Reasoned opinion on the modification of the existing MRLs for tetraconazole in commodities of plant and animal origin


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(5):3223 [40 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
8 mai 2013
Published in the EFSA Journal
13 mai 2013
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State Germany, received an application from Isagro SpA to modify the existing MRLs for the active substance tetraconazole in various plant and animal commodities. Before lowering the existing MRLs on pome fruits from 0.3 mg/kg to 0.2 mg/kg, grapes from 0.5 mg/kg to 0.07 mg/kg and wheat from 0.1 mg/kg to and 0.04 mg/kg, Germany suggested awaiting the finalisation of the ongoing review of the existing MRLs of tetraconazole, whereas they proposed to raise the existing MRLs in the liver of swine and ruminants from 1 mg/kg to 1.5 mg/kg and 2 mg/kg, respectively. Germany 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 0.2 mg/kg on apples, 0.07 mg/kg on grapes and 0.02 mg/kg (LOQ) on wheat. Before the MRLs are lowered it should be confirmed that no more critical GAPs are currently authorised at EU level for these crops. Taking into account the intended and the existing uses of tetraconazole, EFSA proposes to raise to 1.5 mg/kg and 3 mg/kg the existing MRLs for swine and ruminant liver, respectively. The data also support the lowering of the existing MRLs in swine, bovine, sheep and goats meat, fat and kidney and in ruminant milk. Adequate analytical enforcement methods are available to control the residues of tetraconazole in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of tetraconazole on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values for tetraconazole and therefore is unlikely to pose a consumer health risk.

tetraconazole, fruits, wheat and animal origin commodities, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, triazole fungicide, triazole derivative metabolites (TDMs).
Print on demand
Number of Pages