Assessment of the application for renewal of authorisation of Yea‐Sacc® (Saccharomyces cerevisiae) for horses

zootechnical additive, Yea‐sacc®, Saccharomyces cerevisiae, safety, efficacy, QPS, Horses
First published in the EFSA Journal
19 dicembre 2019
Adopted
12 novembre 2019
Type
Scientific Opinion

Abstract

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).

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5918
EFSA Journal 2019;17(12):5918
Question Number
On request from
European Commission