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Conclusion on the peer review of the pesticide risk assessment of the active substance ipconazole
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 the United Kingdom, for the pesticide active substance ipconazole 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 ipconazole as a fungicide for seed treatment of wheat and barley. 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
Ipconazole is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the United Kingdom (hereinafter referred to as the ‘RMS’) received an application from Kureha GmbH, Germany, 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 2008/20/EC of 20 December 2007.
The RMS provided its initial evaluation of the dossier on ipconazole in the Draft Assessment Report (DAR). In accordance with Commission Regulation (EU) No 188/2011 Article 11(6) additional information was requested. The RMS’s evaluation of the additional information was submitted to the EFSA in the format of a revised DAR, which was received by the EFSA on 22 November 2011. The peer review was initiated on 1 February 2012 by dispatching the DAR for consultation of the Member States and the applicant (Kureha GmbH, Germany).
Following consideration of the comments received on the DAR, it was concluded that the EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether ipconazole 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 conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of ipconazole as a fungicide for seed treatment of wheat and barley as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.
In the area of identity, physical/chemical/technical properties and methods of analysis a data gap for further methods of analysis was identified, no areas of concern were identified.
No gaps or areas of concern were identified in the mammalian toxicology section.
No data gaps or areas of concern were identified in the section of residues.
No major gaps or critical areas of concern were identified in the environmental fate and behaviour section, but the lack of data with regard to the metabolism/degradation of each isomers lead to an issue ‘not finalised’.
Several data gaps were identified in the section on ecotoxicology. The long-term risk for small granivorous birds was identified as a concern.
ipconazole, peer review, risk assessment, pesticide, fungicide, seed treatment