Five strains (E. faecium DSM 33761, P. acidilactici DSM 33758, B. animalis DSM 16284, L. reuteri DSM 33751, L. salivarius DSM 16351) for poultry (4b1897) until 31 December 2035: enumeration to EN 15788, EN 15786, EN 15785 and EN 15787; 1 × 10⁸ CFU/kg feed or 5 × 10⁷ CFU/l water; efficacy confirmed only after three new trials
Commission Implementing Regulation (EU) 2025/2497, published on 11 December 2025, authorises until 31 December 2035 a preparation of five bacterial strains (holder: Biomin GmbH) as a gut flora stabiliser for poultry for fattening and reared for laying or reproduction — in a coated form for feed and an uncoated form for water for drinking. In 2023 EFSA found it safe but could not assess efficacy; only after three new trials in chickens for fattening (opinion of 6 May 2025) did it conclude that it has the potential to be efficacious. The additive is a respiratory sensitiser and not a skin irritant; eye irritation and skin sensitisation remain unresolved.
- Methods in the annex: identification of all strains — DNA sequencing or PFGE (CEN/TS 17697); enumeration in the additive, premixtures and compound feed — E. faecium on bile aesculin azide agar or Slanetz and Bartley agar (EN 15788), P. acidilactici on MRS agar (EN 15786), B. animalis on MRS agar (EN 15785), L. reuteri and L. salivarius on MRS agar (EN 15787). The reference laboratory referred to its earlier assessment of the same additive (Article 5(4)(a) of Regulation (EC) No 378/2005).
- Minimum composition: 4 × 10¹⁰ CFU/g in total, including E. faecium and P. acidilactici at 1.3 × 10¹⁰ each, B. animalis 1.2 × 10¹⁰, L. reuteri and L. salivarius at 1.0 × 10⁹ CFU/g each. Dose: 1 × 10⁸ CFU/kg complete feed (coated form) or 5 × 10⁷ CFU/l water (uncoated). Combination with nicarbazin, diclazuril, decoquinate and halofuginone is allowed — in the 2023 opinion the MICs of these coccidiostats exceeded four times their maximum levels in feed (125, 1, 40 and 3 mg/kg); for monensin, robenidine, maduramicin and lasalocid they did not.
- New trials (Ross 308, males, 35–37 days): in trial 1 (1200 birds) higher final body weight (1976 vs 1944 g) and better feed-to-gain ratio (1.67 vs 1.71), in trial 3 — ratio 1.43 vs 1.47, in trial 2 no significant differences. In trial 2 only 5.5 × 10⁶ CFU/kg instead of 1 × 10⁸ was found in the grower feed, and B. animalis, L. reuteri and L. salivarius were < 10⁶ CFU/kg. EFSA considered the water dose efficacious because poultry drink 2–3 times more water than they eat feed dry matter.
- From the 2023 opinion: E. faecium DSM 33761 is susceptible to ampicillin (MIC 0.5 mg/l against a requirement of ≤ 2 mg/l) and lacks the IS16, esp and hylEfm markers typical of clinical isolates; Stauber-Heubach dusting potential — uncoated form 2278 mg/m³ on average (1715–2795), coated 1790 mg/m³ (1330–2250), hence respiratory, eye and skin protection is required. For feed — information on stability to heat treatment, for water — on stability in water for drinking.