Safety and efficacy of a feed additive consisting of sepiolite for all animal species (Sepiol S.A and Tolsa, S.A)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the re-evaluation of the authorisation of sepiolite as a feed additive for all animal species. The FEEDAP Panel considered that sepiolite is unlikely to be absorbed. Harmful amounts of residues of any chemical component in edible tissues/products, as a consequence of the use of sepiolite as a feed additive, are not expected. Sepiolite is not genotoxic and does not induce any toxicity effects following oral administration and, therefore, it was considered safe for the consumers. The additive was considered safe for dairy cows at the recommended use level with a safety factor of 2.5. The conclusion was extrapolated to other dairy ruminants but owing to the lack of sufficient data, no conclusions can be drawn on the safety of the additive for the other target species/categories. Based on the results of a chronic inhalation toxicity study, the additive is considered a respiratory irritant. Owing to the dusting potential of the additive and its silica content, handling the additive was considered a risk by inhalation for the users. It is not irritant or corrosive to skin or eyes. Due to the nickel content, it is considered a skin and respiratory sensitiser. The additive was considered safe for the environment. The FEEDAP Panel concluded that sepiolite was efficacious as a thickener-suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use. (C) 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.

Automated summary

Sepiolite as a feed additive is considered safe for animals and consumers, with potential respiratory risks for users due to its dusting potential and silica content. It is also deemed safe for the environment and efficacious as a thickener-suspending agent, binder, and anticaking agent in feed for all animal species.