Reasoned opinion on the modification of the existing MRLs for bixafen in rape seed, linseed, poppy seed and mustard seed


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(2):3127 [28 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
27 febbraio 2013
Published in the EFSA Journal
28 febbraio 2013
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom, hereafter referred to as the evaluating Member State (EMS), received an application from Bayer CropSciences AG to modify the existing MRL for the active substance bixafen in rape seed. The submitted residue data support the intended use of bixafen in rape seed, linseed, poppy seed and mustard seed in France as well. In order to accommodate for the intended use of bixafen, the United Kingdom proposed to raise the existing MRL from 0.015 mg/kg to 0.1 mg/kg. The United Kingdom 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 0.07 mg/kg for the proposed use on rape seed, linseed, poppy seed and mustard seed. An adequate analytical enforcement method is available to control the residues of bixafen in oilseeds. Based on the risk assessment results, EFSA concludes that the proposed use of bixafen on rape seed, linseed, poppy seed and mustard seed will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. This risk assessment has to be regarded as provisional since the residue definition for enforcement and risk assessment in oilseeds are provisional and pending the need for MRLs in rotational crops and the definitive MRLs in animal origin commodities.

Bixafen, oilseeds, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, pyrazole fungicide, dsesmethyl-bixafen (M21)
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