Pyridaben was included in Annex I to Directive 91/414/EEC on 1 May 2011 by Commission Directive 2010/90/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 the risks for the water compartment resulting from the exposure to aqueous photolysis metabolites, the potential long-term risk for mammals and the assessment of fat soluble residues by 30 April 2013.
In accordance with the specific provision, the applicant, Nissan Chemical Europe S.A.R.L., submitted an updated dossier in April 2013, which was evaluated by the designated rapporteur Member State (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 EFSA for comments on 9 December 2013. The RMS collated all comments in the format of a reporting table, which was submitted to the European Commission in April 2014.
Following consideration of the comments received, the European Commission requested EFSA to organise a peer review of the RMS’s evaluation of the confirmatory data submitted in relation to ecotoxicology and to deliver its conclusions on the risk assessment for herbivorous mammals.
The risk to large herbivorous mammals from the representative use of pyridaben on citrus was not excluded and a data gap was identified.