Reasoned opinion on the modification of the existing MRLs for fenpropimorph in cereals and commodities of animal origin


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(9):3359 [41 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
12 September 2013
Published in the EFSA Journal
16 September 2013
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, the United Kingdom received an application from BASF to modify the existing MRLs for fenpropimorph in commodities of animal origin as a result of the reported use on wheat, barely, rye and oats. The United Kingdom proposed to raise the existing MRLs in tissues of swine and ruminant origin and in milk. In accordance with Article 8 of Regulation (EC) No 396/2005 an Evaluation Report was submitted to the European Commission and forwarded to EFSA. EFSA concluded that the data confirm the MRL of 0.5 mg/kg for the reported use on barley and oats; for wheat and rye a lower MRL of 0.15 mg/kg would be sufficient. For food of animal origin EFSA derived the following MRL proposals: 3 mg/kg (ruminant liver), 0.5 mg/kg (ruminant kidney), 0.2 mg/kg (ruminant fat), 0.15 mg/kg (ruminant muscle), 0.03 mg/kg (swine liver), 0.015 mg/kg (milk) and the LOQ of 0.01 mg/kg (swine muscle, fat, kidney). Adequate analytical enforcement methods are available to control the residues of fenpropimorph in the commodities under consideration. The exposure resulting from the fenpropimorph uses on cereals and the derived MRLs on products of animal origin will not result in an acute consumer health risk. A potential long-term consumer risk could not be excluded for fenpropimorph, with wheat being the major contributor. The overall long-term exposure is significantly reduced if the MRLs on wheat and rye are lowered to the value of 0.15 mg/kg supported in the current application. However, the long-term risk assessment could not be finalised due to lack of information on the full details on all authorised uses and the scientific basis for the existing MRLs.

fenpropimorph, cereals and products of animal origin, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, morpholine fungicide, BF-421-1 and 2,6-dimethylmorpholine (BF-421-10) and fenpropimorph carboxylic acid (BF-421-2)
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