Saccharomyces cerevisiae NCYC R404 yeast (4b1871) renewed until 15 February 2036: counts on CGYE agar to EN 15789, PCR identification to CEN/TS 15790 — the new annex says “cows” instead of “dairy cows” and 1 × 10¹⁰ CFU/animal/day is now a minimum, not a recommended dose
Commission Implementing Regulation (EU) 2026/155, published on 26 January 2026, renews until 15 February 2036 the authorisation of a preparation of Saccharomyces cerevisiae NCYC R404 yeast (isolated from silage; holder: Volac International Ltd) as a gut flora stabiliser and repeals Regulation (EU) 2015/502. The application and the EFSA opinion of 18 March 2025 concerned dairy cows; the title and annex of the new act (PL and EN) refer to “cows”, while the recitals refer to dairy cows. EFSA confirmed the species by phylogenomic analysis and found the additive still safe; it should be considered a potential skin and respiratory sensitiser.
- Methods in the annex (the EURL considered the existing recommendations still valid): count — pour plate method on chloramphenicol glucose yeast extract (CGYE) agar according to EN 15789; identification — PCR according to CEN/TS 15790. Additive: min. 1 × 10¹⁰ CFU/g; five batches on average 1.32 × 10¹⁰ CFU/g (1.20–1.40 × 10¹⁰). Composition: about 98 % yeast cells, 1 % dextrose and 1 % sorbitan monostearate (E 491) as stabiliser — authorised in food but not a feed additive, so EFSA assessed it separately (about 0.31 mg/kg feed against a safe 743.6 mg/kg).
- Purity (EFSA opinion): arsenic, lead, mercury and fluoride below the LOQ, cadmium 0.04–0.05 mg/kg; PCDD/Fs 0.0649–0.0654 ng WHO-TEQ/kg, with DL-PCBs 0.101–0.102 ng/kg, nDL-PCBs 0.354 µg/kg; mycotoxins (incl. aflatoxins, ochratoxin A, DON, T-2/HT-2, fumonisins, citrinin, cyclopiazonic acid, patulin, roquefortine C) below the LOD — limits given in µg/l; pesticides in one batch below LOQs of 0.05–0.50 mg/kg. Dusting potential 0–6.25 mg/m³, particles < 100 µm — 0.02 %. No losses (< 0.5 log) after 4 months at −18, 4, 10 and 20 °C.
- Identification: phylogenomics on 98 single-copy orthogroups — the strain clusters with S. cerevisiae S288C and the nomenclatural type NRRL Y-12632. Antifungal susceptibility (broth microdilution, EUCAST): anidulafungin 0.12, amphotericin B 0.5, micafungin 0.12, caspofungin 0.5, 5-flucytosine < 0.06, posaconazole 1, voriconazole 0.12, itraconazole 0.25, fluconazole 4 mg/l — low according to EFSA. In the EFSA appendix on sorbitan monostearate the NOAEL of 2600 mg/kg bw is attributed both to “a long-term toxicity study in mice” and to “male rats”.
- Conditions in the annex: min. 4.4 × 10⁸ CFU/kg complete feed; “The additive shall be used ensuring a minimum dose of: 1 × 10¹⁰ CFU/animal/day” (previously: recommended dose 1 × 10¹⁰ CFU/head/day); storage conditions and stability to heat treatment; respiratory and skin protection — at a dusting potential of up to 6.25 mg/m³ EFSA considered exposure by inhalation possible. The act provides no transitional period.