Pyriproxyfen was included in Annex I to Directive 91/414/EEC on 1 July 2008 by Commission Directive 2008/69/EC, amended by Commission Directive 2010/39/EU 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. It was a specific provision of the approval that the applicant was required to submit to the European Commission further studies on aquatic insects and pollinators by 30 June 2012.
In accordance with the specific provision, the applicant, Sumitomo Chemical Agro Europe S.A., submitted an updated dossier in July 2012, to address the risk to aquatic insects from Pyriproxyfen and from the metabolite DPH-PYR and to address the risk to pollinators, which was evaluated by the designated RMS, the Netherlands in the form of an Addendum to the Draft Assessment Report. In compliance with Guidance Document SANCO 5634/2009 rev.4.5, the RMS distributed the Addendum to Member States, the applicant and the EFSA for comments on 23 September 2013. The RMS collated all comments in the format of a Reporting Table, which was submitted to the European Commission in January 2014.
Following consideration of the comments received, the European Commission requested the EFSA to organise a peer review of the RMS’s evaluation of the confirmatory data submitted in relation to aquatic insects and pollinators and to deliver its conclusions on the weight of evidence approach to address the risk to aquatic insects from Pyriproxyfen and the validity of the field study on honey bees according to SANCO/10329/2002 rev. 2.
Based on the submitted confirmatory data, a low risk to aquatic organisms including insects was indicated for both pyriproxifen and the pertinent metabolite DPH-PYR for all the representative uses. The risk to pollinators from the insect growth regulator mode of action needs to be addressed further for greenhouse uses on tomato and aubergine in Southern Europe, as the submitted field study was not considered appropriate for the risk assessment for bees.