Outcome of the peer review of bee study protocols submitted by Sumitomo to assess the effects of clothianidin on bees

Question Number
EFSA-Q-2014-00171
Issued
20 May 2014
Download Report (550.63 KB)
Abstract

The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific and technical assistance to perform a peer review of the study protocols as submitted by the applicants until 28 February 2014 to assess the effects of clothianidin, thiamethoxam, imidacloprid and fipronil on bees. The context of the evaluation was that required by the European Commission in accordance with Article 31 of Regulation (EC) No 178/2002. The current report summarises the outcome of the consultation process with Member State experts organised by EFSA on the study protocols submitted by Sumitomo on clothianidin and will serve as recommendations for consideration by the applicant in the upcoming post-approval procedure for this active substance.

Summary

Clothianidin was included in Annex I to Directive 91/414/EEC on 7 July 2006 by Commission Directive 2006/41/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011 and Commission Implementing Regulation (EU) No 485/2013. It was a specific provision of Commission Implementing Regulation (EU) No 485/2013 that the applicant is required to submit by 31 December 2014 further confirmatory information as regards the risk to bees.

In February 2014 EFSA received a request from the European Commission to conduct a peer review of the study protocols submitted by the applicants until 28 February 2014 to assess the effects of clothianidin, thiamethoxam, imidacloprid and fipronil on bees in the context of the relevant regulatory process following approval of these substances.

This peer review aims to support EFSA and Member States in assessing the quality and consistency of the protocols submitted by Sumitomo on clothianidin in the context of the upcoming confirmatory data assessment.

The current report summarises the outcome of the consultation process with Member State experts organised by EFSA on the submitted study protocols and will be considered by the relevant rapporteur Member State in the preparation of their list of recommendations that will be addressed to the applicant in support of the upcoming post-approval procedure.

Published
3 June 2014