Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Italy received an application from Arysta LifeScience Great Britain Ltd to set maximum residue levels (MRL) for the active substance propargite in imported citrus fruits and tea. 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 4 mg/kg for oranges only, as the extrapolation to the whole group is not supported by the EU rules. Based on the residue trials, an MRL of 50 mg/kg for tea could be derived. However, a risk manager decision is required whether the setting of a MRL of 50 mg/kg for tea is acceptable since the MRL reported to be into force in India is 10 mg/kg. Adequate analytical enforcement methods are available to control the residues of propargite on the commodities under consideration. Since the enforcement method of analysis is not enantioselective, residues are determined as the sum of any possible isomer ratio of the active substance propargite. EFSA concluded that the use of propargite on oranges and tea as reported in the countries of origin will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, it should be noted that the risk assessment is affected by uncertainties linked to the toxicological profile and the reliability of results for some of the metabolites included in the residue definition and it is applicable to the technical propargite with the isomer ratio 99:1 under assessment.

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