Conclusion on the peer review of the pesticide risk assessment of the active substance acibenzolar-S-methyl

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(8):3691 [74 pp.].
doi
10.2903/j.efsa.2014.3691
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00807
Approved
7 May 2014
Published
12 August 2014
Last Updated
26 August 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France and the co-rapporteur Member State Spain, for the pesticide active substance acibenzolar-S-methyl are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of acibenzolar-S-methyl as a plant activator on pome fruit, tomato and tobacco. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed.

Summary

Commission Regulation (EU) No 1141/2010, as amended by Commission Implementing Regulation (EU) No 380/2013, (hereinafter referred to as ’the Regulation’) lays down the procedure for the renewal of the approval of a second group of active substances and establishes the list of those substances. Acibenzolar-S-methyl is one of the of active substances listed in the Regulation.

The RMS provided its initial evaluation of the dossier on acibenzolar-S-methyl in the Renewal Assessment Report (RAR), which was received by the EFSA on 01 March 2013. The peer review was initiated on 05 March 2013 by dispatching the RAR for consultation of the Member States and the applicant Syngenta.

Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the area of mammalian toxicology and EFSA should adopt a conclusion on whether acibenzolar-S-methyl can be expected to meet the conditions provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and the Council.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of acibenzolar-S-methyl as a plant activator on pome fruit, tomato and tobacco as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

Data gaps were identified in the section analytical methods for confirmatory methods for the determination of the metabolite SYN546642 in soil and water.

As an endocrine-mediated mode of action could not be ruled out regarding the morphometric changes in the cerebellum of foetuses in the developmental neurotoxicity study, a data gap has been identified in the mammalian toxicology area for the level 2 tests currently indicated in the OECD Conceptual Framework, noting that further tests might be necessary pending on the outcome.

For residues and the consumer risk assessment there are no data gaps. However the use on protected tomatoes results in an exceedence of the ARfD.

No data gaps have been identified in relation to the fate and behaviour of acibenzolar-S-methyl in the environment. Contamination of ground water above the regulatory trigger of 0.1 μg/L is not expected to occur as result of the use of acibenzolar-S-methy for the representative uses proposed.

No critical area of concern has been identified in the area of ecotoxicology. However, risk mitigation measures for aquatic organisms were proposed for the pome fruit use. Data gaps were identified.

Keywords
acibenzolar-S-methyl, peer review, risk assessment, pesticide, plant activator
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Number of Pages
74