Conclusion on the peer review of the pesticide risk assessment of the active substance COS-OGA

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(10):3868 [39 pp.].
doi
10.2903/j.efsa.2014.3868
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2014-00014
Approved
1 October 2014
Published
13 October 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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 COS-OGA 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 COS-OGA as an elicitor to control powdery mildew (Sphaerotheca fuliginea) on cucurbits grown under glasshouses. An application for inclusion of COS-OGA in Annex IV of Regulation (EC) No 396/2005 was assessed. 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.

Summary

COS-OGA 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) Belgium received an application from FytoFend S.A. on 28 June 2012 for approval. In accordance with Article 8(1)(g) of the Regulation, FytoFend S.A. submitted an application for inclusion of the active substance into Annex IV of Regulation (EC) No 396/2005. 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 5 December 2012.

The RMS provided its initial evaluation of the dossier on COS-OGA in the Draft Assessment Report (DAR), which was received by the EFSA on 19 December 2013. The peer review was initiated on 14 January 2014 by dispatching the DAR for consultation of the Member States and the applicant FytoFend S.A.

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, the EFSA should adopt a conclusion on whether COS-OGA 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 reasoned opinion concerning the Annex IV proposal as referred to in Article 10(1) of Regulation (EC) No 396/2005.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative use of COS-OGA as an elicitor to control powdery mildew (Sphaerotheca fuliginea) on cucurbits grown in glasshouses, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

When applied on cucumber according to the proposed GAP against powdery mildew, the efficacy of COS-OGA was seen to be similar to the chemical references in case of low disease pressure.

A data gap was identified for a search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites, dealing with side-effects on the environment and non-target species

In the section on identity, physical/chemical/technical properties and methods of analysis a data gap was identified in relation to the methods of analysis for the environment.

In the section on mammalian toxicology no data gaps or critical areas of concern were identified.

In the section on residues no data gaps or critical areas of concern were identified.

It is proposed to include COS-OGA in Annex IV of Regulation (EC) No 396/2005.

A data gap was identified for a readily biodegradation study. In the absence of this study COS-OGA should be considered as not readily biodegradable. Due to the nature of the substance and to the fact that the representative use proposed is restricted to greenhouse no further assessment is deemed necessary to address the risk to soil organisms and groundwater.

In the section on ecotoxicology a data gap was identified to provide the mandatory toxicity studies on aquatic organisms.

Keywords
COS-OGA, peer review, risk assessment, pesticide, elicitor
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Number of Pages
39