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Reasoned opinion on the modification of the existing MRLs for methoxyfenozide in various leafy vegetables

EFSA Journal 2012;10(4):2667 [30 pp.]. doi:10.2903/j.efsa.2012.2667
European Food Safety Authority Contact pesticides.mrl@efsa.europa.eu
Type: Reasoned Opinion On request from: European Commission Question number: EFSA-Q-2011-01031 Approved: 20 April 2012 Published: 23 April 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, herewith referred to as the evaluating Member State (EMS), received an application from the company Dow AgroSciences to modify the existing MRLs for the active substance methoxyfenozide in leafy vegetables and fresh herbs (except vine leaves, water cress and witloof). In order to accommodate for the intended use of methoxyfenozide in the SEU, the EMS proposed to raise the existing MRLs in these crops (except in scarole) from the limit of quantification (LOQ) of 0.02 mg/kg to 4 mg/kg. Spain drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA.

EFSA considers that the submitted supervised residue trials are sufficient to support the proposed residue data extrapolation from lettuce to other crops under consideration and to derive a MRL proposal of 4 mg/kg for the proposed use on lettuce and other salad plants including Brassicaceae, the whole group of spinach and similar leaves and the whole group of herbs. Adequate analytical enforcement methods are available to control the residues of methoxyfenozide in the commodities under consideration.

EFSA concludes that the intended uses on the leafy vegetables under consideration (except on scarole) will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. EFSA confirms the conclusion of the EMS that the intended use of methoxyfenozide on scarole is not acceptable due to acute consumer intake concerns identified.

© European Food Safety Authority, 2012

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, herewith referred to as the evaluating Member State (EMS), received an application from the company Dow AgroSciences to modify the existing MRLs for the active substance methoxyfenozide in leafy vegetables and fresh herbs (except vine leaves, water cress and witloof). In order to accommodate for the intended use of methoxyfenozide in the SEU, the EMS proposed to raise the existing MRLs in these crops (except in scarole) from the limit of quantification (LOQ) of 0.02 mg/kg to 4 mg/kg. Spain drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 13 September 2011.

EFSA bases its assessment on the evaluation report submitted by the EMS (Spain, 2011), the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC (UK, 2002), the Commission Review Report on methoxyfenozide (EC, 2004), the JMPR Evaluation of methoxyfenozide (FAO, 2004) as well as the conclusions from a previous EFSA opinion on methoxyfenozide (EFSA, 2010).

The toxicological profile of methoxyfenozide was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI value of 0.1 mg/kg bw/day and an ARfD value of 0.2 mg/kg bw.

The metabolism of methoxyfenozide in primary plants has been investigated in fruits and fruiting vegetables (apples, grapes), pulses and oilseeds (cotton) and cereals (rice) in the framework of the peer review of Directive 91/414/EEC. Although metabolism studies with leafy vegetables are not available, a consistent metabolism of methoxyfenozide in three crop groups is demonstrated to conclude that in primary crops after foliar treatment parent methoxyfenozide is the relevant residue for enforcement and risk assessment purposes. EFSA concludes that for the crops under consideration no additional metabolism studies have to be performed and parent methoxyfenozide is the appropriate residue definition for risk assessment and enforcement.

EFSA considers that the submitted supervised residue trials are sufficient to support the proposed residue data extrapolation from lettuce to other crops under consideration and to derive a MRL proposal of 4 mg/kg for the proposed use on lettuce and other salad plants including Brassicaceae, the whole group of spinach and similar leaves and the whole group of herbs. Adequate analytical enforcement methods are available to control the residues of methoxyfenozide in the commodities under consideration.

The effect of processing on the nature of methoxyfenozide residues has been investigated in a hydrolysis study simulating sterilisation, pasteurization and baking/brewing/boiling. No degradation of methoxyfenozide occurs and therefore for processed commodities the same residue definition as for raw agricultural commodities is applicable. Specific studies to assess the magnitude of methoxyfenozide residues during the processing of the crops under consideration have not been submitted. Such studies are desirable for the crops which are consumed processed to refine the acute consumer exposure.

The crops under consideration can be grown in rotation with other plants and therefore the possible occurrence of residues in succeeding/rotational crops resulting from the use of the active substance on primary crops was further assessed, considering the slow degradation of methoxyfenozide in soil. Although the metabolism of methoxyfenozide in succeeding/rotational crops is more extensive, it proceeds in a similar pathway as in primary plants with methoxyfenozide being the major residue in individual crops investigated; the same residue definitions are therefore applicable. The reported rotational crop field studies have been performed with a significantly higher season application rate (9N) than the application rate in the intended use. Residues of methoxyfenozide at significant levels are not expected in edible matrices of rotational crops when grown in crop rotation with leafy vegetables treated according to the intended use. However, in animal feed commodities (straw, forage, hay), a possible occurrence of methoxyfenozide residues cannot be excluded and therefore EFSA recommends Member States to implement necessary risk mitigation measures when granting authorizations of plant protection products containing methoxyfenozide.

Since the crops under consideration are normally not fed to livestock, the nature and magnitude of methoxyfenozide residues in livestock was not assessed in the framework of this application

The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue value as derived from the residue trials on lettuce. The same input value was used for other salad plants including Brassicaceae, the whole group of herbs and the whole group of spinach and similar leaves. For some crops the risk assessment values were available to refine the exposure calculation. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes II and IIIB of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodities under consideration assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level as observed in supervised field trials.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 37.5% of the ADI (DE child diet). The individual contribution of residues in the crops under consideration to the total consumer exposure was below 1% of the ADI.

Short-term consumer risk was identified in relation to the MRL proposal for scarole (104.5% of the ARfD), confirming the findings of the EMS. With regard to other crops under consideration no short-term consumer intake concerns were identified and the calculated maximum exposure in percentage of the ARfD was 32.2 % for lettuce, 27% for spinach, 21% for beet leaves, 18.1% for purslane and below 10% for the rest of the crops.

EFSA concludes that the intended uses on the leafy vegetables under consideration (except on scarole) will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. EFSA confirms the conclusion of the EMS that the intended use of methoxyfenozide on scarole is not acceptable due to acute consumer intake concerns identified.

Keywords

Methoxyfenozide, leaf vegetables and fresh herbs, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, diacylhydrazine insecticide