Bacillus subtilis DSM 32324 and DSM 32325 and B. amyloliquefaciens DSM 25840 (4b1894) also for laying and breeding poultry until 8 January 2036 and in a 10-fold concentrated form (3.2 × 10¹⁰ CFU/g): EN 15784, 1.6 × 10⁹ CFU/kg feed or 5.4 × 10⁸ CFU/l water; in laying hens an effect in 2 of 4 trials
Commission Implementing Regulation (EU) 2025/2576, published on 19 December 2025, authorises until 8 January 2036 a preparation of spores of three Bacillus strains (holder: Chr. Hansen A/S, GalliPro® Fit) as a gut flora stabiliser for all poultry species for laying or breeding, in feed and in water for drinking, and amends Regulation (EU) 2020/1762 for poultry for fattening and reared, allowing a form with a tenfold higher concentration (GalliPro® Fit 10). In its opinion of 20 March 2025 EFSA found both forms safe and not irritant to the eyes, but skin and respiratory sensitisers.
- Methods in the annex: identification — DNA sequencing or PFGE (CEN/TS 17697); enumeration in the additive, premixtures, compound feed and water for drinking — spread plate on tryptone soya agar (EN 15784). Composition in the annex: at least 3.2 × 10⁹ CFU/g (1.6 : 1.0 : 0.6 × 10⁹ for DSM 32324, DSM 32325 and DSM 25840); dose 1.6 × 10⁹ CFU/kg complete feed or 5.4 × 10⁸ CFU/l water. Combination is allowed with diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, nicarbazin with narasin and lasalocid.
- GalliPro® Fit 10 (20 % active agents, 80 % limestone): five batches 5.8–6.2 × 10¹⁰ CFU/g with the strain ratio preserved; cadmium 0.083–0.114, lead 0.517–0.868, mercury 0.0039–0.0065, arsenic 0.323–0.505 mg/kg, aflatoxin B1 < LOQ; coliforms < 17 CFU/g, B. cereus < 10 CFU/g. Bulk density 1329 kg/m³, Stauber-Heubach dusting potential 1700 mg/m³ on average (600–2400), particles < 10 µm up to 13 %; no losses after 24 months at 30 and 37 °C; CV in the premixture 13 %. Isolated chicken eye test (OECD TG 438) — not an eye irritant.
- Trials in laying hens (four, 21–25 weeks): in trial 1 laying rate 95.2 vs 94.0 % at 1.6 × 10⁹ CFU/kg (3.2 × 10⁸–6.4 × 10⁹ were also tested), in trial 3 a better feed-to-egg mass ratio (2.13 vs 2.16), in trial 2 only heavier eggs (58.2 vs 57.6 g — not enough according to EFSA), in trial 4 no effect. Analysis of the control feed showed 5.6 × 10⁶–3.5 × 10⁷ CFU/kg. EFSA derived the water dose from the feed dose.
- Resistance genes: several hits above the EFSA thresholds, none of them acquired genes after analysis — the strains still meet the qualified presumption of safety (QPS). Transitional periods for the existing form for poultry for fattening and reared: additive and premixtures labelled before 8 July 2026, compound feed and feed materials before 8 January 2027. Respiratory and skin protection.