摘要：Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of selenium‐enriched yeast (Saccharomyces cerevisiae NCYC R397) for all animal species, based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is currently authorised as selenomethionine produced by S. cerevisiae NCYC R397 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 that there are no changes in (i) the manufacturing of the product compared to the former application, and (ii) the conditions of use already authorised, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) stated that the modification requested would not affect safety and efficacy of the product, with the exception of safety for the target animals and safety for the users. The applicant provided data of 15 batches which supported a specification for a minimum selenium content of 3,000 mg/kg, with at least 63% and 17% of the organic selenium content from selenomethionine and selenocysteine, respectively. 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. Selenium is hazardous upon inhalation; owing to the high dusting potential, persons handling the additive are at risk by inhalation. The additive is an irritant for the eyes, skin and mucosae, should be considered as a dermal sensitiser, and likely as a respiratory sensitiser.
关键词：nutritional additive;compounds of trace elements;selenium;selenium‐enriched yeast;Alkosel®;safety
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