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Reasoned opinion on the modification of MRLs for etoxazole in cherry, plum and banana

EFSA Journal 2012;10(12):3006 [23 pp.]. doi:10.2903/j.efsa.2012.3006
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2012-00402 Approved: 29 November 2012 Published: 04 December 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from Kenogard S.A./SP to modify the existing MRLs for the active substance etoxazole in cherry, plum and banana. In order to accommodate the intended uses of etoxazole in southern EU, Spain proposed to raise the existing MRLs from the limit of quantification of 0.02* mg/kg to 0.3 mg/kg on cherry, 0.04 mg/kg on plum and 0.2 mg/kg on banana. Spain 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. According to EFSA the data are sufficient to derive MRLs as proposed by Spain (0.3 mg/kg for cherry, 0.04 mg/kg for plum and 0.2 mg/kg for banana) in order to accommodate the uses of etoxazole in southern EU. Adequate analytical enforcement methods are available to control the residues of etoxazole on the commodities under consideration at the validated LOQ of 0.01 mg/kg. However it should be highlighted that samples have to be analysed within a storage period no longer than 6 months, as etoxazole residues were shown not to be stable beyond that time limit when stored frozen at -18°C. Based on the risk assessment results, EFSA concludes that the proposed use of etoxazole on cherry, plum and banana will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk

© European Food Safety Authority, 2012

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, hereafter referred to as the evaluating Member State (EMS), received an application from Kenogard S.A./SP to modify the existing MRLs for the active substance etoxazole in cherry, plum and banana. In order to accommodate the intended uses of etoxazole in southern EU, Spain proposed to raise the existing MRLs from the limit of quantification of 0.02* mg/kg to 0.3 mg/kg on cherry, 0.04 mg/kg on plum and 0.2 mg/kg on banana. Spain 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 on 21 March 2012.

EFSA bases its assessment on the evaluation report submitted by the EMS (Spain, 2012), the Draft Assessment Report (DAR) (and its addendum/addenda) prepared under Council Directive 91/414/EEC (France, 2001), the Commission Review Report on etoxazole (EC, 2004) and the conclusions on the review of the existing MRLs from the EFSA opinion on etoxazole (EFSA, 2012).

The toxicological profile of etoxazole was assessed in the framework of the peer review under Directive 91/414/EEC and data were sufficient to derive an ADI of 0.04 mg/kg bw per day. No ARfD was deemed necessary.

The metabolism of etoxazole in primary crops was investigated in apple and orange (fruit crop group) and in cotton (pulse/oilseed group). From these studies the peer review concluded to establish the residue definition for enforcement and risk assessment as etoxazole. For the use on cherry, plum and banana, EFSA concludes that the metabolism of etoxazole in primary crops is sufficiently addressed and that the derived residue definitions are applicable.

EFSA considers that the submitted supervised residue trials are sufficient to derive MRLs as proposed by Spain (0.3 mg/kg for cherry, 0.04 mg/kg for plum and 0.2 mg/kg for banana) in order to accommodate the uses of etoxazole in southern EU. Adequate analytical enforcement methods are available to control the residues of etoxazole on the commodities under consideration at the validated LOQ of 0.01 mg/kg. However it should be highlighted that samples have to be analysed within a storage period no longer than 6 months, as etoxazole residues were shown not to be stable beyond that time limit when stored frozen at -18°C.

Specific studies investigating the magnitude of etoxazole residues in processed commodities are not required, as the consumer exposure to etoxazole residues from the intake of cherry, plum and banana is expected to be very low and since the total theoretical maximum daily intake (TMDI) amounts to less than 10 % of the ADI.

Since the proposed uses of etoxazole are on permanent/semi-permanent crops, investigations of residues in rotational crops are not required.

Residues of etoxazole in commodities of animal origin were not assessed in the framework of this application, since cherry, plum and banana are normally not fed to livestock.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the review of the existing MRLs for etoxazole according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long-term exposure assessment was performed taking into account the existing uses of etoxazole at EU level and the CXLs set for some commodities at Codex Level. Those food commodities for which no uses of etoxazole were reported were excluded from the exposure calculation. EFSA now updates this risk assessment with the median residue values as derived from the supervised residue trials conducted on cherry, plum and banana. No acute consumer exposure was performed as the setting of an ARfD was not deemed necessary for this active substance. The estimated exposure was then compared with the derived toxicological reference value.

Under the assumption that the MRLs will be amended as proposed in the Article 12 review, the total calculated intake accounted for less than 3 % of the ADI (IE Adult). Thus, no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The contribution of residues on cherry, plum and banana to the total consumer exposure was insignificant, accounting for a maximum of 0.03 % of the ADI.

EFSA concludes that the proposed use of etoxazole on cherry, plum and banana will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Thus EFSA proposes to amend the existing MRLs as reported in the summary table.
 

Keywords

Etoxazole, cherry, plum, banana, MRL application, Regulation (EC) No 396/2005, consumer risk assessment.