acibenzolar-S-methyl

The approval of acibenzolar-S-methyl was renewed under Regulation (EC) 1107/2009 on 1 April 2016 by Commission Implementing Regulation (EU) 2016/389. It was a specific provision of the approval that the applicant was required to submit to the European Commission further information by 1 June 2017 as regards the relevance and reproducibility of the morphometric changes observed in the cerebellum of foetuses linked to exposure to acibenzolar-S-methyl and whether these changes may be produced via an endocrine mode of action. The information to be submitted shall include a systematic review of the available evidence assessed on the basis of available guidance (e.g. EFSA GD on Systematic Review methodology, 2010). In accordance with the specific provision, the applicant, Syngenta, submitted an updated dossier in May 2017 as well as additional information in February 2019 in line with the EFSA/ECHA guidance for the identification of endocrine disruptors (2018), which was evaluated by the designated rapporteur Member State (RMS), France, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009-rev.6.1, the RMS distributed the addendum to Member States, the applicant and EFSA for comments on 12 November 2019. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 11 March 2020. EFSA added its scientific views on the reporting table. The current report summarises the outcome of the consultation process organised by the RMS, France, and presents EFSA’s scientific views and conclusions on the individual comments received. The confirmatory data are considered not addressed. During the commenting period the link between developmental neurotoxicity effects (DNT) and T-mediated endocrine effect, supported by the RMS, was still considered to be further discussed and an experts’ consultation should be organised. It is also proposed to discuss the assessment of the endocrine disrupting (ED) properties of acibenzolar-S-methyl both for humans and non-target organisms and which additional test are needed to conclude on the ED properties.

source: EFSA

doi:10.2903/sp.efsa.2020.EN-1846