Conclusion on the peer review of the pesticide risk assessment of the active substance Adoxophyes orana granulovirus


European Food Safety Authority
EFSA Journal
EFSA Journal 2012;10(4):2654 [32 pp.].
Conclusion on Pesticides
On request from
European Commission
Question Number
4 April 2012
23 April 2012
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 assessments carried out by the competent authority of the rapporteur Member State Germany, for the pesticide active substance Adoxophyes orana granulovirus are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative use of Adoxophyes orana GV as an insecticide on pome fruit. 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.


Adoxophyes orana granulovirus (GV) is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC Germany (hereinafter referred to as the „RMS‟) received an application from Andermatt Biocontrol GmbH for approval. Complying with Article 6(3) of Directive 91/414/EEC, the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Decision 2007/669/EC.

The RMS provided its initial evaluation of the dossier on Adoxophyes orana GV in the Draft Assessment Report (DAR), which was received by the EFSA on 13 August 2008. The peer review was initiated on 30 January 2009 by dispatching the DAR for consultation of the Member States and the applicant Andermatt Biocontrol GmbH.

Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct an expert consultation in the area of ecotoxicology and EFSA should adopt a conclusion on whether Adoxophyes orana GV can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Adoxophyes orana GV as an insecticide on pome fruit, as proposed by the applicant. 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 and a validated method of analysis for 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 Adoxophyes orana GV and its dispersion characteristics in the context of the representative use assessed.

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

Adoxophyes orana granulovirus, Adoxophyes orana GV, AoGV, peer review, risk assessment, pesticide, insecticide
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