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Conclusion on the peer review of the pesticide risk assessment of the active substance Candida oleophila strain O
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 the United Kingdom, for the pesticide active substance Candida oleophila strain O 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 Candida oleophila strain O as a fungicide on apple and pear. 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.
© European Food Safety Authority, 2012
Candida oleophila strain O is a new active substance for which in accordance with Article 6(2) of Council Directive 91/414/EEC the United Kingdom (hereinafter referred to as the ‘RMS’) received an application from Bionext sprl 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 2007/380/EC of 30 May 2007.
The RMS provided its initial evaluation of the dossier on Candida oleophila strain O in the Draft Assessment Report (DAR), which was received by the EFSA on 15 November 2011. The peer review was initiated on 30 November 2011 by dispatching the DAR for consultation of the Member States and the applicant Bionext sprl.
Following consideration of the comments received on the DAR, it was concluded that there was no need to conduct an expert consultation and EFSA should adopt a conclusion on whether Candida oleophila strain O 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 uses of Candida oleophila strain O as a fungicide on apple and pear, 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 the following data gaps were identified: Further data to show compliance with the OECD issues paper on microbial contaminants, a method for identification, toxin production and formulation storage stability issues.
In the area of mammalian toxicology, the operator and worker risk assessment cannot be finalised regarding the possible toxins / secondary metabolites production.
As the microorganism is not pathogenic, the organism itself raises no concerns for the consumer risk assessment. However, there is the outstanding issue on the ability of this strain to produce toxins. For this reason the consumer risk assessment cannot be finalised.
Limited studies on the fate and behaviour of Candida oleophila strain O in the environment are available. A waiver for the environmental data and risk assessment has been proposed on the basis of the representative uses. It was concluded that the waiver is appropriate if the product is used in a closed installation and the treatment solutions are treated as waste residues.
The risk to non-target organisms was considered as low for the representative uses.
Candida oleophila strain O, peer review, risk assessment, pesticide, fungicide