Conclusion on the peer review of the pesticide risk assessment of the active substance fenpyrazamine
No abstract available
Fenpyrazamine is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC Austria received an application from Sumitomo Chemical Agro Europe S.A.S for inclusion in Annex I to Directive 91/414/EEC. Complying with Article 6 of Directive 91/414/EEC, the completeness of the dossier was evaluated and confirmed by Commission Decision of 10 March 2010 (2010/150/EU).
Following the agreement between the European Commission and the European Food Safety Authority (EFSA) for the EFSA to organise a peer review of those new active substances for which the decision on the completeness of the dossier had been published after June 2002, the designated rapporteur Member State Austria (RMS) provided its initial evaluation of the dossier on fenpyrazamine in the Draft Assessment Report (DAR), which was received by the EFSA on 17 January 2011.
The peer review was initiated on 28 January 2011 by dispatching the DAR for consultation of the Member States and the applicant Sumitomo Chemical Agro Europe S.A.S. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the areas of mammalian toxicology and ecotoxicology and deliver its conclusions on fenpyrazamine.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of fenpyrazamine as a fungicide in glasshouses on tomato, aubergine, pepper, and cucurbits with edible peel, and field use on grapes 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 one data gap was identified for a shelf-life study.
No data gaps or areas of concern were identified regarding mammalian toxicology.
No data gaps were identified in the residues section. Based on the plant metabolism studies conducted on three different plant groups, residues in plants were defined as fenpyrazamine for monitoring and as sum of fenpyrazamine and S-2188-DC expressed as fenpyrazamine for risk assessment. MRLs and conversion factors were proposed for all representative uses. No chronic or acute risks were identified for consumers, the highest IEDI being only 3% of the ADI and the highest IESTI 38% of the ARfD.
The fate and behaviour in the environment of fenpyrazamine was investigated with a complete battery of studies. Exposure assessments for soil, suface water and groundwater were presented following the FOCUS scheme. No data gaps or areas of concern were identified with respect to fate and behaviour in the environment.
The risk to non-target species was assessed as low.
Fenpyrazamine, peer review, risk assessment, pesticide, fungicide
