Home Europe European Commission Commission Delegated Regulation (EU) 2024/2562 of 3 June 202...
Date: 27-Sep-2024 Category: Not Applicable State: Union Government Country: Europe

Commission Delegated Regulation (EU) 2024/2562 of 3 June 2024 amending Delegated Regulation (EU) 2022/1644 as regards certain criteria for the selection of samples

Issued by European Commission · Directorate-General for Health and Food Safety

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Executive Summary & Key Takeaways

What it means

  • Commission Delegated Regulation (EU) 2024/2562 amends Delegated Regulation (EU) 2022/1644 regarding criteria for selecting samples for national risk-based control plans and national randomised surveillance plans related to pharmacologically active substances in food-producing animals.
  • The amendment removes mandatory sampling requirements for certain combinations of substance groups and commodity groups where no relevant substances are found based on practical experience.

Key Changes

  • Removes the mandatory sampling requirement for substance group A(3), point (b) (certain prohibited or unauthorized pharmacologically active substances) for raw bovine, ovine, and caprine milk and honey in national risk-based control plans.
  • Removes the mandatory sampling requirement for substance group A(3), point (f) (certain prohibited or unauthorized pharmacologically active substances) for certain commodities in national risk-based control plans.
  • Rephrases the provision on Group A substances in Annex IV to improve clarity regarding criteria for selecting combinations of substance groups and commodity groups for national randomised surveillance plans.
  • Removes the mandatory sampling requirement for substance group B(1), point (e) (certain veterinary drugs) for all commodity groups in national randomised surveillance plans.
  • Removes the mandatory sampling requirement for substance group B(2) (certain contaminants) for raw bovine, ovine, and caprine milk in national randomised surveillance plans.
  • The amended regulation will apply from 1 January 2025, and will be first included in the plans for the year 2025.

Impact Analysis

Member States

  • Member states must ensure that the samples taken for Group A substances are different from those in the national risk-based control plans.

Food Producers

  • Food producers need to remain compliant with regulations regarding pharmacologically active substances, even with reduced sampling.

European Commission

  • The Commission will monitor the implementation of the amended regulation and its impact on food safety and animal health.

Suggested Action Items

  • European Commission: Monitor the implementation of the regulation and assess its effectiveness in achieving its objectives.

Key Entities Referenced

Commission Delegated Regulation (EU) 2024/2562: The amending regulation that modifies Delegated Regulation (EU) 2022/1644. Delegated Regulation (EU) 2022/1644: The original regulation concerning specific requirements for official controls on pharmacologically active substances in food-producing animals. Regulation (EU) 2017/625: The Official Controls Regulation, which provides the framework for 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. Commission Implementing Regulation (EU) 2022/1646: Regulation 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.
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Official Journal EN of the European Union L series 2024/2562 27.9.2024 COMMISSION DELEGATED REGULATION (EU) 2024/2562 of 3 June 2024 amending Delegated Regulation (EU) 2022/1644 as regards certain criteria for the selection of samples (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 2017on 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)(1), and in particular Article 19(2), point (a), thereof, Whereas: (1) Annex II to Commission Delegated Regulation (EU) 2022/1644(2) sets out criteria for the selection of specific combinations of substance groups and commodity groups for the national risk-based control plans for production in the Member States. Based on practical experience with the application of Delegated Regulation (EU) 2022/1644, there are no relevant substances from substance group A(3), point (b) for raw bovine, ovine and caprine milk and for honey in the national risk-based control plans for production in the Member States to be checked. Furthermore, after the entry into force of Delegated Regulation (EU) 2022/1644, the content of the subgroups of prohibited or unauthorised pharmacologically active substances in food-producing animals (‘Group A substances’) referred to in Annex I to that Delegated Regulation has evolved. As a consequence, there are no relevant substances from substance group A(3), point (f) for certain commodities to be checked. Therefore, the mandatory requirement of sampling should be removed from the table in point A.1 of Annex II to Delegated Regulation (EU) 2022/1644 for the combinations of substance groups and commodity groups concerned. (2) Annex IV to Delegated Regulation (EU) 2022/1644 contains a provision on Group A substances that specifies the criteria for the selection of specific combinations of substance groups and commodity groups for the national randomised surveillance plans for production in the Member States. To improve the clarity of that provision, it should be rephrased. (3) Based on practical experience with the application of Delegated Regulation (EU) 2022/1644, there are no relevant substances from substance group B(1), point (e) for all commodity groups and no relevant substances from substance group B(2) for raw bovine, ovine and caprine milk in the national randomised surveillance plans for production in the Member States to be checked. Therefore, the mandatory requirement of sampling should be removed from the table in Annex IV to Delegated Regulation (EU) 2022/1644 for the combinations of substance groups and commodity groups concerned. (4) Delegated Regulation (EU) 2022/1644 should therefore be amended accordingly. (1) OJ L 95, 7.4.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/625/oj. (2) 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 (OJ L 248, 26.9.2022, p. 3, ELI: http://data.europa.eu/eli/reg_del/2022/1644/oj). ELI: http://data.europa.eu/eli/reg_del/2024/2562/oj 1/3EN OJ L, 27.9.2024 (5) As the rules laid down in Delegated Regulation (EU) 2022/1644 are to be included in the national risk-based control plans and the national randomised surveillance plans that are to be submitted to the Commission for evaluation annually in accordance with Commission Implementing Regulation (EU) 2022/1646(3), this Regulation should apply for the first time to the plans for the year 2025. This Regulation should therefore apply from 1 January 2025, HAS ADOPTED THIS REGULATION: Article 1 Annexes II and IV to Delegated Regulation (EU) 2022/1644 are amended in accordance with the Annex to this Regulation. Article 2 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 1 January 2025. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 3 June 2024. For the Commission The President Ursula VON DER LEYEN (3) 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 (OJ L 248, 26.9.2022, p. 32, ELI: http://data. europa.eu/eli/reg_impl/2022/1646/oj). 2/3 ELI: http://data.europa.eu/eli/reg_del/2024/2562/ojEN OJ L, 27.9.2024 ANNEX Annexes II and IV to Delegated Regulation (EU) 2022/1644 are amended as follows: (1) Annex II is amended as follows: (a) in point A.1, in the table, the entry for substance group A(3), point (b) is replaced by the following: ‘A(3), X X X X X X X’ point (b) (b) in point A.1, in the table, the entry for substance group A(3), point (f) is replaced by the following: ‘A(3), X X X X X X X’ point (f) (2) Annex IV is amended as follows: (a) the part on Group A substances is replaced by the following: ‘Group A substances The samples that consist in combinations of substance groups and commodity groups shall be different from the samples taken referred to in the national risk-based control plans for production in the Member States.’; (b) in the part on Group B substances, in the table, the entry for substance group B1e is replaced by the following: ‘B1e’ (c) in the part on Group B substances, in the table, the entry for substance group B2 is replaced by the following: ‘B2 X X X X X X’ ELI: http://data.europa.eu/eli/reg_del/2024/2562/oj 3/3

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