Setting of residue definitions and toxicological reference values for ethiprole

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.

Authors

Publication Details

Journal
EFSA Journal
Published
2024-12-01
DOI
https://doi.org/10.2903/j.efsa.2024.9129
Citations
2
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
0.70
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article

Setting of residue definitions and toxicological reference values for ethiprole

Alessia Verani, Giulia Bellisai, Manuela Tiramani, Marta Szot et al.
2 citations
EFSA Journal
Agricultural safety and regulations
0.70
article

Setting of residue definitions and toxicological reference values for ethiprole

Alessia Verani, Giulia Bellisai, Manuela Tiramani, Marta Szot, Elena Zioga, Silvia Ruocco, Marco Binaglia, Monica Del Aguila, Stéfanie Nave, Federica Crivellente, Irene Castellan, Frédérique Istace, Iris Mangas, Lucien Ferreira, Samira Jarrah, Anna Lanzoni, Renata G.K. Leuschner, Hermine Reich, Anne Theobald, Giovanni Bernasconi, Anna Federica Castoldi, Andrea Terron, Arianna Chiusolo, Luis Carrasco Cabrera, Martina Panzarea, Alessia Pia Scarlato, Luna Greco, Juan Manuel Parra Morte, Andrea Mioč, Andrea Simonati
article en
2 citations

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.

EFSA JournalVol. 22(12)
Openalex Percentile: Top 26%
Agricultural safety and regulations
0.70
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