An application was submitted to the Food Standards Agency and Food Standards Scotland in May 2024 from saqual GmbH for the renewal of authorisation of the feed additive biotin (3a880) which is submitted on behalf of three applicants: ADISSEO France S.A.S, DSM Nutritional Products Ltd., and NHU Europe GmbH (hereby referred to as “the applicants”). The feed additive is currently authorised for use in feed and water for drinking for all animal species, under the category of ‘nutritional additives’ and functional group ‘vitamins, pro-vitamins, and chemically well-defined substances having a similar effect’. The applicant seeks a modification of the authorisation for a change in the formulation of the additive related to its particle size distribution. The European Food Safety Authority (EFSA) Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) previously issued two opinions on the safety and efficacy of biotin as a feed additive for all animal species (EFSA, 2012a, b). The FEEDAP Panel concluded that biotin is safe for the target species, consumers and the environment when used under the proposed conditions. Regarding the user/worker, biotin is not irritant to skin, eyes or mucous membranes and is unlikely to cause skin sensitisation. However, the FEEDAP Panel concluded that there is a potential for inhalation exposure from handling biotin due to its high dusting potential and an absence of data on inhalation toxicity. In 2025 the EFSA FEEDAP Panel published an assessment of the feed additive consisting of biotin for all animal species for the renewal of its authorisation (EFSA, 2025). The FEEDAP Panel concluded there is no new evidence that would lead the Panel to reconsider its previous conclusions regarding the safety of the additive. The FSA/FSS have reviewed the applicant’s authorisation application, supporting documentation, and other regulators’ risk assessments, most notably the 2025 EFSA risk assessment opinion, and consider sufficient evidence has been demonstrated to conclude without the need for further questions or risk assessment.
Agency et al. (Thu,) studied this question.