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)
Commission Implementing Regulation (EU) 2022/1646of 23 September 2022on 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)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(3), points (a) and (b), thereof,Whereas:(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 additional content of the MANCP and specific additional arrangements for its preparation, as well as a uniform minimum frequency of official controls, having regard to the hazards and risks related to 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 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 the content of the MANCP and its preparation, as well as the minimum frequency of official controls, as regards 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)Regulation (EU) 2019/6 of the European Parliament and the CouncilRegulation (EU) 2019/6 of the European Parliament and the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43). establishes the regulatory framework for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and the use of veterinary medicinal products. Furthermore, pharmacologically active substances, which are not authorised in veterinary medicinal products, may not be used in food-producing animals in the EU, with the exception of substances that are essential for the treatment of equine animals as provided for in Commission Regulation (EC) No 1950/2006Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae and of substances bringing added clinical benefit (OJ L 367, 22.12.2006, p. 33)..(5)Member States are required to include 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 both food-producing animals and in products of animal origin in their MANCPs. In order to ensure harmonised and effective controls among Member States to combat the illegal use of growth and productivity promoters in kept animals in all Member States, uniform practical arrangements for the MANCPs should be further defined.(6)In order to verify compliance with Union legislation 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, Member States shall carry out risk-based controls on food-producing animals and products of animal origin, produced in Member States or entering the Union from third countries. Those controls shall be included in each Member State’s MANCP and comprise three plans: a risk-based control plan for production in the Member State, a risk-based control plan for third-country imports, and, in order to collect information useful to orientate future risk-based controls for production in the Member States, Member States should include a randomised surveillance plan.(7)Commission Delegated Regulation (EU) 2022/1644Commission 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 (see page 3 of this Official Journal). lays down rules for the performance of official controls as regards 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.(8)Both the sampling strategy and risk criteria for defining the content of the risk-based control plan for production in the Member State should be set in accordance with Delegated Regulation (EU) 2022/1644 and a justification should be included in that plan regarding the implementation of the risk criteria. Where, in the course of the execution of this control plan during a specific year, new information becomes available on illegal treatments, for example through the surveillance plan, Member States should update the risk-based control plan for production in the Member State without delay in order to ensure responsible use of pharmacologically active substances and a high level of human health protection. In order to guarantee a uniform minimum frequency of controls, this Regulation should define minimum control frequencies to be included in the MANCP.(9)Member States shall also include in their MANCPs a dedicated surveillance plan, based on random sampling and testing for a wide range of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof which might not be included in the risk-based national plans.(10)For the surveillance plan, it is appropriate that about 8000 samples across the Union are taken. The controls and the associated sampling should be apportioned across the Member States. Those minimum sampling frequencies should be included in the MANCP.(11)In order to ensure that the results obtained under the surveillance plan are comparable, this plan should specify the type of analytical methods to be used and the method requirements. For the surveillance plan for prohibited and unauthorised substances, in addition to confirmatory methods, targeted and non-targeted screening methods are effective to identify unexpected illegal uses of authorised, prohibited and unauthorised pharmacologically active substances. For the surveillance plan for authorised substances, screening or confirmatory methods capable of quantifying residues below the maximum residue limit ("MRL") should be used and the concentrations which are quantified below the MRL should be reported in addition to those at or above the MRL.(12)In addition to controls on Member States’ production, Member States should include a control plan for products, which are intended for the entry into the Union from third countries in their MANCP in order to verify the effectiveness of third countries’ residue controls and the compliance of imported products of animal origin with the Union rules. In order to guarantee a uniform minimum frequency of the controls carried out under the plan for third-country imports and to ensure that they are carried out at least at a frequency which is equal to the control frequency for risk-based control plan for production in Member States, this Regulation should define the minimum frequencies for those controls to be applied by Member States, through whose border control posts the animals and products of animal origin enter the Union.(13)In order to ensure a harmonised and comprehensive content of the MANCP on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances in food-producing animals and residues thereof in animals and products of animal origin, the relevant aspects of its content should be defined.(14)Sampling procedures, handling and transport conditions have an influence on the ability to detect the presence 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 samples. Therefore, Member States should follow the rules laid down in 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)..(15)It is necessary to ensure that the analytical results gathered under the control plans 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 the interpretation of the results are comparable. Therefore, the plans should describe the analytical methods to be used as well as their performance requirements, in accordance with the provisions of Implementing Regulation (EU) 2021/808.(16)In order to ensure that Member States’ risk-based control plans for both Union production and for third-country imports, as well as their surveillance plans for production in the Member States, comply with this Regulation, Member States should submit these control plans to the Commission for evaluation annually. The Commission should communicate its comments to the Member States if needed. Member States should prepare a revised and updated plan incorporating the comments no later than 31 March of the following year. However, where the Commission considers that the plans would impair the effectiveness of official controls, it should be able to request the Member State to submit an updated plan addressing the Commission’s comments at an earlier date.(17)In accordance with Article 33 of 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)., the data collected by the Member States through official controls in respect of 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 must be submitted to the European Food Safety Authority ("EFSA"). In order to allow for the monitoring of recent data, all Member States should submit data on a regular basis and by the same date.(18)Commission Decision 97/747/EC97/747/EC: Commission Decision of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products (OJ L 303, 6.11.1997, p. 12)., fixing levels and frequencies of sampling in addition to those provided for in the Annexes to Directive 96/23/EC, should be repealed as its provisions are replaced by the provisions of this Regulation.(19)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.(20)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: