COMMISSION IMPLEMENTING REGULATION (EU) 2023/741

of 5 April 2023

concerning the non-renewal of the approval of the active substance oxamyl, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) No 540/2011

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,

Whereas:

(1) Commission Directive 2006/16/EC (2) included oxamyl as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2) Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3) The approval of the active substance oxamyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 October 2023.

(4) An application for the renewal of the approval of the active substance oxamyl was submitted to Italy, the rapporteur Member State, and France, the co-rapporteur Member State, in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5) The applicant submitted the supplementary dossiers to the rapporteur Member State, the co-rapporteur Member State, the Commission and the European Food Safety Authority (‘the Authority’) in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6) The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the Authority and the Commission on 15 October 2019.

(7) The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8) On 30 March 2022, the Authority communicated to the Commission its conclusion (6) on whether oxamyl can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9) In its conclusion, the Authority identified a number of concerns. In particular, it concluded that there is a high risk for all the representative uses assessed to exceed the acceptable operator exposure level (‘AOEL’) for operators even with the use of personal protective equipment (‘PPE’).

(10) Furthermore, the preliminary acute consumer dietary risk assessment indicated a large exceedance of the acute reference dose (‘ARfD‘) for all the representative uses on all edible crops. In addition, the consumer risk assessment through drinking water indicated that the theoretical maximum daily intake (‘TMDI’) from the groundwater metabolite IN-D2708 exceeded the acceptable daily intake (‘ADI’) for adults, children and infants in all representative uses and that the TMDI from the groundwater metabolite IN-A2213 exceeded the ADI for infants in all representative uses.