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


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(7):3744 [95 pp.].
Conclusion on Pesticides
On request from
European Commission
Question Number
27 June 2014
7 July 2014
5 February 2015. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy
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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 United Kingdom, for the pesticide active substance fenhexamid 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 fenhexamid as a fungicide on grapes, strawberry and tomato. 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.


Commission Regulation (EU) No 1141/2010 (hereinafter referred to as ’the Regulation’), as amended by Commission Implementing Regulation (EU) No 380/2013, lays down the procedure for the renewal of the approval of a second group of active substances and establishes the list of those substances. Fenhexamid is one of the active substances listed in the Regulation. The RMS provided its initial evaluation of the dossier on fenhexamid in the Renewal Assessment Report (RAR), which was received by the EFSA on 30 April 2013. The peer review was initiated on 14 May 2013 by dispatching the RAR for consultation of the Member States and the applicant Bayer CropScience AG.

Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology and ecotoxicology and EFSA should adopt a conclusion on whether fenhexamid 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 fenhexamid as a fungicide on grapes, strawberry and tomato 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 a data gap was identified for the report of the ongoing shelf life study of the formulation.

No data gap or critical area of concern were identified in the mammalian toxicology section.

The assessment of the residue data package revealed no data gaps and the consumer risk assessment could be finalised.

The data available on fate and behaviour in the environment are sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses assessed. The potential for groundwater contamination consequent to these uses from fenhexamid or its metabolite M24 above the parametric drinking water limit of 0.1 μg/L was assessed as low.

Four data gaps were identified in the ecotoxicology section. Furthermore, the risk assessment of metabolite M15 to aquatic organisms and the long-term risk assessments for birds could not be finalised.

fenhexamid, peer review, risk assessment, pesticide, fungicide
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