Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma asperellum strains ICC012, T25 and TV1

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(1):3036 [61 pp.].
doi
10.2903/j.efsa.2013.3036
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2009-00298
EFSA-Q-2009-00300
Approved
11 December 2012
Published
9 January 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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 France, for the pesticide active substance Trichoderma asperellum strains T25 and TV1, and by the competent authority of the rapporteur Member State Sweden, for the pesticide active substance Trichoderma asperellum strain ICC012, 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 asperellum strains ICC012 and TV1 as a fungicide on tomato and of Trichoderma asperellum strain T25 as a fungicide on tomato, pepper, cucumber and courgette. 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.

Summary

Trichoderma asperellum strain ICC012 (formerly identified as Trichoderma harzianum Rifai) and Trichoderma asperellum strains T25 and TV1 (formerly identified as Trichoderma viride strains T25 and TV1 respectively) are two 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 asperellum strains ICC012, T25 and TV1 were 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 reports submitted by the European Commission in accordance with Article 25(1) of the Regulation. These review reports were established as a result of the initial evaluations provided by the designated rapporteur Member States in the Draft Assessment Reports (DARs). The EFSA therefore organised a peer review of the DARs. The conclusions of the peer review are set out in this report.

France being a designated rapporteur Member State submitted the DAR on Trichoderma viride strains ICC080, T25 and TV1 (currently identified as Trichoderma gamsii strain ICC080 and Trichoderma asperellum strains T25 and TV1 respectively), in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 18 June 2007. Sweden being a designated rapporteur Member State submitted the DAR on Trichoderma harzianum Rifai (currently identified as Trichoderma asperellum strain ICC012) in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 12 July 2007. The peer review was initiated on 25 April 2008 by dispatching the DAR on Trichoderma viride strains ICC080, T25 and TV1 (pertinent strains currently identified as Trichoderma asperellum strains T25 and TV1) for consultation of the Member States and the notifier, the Trichoderma viride Task Force; and on 7 May 2008 by dispatching the DAR on Trichoderma harzianum Rifai (currently identified as Trichoderma asperellum strain ICC012), for consultation of the Member States and the notifier, the Trichoderma harzianum Task Force. Following consideration of the comments received on the DARs, it was concluded that EFSA should conduct a focused peer review in the area of mammalian toxicology and deliver its conclusions on Trichoderma asperellum strains ICC012, T25 and TV1.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Trichoderma asperellum strains ICC012 and TV1 as a fungicide on tomato and Trichoderma asperellum strain T25 as a fungicide on tomato, pepper, cucumber and courgette, as proposed by the notifiers. Full details of the representative uses can be found in Appendices A, B and C to this report.

Data gaps were identified for the section on physical and chemical properties and analytical methods.

In the area of mammalian toxicology, several data gaps were identified: for an assessment of the acute toxicity of the representative formulations for Trichoderma asperellum strains T25 and ICC012, and for an acute inhalation study including investigation of the clearance for Trichoderma asperellum strain TV1. In addition, as the production of toxins/secondary metabolites of unknown toxicity cannot be excluded, the risk assessment for human health cannot be finalised.

The consumer risk assessment cannot be finalised as it is not known if this strain produces toxins/secondary metabolites that could be taken up by the plants.

The information on fate and behaviour in the environment is not sufficient to characterise the competitiveness/persistence of Trichoderma asperellum strains ICC012, T25 and TV1 in the context of the representative use assessed, therefore data gaps are identified. It is not shown that Trichoderma asperellum strains ICC012, T25 and TV1 will not persist in the environment in concentrations higher than the natural background levels, taking into account repeated applications over the years. Satisfactory information to demonstrate that, under the conditions of use, any toxins/secondary metabolites produced by Trichoderma asperellum strains ICC012, T25 and TV1 (which may include tricothecenes, viridofungins and peptaibols) will not occur in the environmental compartments in concentrations considerably higher than under natural conditions is also missing. Consequently further data on the persistence, transformation and mobility of these compounds may be needed in order to assess the potential for groundwater contamination and surface water exposure.

 The risk for birds and mammals, aquatic organism and bees was concluded to be low for Trichoderma asperellum strain ICC012. Data gaps were identified for appropriate risk assessments for soil non-target arthropods and soil microorganisms.
 

Keywords
Trichoderma asperellum, strain ICC012, strain T25, strain TV1, peer review, risk assessment, pesticide, fungicide
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Number of Pages
61