COMMISSION REGULATION (EU) 2023/128

of 18 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 benalaxyl, bromoxynil, chlorsulfuron, epoxiconazole and fenamiphos 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) and Article 18(1)(b) thereof,

Whereas:

(1) For benalaxyl, bromoxynil and fenamiphos, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For chlorsulfuron and epoxiconazole, MRLs were set in Part A of Annex III to that Regulation.

(2) The approval of the active substance benalaxyl was not renewed by Commission Regulation (EU) 2020/1280 (2) including for reasons related to human health. That approval expired on 31 July 2021. All existing authorisations for plant protection products containing this active substance have been revoked.

(3) In the context of the non-renewal of the approval of benalaxyl, the European Food Safety Authority (‘the Authority’) could not conclude that the substance has no endocrine disrupting properties (3).

(4) Benalaxyl-M is an approved active substance for use in plant protection products. The residue definition for both benalaxyl and benalaxyl-M is ‘Benalaxyl including other mixtures of constituent isomers including benalaxyl-M (sum of isomers)’. MRLs for benalaxyl on table grapes, potatoes, garlic, onions, shallots, watermelons, lettuces and leeks are safe for consumers and should be maintained to take account of the authorised uses of benalaxyl-M on those products. For wine grapes and melons, the existing MRLs correspond to the Codex maximum residue limits (‘CXLs’). They are safe for consumers and should also be maintained in accordance with Article 14(2), point (e) of Regulation (EC) No 396/2005. MRLs for the authorised uses of benalaxyl-M on aubergines/eggplants and tomatoes are lower than MRLs for benalaxyl. Therefore, MRLs for benalaxyl on these products should be lowered to the current MRLs for benalaxyl-M. For sweet peppers/bell peppers and rapeseeds/canola seeds, no authorised uses for benalaxyl-M exist and there are no CXLs or import tolerances. MRLs for benalaxyl on those products should be lowered in Annex II to Regulation (EC) No 396/2005 to the limit of determination (‘LOD’).

(5) The approval of the active substance bromoxynil was not renewed by Commission Regulation (EU) 2020/1276 (4) including for reasons related to human health. The approval of the substance expired on 31 July 2021. All existing authorisations for plant protection products containing bromoxynil have been revoked and no CXLs or import tolerances exist for that active substance. It is therefore appropriate to delete the MRLs set out for this substance in Annex II to Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1) point (a) thereof. MRLs for all products should be set at the LOD in Annex V to Regulation (EC) No 396/2005 in accordance with article 18 point (1)(b) of that Regulation.

(6) The approval of the active substance chlorsulfuron expired on 31 December 2019 and the applicant has not submitted an application for its renewal. All existing authorisations for plant protection products containing that active substance have been revoked. No CXLs or import tolerances exist for chlorsulfuron. It is therefore appropriate to delete the MRLs set out for this substance in part A of Annex III to Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1) point (a) thereof. MRLs for all products should be set at the LOD in Annex V to Regulation (EC) No 396/2005 in accordance with article 18 point (1)(b) of that Regulation.

(7) The approval of the active substance epoxiconazole expired on 30 April 2020 and the applicant withdrew the application for its renewal. All existing authorisations for plant protection products containing that active substance have been revoked. No CXLs or import tolerances exist for epoxiconazole. It is therefore appropriate to delete the MRLs set out for this substance in part A of Annex III to Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1) point (a) thereof. MRLs for all products should be set at the LOD in Annex V to Regulation (EC) No 396/2005 in accordance with article 18 point (1)(b) of that Regulation.

(8) The approval of the active substance fenamiphos was not renewed by Commission Regulation (EU) 2020/1246 (5), including for reasons related to human health. The approval of the substance expired on 23 September 2020. All existing authorisations for plant protection products containing fenamiphos have been revoked.

(9) In the context of the non-renewal of the approval of fenamiphos, the Authority identified a number of concerns (6), relating to consumer health risk and missing data for the representative uses concerning fruiting vegetables.

(10) The MRLs for table grapes and wine grapes correspond to import tolerances, but since the data package for metabolites M01 and M02 on genotoxicity was incomplete and a consumer risk assessment could not be finalised, a risk for consumers cannot be excluded. The MRLs for tomatoes, sweet peppers/bell peppers, aubergines/eggplants, melons and sugar beet roots are based on EU uses of fenamiphos that have been revoked. It is therefore appropriate to delete the MRLs set out for this substance in Annex II to Regulation (EC) No 396/2005 in accordance with Article 17 of Regulation (EC) No 396/2005 in conjunction with Article 14(1) point (a) thereof. MRLs for all products should be set at the LOD in Annex V to Regulation (EC) No 396/2005 in accordance with article 18 point (1)(b) of that Regulation.

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

(12) 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.

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

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

(15) 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 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 8 August 2023.

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) Commission Implementing Regulation (EU) 2020/1280 of 14 September 2020 concerning the non-renewal of the approval of the active substance benalaxyl, 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 301, 15.9.2020, p. 4).

(3) European Food Safety Authority, ‘Conclusion on the peer review of the pesticide risk assessment of the active substance benalaxyl’, EFSA Journal 2020;18(1):5985.

(4) Commission Implementing Regulation (EU) 2020/1276 of 11 September 2020 concerning the non-renewal of the approval of the active substance bromoxynil, 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 300, 14.9.2020, p. 32).

(5) Commission Implementing Regulation (EU) 2020/1246 of 2 September 2020 concerning the non-renewal of the approval of the active substance fenamiphos, 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 288, 3.9.2020, p. 18).

(6) European Food Safety Authority, ‘Conclusion on the peer review of the pesticide risk assessment of the active substance fenamiphos’, EFSA Journal 2019;17(1):5557.