Commission Delegated Regulation (EU) 2022/1644 of 7 July 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with specific requirements for 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 (Text with EEA relevance)

Article 1

For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council⁽¹⁾, Commission Delegated Regulation (EU) 2019/2090⁽²⁾ and Commission Implementing Regulation (EU) 2021/808⁽³⁾ apply.

In addition, the following definitions apply:

‘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.
‘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.
‘random sampling’ means the taking of an official sample or samples under statistical consideration to provide representative data
‘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.
‘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.
‘food-producing animals’ means animals bred, raised, kept, slaughtered or harvested for the purposes of producing food.
‘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.

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

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

Article 4

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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

ANNEX IICriteria for the selection of specific combination of substance groups and commodity groups for national risk-based control plan for production in the Member States (as referred to in Article 2(2))

ANNEX IIICriteria for sampling strategy for national risk-based control plan for production in the Member States (as referred to in Article 2(2))

ANNEX IVCriteria for the selection of specific combination of substance groups and commodity groups for national randomised surveillance plan for production in the Member States (as referred to in Article 2(3))

ANNEX VCriteria for sampling strategy for national randomised surveillance plan for production in the Member States (as referred to in Article 2(3)

ANNEX VICriteria for the selection of specific combination of substance groups and commodity groups for national risk-based control plan for third country imports (as referred to in Article 2(4))