BAKGRUNN (fra kommisjonsforordningen)

(1) The approval of acibenzolar-S-methyl was renewed by Commission Implementing Regulation (EU) 2016/389.

(2) Commission Regulation (EU) 2018/6053 amended Regulation (EC) No 1107/2009 by introducing new criteria to identify active substances which have endocrine disrupting properties, which became applicable on 10 November 2018. This required that the applicant should submit to the Commission, the Member States and the Authority confirmatory information as regards the endocrine-disrupting properties of acibenzolar-S-methyl. 

(3) The applicant submitted an updated dossier as well as additional information in February 2019. 

(4) On 8 July 2021, the European Food Safety Authority (‘the Authority’) published a peer review of the pesticide risk assessment for the active substance acibenzolar-S-methyl related to the confirmatory data submitted by the applicant, and reporting that the assessment of the endocrine-disrupting properties of acibenzolar-S-methyl could not be finalised based on the available data for both humans and non-target organisms, and identified further data that were necessary to finalise the assessment. 

(5) The Commission therefore launched a review of the existing approval of the active substance in accordance with Article 21 of Regulation (EC) No 1107/2009. The applicant was invited to submit, by end of June 2025, additional information necessary to evaluate if acibenzolar-S-methyl still fulfils the criteria for approval laid down in point 3.6.5 of Annex II to that Regulation. 

(6) On 8 September 2023, the applicant informed the Commission of the cessation of further studies concerning the endocrine-disrupting attributes of acibenzolar-S-methyl and of its decision to self-classify that substance as toxic for reproduction category 1B (R1B) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council5 . 

(7) Consequently, it has not been established that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The Commission therefore considers that acibenzolar-S-methyl no longer fulfils the criteria for approval laid down in point 3.6.5 of Annex II to that Regulation. 

(8) It is therefore appropriate to withdraw the approval of acibenzolar-S-methyl. 

(9) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly and Implementing Regulation (EU) No 2016/389 should be repealed. 

(10) Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing acibenzolar-S-methyl. 

(11) For plant protection products containing acibenzolar-S-methyl, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should be as short as possible and expire no later than 12 months from the date of entry into force of this Regulation. 

(12) This Regulation does not prevent the submission of a new application for the approval of acibenzolar-S-methyl pursuant to Article 7 of Regulation (EC) No 1107/2009. 

(13) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed