EFSA Journal (Dec 2021)
Safety and efficacy of the feed additive consisting of selenium‐enriched yeast (Saccharomyces cerevisiae CNCM I‐3060) for all animal species (Alltech Ireland)
Abstract
Abstract 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 safety and efficacy of selenium‐enriched yeast (Saccharomyces cerevisiae CNCM I‐3060) for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised as selenomethionine produced by S. cerevisiae CNCM I‐3060 as a nutritional additive (compound of trace elements) with a minimum selenium content of 2,000 mg/kg. The applicant proposed the inclusion of an additional formulation with a minimum content of selenium in the additive of 3,000 mg/kg. Considering (i) that the main changes in the manufacturing of the product compared to the former application involve the drying phase (spray‐drying vs drum drying), which has led to slightly different values of the dusting potential and particle size, and (ii) the conditions of use already authorised, the FEEDAP Panel stated that the modification requested would only affect the safety for the target animals and the users, without impacting the safety for the consumers, safety for the environment or the efficacy of the additive. The FEEDAP Panel concluded that there are no concerns for the safety of the target animals based on its previous assessment and an additional study on homogeneity of the additive. The additive is hazardous by inhalation, is not irritant for the eyes, skin and is not a dermal sensitiser.
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