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.
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.
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.
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 ( 10 ) 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).
Additional content of the national risk-based control plans and randomised surveillance plan
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.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
