Statement on the assessment of quality of data available to EFSA to derive the health-based guidance values for carbendazim.

Carbendazim (CBZ) is an active substance in plant protection products that is no longer authorised within the European Union. CBZ is classified according to Regulation (EC) No 1272/2008 as mutagenic, category 1B and toxic for reproduction, category 1B. In 2010, EFSA established consumers' health-based guidance values (HBGVs) for CBZ (ADI and ARfD). In compliance with Article 43 of Regulation (EC) No 396/2005, the European Commission asked EFSA on 1 March 2024 to carry out a follow-up qualitative assessment of the data gaps that were identified in the studies used in the framework of the assessment of the HBGVs for CBZ, in order to confirm the reliability of the existing toxicological studies and their impact for the setting of the HBGVs. By considering missing information in the extensive database and the reliability of the available toxicological studies, EFSA concluded that missing information does not prevent setting of HBGVs and that the critical effects of CBZ were investigated in studies of sufficient reliability and acceptability. Therefore, the HBGVs derived in 2010 are protective for the consumers.