Reasoned opinion on the modification of the existing MRL for tetraconazole in rape seed
23 July 2012
In accordance with Article 6 of Regulation (EC) No 396/2005, Italy received an application from Isagro SpA to modify the existing MRLs for the active substance tetraconazole in several commodities of plant and animal origin. In order to accommodate for the intended uses of tetraconazole, Italy proposed to raise the existing MRL in rape seeds from the limit of quantification (0.02 mg/kg) to 0.1 mg/kg and to lower or maintain unchanged the existing MRLs on certain commodities of plant and animal origin. Italy 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 0.15 mg/kg for the intended use on rape seeds. EFSA is of the opinion that the lowering of the MRLs should be assessed within the framework of Article 12 of Regulation (EC) 396/2005. Adequate analytical enforcement methods are available to control tetraconazole residues in rape seeds at the validated LOQ of 0.01 mg/kg. EFSA concludes that the proposed use on oilseed rape will not result in a consumer exposure exceeding the toxicological reference values and is unlikely to pose a consumer health risk based on the risk assessment performed for the parent compound tetraconazole. EFSA emphasizes that the above assessment does not take into consideration the 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 should be performed for the relevant 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, 2012
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