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

Cyflumetofen is a new active substance for which in accordance with Article 6 (2) of Council Directive 91/414/EEC3 the Netherlands received an application from Otsuka AgriTechno Co. Ltd 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 26 April 2010 (2010/244/EU) 4. 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 Netherlands (RMS) provided its initial evaluation of the dossier on cyflumetofen in the Draft Assessment Report (DAR), which was received by the EFSA on 12 November 2010. The peer review was initiated on 26 January 2011 by dispatching the DAR for consultation of the Member States and the applicant Otsuka AgriTechno Co. 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 cyflumetofen. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of cyflumetofen as an acaricide on ornamental crops, nursery trees, perennial ornamentals and public greens, 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, only a data gap for an analytical method for metabolite B-2 in surface water was identified. Data gaps were identified in the mammalian toxicology section to clarify the positive result in the in vitro mammalian gene mutation assay on the groundwater metabolite B-3 and pending on the fulfilment of this data gap by demonstrating that the B-3 metabolite is not relevant in vivo, to provide sufficient toxicological information to allow the setting of reference values for B-3. Furthermore, the relevance of most of the impurities has to be assessed. Regarding applications on public greens, the exposure assessment for children has not been performed. o data gap was identified in the residues section. The residue definition for fruit crops is limited to, cyflumetofen (sum of isomers). for monitoring and set provisionally as, sum of cyflumetofen (sum of isomers) and metabolite B-1 expressed as cyflumetofen. for risk assessment. As the representative uses refer to plants not used as food or feed items, residue trials were not provided and no consumer risk assessment through dietary intake was conducted. A negligible exposure of the consumers to residues of metabolite B-1 is expected when groundwater is used as drinking water (1% of the ADI). The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses of cyflumetofen, with the exception of a groundwater exposure assessment for the critical GAP on tree nursery, perennial ornamentals and public greens. For the representative use on ornamentals, a high potential for groundwater contamination > 0.1 ae g/L over significant areas of the EU by the metabolite B-3 was identified. On the basis of the available mammalian toxicology data it was concluded that metabolite B-3 is toxicologically relevant and a risk was identified. The risk to birds and mammals, honeybees and non-target arthropods, earthworms and non-target soil macro-and micro-organisms, biological methods for sewage treatment and non-target terrestrial plants for the representative uses of cyflumetofen was considered to be low. Two data gaps were identified regarding the assessments for aquatic organisms.