Assessment of the application for renewal of authorisation of Yea‐Sacc® (Saccharomyces cerevisiae) for horses
Yea‐Sacc® is an additive based on a live preparation of a strain of Saccharomyces cerevisiae intended for use as a zootechnical additive (digestibility enhancer). The current assessment is performed in the context of the renewal of the authorisation of the feed additive; however, the applicant proposed also to lower (6.5 × 108 colony forming unit (CFU)/kg of complete feedingstuff) the minimum dose of the additive when used in feed for horses. The additive is produced in a powder (Yea‐Sacc®) and in a prills (Yea‐Sacc®_TS) forms. The Panel considered that the additive currently on the market complies with the existing conditions of authorisation. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the production strain has been confirmed, safety for the target species, consumer and the environment were presumed. Both formulations are non‐irritant to skin, Yea‐Sacc®_TS is non‐irritant to the eye while Yea‐Sacc® is a moderate irritant. Both formulations should be considered skin sensitisers and because of their high proteinaceous nature, they should be considered as potential respiratory sensitisers. The applicant submitted two efficacy studies: the FEEDAP Panel concluded that in the first study inconsistent results were observed for the two lower doses which are considered microbiologically equivalent. The second study demonstrated that Yea‐Sacc® at the level of 7.5 × 108 resulted in a better digestion of organic matter which may be explained by increases in digestibility of the fibre. Based on the data provided, the FEEDAP Panel cannot conclude on the efficacy of Yea‐sacc® when used as a feed additive in horses at the proposed level (6.5 × 108CFU/kg complete feed).