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

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Article
EFSA Journal 2012;10(11):2955 [89 pp.].
doi
10.2903/j.efsa.2012.2955
European Food Safety Authority
Type
Conclusion on Pesticides
On Request From
European Commission
Question Number
EFSA-Q-2009-00339
Approved
13 Novembre 2012
Published
21 Novembre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (584.12 KB)584.12 KB
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 the Netherlands, for the pesticide active substance emamectin 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 emamectin as an insecticide outdoor grapes, glasshouse and outdoor peppers, melons, tomatoes and lettuce, and glasshouse cucumber. 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

Emamectin is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the Netherlands (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 2007/669/EC.

The RMS provided its initial evaluation of the dossier on emamectin in the Draft Assessment Report (DAR), which was received by the EFSA on 6 March 2008. The peer review was initiated on 5 October 2011 by dispatching the DAR for consultation of the Member States and the applicant Syngenta Crop Protection AG.

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, residues, fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether emamectin 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 emamectin as an insecticide on outdoor grapes, glashouse cucumber and glasshouse and outdoor peppers, melons, tomatoes and lettuce as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

A general data gap was identified for the position of the radio label in the test substance for each study where the test substance was radio-labelled.

In the area of identity, physical/chemical/technical properties and methods of analysis data gaps were identified for quantitative confirmatory validation data for the residue analytical methods in plants, soil, water, air, body fluids and tissues, and for a more sensitive analytical method in surface water.

In the mammalian toxicology section, a data gap was identified for assessment of the photo-metabolites identified in the plant metabolism in order to conclude on their toxicological profile. Since workers re-entering after appliaction to in lettuce might be exposed to these photo-metabolites worker risk assessment to photo-metabolites cannot be finalized.

The plant residue definition was proposed as "emamectin B1a and its salts expressed as emamectin B1a benzoate" for monitoring and provisionally as "sum of emamectin B1a and B1b and photo-metabolites 8,9-Z, AB1a, MFB1a, FAB1a" for risk assessment, pending the submission of additional information to address the toxicity of the photo-metabolites not observed in the rodent metabolism. The use of emamectin on lettuce according to the supported GAP leads to an exceeding of the ARfD.

Environmental exposure assessment has been performed following current guidelines. No data gaps or issues of concern have been identified.

A high risk was identified for aquatic organisms for the grape use. A high risk was identified for non target arthropos and bees. Further higher tier studies should be provided to further address the risk to bees. Data gap to further address the off-field risk to non-target arthropods and to demonstrate the recolonisation of the in-field area.

Keywords
Emamectin, peer review, risk assessment, pesticide, insecticide
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Number of Pages
89