Reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate‐methyl

• Published in: EFSA journal Vol. 19; no. 8; pp. e06773 - n/a
• Main Authors: Bellisai, Giulia, Bernasconi, Giovanni, Brancato, Alba, Carrasco Cabrera, Luis, Ferreira, Lucien, Giner, German, Greco, Luna, Jarrah, Samira, Kazocina, Aija, Leuschner, Renata, Magrans, Jose Oriol, Miron, Ileana, Nave, Stefanie, Pedersen, Ragnor, Reich, Hermine, Ruocco, Silvia, Santos, Miguel, Scarlato, Alessia Pia, Theobald, Anne, Vagenende, Benedicte, Verani, Alessia
• Format: Journal Article
• Language: English
• Published: Hoboken John Wiley & Sons, Inc 01-08-2021; John Wiley and Sons Inc; Wiley
• Subjects: benzimidazole substances; Benzimidazoles; Carbendazim; Cattle; Classification; Commodities; consumer risk assessment; Enforcement; Fungicides; Laboratories; Livestock; Metabolism; Metabolites; MRL; Peer review; Pesticides; Proposals; Reasoned Opinion; Regulation (EC) No 396/2005; Residues; Risk assessment; Risk management; Thiophanate; thiophanate‐methyl; Tolerances
• ISSN: 1831-4732; 1831-4732
• DOI: 10.2903/j.efsa.2021.6773

In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission a mandate to provide its reasoned opinion on the toxicological properties and maximum residue levels (MRLs) for the benzimidazole substances carbendazim and thiophanate‐methyl. Specifically, EFSA was asked to assess whether thiophanate‐methyl or carbendazim have clastogenic potential and, in case clastogenic potential can be excluded, to derive toxicological reference values necessary for consumer risk assessment and assessment of maximum residue levels (MRLs). Although these active substances are no longer authorised within the European Union, MRLs were established by the Codex Alimentarius Commission (codex maximum residue limits; CXLs), and import tolerances are in place. Based on the assessment of the available data, toxicological reference values and MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered.