Commission Regulation (EU) 2024/1314 of 15 May 2024 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dithianon in or on certain products

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), thereof,

Whereas:

(1) The maximum residue levels (‘MRLs’) for dithianon are set out in Part A of Annex III to Regulation (EC) No 396/2005.

(2) The Authority has submitted a reasoned opinion on the review of the existing MRLs for dithianon in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). The Authority noted that the mutagenicity potential of the metabolite 1,4-naphthoquinone remains uncertain, pending the submission of additional studies fulfilling the previously identified data gap (3). Therefore, the values of the acceptable daily intake (ADI) and acute reference dose (ARfD) of 1,4-naphthoquinone are considered provisional and all MRLs for dithianon above the limits of determination (LODs) require further consideration by risk managers. As the missing data is to be submitted as part of the ongoing procedure for the renewal of the approval of dithianon, the MRLs should be reconsidered and revised by risk managers following the finalisation of that procedure.

(3) Additionally, the Authority identified an exceedance of the ARfD of dithianon for apples and pears. The Authority consulted the Member States and requested them to report potential fall-back Good Agricultural Practices (GAPs) for apples and pears, authorised in Member States or third countries and already evaluated at Member State level, which would not lead to an unacceptable risk for consumers. Fall-back GAPs for apples and pears were identified that do not lead to exceedances of the ARfD of dithianon. It is therefore appropriate to lower the MRLs for dithianon on apples and pears to the values identified by the Authority in Part A of Annex III to Regulation (EC) No 396/2005.

(4) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs for dithianon. Those laboratories proposed product-specific LODs that are analytically achievable.

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

(6) Annex III to Regulation (EC) No 396/2005 should therefore be amended accordingly.

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

(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:

Article 1

Part A of 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 5 December 2024.

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

Done at Brussels, 15 May 2024.

For the Commission The President Ursula VON DER LEYEN

(1) OJ L 70, 16.3.2005, p. 1.

(2) European Food Safety Authority; Reasoned opinion on the review of the existing maximum residue levels for dithianon according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2023;21(1):7731.

(3) European Food Safety Authority; Conclusion on the updated peer review of the pesticide risk assessment for the active substance dithianon in light of confirmatory data submitted. EFSA Journal 2020;18(9):6189.