On 23 July 2026, the European Food Safety Authority (EFSA) published a scientific opinion concluding that bentonite (dioctahedral montmorillonite) remains safe for target animals, consumers and the environment under the authorised conditions of use, and that no efficacy reassessment is needed for the renewal of its authorisation as a technological feed additive. The opinion, adopted by EFSA's Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on 30 June 2026, was prepared in response to a request from the European Commission following an application by BASF SE for the renewal of bentonite's authorisation as an anticaking agent for all animal species and as a substance for reduction of feed contamination by mycotoxins for pigs, poultry and ruminants.
The application was submitted under Article 14(1) of Regulation (EC) No 1831/2003, which requires renewal applications to be sent to the Commission at least one year before the authorisation expires. The dossier was received by EFSA on 28 November 2022 and deemed valid on 5 July 2023. The European Union Reference Laboratory confirmed that the conclusions and recommendations from the previous assessment regarding control methods remain valid. The FEEDAP Panel assessed the data provided by the applicant, which showed that the additive currently on the market complies with existing specifications: smectite content of at least 50% for anticaking use and at least 70% for mycotoxin reduction, with aflatoxin B1 binding capacity above 90%. The Panel found no evidence to reconsider its previous conclusions on safety. Regarding user safety, the Panel noted that bentonite is not irritant to skin but is mildly irritant to eyes and is a skin and respiratory sensitiser, concluding that exposure by any route poses a risk and should be minimised. The additive does not interfere with the analysis of aflatoxin B1 in feed. The opinion also notes that the presence of small particles, including nanoparticles, cannot be excluded based on particle size characterisation. The renewal maintains the current maximum content of 20,000 mg/kg of complete feedingstuff and the existing provisions on simultaneous oral use with macrolides and robenidine.