Metosulam is one of the 84 substances of the third stage part B of the review programme covered by Commission Regulation (EC) No 1490/20023, as amended by Commission Regulation (EC) No 1095/20074 Following the Commission Decision of 5 December 2008 (2008/934/EC). In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as 'the Commission'), the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by France, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant's decision, in accordance with Article 11e, to withdraw support for the inclusion of metosulam in Annex I to Council Directive 91/414/EEC. Following the Commission Decision of 5 December 2008 (2008/934/EC)(5) concerning the noninclusion of metosulam in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Bayer CropScience AG made a resubmission application for the inclusion of metosulam in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/20086. The resubmission dossier included further data in response to the issues identified in the DAR. In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology and ecotoxicology, and deliver its conclusions on metosulam. In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, France, being the designated RMS, submitted an evaluation of the additional data in the format of an Additional Report. The Additional Report was received by the EFSA on 7 August 2009. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicant for comments on 10 August 2009. The DAR was also distributed to Member States for comments in view of the fact that the original peer review had been terminated following the applicant's notification of withdrawal of support. The EFSA collated and forwarded all comments received to the Commission on 23 September 2009. In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology and ecotoxicology, and deliver its conclusions on metosulam. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of metosulam as a herbicide on maize, wheat and barley, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. The specification is not agreed and a data gap is identified for batch data. A data gap has also been identified for data to support the tank cleaning recommendations in the section for identity, physical chemical and technical properties. A data gap is identified in the mammalian toxicology section to address the genotoxic potential of an impurity present in the technical specification and not adequately tested in the toxicological studies. As there is no agreed technical specification covered by the toxicological assessment, and the genotoxic potential of this impurity is not finalised, an area of concern was identified on this issue. Based on the metabolism studies performed in wheat and potato, the plant residue definition for monitoring and risk assessment is metosulam alone. A sufficient number of supervised residue trials were provided to propose maximum residue limits (MRLs) on wheat, barley and maize. No risk for the consumer resulting from the representative uses was identified, and no data gaps or areas of concern were identified in the residues section. The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level for the representative uses, with the notable exception that information is missing regarding the potential pH dependence of adsorption of the metabolites 7-OH-metosulam (M02) and ATSA (M01). Consequently, the groundwater, surface water and sediment exposure assessments for these metabolites are not finalised. The risk to birds, mammals, bees, non-target arthropods, earthworms, soil-dwelling macro-and microorganisms, and biological methods of sewage treatment was assessed as low. A high risk was identified for the aquatic environment. No-spray buffer zones/vegetated filter strips of 10 and 20m are needed to mitigate the risk to aquatic organisms, however, for the environmental conditions represented by some FOCUS scenarios, the maximum mitigation afforded by combined 20m no-spray buffer zones and vegetative strips was insufficient to demonstrate low aquatic risk (maize R4; cereals D1, D2, R1stream, R3stream). A potential high risk was identified for non-target plants in the off-field area. Risk mitigation measures such as a 5m in-field no-spray buffer zone are necessary to protect non-target terrestrial plants in the off-field area.
