Following a request from the European Commission, the European Food Safety Authority (EFSA) was asked to deliver a scientific opinion on the safety and efficacy of the product selenium enriched yeast (Saccharomyces cerevisiae CNCM I-3399) (SELSAF) as a feed additive for all species. SELSAF is a dry preparation intended to be used as a source of the essential trace element selenium (Se). It contains a minimum of 2000 mg Se kg(-1). SELSAF has a shelf life of at least 12 months, and a stability of six months in premixes and four months in complete feed when stored under normal conditions. Two inorganic and two organic sources of Se are already authorised as nutritional additives for animal nutrition in the European Union. Studies on chickens for fattening, laying hens, piglets and dairy cows demonstrate that SELSAF supplementation increases the levels of Se in whole blood, tissues and blood GSH-Px activity. Therefore, SELSAF is considered as a bioavailable Se source for all animal species. The tolerance studies with Se supplementation from SELSAF at tenfold the maximum authorised content in complete feed for three major species (laying hens, piglets and dairy cows) demonstrate that SELSAF is safe for major species when supplemented up to the maximum authorised content of Se in complete feed. Provided that the maximum authorised Se content in complete feed is not exceeded, the use of SELSAF as a Se source is considered to be safe for all animal species. Based on data from a series of in vitro and in vivo assays of toxicity and genotoxicity, the Panel on Additives and Products or Substances use in Animal Feed (FEEDAP) considers that SELSAF does not introduce any additional toxicity compared to other sources of Se. Se intake from products of SELSAF-treated animals would amount to 30 % and 25 % of the UL for young children (four to six years old) and adults, respectively. Taking into account other Se sources, Se exposure of adults would not exceed 50 % of the upper tolerable intake level (UL). Consequently, the FEEDAP Panel concludes that the use of SELSAF at the recommended level in feeds is safe for the consumers. SELSAF is not a skin or eye irritant. However, the potential for skin or respiratory sensitisation cannot be excluded and would require that protective measures be taken by the users of the product. The use of SELSAF in feed does not pose an additional risk to the environment compared to other sources of Se for which it will substitute. The FEEDAP Panel made some recommendations with regards to the Register entry.
