Saccharomyces cerevisiae DSM 34246 yeast (Canobios-BL, 4b1873) as a gut flora stabiliser for dogs and cats — at least 5 × 10⁹ CFU/kg feed, until 19 February 2035; plate count EN 15789, identification by PCR (CEN/TS 15790); EFSA — in dogs faecal dry matter 44–46 % instead of 32–35 %, nickel in the additive up to 0.83 mg/kg
Commission Implementing Regulation (EU) 2025/154, published on 30 January 2025, authorises the preparation of Saccharomyces cerevisiae DSM 34246 (authorisation holder: ACEL pharma S.r.l.) as a zootechnical additive in the functional group gut flora stabilisers for dogs and cats. In its opinion of 17 April 2024 EFSA found the preparation safe for dogs and cats; no consumer or environmental assessment was needed, as the additive is intended only for pet food. The preparation is not a skin or eye irritant but is a skin and respiratory sensitiser.
- Conditions: solid form with at least 2 × 10¹⁰ CFU/g; minimum content 5 × 10⁹ CFU/kg complete feed (12 % moisture), no maximum. Methods (EU reference laboratory): enumeration in the additive and feed by pour or spread plate according to EN 15789, identification by PCR according to CEN/TS 15790. The directions for use must state storage conditions and stability to heat treatment; users — risk-reducing procedures and, where that is not possible, respiratory and skin protection.
- Composition and quality (EFSA): a dry powder of 99.5 % S. cerevisiae DSM 34246 cells and 0.5 % lecithin as emulsifier; five batches averaged 2.18 × 10¹⁰ CFU/g (2.1–2.3 × 10¹⁰). Microbiological specifications: total microbial count ≤ 10⁶ CFU/g, Enterobacteriaceae ≤ 100 CFU/g, Salmonella absent in 25 g, E. coli absent in 1 g. Impurities: arsenic 0.021–0.023, cadmium 0.020–0.021, lead 0.010–0.150, nickel 0.030–0.830 mg/kg, mercury below the LOD; aflatoxins B1, B2, G1, G2, deoxynivalenol, T-2 and HT-2 toxins and pesticides below the LOD. EFSA sees no concern except for nickel.
- Dusting potential by the Stauber-Heubach method 1–3 mg/m³, all particles above 250 µm (laser diffraction); at 0.83 mg Ni/kg nickel in the dust would be up to 0.0025 µg/m³, below the transitional limit of 0.1 mg Ni/m³ for the inhalable fraction (8 h). Stability: no losses (< 0.5 log) after 24 months at 25 °C and 3 months at 40 °C in PE-Al-PE multilayer bags; in mash feed for dogs and cats and pelleted feed for dogs (1 × 10¹⁰ CFU/kg) — no losses after 24 months at 25 °C.
- Efficacy (EFSA): three long-term trials in small, medium and large breed dogs (1–8 years) and one in 14 Chartreux cats; after 35 days, faecal dry matter in supplemented dogs was 44.0–45.6 % versus 32.3–34.6 % in controls, and faecal score 3.1–3.4 versus 4.0–4.3 (significant differences; optimum of the scale = 2). Body weight, feed intake and body condition did not change. The Panel concluded that the additive has the potential to be efficacious in dogs and cats at 5 × 10⁹ CFU/kg; no post-market monitoring is required.