Saccharomyces cerevisiae CNCM I-4407 yeast (4b1702) authorised for cattle for fattening until 16 March 2035: at least 5 × 10⁹ CFU/g of additive, 4 × 10⁹ CFU/kg of feed, counting according to EN 15789, PCR identification according to CEN/TS 15790; EFSA extrapolated efficacy from dairy cows and calves, supported by one of five new studies
Commission Implementing Regulation (EU) 2025/364, published on 24 February 2025, authorises the preparation of Saccharomyces cerevisiae CNCM I-4407 (formerly NCYC Sc 47, holder S.I. Lesaffre) as a zootechnical additive — gut flora stabiliser — for cattle for fattening, as part of the re-evaluation of an additive authorised without time limit in 2003 under Directive 70/524/EEC. It repeals Article 1 and Annex I of Regulation (EC) No 316/2003.
- Specification and methods (annex): solid preparation with at least 5 × 10⁹ CFU/g of viable cells; minimum content 4 × 10⁹ CFU/kg of complete feed with a moisture content of 12 %; enumeration in the additive, premixtures and feed — pour plate or spread plate method on chloramphenicol glucose yeast extract agar (EN 15789); identification — PCR (CEN/TS 15790). Valid until 16 March 2035.
- Conditions: the directions for use state storage conditions and stability to heat treatment; personal protective equipment for eyes and skin where procedures do not eliminate the risks. Transitional period: additive E 1702 and premixtures labelled before 16 September 2025, and feed labelled before 16 March 2026, may be used until stocks are exhausted. In Polish recital 3 the category requested by the applicant is “dodatki technologiczne” (technological additives), in the English one “zootechnical additives”; Article 1 and the annex of both versions — zootechnical additives.
- EFSA opinions (of 22 January 2019 and 13 March 2024, e8727): the strain qualifies for QPS, the additive is safe for cattle for fattening, consumers and the environment, it is not a skin irritant and inhalation exposure is unlikely; for lack of data eye irritation and skin sensitisation were not concluded on. In 2019 efficacy was not established — the three studies had design flaws (no statistical replicates, feed intake not measured).
- Efficacy (e8727): of the five new studies, two in calves were discarded (not compliant with the “cattle for fattening” production cycle under Regulation (EC) No 429/2008) and two in cattle (in one, straw intake was not recorded, so dry matter intake was unknown); both meta-analyses were rejected. In the remaining study bulls given 4.0 × 10⁹ CFU/kg had higher final body weight, daily gain and feed efficiency than the control. The Panel also took into account the authorisations for dairy cows (4.0 × 10⁸ CFU/kg) and calves (1.5 × 10⁹ CFU/kg), which allow efficacy to be extrapolated to ruminants.