Safety and efficacy of bentonite as a feed additive for all animal species

Abstract The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) received a request from the European Commission to assess the safety and efficacy of bentonite when used as a technological feed additive (substances for reduction of the contamination of feed by mycotoxins) for all animal species. The applicant, EUBA aisbl (European Bentonite Association) representing six companies, submitted to EFSA a technical dossier to support the application. The applicant proposes to use bentonite at the maximum level of 20,000 mg/kg complete feed. The additive apparently interferes with the analysis of aflatoxin B1 in feed. The safety of the additive was already evaluated by the Panel in an opinion delivered in 2012. Bentonites are safe for all animal species, the consumers and the environment when used at a maximum level of 20,000 mg/kg complete feed. The results of a new genotoxicity study reinforced the previous conclusion that smectites are non‐genotoxic. Bentonites are not skin irritants but might be mildly irritant to the eye; based on a new study submitted, the additive is not a skin sensitiser. Owing to its silica content, the additive is a hazard by inhalation for the users. The in vitro study showed that the di‐ and tri‐octahedral smectites tested can adsorb aflatoxin B1 at different concentrations and at pH 5; however, no adequate in vivo studies were available. Therefore, the Panel cannot draw conclusions on the additive's efficacy. The Panel further considers the safety and efficacy conclusions to apply equally to the di‐ and tri‐octahedral smectites under assessment. The FEEDAP Panel posted some recommendations regarding the maximum content of other minerals in the additive and the incompatibilities of the additive with other medicinal substances. The Panel also drew a remark concerning the denomination of the additive and the current regulatory definition of Bentonite.