Reasoned opinion on modification of the existing MRL for fluazinam in ginseng root


European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(5):3690 [20 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
5 May 2014
Published in the EFSA Journal
14 May 2014
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, Austria, hereafter referred to as the evaluating Member State (EMS), received an application from the company ISK Biosciences Europe NV to set the import tolerance for the active substance fluazinam in ginseng roots from the US at the level of 3 mg/kg. Austria 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 3 mg/kg for the proposed use on ginseng roots. An adequate analytical enforcement method to control the residues of fluazinam in fresh ginseng at the validated LOQ of 0.01 mg/kg is available. Although there are some indications that a liquid chromatography method is applicable for the enforcement of fluazinam in dried roots at the LOQ of 0.1 mg/kg, it would be desirable to get a full method validation. No consumer health risk is expected for the proposed MRL.

fluazinam, ginseng, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, pyridine fungicide, AMPA and DAPA and AMGT
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