Conclusion on the peer review of the pesticide risk assessment of the active substance prochloraz European Food Safety Authority

Prochloraz 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 European Commission, the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by Ireland, 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 prochloraz 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 prochloraz in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicants BASF Agro B.V and Makhteshim Agan made a resubmission application for the inclusion of prochloraz 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, Ireland, 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 3 August 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 13 August 2010. The EFSA collated and forwarded all comments received to the European Commission on 30 September 2010. The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of prochloraz as a fungicide on cereals (foliar spray and seed treatment) and mushrooms, as proposed by the applicants. Full details of the representative uses can be found in Appendix A to this report. For the section identity, physical/chemical/technical properties and methods of analysis it was not possible to finalise the specification and data gaps were identified for prochloraz and the prochloraz copper complex. Data gaps were also identified for a fully validated method of analysis for products of animal origin, a method of analysis for the metabolite BTS 40348 in surface water, and clarification concerning co-formulants in two of the representative formulations. It was not possible to conclude whether the material used in the toxicology testing is comparable to the technical specification (both missing, see section 1) leading to a data gap and a critical area of concern. A data gap was also identified for the evaluation of the studies addressing the acute toxicity of 'Mirage 45 EC' and non-dietary exposure to prochloraz in 'Mirage 45 EC'. Based on the metabolism studies conducted on cereals, rapeseed, apple and mushroom, and considering the availability of two different analytical methods, the plant residue definition for enforcement was proposed as sum of prochloraz, BTS 44595 and BTS 44596, expressed as prochloraz, and for risk assessment as sum of prochloraz and its metabolites containing the 2,4,6-TCP moiety, expressed as prochloraz. On cereals, MRLs and conversion factors were proposed for the BASF dataset only. No MRLs were proposed for cereals from the trials conducted according to the GAPs defined by Makhteshim (540 g a.s./ha), as the samples were only analysed using the common moiety method, and therefore a data gap was identified to provide a full dataset where samples are analysed according to the proposed residue definitions. For animal products, residues were defined as for plants, and MRLs and conversion factors were proposed for ruminant products only. Data gaps were identified for additional information to confirm the stability of prochloraz residues in plant and animal matrices when stored frozen. No acute or chronic risks were identified for consumers. The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at the EU level for the representative uses, with the notable exception that: information is missing to confirm that the available fate and behaviour data for prochloraz are appropriate to be used to assess the copper complex and zinc complex variants of prochloraz, and exposure assessments for the representative uses on mushrooms and cereals as foliar spray at an application rate higher than 450g prochloraz/ha were not presented in the RMS assessments. The potential for endocrine disruption effects in birds needs to be further addressed. Data gaps were also identified to further address the long-term risk to mammals and the risk to earthworm-eating mammals for the representative use as a spray on cereals at rates up to 450 g a.s./ha, and for a risk assessment for the variant zinc complex. Risk assessments for non-target species for the representative uses on cereals with dose rates above 450g a.s./ha and for the representative use on mushrooms were not presented in the RMS assessments.