CONCLUSION ON PESTICIDE PEER REVIEW Conclusion on the peer review of the pesticide risk assessment of the active substance azadirachtin

Azadirachtin 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 1095/20074. In accordance with the Regulation, at the request of the Commission of the European Communities (hereafter referred to as 'the Commission'), the EFSA organised a peer review of the initial evaluation, i.e. the Draft Assessment Report (DAR), provided by Germany, being the designated rapporteur Member State (RMS). The peer review process was subsequently terminated following the applicants' decision, in accordance with Article 24e, to withdraw support for the inclusion of azadirachtin in Annex Ito Council Directive 91/414/EEC. Following the Commission Decision of 2008/941/EC5 concerning the non -inclusion of azadirachtin in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance, the applicants Trifolio-M GmbH, Sipcam S.p.A, and Mitsui AgriScience International S.A/B.V made a resubmission application for the inclusion of azadirachtin in Annex Tin accordance with the provisions laid down in Chapter III of Commission Regulation (EC) No. 33/20086. The resubmission dossier included further data in response to the issues identified in the DAR. In accordance with Article 18 of Commission Regulation (EC) No. 33/2008, Germany, being the designated RMS, submitted an evaluation of the additional data in the format of an Additional Report. The Additional Report was received by the EFSA on 10 December 2009. In accordance with Article 19 of Commission Regulation (EC) No. 33/2008, the EFSA distributed the Additional Report to Member States and the applicants for comments on 11 December 2009. The EFSA collated and forwarded all comments received to the Commission on 25 January 2010. In accordance with Article 20, following consideration of the Additional Report, the comments received, and where necessary the DAR, the Commission requested the EFSA to conduct a focused peer review in the areas of mammalian toxicology, residues, fate and behaviour, and ecotoxicology and to deliver its conclusions on azadirachtin. The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of azadirachtin as an insecticide on potato, as proposed by the applicants. Full details of the representative use can be found in Appendix A. Azadirachtin A was the proposed lead substance, however this was not accepted and the content of the total biologically active extract is not yet defined. A general data gap is identified for data in the area of identity, physical/chemical/technical properties and methods of analysis for the other biologically active components, as the original proposal that azadirachtin A is the lead compound was not accepted by the experts' meeting on mammalian toxicology (see section 2). Pending on the residue definitions in all compartments, data gaps might be identified for monitoring analytical methods. Data gaps were identified in the toxicology section to address the toxicological equivalence of the Mitsui source (ATI 720) to the Trifolio-M (Neem Azal) and Sipcam (Fortune Aza) sources, therefore no reference values could be set for the Mitsui source. Insufficient information is available on the batches used in the toxicological studies conducted with the Mitsui source to conclude if they are representative of the respective technical specification. Regarding the specification, the relevance of the impurities/by-products of azadirachtin extracts from the three sources is not addressed (except for the aflatoxins, which are known relevant impurities). There is no conclusion in the residues area. The nature of residues in plants is unknown and a critical area of concern is identified. Data gaps for all or some of the known active components of azadirachtin extract and its metabolites have been identified for all the environmental compartments. A critical area of concern has been identified since contamination of groundwater above the regulatory limits cannot be excluded. Degradation of the polycyclic structure common to all known active components of azadirachtin in the environment has not been demonstrated. Azadirachtin is very toxic to aquatic organisms. The risk to aquatic organisms was assessed as low for the majority of FOCUS scenarios. The risk assessment is not finalised for the run-off scenario R1 (stream). An initial impact on populations of sensitive arthropod species can be expected based on the observations in laboratory studies. However higher tier data suggest that recolonisation of the in-field area is possible within one year. An in-field no-spray buffer zone of 5m was suggested to protect sensitive arthropod populations in the off-field area. The risk to soil-dwelling organisms was assessed as low for the azadirachtin extract and for azadirachtin A. However the risk assessment for the individual compounds of the extract and potential degradation products could not be finalised. The risk to birds and mammals, bees, non-target plants and biological methods of sewage treatment was assessed as low.