Setting of residue definitions and toxicological reference values for ethiprole

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the original evaluating Member State (EMS), the United Kingdom, received an application from Bayer CropScience to set an import tolerance for the non-approved active substance ethiprole in rice. In the framework of the assessment process, the application was re-allocated to the Netherlands and the purpose of the application was changed to only set European residue definitions and toxicological reference values for the active substance ethiprole. Based on the assessment of the available toxicological data, an acceptable daily intake of 0.002 mg/kg bw per day and an acute reference dose of 0.005 mg/kg bw were derived. The data submitted in support of the request were found to be sufficient to derive residue definitions in primary crops and in processed commodities. The residue definition for enforcement was derived as ‘ethiprole’. Adequate analytical methods for enforcement are available to control the residues of ethiprole in dry commodities at the validated LOQ of 0.002 mg/kg. A residue definition for risk assessment was derived as the ‘sum of ethiprole, ethiprole-sulfone (RPA097973) and ethiprole-amide (RPA112916), expressed as ethiprole’. This residue definition is applicable for foliar treatment in all primary crops, for both foliar and soil treatments in cereals crops, and is also valid for processed commodities.