Italy
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in wheat and rye grain. The data submitted in support of the request were found sufficient to derive MRL proposals for wheat and rye grain. Adequate analytical methods for enforcement are available to control the residues of difenoconazole in plant matrices under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. The submitted data indicate no need to modify the EU MRLs in animal commodities for the existing enforcement residue definition. EFSA concluded that the dietary exposure to difenoconazole residues from the intake of wheat and rye grain is low, noting that the impact of intended uses on the residues in animal commodities and the consumer exposure could not be properly addressed. Overall, the present risk assessment confirms a very narrow margin of safety for the overall chronic exposure and is considered provisional, pending the submission of confirmatory data on possible preferential metabolism/degradation of the four stereo isomers of difenoconazole in plants and animals and the impact of isomerisation on the toxicity of difenoconazole. The assessment is also affected by uncertainties related to the toxicological profile of animal metabolite CGA205375 and, additionally, it does not take into consideration triazole derivative metabolites (TDMs).
