Difenoconazole is one of the 84 substances of the third stage part B of the review programme covered by Commission Regulation (EC) No 1490/2002,(3) as amended by Commission Regulation (EC) No 1095/2007.(4) Difenoconazole was included in Annex I to Directive 91/414/EEC on 1 January 2009 pursuant to Article 11b of the Regulation (EC) No 1490/2002, as amended by Commission Regulation (EC) No 1095/2007 (hereinafter referred to as, the Regulation.). In accordance with Article 12a of the Regulation the European Food Safety Authority (EFSA) is required to deliver by 31 December 2010 its view on the draft review report submitted by the Commission of the European Communities (hereinafter referred to as, the Commission.) in accordance with Article 12(1) of the Regulation. This review report was established as a result of the initial evaluation provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in this report. Sweden being the designated rapporteur Member State submitted the DAR on difenoconazole in accordance with the provisions of Article 10(1) of the Regulation, which was received by the EFSA on 22 December 2006. The peer review was initiated on 6 March 2007 by dispatching the DAR for consultation of the Member States and the notifier Syngenta Ltd. 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, environmental fate and behaviour and ecotoxicology and deliver its conclusions on difenoconazole. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of difenoconazole as a fungicide on pome fruit, carrot, wheat, barley, triticale, rye and oats as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report. No critical areas of concern were identified in the physical-chemical properties section. However, data gaps were identified for data to support the ranges of the cis/trans isomers in the technical specification, the biological activity of the isomers, the validation of the isomer method, the consequence for the physical-chemical properties of the active substance of the wide range of isomer content and the formulation's adhesion to seeds. No critical areas of concern were identified in the mammalian toxicology section. Two data gaps were identified: for an assessment of the toxicological relevance of some impurities; and to clarify the uncertainties related to the isomer ratio of the tested compound (for which reference values have been derived), the isomer ratio to which the workers will be exposed and the relative toxicity of the different isomers. Based on the metabolism studies conducted on four plant groups, the residue in plants was defined as difenoconazole for monitoring and provisionally as difenoconazole and TDM for risk assessment. Residue definitions were also proposed for animal products. No critical areas of concern were identified in the residue section. Data gaps were identified to provide information on the possible residues of TDM metabolites in primary crops, rotational crops, processed commodities and animal products. Additional residue trials and processing studies on carrots are also required. No acute or chronic intake concerns were identified for consumers, but this evaluation has to be considered provisional, since the contribution of the TDM metabolites and the isomeric composition of the residues were not taken into account. The data available on environmental fate and behaviour were generally 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 by difenoconazole and the metabolites 1,2,4-triazole and CGA 205375 above the parametric drinking water limit of 0.1 mu g/L was assessed as low. However, data gaps were identified for identification of the metabolites V3 and M4 formed in soil incubation, and for the rate of dissipation of difenoconazole in the field under Southern European conditions. The assessment of the environmental behaviour and consequent exposure levels of individual enantiomers of difenoconazole was not finalised. Data gaps were identified in the ecotoxicology section. Further refinement of the risk to aquatic sediment-dwelling organisms for the use in cereals is necessary. Furthermore, the potential endocrine disruption effects in fish should be addressed. A data gap was also identified to demonstrate that the increase in body weight would not lead to adverse effects on earthworm populations in order to be able to use the reproduction NOEC from the reproduction study. Data gaps were identified to address the chronic risk to earthworms and Collembola. The possible impact on the ecotoxicity and the environment of potential enantio-selective biologically mediated metabolism/degradation or transformation needs to be addressed in order to the risk assessment for non-target organisms.
