Reasoned Opinion on the modification of the existing MRL for formetanate in strawberries

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(3):3596 [23 pp.].
doi
10.2903/j.efsa.2014.3596
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2013-00819
Approved
28 February 2014
Published
3 March 2014
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, Italy, hereafter referred to as the evaluating Member State (EMS), received an application from Gowan Comercio Internacional e Servicos Ltd. to modify the existing MRL for the active substance formetanate in strawberries. In order to accommodate for the intended use of formetanate, Italy proposed to raise the existing MRL to 0.4 mg/kg. Italy 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 a MRL proposal of 0.4 mg/kg for the intended use on strawberries. Adequate analytical enforcement methods are available to control the residues of formetanate in strawberries. Based on the risk assessment results, EFSA concludes that according to the internationally agreed methodology for estimation of the consumer exposure, the intended use of formetanate on strawberries will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. However, the safety margin for the acute exposure as regards formetanate residues on strawberries is very narrow.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, hereafter referred to as the evaluating Member State (EMS), received an application from Gowan Comercio Internacional e Servicos Ltd. to modify the existing MRL for the active substance formetanate in strawberries. In order to accommodate for the intended use of formetanate, Italy proposed to raise the existing MRL to 0.4 mg/kg. Italy 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 10 October 2013.

EFSA bases its assessment on the evaluation report, the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC, the Commission Review Report on formetanate, the conclusion on the peer review of the pesticide risk assessment of the active substance formetanate as well as the conclusions from previous EFSA opinions on formetanate, including the review of all existing MRLs according to Article 12 of Regulation (EC) No 396/2005.

The toxicological profile of formetanate was assessed in the framework of the peer review under Council Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.004 mg/kg bw per day and an ARfD of 0.005 mg/kg bw for formetanate hydrochloride.

The metabolism of formetanate in primary crops was investigated in fruits and fruiting vegetables and leafy vegetables. The review of the existing MRLs for formetanate performed under Article 12 of Regulation (EC) No 396/2005 confirmed the conclusion of the peer review that the relevant residue definition for both enforcement and risk assessment is the sum of formetanate and its salts, expressed as formetanate hydrochloride. For the use on strawberries, EFSA concludes that the metabolism of formetanate is sufficiently addressed and that the residue definitions derived are applicable.

EFSA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.4 mg/kg for the intended use on strawberries. Adequate analytical enforcement methods are available to control the residues of formetanate in strawberries at validated LOQs of 0.005-0.01 mg/kg.

The review of the existing MRLs under Article 12 confirmed the conclusion of the peer review that for processed commodities the same residue definition as for raw agricultural commodities (RAC) is applicable. Specific studies investigating the magnitude of formetanate residues during the processing of strawberries were not submitted. Such studies are not required as the total theoretical maximum daily intake (TMDI) is expected to be below the trigger value of 10 % of the ADI.

The occurrence of formetanate 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 in succeeding crops, EFSA concludes that significant residue levels are unlikely to occur in rotational crops provided that the compound is used on strawberries according to the proposed GAP.

Since the strawberries are not fed to livestock, residues of formetanate in commodities of animal origin were not assessed in the framework of this application.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the risk assessment performed in the framework of the MRL review with the median residue value for strawberries derived from the submitted supervised residue trials and the median residue values proposed by EFSA for peaches, grapes, tomatoes, aubergines, gherkins, cucurbits with inedible peel, lettuce and scarole based on intended uses notified after the MRL review.

No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake accounted for up to 9.3 % of the ADI (WHO Cluster diet B). The contribution of residues in strawberries to the total consumer exposure accounted for a maximum of 0.9 % of the ADI (French toddler diet). Using the internationally agreed methodology for acute risk assessment, no acute consumer risk was identified in relation to the intended use on strawberries. The calculated maximum exposure in percentage of the ARfD was 50 % (German child diet). EFSA noted that the short-term exposure exceeds the ARfD if strawberries containing residues at the level of the proposed MRL (0.4 mg/kg) are consumed without washing or any other treatment that would lead to a reduction of the residues in the edible portion; the acute exposure accounts for 125 % of the ARfD.

EFSA concludes that, according to the internationally agreed methodology for estimation of the consumer exposure, the intended use of formetanate on strawberries will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. However, the safety margin for the acute exposure as regards formetanate residues on strawberries is very narrow.

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

Keywords
formetanate, strawberries, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, formamidine insecticide and acaricide
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Number of Pages
23