Bacillus velezensis CECT 5940 (Ecobiol) for laying poultry and a new name for the former Bacillus amyloliquefaciens: spores counted on tryptone soya agar according to EN 15784, dose 1 × 10⁹ CFU/kg feed
Commission Implementing Regulation (EU) 2026/1036, published on 8 May 2026, authorises until 28 May 2036 a preparation of B. velezensis CECT 5940 (holder: Evonik Operations) as a gut flora stabiliser for laying poultry at 1 × 10⁹ CFU/kg complete feed. In authorisations 2020/1395 and 2021/2050 it replaces the name Bacillus amyloliquefaciens with B. velezensis and aligns user protection measures.
- Methods: enumeration — spread plate on tryptone soya agar (EN 15784); identification — DNA sequencing or pulsed-field gel electrophoresis PFGE (CEN/TS 17697). The additive contains at least 1 × 10⁹ CFU/g of viable spores. The EU reference laboratory considered valid the conclusions of the assessment verified by EFSA on 16 July 2008.
- EFSA data for three commercial forms (Ecobiol, Ecobiol 500, Ecobiol Plus): in 5 batches of each 1.1–1.5 × 10⁹, 2.3–2.5 × 10⁹ and 1.0–1.3 × 10¹⁰ CFU/g; in one batch cadmium 0.22 mg/kg, Clostridium spp. < 1.8 MPN/g, Bacillus cereus < 100 CFU/g. The opinion’s table gives PCDD/F 0.30 and the sum PCDD/F + PCB 0.16 ng WHO-TEQ/kg.
- Efficacy: of five trials in laying hens two were excluded — in one, feather pecking led to mortality and culling of up to 6.25 % in the control group, the other (Salmonella Enteritidis challenge, 42 days, three replicates per group) was not suitable for assessing performance. The remaining three lasted 84 days from week 25 of age. In the opinion’s table, feed analyses in trial 1 showed 3.5 × 10⁶, 1.4 × 10⁷ and 1.0 × 10⁸ CFU/kg against intended 0, 1.0 × 10⁸ and 1.0 × 10⁹, in trial 3 — 8.6 × 10⁹ against intended 1.0 × 10⁹; the opinion’s text states that counts in feed were analytically confirmed.
- Users: the preparation is not an eye irritant but is a skin and respiratory sensitiser; in its reply of 9 January 2026 EFSA confirmed that this conclusion also applies to its 2020 and 2021 opinions. Therefore all authorisations require respiratory and skin protection, and the additive under 2021/2050 received number 4b1822. Under the old rules: additive and premixtures made before 28 November 2026, feed before 28 May 2027.