Etridiazole is one of the 84 substances of the third stage part B of the review programme covered by Commission Regulation (EC) No 1490/2002,(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 the Netherlands, 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 etridiazole in Annex I to Council Directive 91/414/EEC. Following the Commission Decision of 5 December 2008 (2008/934/EC)(5) concerning the non-inclusion of etridiazole in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicant Chemtura Europe Ltd made a resubmission application for the inclusion of etridiazole 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, the Netherlands, 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 2 December 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 4 December 2009. The EFSA collated and forwarded all comments received to the Commission on 15 January 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 area of mammalian toxicology and deliver its conclusions on etridiazole. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of etridiazole as a fungicide on glasshouse grown fruiting vegetables and cut flowers in non-soil production systems, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report. Data gaps have been identified in the section on identity, physical and chemical properties and analytical methods. Data gaps were identified in the toxicology section to address the relevance of the impurities present in the technical specification, and the toxicological profile of the plant metabolites 5-hydroxy-ethoxyetridiazole acid and 3-hydroxymethyl etridiazole. The plant residue definition was provisionally proposed as the sum of etridiazole and metabolites 5-hydroxy-ethoxyetridiazole acid and 3-hydroxymethyl etridiazole (and its conjugates), pending the conclusion on the toxicological profile of these two metabolites. A data gap was set to provide a full residue data set where samples are analysed according to the proposed residue definition and as a consequence the consumer risk assessment could not be performed for the representative uses on fruiting vegetables. The data available on fate and behaviour in the environment were considered insufficient to carry out a complete environmental exposure assessment at the EU level for the representative uses. The necessary estimations for short-range and long-range transport for the metabolite etridiazole acid were not available. No estimations for the leaching potential were available for etridiazole and its potentially volatile metabolites, which can potentially reach the environment outside of the glasshouses via deposition after volatilisation. A data gap was identified for assessment of the compliance of ecotoxicological test material with the technical specification of the five-batch analysis. A data gap remains for the applicant to address the risk to soil-dwelling organisms from the volatilization-deposition of etridiazole and all routes of formation of dichloro-etridiazole and etridiazole acid. Buffer zones of 5 m to water bodies are required for the intended use in ornamentals.
