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.