Conclusion on the peer review of the pesticide risk assessment of the active substance mandipropamid

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Article
EFSA Journal 2012;10(11):2935 [76 pp.].
doi
10.2903/j.efsa.2012.2935
European Food Safety Authority
Type
Conclusion on Pesticides
On Request From
European Commission
Question Number
EFSA-Q-2009-00328
Approved
18 Ottobre 2012
Published
5 Novembre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (1.11 MB)1.11 MB
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 Austria, for the pesticide active substance mandipropamid are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of mandipropamid as a fungicide on potato, tomato, melon, cucumber, lettuce and grape. 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. Concerns are identified.

Summary

Mandipropamid is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC Austria (hereinafter referred to as the ‘RMS’) received an application from Syngenta Crop Protection AG for approval. Complying with Article 6(3) of Directive 91/414/EEC, the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Decision 2006/589/EC of 31 August 2006.

The RMS provided its initial evaluation of the dossier on mandipropamid in the Draft Assessment Report (DAR), which was received by the EFSA on 30 November 2006. The peer review was initiated on 18 December 2007 by dispatching the DAR for consultation of the Member States and the applicant Syngenta Crop Protection AG. In accordance with Commission Regulation (EU) No 188/2011 Article 11(6) additional information was requested. The RMS’s evaluation was submitted to the EFSA on 7 July 2011. The updated DAR and addenda were dispatched for consultation of the Member States and the applicant Syngenta Crop Protection AG on 5 October 2011.

Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether mandipropamid can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of mandipropamid as a fungicide on potato, tomato, melon, cucumber, lettuce and grape, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

In the area of identity, physical/chemical/technical properties and methods of analysis no data gaps were identified.

In the area of mammalian toxicology, one data gap was identified in relation to the derivation of reference values for the plant metabolite SYN 500003.

The metabolism in plants was investigated in three plant groups, on fruit crops, leafy crops and root/tuber crops. The residue for monitoring was defined as mandipropamid. The same definition was proposed for risk assessment, except for the root/tuber plant group where it was provisionally proposed as "mandipropamid and SYN 500003". The consumer risk assessment could not be finalised for potato, pending the submission of information to address the toxicity of the metabolite SYN 500003.

The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses. The potential for groundwater contamination, consequent to the representative uses assessed, by mandipropamid and its soil metabolite CGA 380778, was assessed as low.

A data gap was identified for the representative use in grapes to further address the long-term risk assessment to herbivorous mammals.
 

Keywords
mandipropamid, peer review, risk assessment, pesticide, fungicide
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Number of Pages
76