Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance ethoprophos

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(2):3089 [27 pp.].
doi
10.2903/j.efsa.2013.3089
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2012-01005
Approved
30 January 2013
Published
11 February 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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 the United Kingdom, for the pesticide active substance ethoprophos 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 ethoprophos as an insecticide and nematicide on potatoes. 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.

Summary

Ethoprophos was included in Annex I to Directive 91/414/EEC on 1 October 2007 by Commission Directive 2007/52/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 short and long-term risk assessment for birds and for earthworm-eating mammals by 30 September 2009.

In accordance with the specific provision, the notifier Bayer CropScience AG submitted an updated dossier in September 2009, which was evaluated by the designated rapporteur Member State (RMS), the United Kingdom, in the form of an Addendum to the Draft Assessment Report. In December 2010 Bayer announced the divestment of ethoprophos and all related products to American Vanguard Corporation (AMVAC). In compliance with Guidance Document SANCO 5634/2009 rev.3, the RMS distributed the Addendum to Member States and the EFSA for comments on 11 July 2011. The RMS collated all comments in the format of a Reporting Table, which was submitted to the European Commission in September 2011.

Following consideration of the comments received, the European Commission requested the EFSA to deliver its conclusions on the short and long-term risk assessment for birds and for earthworm-eating mammals.

The conclusions are as follows:

Representative use of ‘Mocap 10G’ in Northern Europe: a high risk to small granivorous birds (acute and long-term), herbivorous birds (acute and long-term), earthworm-eating birds (acute and long-term), earthworm-eating mammals (acute) and birds from soil ingestion (long-term) was concluded. The risk to fish-eating birds could not be finalised.

Representative use of ‘Mocap 10G’ in Southern Europe: a high risk to small granivorous birds (acute and long-term) and birds from soil ingestion (long-term) was concluded. The risk to herbivorous birds, earthworm-eating birds, earthworm-eating mammals and fish-eating birds could not be finalised.

Representative use of ‘EPP GR15’ in Northern Europe: a high risk to herbivorous birds (acute and long-term), earthworm-eating birds (acute and long-term), earthworm-eating mammals (acute) and birds from soil ingestion (long-term) was concluded. The risk to fish-eating birds could not be finalised.

Representative use of ‘EPP GR15’ in Southern Europe: a high risk to birds from soil ingestion (long-term) was concluded. The risk to herbivorous birds, earthworm-eating birds, earthworm-eating mammals and fish-eating birds could not be finalised.
 

Keywords
ethoprophos, peer review, risk assessment, pesticide, insecticide, nematicide
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Number of Pages
27