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


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(3):3596 [23 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
28 February 2014
Published in the EFSA Journal
3 March 2014
European Food Safety Authority (EFSA), Parma, Italy

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.

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