Modification of the existing maximum residue levels for cyantraniliprole in various crops

Tabs

Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(10):4263 [25 pp.].
doi
10.2903/j.efsa.2015.4263
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2015-00076
Approved
30 September 2015
Published
19 October 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (653.47 KB)
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), France, received an application from Du Pont de Nemours and Syngenta Crop protection AG to modify the existing maximum residue levels (MRLs) for the active substance cyantraniliprole in various crops. In order to accommodate for the intended uses of cyantraniliprole, France proposed to modify the MRLs for cyantraniliprole on cherries, strawberries, carrots, other root and tuber vegetables except sugar beet, Brussels sprouts, beans and peas (without pods), globe artichokes, herbal infusions from roots and root and rhizome spices. An import tolerance based on the US/Canadian good agricultural practices is also requested for cucumbers. France drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. The intended uses on the crops under consideration, except for cucumbers are adequately supported by residue data and MRL proposals can therefore be derived. Adequate analytical enforcement methods are available to control the residues of cyantraniliprole on the relevant crop commodities. Based on the risk assessment results, EFSA concludes that the proposed use of cyantraniliprole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), France, received an application from Du Pont de Nemours and Syngenta Crop protection AG to modify the existing maximum residue levels for cyantraniliprole in various crops. In order to accommodate for the intended uses of cyantraniliprole, France proposed to raise the existing MRLs from the limit of quantification of 0.01 mg/kg to 0.5 mg/kg on strawberries, to 0.15 mg/kg on beans and peas (without pods), to 0.1 mg/kg on globe artichokes and to 0.03 mg/kg on herbal infusions from roots and root and rhizome spices (extrapolated from residue trials on carrots); to decrease the MRL on carrots and other root and tuber vegetables, except sugar beet from 0.05 mg/kg to 0.03 mg/kg, from 2 mg/kg to 0.3 mg/kg on Brussels sprouts and to increase the MRL on cucumbers from 0.3 mg/kg to 0.4 mg/kg. The MRL proposal of 6 mg/kg on cherries (sweet) remained unchanged. France drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 28 January 2015.

EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Regulation (EC) 1107/2009, the conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole and the JMPR Evaluation report.

The toxicological profile of cyantraniliprole was assessed in the framework of the peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.01 mg/kg bw per day. No acute reference dose (ARfD) was deemed necessary.

The metabolism of cyantraniliprole in primary crops was investigated in the fruit, leafy, cereal/grass and pulses/oilseeds crop groups following foliar and soil applications. From these studies the peer review established the residue definition as cyantraniliprole for monitoring and risk assessment. For the uses on the crops under consideration, EFSA concludes that the metabolism of cyantraniliprole in primary crops has been sufficiently addressed and that the residue definitions derived are applicable.

EFSA concludes that the submitted residue trials are sufficient to propose an MRL of 0.5 mg/kg on strawberries, 0.2 mg/kg on the crop groups “herbal infusions from roots” and “root and rhizome spices”, 0.04 mg/kg on beans without pods, 0.15 mg/kg on peas without pods and 0.1 mg/kg on globe artichokes. No MRL modification is proposed for cherries, carrots, root and tuber vegetables and Brussels sprouts, since the GAPs supported in the framework of this MRL application result in lower MRL proposals than the MRLs currently into force under Regulation (EC) No 396/2005. Sufficient residue trials have not been submitted to derive an import tolerance for cucumbers according to the US/Canadian GAPs. Adequate analytical enforcement methods are available to monitor the residues of cyantraniliprole in the commodities under consideration at the validated LOQ of 0.01 mg/kg.

Studies investigating the nature of cyantraniliprole residues under standard hydrolysis conditions were assessed during the peer review and showed the active substance to be stable under pasteurisation and sterilisation, but slightly degraded to metabolites IN J9Z38, IN N5M09 and IN F6L99 under boiling conditions. Therefore for processed commodities the residue definition was proposed as cyantraniliprole only for enforcement and as the sum of cyantraniliprole and IN J9Z38 expressed as cyantraniliprole for risk assessment. It is however highlighted that toxicological data were requested for metabolites IN-N5M09 and IN-F6L99 since these compounds were recovered at significant levels in cooked spinach leaves only (up to 0.09 mg/kg). These compounds were either not detected or recovered at a very low level (close to the LOQ of 0.01 mg/kg) in other processed commodities (grapes, tomato, olive, citrus fruit, apple, plum and cotton).

Specific studies to assess the magnitude of cyantraniliprole residues in processed cherries and strawberries commodities are not required since these crops are considered as covered by the available processing studies on fruit crops assessed during the peer review. Since the TMDI is less than 10 % of the ADI with regard to the other crops, processing studies on cooked commodities of these crops are not triggered.

The occurrence of cyantraniliprole residues in rotational crops was investigated in the framework of the peer review. Based on the available information on the nature and magnitude of residues, it was concluded that the rotational crop studies were not fully appropriate to address the transfer of the persistent soil metabolites in plants and that long term rotational crop studies considering cyantraniliprole and its most persistent metabolites following several years of consecutive applications are required. Meanwhile, Member States should consider this point when granting authorisations and where relevant, take appropriate risk mitigation measures in order to avoid the presence of residues of cyantraniliprole and relevant metabolites in rotational crops.

As swedes and turnips are used as feed products as well as citrus/apple pomace and potatoes, a potential carry-over into food of animal origin was assessed. The calculated dietary burden indicated that the trigger value of 0.1 mg/kg dry matter (DM) was exceeded for ruminants and pigs. However, based on the cattle feeding study, no residues above the LOQ are expected in animal matrices and the setting of MRLs is therefore not necessary.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). The CXLs that have been recently transposed in the EU legislation were taken into account in the long-term consumer intake calculation and compared with respectively the MRL proposals on the crops under consideration in this MRL application and the MRLs derived from the representative uses assessed during the peer review.

The total chronic intake calculated accounted for up to 45 % of the ADI (DE child) when these MRLs were considered. The contribution of residues in the crops under consideration to the total consumer exposure was negligible.

EFSA concludes that the proposed use of cyantraniliprole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a health risk to consumers.

Keywords
cyantraniliprole, MRL application, pesticide, insecticide, maximum residue level, consumer risk assessment
Print on demand
Number of Pages
25