Fluxapyroxad, with the development code BAS 700 F, is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the United Kingdom received an application from BASF SE 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 5 November 2010 (2010/672/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 the United Kingdom (RMS) provided its initial evaluation of the dossier on fluxapyroxad (BAS 700 F) in the Draft Assessment Report (DAR), which was received by the EFSA on 11 January 2011. The peer review was initiated on 27 January 2011 by dispatching the DAR for consultation of the Member States and the applicant BASF SE. Following consideration of the comments received on the DAR, it was concluded that the EFSA should conduct a focused peer review in the areas of mammalian toxicology and environmental fate and behaviour, and deliver its conclusions on fluxapyroxad (BAS 700 F). The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of fluxapyroxad (BAS 700 F) as a fungicide on wheat, durum wheat, triticale, barley, rye and oat, 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 in the section on identity, physical and chemical properties and analytical methods. No data gaps or critical areas of concern were identified in the mammalian toxicology section. A data gap was identified in the residues section for two additional residue trials on wheat covering respectively northern and southern Europe in order to derive a maximum residue limit (MRL) in wheat with extrapolation to rye and triticale. The fate and behaviour of fluxapyroxad (BAS 700 F) in the environment was investigated with a complete set of studies, however a data gap was identified for the final report of the study on the accumulation in soil. The risk for non-target organisms was assessed as low for the representative uses. Pending on the outcome of the data gap in the environmental fate and behaviour section, in particular, if the plateau concentration in soil observed in the field study will be greater than the estimated peak plateau predicted environmental concentrations (PECs), the risk assessment for non-target soil-organisms may need to be reconsidered. No critical areas of concern were identified.
