delegated Regulation (EU) 2022/1644; (c) the actual sampling frequencies as decided by the Member State taking into account the minimum sampling frequencies prescribed in Annex II to this Regulation; (d) the detailed information referred to in Article 7(1). In accordance with the requirements for methods of analysis provided for in Implementing Regulation (EU) 2021/808, Member State shall use analytical methods for the analysis of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof in products of animal origin, which provide quantitative or semi-quantitative results, including when these residues are identified and quantified at levels below the MRL. Member States shall include reporting requirements for the controls on the use of authorised substances, which ensure the reporting of all concentrations at or above the detection capability for screening (‘CCβ’) of the method, while ensuring that the lowest CCβ, which is reasonably achievable, is obtained for the methods, which are used to perform the screening analyses. For testing carried out with confirmatory methods only, all quantifiable results shall be reported. In case of use of targeted and non-targeted screening methods, Member States shall report on the use and the findings of these analytical methods.

Member States shall prepare a national risk-based control plan for food-producing animals and products of animal origin entering into the Union and intended for placing on the Union market through their border control posts (‘BCP’) and other points of entry such as on vessels according to Commission Implementing Regulation (EU) 2019/627 to verify compliance with Union legislation on the use of pharmacologically active substances as listed in Annex I to Delegated Regulation (EU) 2022/1644 and compliance with applicable MRLs and MLs. Controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof shall be carried out as part of the official controls at BCP provided for in Article 47 and Article 65 of Regulation (EU) 2017/625. The national risk-based control plan for third-country imports shall contain the following: (a) the list of combinations of substances and species, products and matrices in accordance with Annex VI to Delegated Regulation (EU) 2022/1644; (b) the sampling strategy as decided by the Member State in accordance with Annex VII to Delegated Regulation (EU) 2022/1644; (c) the actual sampling frequencies for controls carried out at BCP as decided by the Member State taking into account the annual minimum sampling frequencies in accordance with Annex III to this Regulation. The samples taken for the purpose of official controls carried out pursuant to Article 65(1), (2) and (4) of Regulation (EU) 2017/625, shall, however, not be considered as samples contributing to reach the minimum sampling frequencies of Annex III of this Regulation; (d) the analytical methods to be used and their performance characteristics; (e) the detailed information referred to in Article 7(1) and (2).

1 The national risk-based control plans, referred to in Articles 4 and 6, and national randomised surveillance plan, referred to in Article 5, shall specify the following information: (a) the details on species to be sampled and on place of sampling; (b) information on the national legislation on the use of pharmacologically active substances and, in particular, on their prohibition or authorisation, distribution and placing on the market and the rules governing their administration, in so far as such legislation is not harmonised; (c) information about the competent authorities responsible for the implementation of the plans; (d) the type of follow-up measures taken by the competent authorities with regard to animals or products of animal origin in which non-compliant residues have been detected in the previous years 2. The national risk based control plans referred to in Articles 4 and 6 shall, in addition to the information specified in paragraph 1, provide the following: (a) a justification for the selected substances, species, products and matrices included in the plans on the basis of the criteria listed in Annexes II and VI to Delegated Regulation (EU) 2022/1644, including a justification on how the criteria listed in those Annexes were taken into account, even if no changes were made compared to the plan of the previous year; (b) a justification on how information from an overview of the non-compliances in the relevant Member State of the previous three calendar years provided by EFSA was taken into account for optimising the plan. Member States do not need submit information already provided in the general part of the MANCP or described in Union legislation according to Article 110(2) of Regulation (EU) 2017/625.

By 31 March of each year, Member States shall submit, in an agreed format, revised and updated national risk-based control plans and randomised surveillance plan for the current calendar year to the Commission electronically. The Commission shall evaluate those plans on the basis of this Regulation and Delegated Regulation (EU) 2022/1644 and shall communicate its evaluation together with comments or recommendations, where needed, to each Member State within 4 months of receipt of the plans. Member States shall provide the Commission with updated versions of the respective plans, outlining how the Commission’s comments have been taken into account, at the latest by 31 March of the following year. Where a Member State decides not to update its control plans based on the Commission’s comments, it shall justify its position. Where the Commission considers that the plans would impair the effectiveness of official controls, updated versions of the concerned plans shall be submitted earlier upon request of, and within a reasonable time period set by the Commission.

By 30 June of each year, Member States shall transmit to EFSA all data from the previous year, including compliant results of screening methods where no confirmatory analyses were performed, gathered under the control plans referred to in Article 3. By 31 August each year, the data validation, review and final acceptance in EFSA data repository systems shall be finalised by each Member State.

Decision 97/747/EC is hereby repealed.

References to Articles 3, 4, 5, 6, 7 and 8 of Directive 96/23/EC and Annexes I and IV to that Directive and to Decision 97/747/EC shall be construed as references to this Regulation.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 15 December 2022.