COMMISSION REGULATION (EU) 2023/163

of 18 January 2023

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for DDT and oxathiapiprolin 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), point (a), and Article 16 thereof,

Whereas:

(1) For oxathiapiprolin, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For DDT, MRLs were set in in Annex II and Part B of Annex III to that Regulation, depending on the product.

(2) An application for import tolerance pursuant to Article 6(2) and (4) of Regulation (EC) No 396/2005 was submitted for oxathiapiprolin used in the United States on blueberries. The applicant provided data showing that the authorised uses of that substance on this crop in the United States lead to residues exceeding the MRL contained in Regulation (EC) No 396/2005 and that a higher MRL is necessary to avoid trade barriers for the importation into the Union of that crop.

(3) In accordance with Article 8 of Regulation (EC) No 396/2005, this application was evaluated by the Member State concerned and the evaluation report was forwarded to the Commission.

(4) The European Food Safety Authority (‘the Authority’) assessed the application and the evaluation report, examining in particular the risks to consumers and, where relevant, to animals, and gave a reasoned opinion on the proposed MRL (2). It forwarded this opinion to the applicant, the Commission and the Member States and made them available to the public.

(5) The Authority concluded that all requirements with respect to completeness of data submission were met and that the modification to the MRL requested by the applicant was acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substance. Neither the long-term exposure to this substance via consumption of all food products that may contain it, nor the short-term exposure due to high consumption of the relevant product showed a risk that the acceptable daily intake or the acute reference dose is exceeded.

(6) Based on the reasoned opinion of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modification to the MRLs fulfils the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(7) As regards DDT, this active substance is a persistent organic pollutant (POP), and as such the placing on the market and use of plant protection products containing it was prohibited by Commission Directive 83/131/EEC (3). Nevertheless, despite the fact that DDT is no longer used in the Union, it can still be detected at very low levels in some plant and animal products due to its persistency in the environment. Therefore, MRLs were set for DDT in all products of plant and animal origin by Commission Regulation (EC) No 149/2008 (4). That Regulation set the MRLs for commodities from swine (which include farmed wild boars) at 1 mg/kg, and the MRL for wild terrestrial animals (which include wild boars) at 0,05 mg/kg.

(8) The Authority provided to the Commission monitoring data ranging from 2016 to 2020, showing that residues of DDT occur in wild boar products at levels higher than the current MRL for wild terrestrial animals, but in the same order of magnitude as the current MRL set for swine. Based on those most recent monitoring data, which reflect persistent levels in the environment, and in order to allow consistency in enforcement action taken by Member States, it is appropriate to align the existing MRL for DDT in wild boars with the MRL for that substance in swine.

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

(10) 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 Annexes II and III to Regulation (EC) No 396/2005 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 18 January 2023. For the Commission The President Ursula VON DER LEYEN

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

(2) EFSA scientific reports are available online: http://www.efsa.europa.eu.

Reasoned Opinion on the setting of an import tolerance for oxathiapiprolin in blueberries. EFSA Journal 2022;20(5):7347.

(3) Commission Directive 83/131/EEC of 14 March 1983 amending the Annex to Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances (OJ L 91, 9.4.1983, p. 35).

(4) Commission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex I thereto (OJ L 58, 1.3.2008, p. 1).