Saccharomyces cerevisiae CNCM I-1077 (4b1711) extended to all dairy and breeding ruminants and camelids, young ruminants for fattening and Equidae other than horses: EN 15789 and CEN/TS 15790, for lambs the dose lowered from 3 × 10⁹ to 1 × 10⁹ CFU/kg
Commission Implementing Regulation (EU) 2025/1426, published on 18 July 2025, authorises until 7 August 2035 a preparation of Saccharomyces cerevisiae CNCM I-1077 yeast (isolated from a fruit; holder: Lallemand SAS) as a gut flora stabiliser for ruminants (other than lambs) and camelids for milk production or reproduction, young ruminants for fattening and camelid calves for fattening, and as a digestibility enhancer for Equidae other than horses; in Regulation (EU) 2020/149 it lowers the minimum dose for lambs. EFSA (opinion of 15 October 2024) confirmed safety and extrapolated efficacy from calves, cattle for fattening and horses.
- Methods in the annex: count in the additive, premixtures and compound feed — pour or spread plate on chloramphenicol dextrose yeast extract agar according to EN 15789; identification — PCR according to CEN/TS 15790. Two forms: not coated — min. 2 × 10¹⁰ CFU/g, coated (microencapsulated with vegetable oil derivatives) — min. 1 × 10¹⁰ CFU/g. Five batches of each: on average 2.8 × 10¹⁰ (2.4–3.4 × 10¹⁰) and 1.9 × 10¹⁰ CFU/g (1.7–2.0 × 10¹⁰). E. coli < 10 CFU/g, Enterobacteriaceae and coliforms < 1000 CFU/g, Salmonella absent in 25 g.
- Dusting potential (Stauber-Heubach): not-coated form on average 600 mg/m³ (400–800), coated — dust-free. Identification was confirmed from the genome sequence with two data sets: read mapping (closest to the S. cerevisiae S288C reference genome) and comparison of the ITS region with type strains (closest to S. cerevisiae NRRL Y-12632ᵀ). An old eye irritation study, reinterpreted according to the latest version of OECD 405, showed that the not-coated form is not an eye irritant — it had previously been considered irritant; for the coated form there are no data.
- Minimum levels in the annex (CFU/kg complete feed): ruminants (other than lambs) and camelids for milk production or reproduction — 5 × 10⁸; young ruminants for fattening (other than calves and lambs) and camelid calves for fattening — 1 × 10⁹; Equidae other than horses — 3 × 10⁹; lambs (amendment of 2020/149) — 1 × 10⁹ instead of 3 × 10⁹. The extrapolation was based on efficacy shown earlier in calves at 1 × 10⁹, cattle for fattening at 6 × 10⁸ and horses at 3 × 10⁹ CFU/kg.
- Other provisions: storage conditions and stability to heat treatment; respiratory, skin and eye protection (the latter only for the coated form, for which irritation was not excluded). A skin sensitisation test (OECD 429) was negative, but EFSA recalls that OECD guidelines are not validated for microorganisms — both forms are considered sensitisers. Transitional period for lambs: additive and premixtures labelled before 7 February 2026, compound feed before 7 August 2026.