Conclusion on the peer review of the pesticide risk assessment of the active substance Trichoderma polysporum strain IMI 206039

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(1):3035 [38 pp.].
doi
10.2903/j.efsa.2013.3035
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2009-00299
Approved
11 December 2012
Published
9 January 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (494.39 KB)
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 Sweden, for the pesticide active substance Trichoderma polysporum IMI 206039 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 polysporum strain IMI 206039 as a fungicide on strawberries and ornamental trees. 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 polysporum 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 polysporum strain IMI 206039 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.

Sweden being the designated rapporteur Member State submitted the DAR on Trichoderma polysporum IMI 206039 in accordance with the provisions of Article 22(1) of the Regulation, which was received by the EFSA on 11 October 2007. The peer review was initiated on 25 April 2008 by dispatching the DAR to the notifier BINAB Bio-Innovation AB and on 15 June 2011 to the Member States, for consultation and comments. Following consideration of the comments received on the DAR, it was concluded that EFSA should conduct a focused peer review in the areas of mammalian toxicology and ecotoxicology and deliver its conclusions on Trichoderma polysporum IMI 206039.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Trichoderma polysporum strain IMI 206039 as a fungicide on strawberries and ornamental trees, as proposed by the notifier. Full details of the representative uses can be found in Appendix A to this report.

Data gaps were identified for the section identity, physical and chemical properties.

Further to the data gaps identified in the physical and chemical properties section on secondary metabolites/toxins potentially present in the product and after application, data gaps were identified for, at least, an acute inhalation toxicity, infectivity and pathogenicity study and a second acute study performed with a second route of exposure conducted with Trichoderma polysporum. Due to the insufficient data package available on Trichoderma polysporum to address the toxicity, infectivity and pathogenicity of the microorganism, no operator, worker and bystander exposure risk assessment could be conducted and this was regarded as a critical area of concern.

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 polysporum strain IMI 206039 in soil and water and its dispersion characteristics in the context of the representative use assessed, therefore data gaps are identified. Sufficient information on the mobility of Trichoderma polysporum strain IMI 206039 via air was not available, therefore is a data gap was identified. Satisfactory information to demonstrate that, under the conditions of use, any toxins/secondary metabolites, such as trichothecenes, suzukacillin, alamethicine and peptaibols, produced by Trichoderma polysporum strain IMI 206039 will not occur in the environmental compartments in concentrations considerably higher than under natural conditions is not available. 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.

Regarding the potential effects on non-target organisms, data gaps were identified for appropriate risk assessments for wild mammals, aquatic organism, bees, non-target arthropods and soil organisms. The risk to birds was considered to be low.
 

Keywords
Trichoderma polysporum strain IMI 206039, peer review, risk assessment, pesticide, fungicide
Print on demand
Number of Pages
38