Reasoned opinion on the modification of the existing MRLs for cyproconazole in mustard seed and gold of pleasure

Cyproconazole, seeds of mustard and gold of pleasure, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, triazole fungicide, triazole derivative metabolites (TDM).
First published in the EFSA Journal
16 April 2013
12 April 2013
Reasoned Opinion


In accordance with Article 6 of Regulation (EC) No 396/2005, France, herewith referred to as the evaluating Member State (EMS), received an application from Syngenta Agro S.A.S. to modify the existing MRLs for the active substance cyproconazole in mustard seed and gold of pleasure. In order to accommodate for the intended use of cyproconazole in France, the EMS proposed to raise the existing MRLs in these crops to 0.4 mg/kg. France 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 proposed extrapolation of residue data from rape seed to mustard seed and gold of pleasure is acceptable and a sufficient number of residue trials has been submitted to derive a MRL proposal of 0.4 mg/kg in the crops under consideration. The submitted residue trials data support the NEU use only. Based on the risk assessment results, EFSA concludes that the intended use of cyproconazole on mustard seed and gold of pleasure will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. EFSA emphasizes that the above assessment does not take into consideration triazole derivative metabolites (TDMs). Since these metabolites may be generated by several pesticides belonging to the group of triazole fungicides, EFSA recommends that a separate risk assessment is performed for TDMs as soon as the confirmatory data requested for triazole compounds in the framework of Regulation (EC) No 1107/2009 have been evaluated and a general methodology on the risk assessment of triazole compounds and their triazole derivative metabolites is available.

European Food Safety Authority
pesticides.mrl [at]
EFSA Journal 2013;11(4):3194
Question Number
On request from
European Commission

Background documents