Peer review of the pesticide risk assessment for the active substance pyridaben in light of confirmatory data submitted


European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(1):4376 [11 pp.].
Conclusion on Pesticides
Question Number
18 December 2015
14 January 2016
European Food Safety Authority (EFSA), Parma, Italy
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The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State the Netherlands, for the pesticide active substance pyridaben are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory ecotoxicology data. The conclusions were reached on the basis of the evaluation of the representative uses of pyridaben as an insecticide on citrus and tomatoes. 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. Concerns are identified.  


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.

pyridaben, peer review, confirmatory data, risk assessment, pesticide, insecticide
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