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


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(4):3052 [76 pp.].
Conclusion on Pesticides
On request from
European Commission
Question Number
13 dicembre 2012
8 aprile 2013
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 Germany, for the pesticide active substance fluopyram 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 fluopyram as a fungicide on table and vine grapes and greenhouse and field tomatoes and strawberries. 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 and concerns were identified.


Fluopyram is a new active substance for which in accordance with Article 6 (2) of Council Directive 91/414/EEC Germany received an application from Bayer CropScience 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 2009/464/EC of 15 June 2009.

The RMS provided its initial evaluation of the dossier on fluopyram in the Draft Assessment Report (DAR), which was received by the EFSA on 30 August 2011. The peer review was initiated on 12 September 2011 by dispatching the DAR for consultation of the Member States and the applicant Bayer CropScience.

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 fluopyram 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 fluopyram as a fungicide on table and vine grapes and greenhouse and field tomatoes and strawberries as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

No data gaps were identified for the sections identity, physical and chemical properties and analytical methods.

No data gaps or areas of concern were identified in the mammalian toxicology section.

The available data in the residues section were sufficient to proposed residue definitions for plant and animal commodities and to derive MRLs. No acute or chronic risks for the consumers were identified.

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 assessed. For these representative uses, the potential for groundwater exposure above the parametric drinking water limit of 0.1µg/L was assessed as low for fluopyram and its minor but non transient soil transformation product fluopyram 7-hydroxy.

A high long-term risk to birds was identified for the representative field uses. A hight long-term risk to mammals was identified for the representative use on grapes. A high risk to acquatic organisms was identified for the representative filed use. Data gaps were identified in the ecotoxicological section: 1) to further address the long-term risk for insectivorous birds and for herbivorous mammals: 2) to further consider the potential effects on the endocrine system of birds and fish; 3) to provide an aquatic risk assessment based on FOCUS step 4 calculations.

Fluopyram, peer review, risk assessment, pesticide, fungicide
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