Conclusion on the peer review of the pesticide risk assessment of the active substance Paecilomyces fumosoroseus strain FE 9901

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Article
EFSA Journal 2012;10(9):2869 [26 pp.].
doi
10.2903/j.efsa.2012.2869
European Food Safety Authority
Type
Conclusion on Pesticides
On Request From
European Commission
Question Number
EFSA-Q-2009-00323
Approved
16 Août 2012
Published
12 Septembre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (402.5 KB)402.5 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 Belgium for the pesticide active substance Paecilomyces fumosoroseus strain FE 9901 are reported. The context of the peer review was that required by Commission Regulation (EU) No 188/2011. The conclusions were reached on the basis of the evaluation of the representative uses of Paecilomyces fumosoroseus as an insecticide in glasshouses on tomatoes. 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

Paecilomyces fumosoroseus strain FE 9901 is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC Belgium (hereinafter referred to as the ‘RMS’) received an application from FuturEco S.L. for approval. Complying with Article 6(3) of Directive 91/414/EEC the completeness of the dossier was checked by the RMS. The European Commission recognised in principle the completeness of the dossier by Commission Decision 2008/565/EC.

The RMS provided its initial evaluation of the dossier on Paecilomyces fumosoroseus strain FE 9901 in the Draft Assessment Report (DAR), which was received by the EFSA on 29 March 2007. The peer review was initiated on 30 January 2009 by dispatching the DAR for consultation of the Member States and the applicant FuturEco S.L. In accordance with Commission Regulation (EU) No 188/2011 Art 11(6) additional information was requested. The RMS’s evaluation was submitted to the EFSA on 31 May 2011. The updated DAR and addenda were dispatched for consultation of the Member States and the applicant FuturECO S.L. on 5 October 2011.

Following consideration of the comments received on the DAR and the addenda, it was concluded that there was no need to conduct an expert consultation and the EFSA should adopt a conclusion on whether Paecilomyces fumosoroseus strain FE 9901 can be expected to meet the conditions provided for in Article 5 of Directive 91/414/EEC, in accordance with Article 8 of Commission Regulation (EU) No 188/2011.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of Paecilomyces fumosoroseus strain FE 9901 as an insecticide in glasshouses on tomatoes, as proposed by the applicant. 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 no data gaps or areas of concern were identified.

In the area of mammalian toxicology no data gaps or areas of concern were identified.

As the formulation contains no significant secondary metabolites a quantitative consumer risk is not necessary and the consumer risk assessment could be finalised.

The information on fate and behaviour in the environment is sufficient to complete the necessary assessments at the EU level, with the exception that the available information is considered insufficient to properly characterise the competitiveness/persistence of Paecilomyces fumosoroseus strain FE 9901 in soil and the fate, survival and persistence in natural surface water. Consequently data gaps are identified for more information on these issues.This leads to issues not finalised.

A low risk to birds, mammals and non-target plants was concluded. The surface water, soil exposure assessment and consequentially the risk to aquatic and soil-swelling organisms was not finalised. A low risk to natural populations of bees and non-target arthropods was concluded; however, a risk to pollinators and other beneficial arthropods which may be present in the glasshouse was identified. Therefore, a data gap to address the risk to pollinators and other beneficial arthropods was identified, if Paecilomyces fumosoroseus strain FE 9901 is to be used in glasshouses with pollinators and integrated pest management techniques. A data gap to address the risk to sewage treatment organisms was also identified.

Keywords
Paecilomyces fumosoroseus strain FE 9901, peer review, risk assessment, pesticide, insecticide
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Number of Pages
26