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Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma gamsii ICC080
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, France, for the pesticide active substance Trichoderma gamsii ICC080 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 Trichoderma gamsii ICC080 as a fungicide on flowers, ornamentals, vegetables (e.g. tomato, pepper, salad, celery, eggplant, cucumber), aromatic herbs and strawberries. 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. Concerns are identified.
© European Food Safety Authority, 2013
Trichoderma gamsii ICC080 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.
Trichoderma gamsii ICC080 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.
France being the designated rapporteur Member State submitted the DAR on Trichoderma gamsii ICC080 (formerly Trichoderma viride ICC080) in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 18 June 2007. The peer review was initiated on 25 April 2008 by dispatching the DAR for consultation of the notifier, The Trichoderma viride Task Force, and on 15 June 2011 for consultation of the Member States. Following consideration of the comments received on the DAR, it was concluded that there was no need to conduct an expert consultation and EFSA should deliver its conclusions on Trichoderma gamsii ICC080.
The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Trichoderma gamsii ICC080 as a fungicide on flowers, ornamentals, vegetables (e.g. tomato, pepper, salad, celery, eggplant, cucumber), aromatic herbs and strawberries, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report.
Data gaps were identified in the section on identity, physical and chemical properties and analytical methods.
In the area of mammalian toxicology, two data gaps were identified in relation to the lack of studies performed with the representative formulation. Finally, the production of toxins/secondary metabolites of unknown toxicity cannot be excluded and therefore the risk assessment for human health cannot be finalised.
The consumer risk assessment for the edible uses cannot be finalised as it is not known if this strain produces toxins/secondary metabolites that could be taken up by plants.
A data gap was identified for satisfactory information to demonstrate that, under the conditions of use, any toxins/secondary metabolites produced by Trichoderma gamsii strain ICC080 will not occur in the environmental compartments in concentrations considerably higher than under natural conditions. Further data on the persistence, transformation and mobility of these compounds might be needed in order to assess the potential level of environmental exposure including groundwater.
Data gaps were identified to further assess the risk from infectiveness and pathogenicity for bees and soil non-target arthropods for the representative uses where the method of application is soil spraying.
Trichoderma gamsii ICC080, peer review, risk assessment, pesticide, fungicide