Reasoned opinion on the modification of the existing MRLs for cycloxydim in various crops

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(9):4219 [30 pp.].
doi
10.2903/j.efsa.2015.4219
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2013- 00984
Approved
19 August 2015
Published
3 September 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from company BASF SE to modify the existing MRLs for cycloxydim in a wide range of crops. Many of the MRL proposals have in the meanwhile been evaluated by the Joint FAO/WHO Meeting on Pesticide Residues and implemented in the EU legislation. Only those crops for which an increase in the existing MRL for cycloxydim is still required according to the original application were considered by EFSA. According to EFSA, the data are sufficient to derive MRL proposals on beetroots, celeriacs, horseradishes, Jerusalem artichokes, parsnips, salsifies, swedes, aubergines, Brussels sprouts, head cabbages, Chinese cabbages, kales, escaroles, purslanes, beet leaves, rapeseeds, herbal infusions from roots and  horseradish spices. Based on the risk assessment results, EFSA concludes that the intended EU uses of cycloxydim will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health concern. 

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from company BASF SE to modify the existing MRLs for the active substance cycloxydim in a wide range of crops in order to accommodate uses within the European Union (EU). The EMS 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. These MRL proposals have in the meanwhile been evaluated by the JMPR and adopted as Codex limits (CXL) by the Codex Alimentarius Commission (CAC) in 2013. Since most of the CXLs have been transposed in the EU legislation by Regulation (EU) No 491/2014, EFSA has considered under the current assessment, only those crops for which the raising of the existing MRL for cycloxydim would still be required according to the original application.

EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared under Directive 91/414/EEC, the Commission Review Report on cycloxydim, the conclusion on the peer review of the pesticide risk assessment of the active substance cycloxydim and the JMPR Evaluation report.

The toxicological profile of cycloxydim was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.07 mg/kg bw per day and an acute reference dose (ARfD) of 2 mg/kg bw.

The metabolism of cycloxydim in primary crops was investigated in the root (sugar beet), pulses/oilseeds (soybean) and cereals (maize) crop groups, using a single foliar application. From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as “cycloxydim including degradation and reaction products which can be determined as 3-(3-thianyl)glutaric acid S-dioxide (BH 517-TGSO2) and 3-hydroxy-3-(3-thianyl)glutaric acid S-dioxide (BH 517-5-OH-TGSO2) or methyl esters thereof, calculated in total as cycloxydim”. For the uses on the crops under consideration, EFSA concludes that the metabolism of cycloxydim is sufficiently addressed and the residue definitions agreed in the peer review are applicable. Sufficiently validated analytical methods are available to control residues of cycloxydim according to the enforcement residue definition at the LOQ of 0.05 mg/kg for each analyte.

EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals for beetroots, celeriacs, Jerusalem artichokes, parsnips, horseradishes, salsifies, swedes, aubergines, Brussels sprouts, head cabbages, Chinese cabbages, kales, escaroles, purslanes, beet leaves, rapeseeds, herbal infusions from roots and horseradish spices.

Studies investigating the nature of cycloxydim residues in processed commodities were assessed in the framework of the peer review. Under standard hydrolysis conditions, cycloxydim was almost totally degraded to metabolites covered by the common moiety analytical methods and therefore by the residue definitions proposed for primary crops. Processing studies on carrots were submitted and processing factors were proposed. However, lacking details of processing conditions, EFSA does not recommend the inclusion of the derived processing factors in Annex VI of Regulation (EC) No 396/2005. Processing studies will be reconsidered in the MRL review according to Article 12 of Regulation (EC) No 396/2005.

The occurrence of cycloxydim residues in rotational crops was investigated in the framework of the peer review. Based on the available information, it was concluded that significant residues of cycloxydim are unlikely to occur in rotational crops.

The calculated livestock dietary burdens indicate that the trigger value of 0.1 mg/kg dry matter (DM) is exceeded for all relevant livestock species. Considering that the dietary livestock burdens based on the uses authorised within EU are lower than the animal burdens estimated by the 2012 JMPR for the setting of CXLs in products of animal origin that have been recently transposed in the EU legislation, EFSA concludes that there is no need to change the existing MRL values set for animal products.

The consumer risk assessment was performed with a revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used STMR values as derived from the submitted residue trials. Where a lower MRL or no MRL proposal was derived, the existing MRL was used as input value. For the remaining commodities of plant and animal origin, the existing MRLs as established in Regulation (EC) No 491/2014 were used as input values. Acute exposure assessment was undertaken only for the crops under consideration.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The Highest chronic intake accounted for 68 % of the ADI (FR, toddler). No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The highest acute exposure was calculated to be 8% the ARfD for celeriac (BE, Child).

EFSA concludes that the intended use of cycloxydim on beetroots, celeriacs, horseradishes, parsnips, salsifies, Jerusalem artichokes, swedes, aubergines, Brussels sprouts, head cabbages, Chinese cabbages, kales, escaroles, beet leaves, purslanes, rapeseeds, herbal infusions from roots and horseradish spices will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern.

Keywords
cycloxydim, various crops, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, cyclohexene oxime herbicide
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