Abstract
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 CNCM I-3399) 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 CNCM I-3399 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 there are no relevant changes in the manufacturing of the product compared to the former application and (ii) that the conditions of use already authorised remain the same, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) stated that the modification requested would not affect the conclusions of the FEEDAP Panel on safety for the consumer, safety for the environment and efficacy of the product made in a previous assessment of a similar product with a lower selenium concentration. Since the capacity of the additive to homogeneously distribute in feed was proven, the tolerance studies already provided for the currently authorised product could be used to conclude on the safety of the additive for the target animals. Selenium is hazardous upon inhalation; owing to the dusting potential and the selenium content of dust, persons handling the additive are at risk. The additive should be considered as a respiratory sensitiser. The additive is not an irritant for eyes and skin. No conclusions can be reached on the dermal sensitising properties of the additive.