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 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/808of 22 March 2021on 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(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 of 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 34(6) 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, inter alia, in the area of food safety at all stages of production, processing and distribution. It provides for specific rules on official controls in relation to substances whose use may result in residues in food and feed and sets general requirements for the methods to be used for sampling, laboratory analyses and tests during official controls and other official activities.(2)Commission Decision 2002/657/ECCommission Decision 2002/657/EC of 14 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (OJ L 221, 17.8.2002, p. 8). sets requirements for the performance of analytical methods and the interpretation of results of analyses of certain substances and residues thereof in live animals and animal products and Commission Decision 98/179/ECCommission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products (OJ L 65, 5.3.1998, p. 31). lays down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products. Both Decisions were adopted on the basis of 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)., which was repealed by Regulation (EU) 2017/625. In view of new scientific developments, those rules should be updated and they should be integrated into the framework for official controls defined by Regulation (EU) 2017/625.(3)In accordance with Article 1(2) of Decision 2002/657/EC, that Decision is not to apply to substances for which more specific rules have been laid down in other Union legislation. Those substances are mycotoxins in foodstuffs, dioxins and dioxins-like polychlorinated biphenyls (PCBs) in foodstuffs and lead, cadmium, mercury and benzo(a)pyrene in foodstuffs. Mycotoxins in foodstuffs are to fulfil the requirements set by Commission Regulation (EC) No 401/2006Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12). laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs. Commission Regulation (EU) 2017/644Commission Regulation (EU) 2017/644 of 5 April 2017 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014 (OJ L 92, 6.4.2017, p. 9). laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs apply in the case of dioxins and dioxins-like PCBs. Provisions for the sampling and analysis for the official controls for lead, cadmium, mercury and benzo(a)pyrene in foodstuffs are laid down in Commission Regulation (EC) No 333/2007Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (OJ L 88, 29.3.2007, p. 29)..(4)For reasons of clarity and legal certainty, it is appropriate to merge the provisions applicable to sampling and analysis for pharmacologically active substances into one legal act as in case of mycotoxins, dioxins, dioxin-like PCBs, lead, cadmium, mercury and benzo(a)pyrene in foodstuffs.(5)Decisions 98/179/EC and 2002/657/EC should therefore be repealed and replaced by this Regulation.(6)In accordance with Regulation (EC) No 1831/2003 of the European Parliament and of the CouncilRegulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29). coccidiostats and histomonostats can be used as feed additives, therefore Commission Regulation (EC) No 152/2009Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1). laying down the methods of sampling and analysis for the official control of feed applies to analyses of their content in feed. However, this Regulation should apply where feed are analysed as part of follow-up actions during investigations of the source of non-compliant samples in 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.(7)In order to ensure continuity in the performance of official controls and other official activities on residues of pharmacologically active substances and in order to avoid that all methods need to be re-validated at once, methods which have been validated before the date of entry into force of this Regulation may remain in use for a limited period, subject to the requirements of points 2 and 3 of Annex I to Decision 2002/657/EC. It is therefore appropriate to provide the Member States with sufficient time to apply the requirements laid down in this Regulation to all analytical methods.(8)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: