Commission Regulation (EU) 2021/663 of 22 April 2021 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlordecone in or on certain products (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), and in particular Article 14(1)(a) in conjunction with Article 16(1)(a) thereof,

Whereas:

(1) For chlordecone, maximum residue levels (MRLs) were set in Annex III to Regulation (EC) No 396/2005.

(2) Regulation (EC) No 850/2004 of the European Parliament and of the Council (2) prohibited the placing on the market and use of plant protection products containing chlordecone. Residues of chlordecone are resulting from environmental contamination in soil due to the use of this persistent compound in the past.

(3) On 12 July 2019, the French competent authorities notified to the Commission two emergency measures (3) (4), which had been taken at national level pursuant to Article 54 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (5). Following the opinions (6) (7) of the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), France had fixed national MRLs for chlordecone in bovine, ovine, caprine, porcine and poultry products at lower values than the ones currently applicable under Regulation (EC) No 396/2005, to ensure the protection of consumers in Guadeloupe and Martinique.

(4) The Commission requested the European Food Safety Authority (‘the Authority’) to carry out a consumer exposure assessment in relation to the MRLs recommended by ANSES for chlordecone in products of animal origin.

(5) The Authority submitted a scientific statement for chlordecone in certain products of animal origin (8) in accordance with Article 43 of Regulation (EC) No 396/2005. In that statement, the Authority concluded that the MRLs proposed in the opinions of ANSES for animal products, rounded according to the Organisation for Economic Cooperation and Development (OECD) guidelines on the MRL calculation, are acceptable with regard to consumer safety. Neither the lifetime nor the short-term exposure due to high consumption of the relevant products showed that there is a risk that the acceptable daily intake or the acute reference dose is exceeded. The MRLs for chlordecone should be set as temporary in Annex III to Regulation (EC) No 396/2005. Those MRLs will be reviewed; the review will take into account the information available within 10 years from the publication of this Regulation.

(6) Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

(7) Regulation (EC) No 396/2005 should therefore be amended accordingly.

(8) A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.

(9) 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

Annex III to Regulation (EC) No 396/2005 is 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 13 November 2021.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 April 2021.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

(2) Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants and amending Directive 79/117/EEC (OJ L 158, 30.4.2004, p. 7).

(3) Arrêté du 25 janvier 2019 modifiant l’arrêté du 30 juin 2008 relatif aux limites maximales applicables aux résidus de chlordécone que ne doivent pas dépasser certaines denrées alimentaires d’origine végétale et animale pour être reconnues propres à la consommation humaine (NOR: AGRG1901040A).

(4) Arrêté du 23 mai 2019 modifiant l’arrêté du 25 janvier 2019 relatif aux limites maximales applicables aux résidus de chlordécone que ne doivent pas dépasser certaines denrées alimentaires d’origine végétale et animale pour être reconnues propres à la consommation humaine (NOR: AGRG1913466A).

(5) Regulation (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).

(6) Note d’appui scientifique et technique de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relative à la fixation d’une limite maximale de résidus de chlordécone dans la graisse pour les denrées carnées (2018-SA-0202).

(7) Avis de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à la fixation d’une limite maximale de résidus de chlordécone dans les muscles et dans la graisse pour les denrées carnées (2018-SA-0265).

(8) Statement on the dietary exposure assessment for the temporary maximum residue levels for chlordecone in certain products of animal origin. EFSA Journal 2020;18(3):6052.