Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product Biosaf Sc 47, a preparation of Saccharomyces cerevisiae, as a feed additive for dairy small ruminants

Biosaf Sc 47 is an additive consisting of dried live yeast Saccharomyces cerevisiae (NCYC Sc 47). This additive is already permanently authorised for use in cattle for fattening, dairy cows, rabbits for fattening, sows and piglets. The applicant is now asking for authorisation to use the additive in dairy small ruminants. According to Regulation (EC) No 1831/2003, the European Food Safety Authority should deliver an opinion on the efficacy and the safety of the product Biosaf Sc 47 for the target animal, consumers, users and the environment. In its previous assessment, the FEEDAP Panel considered that the safety of this organism (and its growth medium) for the consumer, the user and the environment had already been established and would not be changed by the proposed extension of use. Consequently, this opinion deals only with the safety and the efficacy of the additive for the proposed additional target species. Evidence for efficacy of the additive was demonstrated in one study with dairy goats (2.8 x 109 CFU animal-1 day-1) and one study with dairy ewes (1.8 x 109 CFU animal-1 day-1). In both trials the inclusion of Biosaf Sc 47 significantly improved milk yield in comparison with animals fed the same diet without the additive. As current knowledge indicates that the mode of action of yeasts is essentially similar in the rumen of cattle, sheep and goats and since the product is already authorised for dairy cows, the FEEDAP Panel considers the two trials in the minor species to be sufficient to demonstrate efficacy. When Biosaf Sc 47 was given to dairy goats at a concentration ten times greater than the maximum recommended dose, no negative health or other adverse affects were observed. The FEEDAP Panel acknowledges that Saccharomyces cerevisiae has been incorporated into feeds for a variety of livestock species including ruminants for many years apparently without adverse affects. The tolerance study in which no adverse affects were seen is consistent with this view. The FEEDAP Panel therefore considers the use of Biosaf Sc 47 to be safe and potentially efficacious when used with dairy small ruminants.