Conclusion on the peer review of the pesticide risk assessment of the active substances Beauveria bassiana strains ATCC-74040 and GHA

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Article
EFSA Journal 2013;11(1):3031 [44 pp.].
doi
10.2903/j.efsa.2013.3031
European Food Safety Authority
Type
Conclusion on Pesticides
On Request From
European Commission
Question Number
EFSA-Q-2009-00252
EFSA-Q-2009-00251
Approved
12 Dezember 2012
Published
7 Juli 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (553.67 KB)553.67 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 Germany, for the pesticide active substances Beauveria bassiana strains ATCC-74040 and GHA 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 and Commission Regulation (EU) No 114/2010. The conclusions were reached on the basis of the evaluation of the representative uses of Beauveria bassiana strains ATCC-74040 and GHA as an insecticide on tomatoes for strain ATCC-74040 and on tomatoes, cucumbers and ornamentals for strain GHA. 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

Beauveria bassiana strains ATCC-74040 and GHA 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.

Beauveria bassiana strains ATCC-74040 and GHA 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 have 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. 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.

Germany being the designated rapporteur Member State submitted the DARs on Beauveria bassiana strains ATCC-74040 and GHA in accordance with the provisions of Article 22(1) of the Regulation, which were received by the EFSA on 3 December 2007. The peer review was initiated on 22 April 2008 by dispatching the DARs to the notifiers (Intrachem Bio Italia S.p.A. for strain ATCC-74040 and Mycotech Europe Ltd. for strain GHA) and on 11 June 2008 to the Member States for consultations and comments. Following consideration of the comments received on the DARs, it was concluded that EFSA should conduct a focused peer review in the area of ecotoxicology and deliver its conclusions on Beauveria bassiana strains ATCC-74040 and GHA.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Beauveria bassiana strains ATCC-74040 and GHA as an insecticide on tomatoes for strain ATCC-74040 and on tomatoes, cucumbers and ornamentals for strain GHA, as proposed by the notifiers. Full details of the representative uses can be found in Appendix A to this report.

In the area of identity of the microorganism, biological properties, physical and technical properties and methods of analysis, data gaps were identified for both strains and both formulations.

The operator, worker and bystander risk assessment cannot be finalised due to the lack of information on toxins/secondary metabolites production.

The consumer risk assessment cannot be finalised until the toxins/secondary metabolite issue is addressed.

The information on fate and behaviour in the environment was not sufficient to characterise the competitiveness/persistence of B. bassiana strains ATCC-74040 and GHA in soil in the context of the representative uses assessed and therefore data gaps were identified. Satisfactory information is not available to demonstrate that, under the conditions of use, any toxins/secondary metabolites produced by Beauveria bassiana strains ATCC-74040 and GHA 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.

Beauveria bassiana strain ATCC-74040: From infectivity and pathogenicity a low risk to birds, mammals, fish, algae, earthworms, soil micro-organisms and non-target plants was concluded. A data gap was identified to address the risk from infectivity and pathogenicity to aquatic invertebrates and pollinators for both the field and greenhouse uses. Data gaps were concluded to address the risk to honey bee brood and the risk to non-target arthropods infectivity and pathogenicity for the field use. A data gap was concluded for information to address the risk to sewage treatment organisms for the greenhouse use. Pending the data gaps for identification of secondary metabolites/toxins a risk assessment for non-target organisms may be required for both the field and greenhouse uses.

Beauveria bassiana strain GHA: From infectivity and pathogenicity a low risk to birds, mammals, fish, aquatic invertebrates, algae, and earthworms was concluded. Data gaps were identified to address the risk to pollinators and sewage treatment organisms. Pending the data gap to finalise the soil exposure assessment it may be necessary to address the risk to soil-dwelling non-target arthropods and soil microorganisms. Pending the data gaps for identification of secondary metabolites/toxins a risk assessment for non-target organisms may be required.
 

Keywords
Beauveria bassiana strains ATCC-74040 and GHA, peer review, risk assessment, pesticide, insecticide
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Number of Pages
44