Saccharomyces cerevisiae MUCL 39885 yeast (Biosprint®, 4b1710) for cattle for fattening renewed until 10 March 2035: ≥ 1 × 10⁹ CFU/g, 4 × 10⁹ CFU/kg of feed, EN 15789 and PCR; EFSA: 54 batches averaging 1.74–1.75 × 10¹⁰ CFU/g, mercury 27.1 mg/kg in one batch
Commission Implementing Regulation (EU) 2025/314, published on 18 February 2025, renews the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 (holder Prosol SPA) as a zootechnical additive — gut flora stabiliser — for cattle for fattening and repeals Implementing Regulation (EU) No 1059/2013. It is based on the EFSA opinion of 13 March 2024 (e8720).
- Specification and methods (annex): preparation in solid forms with at least 1 × 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 method (EN 15789); identification — PCR (CEN/TS 15790). The directions for use state storage conditions and stability to heat treatment; personal protective equipment for the respiratory tract and skin. Valid until 10 March 2035; the additive and premixtures labelled before 10 September 2025, and feed labelled before 10 March 2026, may be used until stocks are exhausted.
- Change of conditions according to EFSA: the previous authorisation recommended a minimum dose of 3.6 × 10¹⁰ CFU per head per day and the use of glasses and gloves during handling. The new annex contains no per-head dose and the protective measures concern the respiratory tract and skin. EFSA considered the additive non-irritant to skin (in vitro study according to OECD TG 439) and eyes (in vitro on reconstructed corneal epithelium), but a potential skin and respiratory sensitiser.
- Data from the EFSA opinion (e8720): the additive comes in two forms differing in the drying process — spherical (Biosprint® S) and granulated (Biosprint® G); in 54 batches (33 G, 21 S) on average 1.75 × 10¹⁰ CFU/g (1.6–1.98 × 10¹⁰) for G and 1.74 × 10¹⁰ CFU/g (1.61–1.88 × 10¹⁰) for S. In three G batches: in two, arsenic, cadmium and lead were below the limits of detection; in one, mercury 27.1 mg/kg and copper 3.5 mg/kg were quantified; in a batch analysed in another laboratory mercury was below the LOQ of 0.01 mg/kg, arsenic 0.05, cadmium 0.014, lead 0.013, copper 6.75 mg/kg; iron 3.6–43 mg/kg. The Panel considered that the impurities do not raise concerns.
- Further data (e8720): dioxins and DL-PCBs combined (upper bound) 0.119–0.182 ng WHO-TEQ/kg; mycotoxins below the LOQ; in the pesticide multiresidue analysis — difenoconazole 0.015–0.016 mg/kg and epoxiconazole 0.05–0.073 mg/kg; Salmonella and Listeria not detected in 25 g; total bacteria on average 570 CFU/g (G) and 18 330 CFU/g (S). Stability in premixture (20 batches, 3.5 × 10¹⁰ CFU/kg, room temperature): no losses up to month 9, losses of up to 3 log after 18 months. Identity confirmed by WGS (OrthoANI 99.36 % against S288C); the strain is susceptible to amphotericin B and itraconazole.