Nařízení Komise v přenesené pravomoci (EU) 2022/1644 ze dne 7. července 2022, kterým se doplňuje nařízení Evropského parlamentu a Rady (EU) 2017/625 o zvláštní požadavky na provádění úředních kontrol používání farmakologicky účinných látek povolených jako veterinární léčivé přípravky nebo jako doplňkové látky a zakázaných nebo nepovolených farmakologicky účinných látek a jejich reziduí (Text s významem pro EHP)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/625 of the European Parliament and the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)OJ L 95, 7.4.2017, p. 1 . , and in particular Article 19(2), point (a), thereof,

For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the CouncilRegulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1 ). , Commission Delegated Regulation (EU) 2019/2090Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317, 9.12.2019, p. 28 ). and Commission Implementing Regulation (EU) 2021/808Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC (OJ L 180, 21.5.2021, p. 84 ). apply.

In addition, the following definitions apply:

OJ L 95, 7.4.2017, p. 1 .

(1) Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities by the competent authorities of the Member States to verify compliance with Union legislation in the area of food and feed safety. In particular, Article 9 of that Regulation requires competent authorities to perform official controls on all operators regularly, on a risk basis and with an appropriate frequency. Article 109 of that Regulation obliges Member States to ensure that official controls are performed by the competent authorities on the basis of a multi-annual national control plan (MANCP). Regulation (EU) 2017/625 furthermore specifies the general content of the MANCP, including the requirement for Member States to provide in their MANCP 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. Regulation (EU) 2017/625 empowers the Commission to lay down specific requirements for the performance of those official controls, including, where appropriate, the range of samples and the stage of production, processing and distribution where the samples have to be taken, having regard to the hazards and risks related to the substances referred to in Article 19(1) of that Regulation.

(2) Regulation (EU) 2017/625 repealed Council Directive 96/23/ECCouncil Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10 ). with effect from 14 December 2019 and lays down the relevant transitional measures. Those transitional measures provide that, until 14 December 2022 , competent authorities are to continue to perform the official controls necessary in accordance with Directive 96/23/EC to detect the presence of certain substances and groups of residues. Specifically, the transitory measures set requirements for Member States’ monitoring plans for the detection of residues or substances within its scope.

(3) This Regulation ensures the continuity of the rules laid down in Directive 96/23/EC concerning official controls of residues of substances having a pharmacological action, of their metabolites and of other substances transmissible to animal products that are likely to be harmful to human health.

(4) This Regulation sets rules for the range of samples and the stage of production, processing and distribution at which the samples are to be taken 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.

(5) In order to ensure that controls are effectively targeted in all Member States, it is appropriate to set out rules on the combinations of substance groups and commodity groups to be sampled by Member States and the sampling strategy, including criteria to define the content of national risk-based plans and randomised surveillance plans and the performance of the related official controls.

(6) Commission Implementing Regulation (EU) 2022/1646Commission Implementing Regulation (EU) 2022/1646 of 7 July 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 (See page 32 of this Official Journal). lays down the 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 and also specifies the content and arrangements of the MANCP as regards these substances and residues

(7) Articles 4, 5 and 6 of Implementing Regulation (EU) 2022/1646 specify the content of national risk-based plans and randomised surveillance plan focused on 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. These plans should contain, inter alia, the list of combinations of substances and species, products and matrices which are included in the control plans for which the rules for that selection are defined in this Delegated Regulation. Member States should include in their national plans also sampling strategy for which criteria mentioned in this Delegated Regulation should be taken into account.

(8) As the rules laid down in the Annexes to Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and products of animal origin are to be applied until 14 December 2022 , this Regulation should apply from 15 December 2022 ,

(1) official sample means a sample taken by the competent authority, which bears, for the purposes of examination of the residues or substances listed in Annex I, a reference to the species, the type, the quantity concerned, the method of collection and particulars identifying the sex of the animal and the origin of the animal or of the product of animal origin, as applicable.

(2) targeted sampling means taking official sample or samples with the aim of maximising the possibility of detecting non-compliance with maximum residue limits or maximum levels, established under Union legislation for pharmacologically active substances.

(3) random sampling means the taking of an official sample or samples under statistical consideration to provide representative data

(4) suspect sampling means taking official samples as a follow-up to non-compliant control results or as the follow-up to any suspected or established non-compliance with Union rules on pharmacologically active substances, as laid down in Regulation (EU) 2019/2090.

(5) matrix means the material from which a sample is taken, including animal body parts, fluids, excrements, tissues, products of animal origin, animal by-products, animal feed and water.

(6) food-producing animals means animals bred, raised, kept, slaughtered or harvested for the purposes of producing food.

(7) residue means a residue of substances having a pharmacological action, of metabolites of such substances, degradation products of such substances and of other related substances present in animals or products of animal origin.

Member States shall control the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and the presence of prohibited or unauthorised pharmacologically active substances and residues thereof listed in Annex I.

For national risk-based control plans for production in the Member States, as specified in Article 4 of Implementing Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and commodity groups in accordance with Annex II to this Regulation and they shall adopt a sampling strategy in accordance with the criteria set out in Annex III to this Regulation.

For national randomised surveillance plans for production in the Member States, as specified in Article 5 of Implementing Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and commodity groups in accordance with Annex IV to this Regulation and they shall adopt a sampling strategy in accordance with the criteria set out in Annex V to this Regulation.

For national risk-based control plans for third country imports, as specified in Article 6 of Implementing Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and commodity groups in accordance with Annex VI to this Regulation and they shall adopt a sampling strategy in accordance with the criteria set out in Annex VII to this Regulation.

Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10 ).

Article 1 Article 1

Article 2 Article 2 1.Member States shall control the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and the presence of prohibited or unauthorised pharmacologically active substances and residues thereof listed in Annex I. 2.For national risk-based control plans for production in the Member States, as specified in Article 4 of Implementing Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and commodity groups in accordance with Annex II to this Regulation and they shall adopt a sampling strategy in accordance with the criteria set out in Annex III to this Regulation. 3.For national randomised surveillance plans for production in the Member States, as specified in Article 5 of Implementing Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and commodity groups in accordance with Annex IV to this Regulation and they shall adopt a sampling strategy in accordance with the criteria set out in Annex V to this Regulation. 4.For national risk-based control plans for third country imports, as specified in Article 6 of Implementing Regulation (EU) 2022/1646, Member States shall control combinations of substance groups and commodity groups in accordance with Annex VI to this Regulation and they shall adopt a sampling strategy in accordance with the criteria set out in Annex VII to this Regulation.

Article 3 Article 3

Article 4 Article 4

References to Annexes II and III to Directive 96/23/EC shall be construed as references to this Regulation.

Commission Implementing Regulation (EU) 2022/1646 of 7 July 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 (See page 32 of this Official Journal).

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 .

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1 ).

Commission Delegated Regulation (EU) 2019/2090 of 19 June 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and Council regarding cases of suspected or established non-compliance with Union rules applicable to the use or residues of pharmacologically active substances authorised in veterinary medicinal products or as feed additives or with Union rules applicable to the use or residues of prohibited or unauthorised pharmacologically active substances (OJ L 317, 9.12.2019, p. 28 ).

Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC (OJ L 180, 21.5.2021, p. 84 ).

HAS ADOPTED THIS REGULATION: