Conclusion on the peer review of the risk assessment of penflufen

By CnAgri2012-08-27 16:52:06 Print

Penflufen is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the United Kingdom (hereinafter referred to as the „RMS?) received an application from Bayer CropScience 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 2010/672/EU of 5 November 2010.

The RMS provided its initial evaluation of the dossier on penflufen in the Draft Assessment Report (DAR), which was received by the EFSA on 4 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 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 and ecotoxicology and EFSA should adopt a conclusion on whether penflufen 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 penflufen as a fungicide on potatoes, 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 method of analysis for the metabolite M01 in groundwater.

In the mammalian toxicology chapter one data gap was identified on the toxicological relevance of impurities present in the technical specification. No critical areas of concern were identified.

EFSA was unable to conclude whether a specific residue definition is needed for the rotational crops and a data gap was set to provide rotational crop field trials on cereals, leafy vegetables, root vegetables and soybean at a dose rate covering the calculated plateau concentration of penflufen in soil in order to determine the residue levels of penflufen and metabolites M01 (free and conjugated), M49, M58, M63, M64 and M65.The consumer risk assessment could not be concluded on.

Isomers of penflufen and its metabolite M01 have not been separately analysed in any of the studies performed to investigate the fate and behaviour of penflufen in the environment and potential enantioselective transformation is not addressed by the available data. Due to the lack of a soil photolysis study, available data permit only to assess uses with immediate incorporation and no direct exposure of the active substance to sunlight. Potential groundwater contamination was assessed for the use in seed potatoes planted only once every three years. The limit of 0.1 μg/l was exceeded for 1 of 9 scenarios when the PEARL model was used. The limit of 0.1 μg/l was exceeded by metabolite M01 in all 9 scenarios when simulated with PEARL and the accepted default uptake factor of 0. A critical area of concern was identified for potential groundwater contamination by metabolite M01. In this case the level of 0.75 μg/l was exceeded in 7 of the 9 scenarios. Metabolite M02 did not exceed the limit of 0.1 μg/l for any of the scenarios simulated.

Based on the available information a low risk to non-target organisms was concluded for penflufen used as a seed treatment on potato, with the exception of the long-term risk to birds. A data gap for a further assessment of the long-term risk to birds was therefore identified.