Imidacloprid was included in Annex I to Directive 91/414/EEC on 1 August 2009 by Commission Directive 2008/116/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 the approval that the applicant was required to submit to the European Commission by 31 July 2011 further studies to address the risk assessment for operators and workers, and the risk to birds and mammals.
In accordance with the specific provision, the applicant, Bayer CropScience, submitted an updated dossier in July 2011, which was evaluated by the designated RMS, Germany, in the form of an Addendum to the Draft Assessment Report. In compliance with the Guidance Document SANCO 5634/2009 rev.4.5, the RMS distributed the Addendum to Member States, the applicant and the EFSA for comments on 26 January 2012. The RMS collated all comments in the format of a Reporting Table, which was submitted to the European Commission in May 2012. As a follow up, the open points of the Reporting Table were evaluated by the RMS in revised addenda and a further commenting was launched on 18 December 2012. The comments were summarised by the RMS in a revised Reporting Table, which was submitted to the European Commission in May 2013.
Following consideration of the comments received, the European Commission requested the EFSA to deliver its conclusions on the RMS’s evaluation of the confirmatory data submitted in relation to the risk assessment for operators and workers, and as regards the risk to birds and mammals.
EFSA concluded that the confirmatory data requirements on information to further address the risk assessment for operators and workers have been fulfilled.
It was concluded that the confirmatory data assessments for birds and mammals addressed the issues that had been indentified as concerns. However some uncertainties were identified.