Conclusion on the peer review of the pesticide risk assessment of the active substance kresoxim-methyl

Commission Regulation (EC) No 737/2007' (hereinafter referred to as 'the Regulation') lays down the procedure for the renewal of the inclusion of a first group of active substances in Annex Ito Council Directive 91/414/EEC and establishes the list of those substances. Kresoxim-methyl is one of the first group of active substances listed in the Regulation. In accordance with Article 6 of the Regulation, the notifier BASF SE submitted a dossier on kresoximmethyl to Belgium and Lithuania, being the designated rapporteur Member State (RMS), and corapporteur Member State, respectively. In accordance with Article 10 of the Regulation, Belgium prepared an Assessment Report in consultation with Lithuania, which was submitted to the EFSA and the Commission of the European Communities (hereafter referred to as 'the Commission'). The Assessment Report was received by the EFSA on 31 March 2010. In accordance with Article 11 of the Regulation, the EFSA distributed the Assessment Report to Member States and the notifier for comments on 19 April 2010. The EFSA collated and forwarded all comments received to the Commission on 20 May 2010. In accordance with Article 12, following consideration of the Assessment Report and the comments received, the Commission requested the EFSA to arrange an expert consultation on the Assessment Report as appropriate and deliver its conclusions on kresoxim-methyl. The conclusions presented in this report were reached on the basis of the evaluation of the representative uses of kresoxim-methyl as a fungicide on cereals, apples, pears and grapes 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. Data gaps were identified for the specification and for the products of animal origin method. The available data in the mammalian toxicology data package were sufficient to derive health based reference values and to perform the risk assessment for operators, workers and bystanders. No data gaps or critical areas of concern were identified. Based on the metabolism studies conducted on the fruit crops, cereals and root/tuber crop groups, the residue in plant was defined as kresoxim-methyl for monitoring and as sum of kresoxim-methyl, BF 490-2 and BF 490-9 free and conjugated for risk assessment. A conversion factor was proposed for grape but additional information is required to derive such a factor for pome fruits. The animal residue definition was proposed for ruminant products only and was defined as BF 490-1 for monitoring and sum of BF 490-1, BF 490-2 and BF 490-9 for risk assessment. No intake concern is expected for the consumers, the highest TMDI being less than 1% of the ADI. The data available on fate and behaviour in the environment were sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses, with the exception that data were not available to clearly demonstrate that leachate from a pertinent lysimeter study did not contain individual metabolites in annual average concentrations exceeding 0.1 pg/L. In addition, the groundwater exposure related to the late application in grapes and apples was not finalised as no modelling was provided for these application patterns. The potential for groundwater contamination above the parametric drinking water limit of 0.1pg/L consequent to the other representative uses was assessed as low for kresoxim-methyl and the metabolites BF 490-1 (acid of kresoxim-methyl) and BF 490-5 (diacid of kresoxim-methyl). A low risk was identified for non-target organisms following the representative uses.