Reasoned opinion on the modification of the existing MRLs for tebufenozide in various crops

tebufenozide, stone fruits, grapes, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, diacylhydrazine insecticide
First published in the EFSA Journal
6 June 2014
28 May 2014
Reasoned Opinion


In accordance with Article 6 of Regulation (EC) No 396/2005, Germany, hereafter referred to as the evaluating Member State (EMS), received an application from Exponet International Ltd. to modify the existing MRLs for the active substance tebufenozide in various crops. In order to accommodate for the intended uses of tebufenozide, Germany proposed to raise the existing MRL in table and wine grapes from 3 mg/kg to 4 mg/kg and to lower the existing MRL in apricots, cherries and plums from 1 mg/kg to 0.03 mg/kg, whereas an amendment of the existing MRL was not proposed for pome fruits and lettuce. 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 0.03 mg/kg for apricots, cherries and plums, a tentative MRL of 0.7 mg/kg for pome fruit and a MRL proposal of 9 mg/kg for lettuce. A risk manager decision should be taken before lowering of the existing MRLs for pome fruit, lettuce and the stone fruit. As the intended uses on grapes are not adequately supported by residue data no MRL proposal can be derived. Adequate analytical enforcement methods are available to control the residues of tebufenozide in the crops under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of tebufenozide on apricots, cherries, plums, pome fruits and lettuce will not result in a consumer exposure exceeding the toxicological reference value and therefore are unlikely to pose a consumer health risk.

European Food Safety Authority
pesticides.mrl [at]
EFSA Journal 2014;12(6):3733
Question Number
On request from
European Commission

Background documents