Reasoned opinion on the modification of the existing MRLs for epoxiconazole in products of animal origin

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2012;10(6):2795 [34 pp.].
doi
10.2903/j.efsa.2012.2795
Type
Reasoned Opinion
On request from
European Commission
Question Number
EFSA-Q-2011-01259
Approved
22 June 2012
Published in the EFSA Journal
27 June 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, herewith referred as the evaluating Member State (EMS), received an application from BASF SE to modify the existing MRLs for the active substance epoxiconazole in products of animal origin considering residue levels in feed items derived from maize. In order to accommodate the intended use of epoxiconazole in Germany, France, Bulgaria, Spain, Greece and Portugal on maize, it proposed to raise the existing MRL for milk from 0.002 mg/kg to 0.003 mg/kg and that for ruminant kidney from the limit of quantification to 0.015 mg/kg. However since this proposal from the RMS was submitted, the MRL for ruminant kidney was raised to the higher level of 0.02mg/kg.  Germany drafted an evaluation report according to 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 MRL proposals. However, the existing MRLs for maize ruminant kidney and milk are considered sufficient to cover the intended uses requested so no modification is necessary. Adequate analytical enforcement methods are available to control the residues of epoxiconazole in the commodities under consideration at the validated LOQ of 0.01 mg/kg and 0.001mg/kg in milk. Based on the risk assessment results, EFSA concludes thatthat the proposed use of epoxiconazole on maize under consideration will not result in a consumer exposure exceeding the toxicological reference values set for parent epoxiconazole and therefore is unlikely to pose a consumer health risk. However the residue definition for risk assessment was set on a provisional basis, pending additional data on the presence of the triazole derivative metabolites (TDMs) being available and a methodology for assessing the consumer exposure to TDMs becoming available.

Keywords
Epoxiconazole, maize, milk, liver, kidney, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, triazole fungicide, triazole derivative metabolites, triazole alanine, triazole acetic acid, triazole lactic acid
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Number of Pages
34