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)

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter

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.

Article 2

Definitions

For the purposes of this Regulation, the definitions in Regulation (EC) No 178/2002, Commission Delegated Regulation (EU) 2019/2090 (¹), Implementing Regulation (EU) 2021/808 and Delegated Regulation (EU) 2022/1644 apply.

CHAPTER II

SPECIFIC ADDITIONAL CONTENT OF THE MANCP

Article 3

General provisions

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.

Article 4

National risk-based control plan for production in the Member States

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.

Article 5

National randomised surveillance plan for production in the Member States

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.

Article 6

National risk-based control plan for third-country imports

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 (²) 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).

Article 7

Additional content of the national risk-based control plans and the national randomised surveillance plan

The national risk-based control plans, referred to in Articles 4 and 6, and the national randomised surveillance plan, referred to in Article 5, shall specify the following:

(a) the species to be sampled and the place of sampling;

(b) the national legislation on the use of pharmacologically active substances and, in particular, their prohibition or their authorisation, distribution, placing on the market and administration, in so far as that legislation is not harmonised by Union legislation;

(c) the competent authorities responsible for the implementation of the plans.

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 plans of the previous year;

(b) a justification on how cases of non-compliance in the relevant Member State detected in the previous three calendar years were taken into account for optimising the plans.

Member States are not required to submit information already provided in the general part of MANCPs in accordance with Article 110(2) of Regulation (EU) 2017/625.

CHAPTER III

SUBMISSION AND EVALUATION OF THE PLANS AND SUBMISSION OF DATA BY THE MEMBER STATES

Article 8

Submission and evaluation of the national risk-based control plans and the national randomised surveillance plan

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.

Article 9

Submission of data by the Member State

By 30 June each year, Member States shall transmit to the European Food Safety Authority (‘EFSA’) all data from the previous year, including compliant results of screening methods where no confirmatory analyses were performed, gathered under the control plans and the surveillance plan referred to in Article 3. Those data shall also contain 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 were detected in the previous year.

By 31 August each year, Member States shall finalise the data validation, review and final acceptance in the EFSA data repository systems.

CHAPTER IV

GENERAL PROVISIONS

Article 10

Repeal of Decision 97/747/EC

Decision 97/747/EC is hereby repealed.

Article 11

References

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.

Article 12

Entry into force and application

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

Minimum sampling frequency per Member State in the national risk-based control plan for production in the Member States (as referred to in Article 4(c))

The minimum number of samples is as follows:

	Sampling frequency – Group A substances
Bovine	Minimum 0,25 % of the slaughtered animals (minimum 25 % of the samples to be taken from live animals on the farm and minimum 25 % of the samples to be taken at the slaughterhouse)
Sheep and goats	Minimum 0,01 % of the slaughtered animals per species
Porcine	Minimum 0,02 % of the slaughtered animals
Equine	Minimum 0,02 % of the slaughtered animals
Poultry	For each category of poultry considered (broiler chickens, spent hens, turkeys and other poultry) minimum 1 sample per 400 tons of annual production (deadweight)
Aquaculture (finfish, crustaceans and other aquaculture products)	Minimum 1 sample per 300 tonnes of annual production of aquaculture for the first 60 000 tonnes of production and then 1 additional sample for each additional 2 000 tonnes
Bovine, ovine and caprine milk	Minimum 1 sample per 30 000 tonnes of annual production of milk per species
Hen eggs and other eggs	Minimum 1 sample per 2 000 tonnes of annual production of eggs per species
Rabbits, farmed game, reptiles and insects	Minimum 1 sample per 100 tonnes of annual production (dead weight) of rabbits, farmed game or reptiles for the first 3 000 tonnes of production and 1 sample for each additional 1 000 tonnes Minimum 1 sample per 25 tonnes annual production of insects
Honey	Minimum 1 sample per 50 tonnes of annual production for the first 5 000 tonnes of production and then 1 additional sample for each additional 500 tonnes
Casings ()	Minimum 1 sample per 300 tonnes of annual production
(1) As defined in Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).
	Sampling frequency – Group B substances
---	---
Bovine	Minimum 0,10 % of the slaughtered animals
Sheep and goats	Minimum 0,02 % of the slaughtered animals per species
Porcine	Minimum 0,02 % of the slaughtered animals
Equine	Minimum 0,02 % of the slaughtered animals
Poultry	For each category of poultry considered (broiler chickens, spent hens, turkeys and other poultry) minimum 1 sample per 500 tonnes of annual production (deadweight)
Aquaculture (finfish, crustaceans and other aquaculture products)	Minimum 1 sample per 300 tonnes of annual production of aquaculture for the first 60 000 tonnes of production and then 1 additional sample for each additional 2 000 tonnes
Bovine, ovine and caprine milk	Minimum 1 sample per 30 000 tonnes of annual production of milk per species
Hen eggs and other eggs	Minimum 1 sample per 2 000 tonnes of annual production of eggs per species
Rabbits, farmed game, reptiles and insects	Minimum 1 sample per 50 tonnes of annual production (dead weight) of rabbits, farmed game or reptiles for the first 3 000 tonnes of production and 1 sample for each additional 500 tonnes Minimum 1 sample per 25 tonnes annual production of insects
Honey	Minimum 1 sample per 50 tonnes of annual production for the first 5 000 tonnes of production and then 1 additional sample for each additional 500 tonnes

Additional provisions

(a) If relevant to verify compliance with Union legislation on the use of prohibited or unauthorised pharmacologically active substances, Member States may take samples from feed, water or another relevant matrix or environment and counted towards achieving the minimum sampling frequencies provided for in this Annex.

(b) Controls on each combination of sub-groups of Group A substances and commodity groups as listed in Annex II to Delegated Regulation (EU) 2022/1644 shall be performed annually in minimum 5 % of the samples taken in accordance with the table of this Annex for that commodity group. This minimum percentage does not apply to casings, and it does not apply to substance groups A(3), point (b) and A(3), point (f) for all commodity groups.

(c) For the Group B substances, the selection of specific substances for testing within each substance group is to be decided according to criteria listed in Annex II to Delegated Regulation (EU) 2022/1644.

(d) Within bovine, ovine and caprine group, the samples shall be taken from all species, taking into account their relative production volume. Sampling shall cover both animals for dairy production and for meat production.

(e) Within the poultry group, samples shall be taken from broiler chickens, spent hens, turkey and other poultry, taking into account their relative production volume.

(f) Within the aquaculture group, samples shall be taken from fresh and seawater aquaculture species, taking into account their relative production volume.

(g) When there is a reason to believe that pharmacologically active substances are being applied to the other aquaculture products, then these species must be included in the sampling plan in proportion to their production as additional samples to those taken for finfish farming products.

(h) The necessary number of targeted samples shall be taken in order to achieve the prescribed sampling frequency. This refers to the number of animals sampled (or group of animals likely to be treated in a certain group (e.g. fish)) irrespective of number of tests carried our per sample.

(i) When substances from Group A and Group B are analysed in one sample from a single animal, this sample can be taken into account towards the minimum sampling frequency for both groups (Group A and Group B) given that it can be documented, and that the risk criteria for Group A and Group B are the same. If another sample of another matrix is taken from the same animal for the analysis of group A and/or group B substances, the result is not taken into account towards the minimum sampling frequency. However in case substances from Group A are analysed in a sample of one matrix from a single animal and substances from Group B are analysed in a sample of another matrix from the same animal, then both samples can be taken into account towards the minimum sampling frequency for both groups (Group A and Group B) given that it can be documented, and that the risk criteria for Group A and Group B have been applied.