Conclusion on the peer review of the pesticide risk assessment of the active substance Cydia pomonella granulovirus (CpGV)

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Article
EFSA Journal 2012;10(4):2655 [40 pp.].
doi
10.2903/j.efsa.2012.2655
European Food Safety Authority
Type
Conclusion on Pesticides
On Request From
European Commission
Question Number
EFSA-Q-2009-00254
Approved
4 Aprile 2012
Published
23 Aprile 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (531.39 KB)531.39 KB
Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Germany, for the pesticide active substance Cydia pomonella granulovirus are reported. The context of the peer review was that required by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007. The conclusions were reached on the basis of the evaluation of the representative uses of Cydia pomonella granulovirus as an insectcide on pome fruit and nut trees. 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. Missing information identified as being required by the regulatory framework is listed. A concern is identified.

Summary

Cydia pomonella granulovirus (GV) is one of the 295 substances of the fourth stage of the review programme covered by Commission Regulation (EC) No 2229/2004, as amended by Commission Regulation (EC) No 1095/2007.

Cydia pomonella GV was included in Annex I to Directive 91/414/EEC on 1 May 2009 pursuant to Article 24b of the Regulation (EC) No 2229/2004 (hereinafter referred to as „the Regulation‟) and has subsequently 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. In accordance with Article 25a of the Regulation, as amended by Commission Regulation (EU) No 114/2010, the European Food Safety Authority (EFSA) is required to deliver by 31 December 2012 its view on the draft review report submitted by the European Commission in accordance with Article 25(1) of the Regulation. This review report was established as a result of the initial evaluation provided by the designated rapporteur Member State in the Draft Assessment Report (DAR). The EFSA therefore organised a peer review of the DAR. The conclusions of the peer review are set out in this report.

Germany being the designated rapporteur Member State submitted the DAR on Cydia pomonella GV in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 15 April 2008. The peer review was initiated on 24 April 2008 by dispatching the DAR to the notifiers Arysta LifeScience S.A.S., Sipcam S.p.A., and the CpGV Task Force, and on 21 January 2009 to the Member States for consultation and comments. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the area of ecotoxicology and deliver its conclusions on Cydia pomonella GV.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Cydia pomonella GV as an insecticide on pome fruit and nut trees, as proposed by the notifiers. Full details of the representative uses can be found in Appendix A to this report.

In the areas of identity of the microorganism, biological properties, physical and technical properties and methods of analysis, the following data gaps remain: level of contaminating microorganisms, data gap for the relevant impurity in the Arysta source, data gaps for the formulation 'Carpovirusine' and data gaps for the methods of analysis for quantification and identification.

In the area of mammalian toxicology, there is no data gap and no critical area of concern.

The consumer risk assessment can be finalised and a quantitative assessment is not necessary.

The information on fate and behaviour in the environment is sufficient to characterise the competitiveness / persistence of Cydia pomonella GV and its dispersion characteristics in the context of the representative uses assessed.

A low risk to birds, mammals, aquatic organisms, non-target arthropods, earthworms and soil microorganisms was concluded. A low risk from direct toxicity to bees was also concluded, however, a data gap for further information to address the risk to bee brood was identified.

Keywords
Cydia pomonella granulovirus, Cydia pomonella GV, CpGV, peer review, risk assessment, pesticide, insecticide
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Number of Pages
40