Jun. 6, 2008
The European Commission has issued guidance on the registration of baculovirus-based bio-insecticides and their listing in Annex I of the EU agrochemical registration Directive (91/414). Approved baculovirus active ingredients will be added to Annex I at the host species level only, rather than at the strain level. Subsequent applications for new isolates of EU-approved baculoviruses will be maintained in a separate list, once they have been evaluated. The move reflects the specificity and low risk of baculovirus-based pesticides, which means that the full Annex I listing process is not required for each isolate, the Commission says.
Applications for new isolates of EU-approved baculoviruses will be submitted and approved at EU member state level. The Commission points out that, while a full data dossier would be required "in principle", many data requirements could be met by reference to the existing draft assessment reports for the approved baculovirus. Member states will assess and compare the properties of the new isolate with the "reference" isolate, which will be the one in the first Annex I listing.
The member state will submit its evaluation report to the EU regulatory committee, which will merely "take note" of the report. However, if the member state finds that the isolate is not comparable to the reference isolate, then the normal EU procedure for inclusion in Annex I will have to be followed.
The arrangements reflect OECD advice on the assessment of environmental applications involving baculoviruses, the Commission points out. The measures are also based on experience with the first EU evaluations of virus-based ais under Directive 91/414, which were Spodoptera exigua nucleopolyhedrovirus (NPV), Cydia pomonella granulovirus (GV) and Adoxophyes orana GV, it adds. Certis Europe's S exigua NPV, sold as Spod-X, was listed in Annex I in 2007. Swiss company Andermatt Biocontrol's A orana GV is still going through the EU registration process. Certis, Andermatt and German company Probis are supporting C pomonella GV through the fourth round of the EU review of existing ais.
Pesticides based on other micro-organisms, such as bacteria or fungi, will continue to be listed in Annex I at the strain level.
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