COMMISSION REGULATION (EU) 2023/147

of 20 January 2023

amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyromazine, topramezone and triflumizole 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 18(1), point (b), thereof,

Whereas:

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

(2) The approval of cyromazine as active substance for plant protection products expired on 31 December 2019 and no application for its renewal was submitted. However, cyromazine is also a pharmacologically active substance in veterinary medicines and MRLs for that substance in ovine products (except milk) were set based on the recommendations from the European Agency for the Evaluation of Medicinal Products (2) in Commission Regulation (EU) No 37/2010 (3). Those MRLs should be maintained at the existing levels to cover the exposure from use in veterinary medicinal products in ovine animals. For all other products it is appropriate to delete the respective MRLs set out for cyromazine in Annex II of Regulation (EC) No 396/2005 in accordance with Article 14(1)(a) in conjunction with Article 17 of that Regulation.

(3) The European Food Safety Authority (‘the Authority’) performed a pesticide risk assessment of the active substance topramezone for the uses proposed by the applicant in 2014 (4). In 2020, all applications for the renewal of the approval of the active substance topramezone were withdrawn and the renewal procedure concluded with the non-approval of topramezone (5). All existing authorisations for plant protection products containing topramezone have been revoked. It is therefore appropriate to lower the MRLs set out for topramezone in Part A of Annex III to Regulation (EC) No 396/2005 to the LOD and to list the respective LODs in Annex V to that Regulation in accordance with Article 14(1)(a) in conjunction with Article 17 of that Regulation.

(4) The approval of triflumizole expired on 30 June 2020 and no application for its renewal was submitted. All existing authorisations for plant protection products containing triflumizole have been revoked. It is therefore appropriate to lower the MRLs set out for triflumizole in Annex II to Regulation (EC) No 396/2005 to the LOD and to list the respective LODs in Annex V to that Regulation in accordance with Article 14(1)(a) in conjunction with Article 17 of that Regulation.

(5) The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain LODs. For all active substances covered by this Regulation those laboratories proposed product specific LODs that are analytically achievable.

(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) For all active substances covered by this Regulation, to allow for the normal marketing, processing and consumption of products, this Regulation should not apply to products which have been produced in the Union or imported into the Union before the modified MRLs star applying and for which information shows that a high level of consumer protection is maintained.

(9) 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 adapt to meet the requirements that result from the modification of the MRLs.

(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, III and V to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2 Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced in the Union or imported into the Union before 12 August 2023.

Article 3 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 6 months after the date of entry into force of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 January 2023. For the Commission The President Ursula VON DER LEYEN

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

(2) Summary report of the Committee for veterinary medicinal products. The European Agency for the Evaluation of Medicinal Products, Veterinary Medicines and Inspections. EMEA/MRL/606/99-Final. June 1999.

(3) Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

(4) European Food Safety Authority, 2014. Conclusion on the peer review of the pesticide risk assessment of the active substance topramezone. EFSA Journal 2014;12(2):3540. https://doi.org/10.2903/j.efsa.2014.3540.

(5) Commission Implementing Regulation (EU) 2021/79 of 27 January 2021 concerning the non-approval of the active substance topramezone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 29, 28.1.2021, p. 8).