Oxyfluorfen 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. 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 Spain, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicants' decision, in accordance with Article 11e, to withdraw support for the inclusion of oxyfluorfen 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 oxyfluorfen in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicants Dow AgroSciences and Makhteshim Agan made a resubmission application for the inclusion of oxyfluorfen 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 18 of Commission Regulation (EC) No. 33/2008, Spain 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 13 January 2010. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicants for comments on 15 January 2010. The EFSA collated and forwarded all comments received to the Commission on 1 March 2010. 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, environmental fate and behaviour, and ecotoxicology and deliver its conclusions on oxyfluorfen. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of oxyfluorfen as a herbicide on grapes, pome fruit and sunflowers, as proposed by the applicants. 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. Several data gaps were identified for the technical materials and one data gap for the Plant Protection Product. In the mammalian toxicology section a critical area of concern was identified in relation to the compliance of the batches tested to the proposed specification, which could not be demonstrated. Based on the metabolism studies conducted on three different plant groups, the plant residue definition for monitoring and risk assessment was defined as oxyfluorfen only. A single data gap was identified in the residue section concerning additional residue data on sunflower in Northern EU. No areas of concern were identified with respect to consumer exposure. The data available on fate and behaviour in the environment were essentially sufficient to carry out the required environmental exposure assessments at EU level for the representative uses. However, a data gap is identified for justification of the higher concentrations in soil of the impurity RH-4672 (I-3) measured in the Californian field dissipation trials with respect to the levels of the same compound in the technical product. No areas of concern were identified with respect to the potential for groundwater contamination. Critical areas of concern were identified for the risk to algae and Lemna for all representative uses, the risk from bioaccumulation and biomagnification in the aquatic food chains and for the missing aquatic risk assessments for all representative uses for the metabolites RH-45469, MW 306, MW 347, MW 274 and unidentified Deg 27. Data gaps remain to address the risk to earthworm-eating mammals and the risk to soil-living macro-organisms from the use in pome fruits and grapes. Risk mitigation equivalent to 5 m no-spray buffer zones was required to identify a low off-field risk for non-target organisms for all representative uses. Additionally, risk mitigation equivalent to 5 m no-spray buffer zones was required to identify a low risk to non-target plants for the representative uses in pome fruits and grapes. The risk to bees, non-target micro-organisms and biological methods for sewage treatment was assessed as low for all representative uses.
