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Conclusion on the peer review of the pesticide risk assessment of the active substance sedaxane
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State France, for the pesticide active substance sedaxane are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of sedaxane as a fungicide for seed treatment on wheat. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.
© European Food Safety Authority,2013
Sedaxane is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC France (hereinafter referred to as the designated rapporteur Member State (RMS)) received an application from Syngenta Crop Protection AG for approval. Complying with Article 6(3) of Directive 91/414/EEC, the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Decision 2011/123/EU of 23 February 2011.
The RMS provided its initial evaluation of the dossier on sedaxane in the Draft Assessment Report (DAR), which was received by the EFSA on 10 May 2011. The peer review was initiated on 10 June 2011 by dispatching the DAR for consultation of the Member States and the applicant Syngenta Crop Protection AG. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology and ecotoxicology, and should adopt a conclusion on whether sedaxane can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011. The outcome of the peer review of the risk assessment was reported in the EFSA Conclusion on sedaxane, published on 18 July 2012.
Upon consideration of the EFSA Conclusion the European Commission noted that sedaxane is classified by the US Environmental Protection Agency (EPA) as ‘Likely to be carcinogenic to humans’, whereas no classification was proposed in the EFSA Conclusion with regard to carcinogenicity. Therefore, in November 2012, EFSA received a request from the European Commission to re-consider the toxicological assessment and confirm its conclusions on sedaxane.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of sedaxane as a fungicide for seed treatment on wheat, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
No data gaps or areas of concern were identified in the section on identity, physical/chemical/technical properties and methods of analysis.
No data gaps or areas of concern were identified in the mammalian toxicology section.
No data gaps or areas of concern were identified in the residue section.
The fate and behaviour of sedaxane in the environment was investigated with a complete set of studies, however a data gap was identified for a groundwater exposure assessment for the minor non-transient metabolite CSCD728931. No information has been provided on the environmental behaviour of each individual enantiomer of this metabolite, which contains one chiral carbon atom. It is not known if one isomer is degraded more quickly than the other or if any other conversion between isomers occurs. The relevant groundwater metabolite CSCD465008 exceeds the parametric drinking water limit of 0.1 µg/L in all of the pertinent groundwater scenarios. This has been identified as a critical area of concern.
On the basis of the available data, a high long-term risk was identified for granivorous birds and mammals. The acute and long-term risk to birds and mammals from other routes of exposure was concluded to be low. A low risk to aquatic organisms, bees, non-target arthropods, earthworms, soil microorganisms, soil macroorganisms, non-target plants and sewage treatment organisms was concluded.
Sedaxane, peer review, risk assessment, pesticide, fungicide