Conclusion on the peer review of the pesticide risk assessment of the active substance terpenoid blend QRD-460

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(10):3816 [41 pp.].
doi
10.2903/j.efsa.2014.3816
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00730
Approved
20 August 2014
Published
7 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 the Netherlands for the pesticide active substance terpenoid blend QRD-460 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 uses of terpenoid blend QRD-460 as an insecticide on tomato, melon, cucumber and pepper. 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

Terpenoid blend QRD-460 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) the Netherlands received an application from Bayer CropScience AG (former AgraQuest Inc.) on 14 September 2011 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 October 2011.

The RMS provided its initial evaluation of the dossier on terpenoid blend QRD-460 in the Draft Assessment Report (DAR), which was received by the EFSA on 30 July 2013. The peer review was initiated on 28 August 2013 by dispatching the DAR for consultation of the Member States and the applicant Bayer CropScience AG (former AgraQuest Inc.).

Following consideration of the comments received on the DAR, it was concluded that additional information should be requested from the applicant and that the EFSA should conduct an expert consultation in the areas of mammalian toxicology and environmental fate and behaviour.

In accordance with Article 12 of the Regulation, the EFSA should adopt a conclusion on whether terpenoid blend QRD-460 can be expected to meet the approval criteria provided for in Article 4 of the Regulation taking into consideration recital (10) of the Regulation.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of terpenoid blend QRD-460 as an insecticide on tomato, melon, cucumber and pepper, as proposed by the applicant. Full details of the representative uses can be found in Appendix A to this report.

A data gap was identified to provide additional information to confirm the efficacy of the active substance when applied according to the representative uses.

A data gap was identified for a search of the scientific peer-reviewed open literature on the active substance and its relevant metabolites.

In the area of identity, physical/chemical/technical properties and methods of analysis data gaps were identified for specifications and supporting data, physical and chemical properties of the 3 active substances, formulation data and methods of analysis.

In the mammalian toxicology section a major concern was identified as it was impossible to set any reference values (due to the limited toxicological database), therefore no risk assessment could be performed.

Following application, α-terpinene, p-cymene and d-limonene residues are expected to quickly decline to the natural background levels. The setting of MRLs is therefore concluded to be unnecessary and terpenoid blend QRD-460 could be a candidate for the inclusion in Annex IV of Regulation (EC) No 396/2005.

The data available on environmental fate and behaviour are not sufficient to carry out the required environmental exposure assessment, with the exception for the predicted environmental concentrations in soil for α-terpinene, p-cymene and d-limonene. Data gaps were identified for the route and rate of degradation in soil and in water for terpenoid blend QRD 460, and for predicted environmental concentration in surface water, in sediment and in groundwater for α-terpinene, p-cymene and d-limonene.

In the area of ecotoxicology data gaps were identified for aquatic organisms, bees, non-target arthropods and for organisms involved in biological methods for sewage treatment.

Keywords
terpenoid blend QRD-460, α-terpinene, p-cymene, d-limonene, peer review, risk assessment, pesticide, insecticide
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Number of Pages
41