Reasoned opinion on the modification of the existing MRL for tricyclazole in rice


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(4):3198 [31 pp.].
Reasoned Opinion
On request from
European Commission
Question Number
16 April 2013
Published in the EFSA Journal
18 April 2013
European Food Safety Authority (EFSA), Parma, Italy

In accordance with Article 6 of Regulation (EC) No 396/2005, Italy, herewith referred to as the evaluating Member State (EMS), received an application from Dow AgroScience to set an import tolerance for tricyclazole in rice to accommodate the authorized use in Brazil. Tricyclazole is a non-included active substance and no EU uses are currently authorized. Thus, the existing EU MRL of 1 mg/kg in rice should be lowered to the LOQ. The applicant requested to maintain the existing EU MRL to allow the import of rice treated with tricyclazole from third countries. The EMS confirmed that the MRL should be set provisionally at the level 1 mg/kg to accommodate the Brazilian GAP. EFSA is of the opinion that on the basis of the currently available studies, the toxicological reference values for tricyclazole cannot be set, since the genotoxic potential of tricyclazole could not be totally disregarded. In addition, uncertainties regarding the carcinogenic potential of tricyclazole were identified by EFSA. The submitted residue trials data were found to be insufficient to derive an MRL proposal which accommodates the use of tricyclazole on rice in Brazil. EFSA concludes that the import tolerance request for tricyclazole in rice is not sufficiently supported by data which are needed to justify maintaining the existing EU MRL of 1 mg/kg in rice.

Tricyclazole, rice, import tolerance, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, fungicide
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