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Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance dichlorprop-P

EFSA Journal 2012;10(11):2950[20 pp.]. doi:10.2903/j.efsa.2012.2950
European Food Safety Authority Contact pesticides.peerreview@efsa.europa.eu
Type: Conclusion on Pesticides On request from: European Commission Question number: EFSA-Q-2012-00756 Approved: 05 November 2012 Published: 13 November 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

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 Denmark, for the pesticide active substance dichlorprop-P are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory data concerning the risk assessment in the areas of consumer exposure and birds and mammals. The conclusions were reached on the basis of the evaluation of the representative uses of dichlorprop-P as a herbicide on cereals, grassland and grass seed crops. 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.

© European Food Safety Authority,2012

Summary

Dichlorprop-P was included in Annex I to Directive 91/414/EEC on 1 June 2007 by Commission Directive 2006/74/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. It was a specific provision of the approval that the notifier was required to submit to the European Commission further studies to confirm the results on animal metabolism and the risk assessment on acute and short-term exposure for birds and on acute exposure for herbivorous mammals by 31 May 2009.

In accordance with the specific provision, the notifier, Nufarm, submitted an updated dossier in July 2009, which was evaluated by the designated RMS, Denmark, in the form of an Addendum to the Draft Assessment Report. In compliance with Guidance Document SANCO 5634/2009 rev.3, the RMS distributed the Addendum to Member States and the EFSA for comments on 22 July 2011. The RMS collated all comments in the format of a Reporting Table, which was submitted to the European Commission in October 2011.

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 consumer exposure and birds and mammals and to deliver its conclusions on the risk assessment for birds and mammals, the residue definition and the derivation of MRLs for animal products.

The experts at the Pesticide Peer Review meeting 96 on residues in September 2012 concluded that sufficient information was available to identify the metabolite 11 in wheat straw as dichlorprop-P methyl ester and derived the residue definition for enforcement purposes and risk assessment in plant commodities as the “sum of dichlorprop (including dichlorprop-P), its salts, esters and conjugates expressed as dichlorprop”. The meeting also confirmed the MRLs of 0.7 mg/kg for bovine kidney and 0.1 mg/kg for bovine liver based on the available goat metabolism study reported in the Draft Assessment Report.

The acute risk for herbivorous and insectivorous birds and herbivorous mammals was not addressed with the confirmatory data and a critical area of concern was identified.
 

Keywords

Dichlorprop-P, peer review, risk assessment, pesticide, herbicide

Background documents
Additional information is available in theAssessment report
Background documents are available in theRegister of Questions