Conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(9):3814 [249 pp.].
doi
10.2903/j.efsa.2014.3814
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2013-00588
Approved
13 August 2014
Published
9 September 2014
Last Updated
28 May 2015. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (3.9 MB)
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 United Kingdom and the co-rapporteur Member State France for the pesticide active substance cyantraniliprole and the assessment of applications for maximum residue levels (MRLs) 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 cyantraniliprole as an insecticide on various crops in agriculture and horticulture. MRLs were assessed in oranges, mandarins, apples/pears, peaches, apricots, plums, vine grapes, potatoes, tomatoes, cucumber/courgettes, melon, lettuce, beans and olives. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment and the proposed MRLs, 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

Cyantraniliprole 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 United Kingdom and the co-rapporteur Member State (co-RMS) France received an application from DuPont Crop Protection and Syngenta Crop Protection on 29 June 2011 for approval. In accordance with Article 8(1)(g) of the Regulation, DuPont Crop Protection and Syngenta Crop Protection submitted applications for maximum residue levels (MRLs) as referred to in Article 7 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 co-RMS and the date of admissibility of the application was recognised as being 10 August 2011.

The RMS and the co-RMS provided its initial evaluation of the dossier on cyantraniliprole in the Draft Assessment Report (DAR), which was received by the EFSA on 31 May 2013. The DAR included a proposal to set MRLs, in accordance with Article 11(2) of the Regulation. The peer review was initiated on 20 June 2013 by dispatching the DAR for consultation of the Member States and the applicant DuPont Crop Protection and Syngenta Crop Protection.

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, environmental fate and behaviour and ecotoxicology.

In accordance with Article 12 of the Regulation, the EFSA should adopt a conclusion on whether cyantraniliprole 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 MRL applications as referred to in Article 10(1) of Regulation (EC) No 396/2005 as part of this conclusion.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of cyantraniliprole as an insecticide on various crops in agriculture and horticulture as proposed by the applicant. MRLs were assessed in oranges, mandarins, apples/pears, peaches, apricots, plums, vine grapes, potatoes, tomatoes, cucumber/courgettes, melon, lettuce, beans and olives. Full details of the representative uses and the proposed MRLs can be found in Appendix A to this report.

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

Sufficient data were submitted to conclude that the uses of cyantraniliprole according to the representative uses proposed at EU level result in a sufficient insecticidal efficacy against the target organisms.

In the area of identity a data gap was identified for a new technical specification.

In the area of mammalian toxicology, there is no critical area of concern. Data gaps were identified for further assessment of some metabolites.

The data were sufficient to propose plant and animal residue definitions for monitoring and risk assessment. No critical area of concern was identified in the residues section. Data gaps were identified for additional residue trials on lettuce, apricot and bean, conducted according to the representative uses proposed at EU level and for additional information to address the residues in rotational crops for the persistent metabolites. Data gap was identified for the setting of import tolerances that could not be taken into consideration in the conclusion.

The data available on environmental fate and behaviour are sufficient to carry out the required environmental exposure assessments at EU level, with the notable exception that a data gap was identified for information on the effect of water treatment processes on the nature of residues of both the active substance and its identified metabolites potentially present in surface and groundwater, when surface water or groundwater are abstracted for drinking water. This gap leads to the consumer risk assessment from the consumption of drinking water being not finalised for all the representative uses. For a few of the representative uses environmental exposure assessments are missing leading to some data gaps and risk assessments not being finalised. On the basis of the available mammalian toxicology data for the groundwater metabolites IN-K5A78, IN-M2G98 and IN-K5A79, following the pertinent Commission guidance, the assessment of impact on groundwater quality could not be finalised as it is not clear if the parametric drinking water limit of 0.1 µg/L is applicable to these metabolites. I.e. the assessment of the groundwater relevance of these metabolites remains open for all the representative uses except crops grown using hydroponic cultivation systems.

In the area of ecotoxicology data gaps were identified to further address the risk to mammals, bees and non-target arthropods. The risk assessment could not be finalised for all non target organisms.

Keywords
cyantraniliprole, peer review, risk assessment, pesticide, insecticide, maximum residue level
Print on demand
Number of Pages
249