Saccharomyces cerevisiae DBVPG 48 SF yeast (4d24) authorised for ruminants other than dairy — at least 4 × 10⁹ CFU/kg feed, until 20 February 2035; identification by PCR (CEN/TS 15790), plate count (EN 15789); EFSA — efficacy confirmed by three trials in calves, the powder formulation releases up to 2,390 mg/m³ of dust
Commission Implementing Regulation (EU) 2025/169, published on 31 January 2025, authorises the preparation of Saccharomyces cerevisiae DBVPG 48 SF (authorisation holder: Mazzoleni S.p.A., trade name BioCell®) as a zootechnical additive (other zootechnical additives — improvement of performance parameters) for ruminants other than dairy cows and minor dairy ruminants. For horses, dairy ruminants and pigs the preparation had already been authorised by Regulation 2023/2734; there was no authorisation for fattening ruminants then, because in 2023 EFSA could not assess efficacy in calves.
- Conditions: solid additive with at least 1 × 10⁹ CFU/g; minimum content 4 × 10⁹ CFU/kg complete feed (12 % moisture), no maximum and no age limit. Methods (EU reference laboratory): identification of the strain by PCR according to CEN/TS 15790, enumeration in the additive, premixtures and feed by pour or spread plate method according to EN 15789. Users: risk-reducing procedures and, where that is not possible, respiratory and skin protection.
- The preparation (EFSA 2023) comes in three formulations: microspheres BioCell® S12 (guaranteed 1.2 × 10¹⁰ CFU/g; six batches averaging 1.5 × 10¹⁰), micropellet M16 (1.6 × 10¹⁰; eight batches averaging 2.0 × 10¹⁰) and powder P (1.0 × 10⁹; five batches averaging 5.3 × 10⁹). Microbiological specifications: total coliforms ≤ 1,000 CFU/g, β-glucuronidase-positive E. coli ≤ 10, coagulase-positive staphylococci ≤ 10, sulfite-reducing bacteria ≤ 100, Listeria monocytogenes ≤ 100 CFU/g, Salmonella absent in 25 g; arsenic up to 0.06 mg/kg in the micropellet.
- Dusting potential by the Stauber-Heubach method: microspheres and micropellet — zero, powder — on average 2,292 mg/m³ (up to 2,390 mg/m³), so inhalation exposure is likely only for the powder. Stability: losses ≤ 0.5 log after 24 months (microspheres, micropellet) and 12 months (powder) in aluminium bags at −2.8 to 32.8 °C; pelleting of feed at 70 °C — a drop of 0.5 log. The strain has QPS status and the antifungal MIC values were low (e.g. voriconazole 0.25 mg/L).
- Efficacy (EFSA 2024): three new trials in veal calves showed improved performance at 1.7 × 10⁹ CFU/kg feed; together with the earlier trials in dairy cows the Panel concluded that the additive has the potential to be efficacious for all ruminants — 4.0 × 10⁸ CFU/kg for dairy and 4.0 × 10⁹ CFU/kg for fattening and rearing ruminants. The preparation is not irritant to eyes or skin but is considered a respiratory sensitiser; EFSA could not conclude on skin sensitisation.