Safety of a feed additive consisting of Sepiolitic clay for all animal species (MYTA S.A.)

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of Sepiolitic clay as a technological feed additive for all animal species. In 2022, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of the same additive. The Panel concluded that Sepiolitic clay used as a feed additive is safe for the consumers and the environment, and efficacious as a binder and anticaking agent in feed for all animal species under the proposed conditions of use. The additive was not considered an eye or skin irritant. However, it was considered a respiratory and dermal sensitiser. Due to the dusting potential and its silica content, the additive was considered a risk by inhalation. Regarding the target species, in the previous Opinion, the Panel concluded that the additive was safe for dairy ruminants and growing Suidae at the recommended use level (20,000 mg/kg feed), for chickens for fattening at 10,000 mg/kg feed and for salmonids at 17,600 mg/kg feed. No conclusion could be drawn for all other species/categories. Based on the tolerance studies in chickens for fattening and trout evaluated in the current assessment, and the ones in weaned piglets and dairy cows previously assessed, the Panel concluded that the inclusion of Sepiolitic clay at the maximum recommended level of 20,000 mg/kg complete feed is safe for all animal species.