Ethoxyquin is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004,(3) as amended by Commission Regulation (EC) No 1095/2007.(4) 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 Germany, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicant's decision, in accordance with Article 24e, to withdraw support for the inclusion of ethoxyquin in Annex I to Council Directive 91/414/EEC. Following the Commission Decision of 8 December 2008 (2008/941/EC)(5) concerning the noninclusion of ethoxyquin in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant XEDA International S.A. made a resubmission application for the inclusion of ethoxyquin in Annex I in accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/2008.(6) 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, Germany, 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 16 October 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 22 October 2010. The DAR was also distributed for comments. The EFSA collated and forwarded all comments received to the Commission on 7 December 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 area of mammalian toxicology and to deliver its conclusions on ethoxyquin. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of ethoxyquin as an anti-oxidant and fungicide on pears, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. For physical chemical properties no critical areas of concern were identified. Numerous data gaps have been identified, mostly related to the methods of analysis, see section 1. A data gap and a critical area of concern were identified in the toxicology section regarding the genotoxic potential of an impurity in the technical specification. Critical areas of concern were raised due to the limited data package, which was considered to be insufficient to set reference values. As no acceptable operator exposure level (AOEL) was set, the operator and worker exposure risk assessment could not be conducted. Bystander exposure is not relevant to the representative use. An area of concern and several data gaps were identified in the residue section. No residue definition could be proposed and, in the absence of toxicological reference values for ethoxyquin, the consumer risk assessment could not be conducted. The environmental exposure assessment is based on the representative use as a post-harvest drench treatment indoors with sealed floor surface, and recycling of the treatment solutions. Therefore exposure of the environmental compartments to ethoxyquin during application was considered to be negligible. However, ethoxyquin is a moderately volatile compound, and potentially volatile photolytic transformation products can be formed during application. Therefore a data gap was identified for an assessment of the exposure of the environmental compartments to potentially volatile photolytic transformation products. The risk to non-target organism was assessed as low for the representative use based on negligible exposure of the environment. Data gaps have been identified to address the risk to the environment from potential aerial transformation products and impurity 7. (C) European Food Safety Authority, 2010
