Peer review of the pesticide risk assessment of the active substance Bacillus amyloliquefaciens strain MBI 600

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2016;14(1):4359 [37 pp.].
doi
10.2903/j.efsa.2016.4359
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2014-00323
Approved
4 December 2015
Published
8 January 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (914.17 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 France for the pesticide active substance Bacillus amyloliquefaciens strain MBI 600 and the considerations as regards the application for inclusion of the active substance in Annex IV of Regulation (EC) No 396/2005, are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of Bacillus amyloliquefaciens strain MBI 600 as a fungicide on table and wine grapes. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified.

Summary

Bacillus amyloliquefaciens strain MBI 600 is a new active substance for which, in accordance with Article 7 of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (hereinafter referred to as ‘the Regulation’), the rapporteur Member State (RMS) France, received an application from BASF Agricultural Specialties Ltd on 28 June 2013 for approval. Complying with Article 9 of the Regulation, the completeness of the dossier was checked by the RMS and the date of admissibility of the application was recognised as being 4 September 2013.

The RMS provided its initial evaluation of the dossier on Bacillus amyloliquefaciens strain MBI 600 in the draft assessment report (DAR), which was received by the European Food Safety Authority (EFSA) on 5 January 2015. The peer review was initiated on 17 February 2015 by dispatching the DAR for consultation to the Member States and the applicant, BASF Agricultural Specialties Ltd.

Following consideration of the comments received on the DAR, it was concluded that additional information should be requested from the applicant, and that there was no need to conduct an expert consultation.

In accordance with Article 12 of the Regulation, EFSA should adopt a conclusion on whether Bacillus amyloliquefaciens strain MBI 600 can be expected to meet the approval criteria provided for in Article 4 of the Regulation taking into consideration recital (10) of the Regulation and give a view concerning the application for inclusion of the active substance in Annex IV of Regulation (EC) No 396/2005. Furthermore, this conclusion also addresses the assessment required from EFSA under Article 12 of Regulation (EC) No 396/2005.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of Bacillus amyloliquefaciens strain MBI 600 as a fungicide on wine and table grapes, as proposed by the applicant. Full details of the representative uses can be found in Appendix A of this report.

The uses of Bacillus amyloliquefaciens strain MBI 600 according to the representative uses proposed result in a sufficient fungicidal efficacy against grey mould.

With regard to the review of the scientific open literature on the active substance and its relevant metabolites, a data gap was identified in all sections of the conclusion.

Data gaps were identified in the section identity, physical-chemical and technical properties and analytical methods.

In the area of mammalian toxicology, the potential transfer of genetic material responsible of anti-bioresistance could not be excluded. Furthermore, the risk assessment for operators, workers, bystanders and residents possibly exposed to metabolites of Bacillus amyloliquefaciens strain MBI 600 cannot be concluded (data gaps).

In the area of residues and consumer exposure the risk assessment cannot be finalised due to the possible production of secondary metabolites/toxins and EFSA can therefore not support the inclusion of Bacillus amyloliquefaciens strain MBI 600 in Annex IV of Regulation (EC) No 396/2005.

As satisfactory information has not been provided on the potential transfer of genetic material from Bacillus amyloliquefaciens strain MBI 600 to other organisms, a data gap pertaining to the environment has been identified and this is an issue that cannot be finalised. Satisfactory information to demonstrate that, under the conditions of use, any secondary metabolites/toxins present in the technical MPCA or produced by Bacillus amyloliquefaciens strain MBI 600 will not occur in the environmental compartments in concentrations considerably higher than under natural conditions is missing. Consequently further data on the persistence, transformation and mobility of these compounds may be needed in order to assess the potential level of environmental exposure including the exposure of groundwater.

A low risk was concluded for birds, mammals, fish, aquatic invertebrates, algae, honeybees, non-target arthropods and earthworms from the potential of infectivity and pathogenicity. A data gap for information to address the risk to soil microorganisms was concluded and therefore the assessment could not be finalised. Furthermore, the assessment of the risk to non-target organisms from secondary metabolites and toxins, in the technical MPCA and produced in the environment, could not be finalised. 

Keywords
Bacillus amyloliquefaciens strain MBI 600, peer review, risk assessment, pesticide, fungicide, maximum residue level
Print on demand
Number of Pages
37