COMMISSION IMPLEMENTING REGULATION (EU) 2021/601

of 13 April 2021

concerning a coordinated multiannual control programme of the Union for 2022, 2023 and 2024 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), in particular Article 29(2) thereof,

Whereas:

(1) Commission Regulation (EC) No 1213/2008 (2) established a first coordinated multiannual Community control programme, covering the years 2009, 2010 and 2011. That programme continued under consecutive Commission Regulations. The latest one was Commission Implementing Regulation (EU) 2020/585 (3).

(2) Thirty to forty foodstuffs constitute the major components of the diet in the Union. Since pesticide uses show significant changes over a period of three years, pesticides should be monitored in those foodstuffs over a series of three-year cycles to allow consumer exposure and the application of Union legislation to be assessed.

(3) The European Food Safety Authority (‘the Authority’) submitted a scientific report on a design assessment of the pesticide monitoring program. It concluded that an MRL exceedance rate above 1 % could be estimated with a margin of error of 0,75 % by selecting 683 sample units for a minimum of 32 different food items (4). Collection of those samples should be apportioned among Member States according to population numbers, with a minimum of 12 samples per product and per year.

(4) Analytical results from the previous official control programmes of the Union have been taken into account to ensure that the range of pesticides covered by the control programme is representative for the pesticides used.

(5) Guidance concerning ‘Analytical quality control and validation procedures for pesticide residues analysis in food and feed’ is published on the Commission website (5).

(6) Where the residue definition of a pesticide includes other active substances, metabolites and/or breakdown or reaction products, those compounds should be reported separately as far as they are measured individually (6).

(7) Implementing measures, such as the Standard Sample Description version 2 (SSD2) and the Chemical Monitoring Reporting Guideline, for submitting results of pesticide residues analysis, relating to the submission of information by Member States, have been agreed by Member States, the Commission and the Authority.

(8) For the sampling procedures, Commission Directive 2002/63/EC (7), which incorporates the sampling methods and procedures recommended by the Codex Alimentarius Commission, should apply.

(9) It is necessary to assess whether maximum residue levels for food for infants and young children provided for in Article 10 of Commission Directive 2006/141/EC (8), Article 7 of Commission Directive 2006/125/EC (9) and Article 4 of Commission Delegated Regulation (EU) 2016/127 (10) are respected, taking into account only the residue definitions as they are set out in Regulation (EC) No 396/2005.

(10) As regards single residue methods, Member States may be able to meet their obligations of analysis by having recourse to official laboratories already having the required validated methods.

(11) Member States should submit by 31 August of each year the information concerning the previous calendar year.

(12) In order to avoid any confusion due to an overlap between consecutive multiannual programmes, Implementing Regulation (EU) 2020/585 should be repealed in the interest of legal certainty. It should, however, continue to apply to samples tested in 2021.

(13) 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:

Article 1 Member States (*1) shall, during the years 2022, 2023 and 2024, take and analyse samples for the pesticide/product combinations, as set out in Annex I. The number of samples of each product, including foods for infants and young children and products originating from organic farming, shall be as set out in Annex II.

Article 2 1. The lot to be sampled shall be chosen randomly. The sampling procedure, including the number of units, shall comply with Directive 2002/63/EC. 2. All samples, including those of foods intended for infants and young children and products originating from organic farming, shall be analysed for the pesticides referred to in Annex I in accordance with the residue definitions set out in Regulation (EC) No 396/2005. 3. For foods intended for infants and young children, samples shall be evaluated on the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers, taking into account the MRLs set out in Directives 2006/125/EC and 2006/141/EC and in Delegated Regulation (EU) 2016/127. Where such foods can be consumed both as sold and as reconstituted, the results shall be reported on the non-reconstituted product as sold.

Article 3 Member States shall submit the results of the analysis of samples tested in 2022, 2023 and 2024 by 31 August 2023, 2024 and 2025 respectively. Those results shall be submitted in the electronic reporting format as set out by the Authority. Where the residue definition of a pesticide includes more than one compound (active substance and/or metabolite or breakdown or reaction product), Member States shall report the analysis results in accordance with the full residue definition. In addition, the results of all analytes that are part of the residue definition shall be submitted separately, as far as they are measured individually.

Article 4 Implementing Regulation (EU) 2020/585 is repealed. However, as regards samples tested in 2021, it shall continue to apply until 1 September 2022.

Article 5 This Regulation shall enter into force on 1 January 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 13 April 2021. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

(2) Commission Regulation (EC) No 1213/2008 of 5 December 2008 concerning a coordinated multiannual Community control programme for 2009, 2010 and 2011 to ensure compliance with maximum residue levels of and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 328, 6.12.2008, p. 9).

(3) Commission Implementing Regulation (EU) 2020/585 of 27 April 2020 concerning a coordinated multiannual control programme of the Union for 2021, 2022 and 2023 to ensure compliance with maximum levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 135, 29.4.2020, p. 1).

(4) European Food Safety Authority; pesticide monitoring program: design assessment. EFSA Journal 2015;13(2):4005.

(5) Document No. SANTE/12682/2019.

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_wrkdoc_2019-12682.pdf in its most recent version.

(6) SANCO/12574/2014, Working Document on the summing up of LOQs in case of complex residue definitions.

(7) Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30).

(8) Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1).

(9) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).

(10) Commission Delegated Regulation (EU) 2016/127 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding (OJ L 25, 2.2.2016, p. 1).

(*1) Pursuant to Article 5(4) and Section 24 of Annex 2 of the Protocol on Ireland/Northern Ireland, which is an integral part of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, this Regulation applies to and in the United Kingdom in respect of Northern Ireland and references to Member States are read as including the United Kingdom in respect of Northern Ireland as long as that Protocol applies.