Bacillus velezensis ATCC PTA-6737 (PB6, 4b1823i) for laying hens renewed until 4 February 2036 and extended to other birds for laying and breeding: minimum in the additive 8 × 10¹⁰ instead of 1 × 10¹⁰ CFU/g, enumeration to EN 15784, 1 × 10⁸ CFU/kg feed; fluoride 49.8–152 mg/kg
Commission Implementing Regulation (EU) 2026/92, published on 15 January 2026, renews until 4 February 2036 the authorisation of a preparation of spores of Bacillus velezensis ATCC PTA-6737 (formerly B. subtilis; holder Kemin Europa N.V.) as a gut flora stabiliser for laying hens and minor poultry species for laying, authorises it for other birds kept for egg production or breeding and repeals Regulation (EU) 2015/1020. In its opinion of 6 May 2025 EFSA found the additive still safe, also in the more concentrated form; it does not irritate skin or eyes but is a skin and respiratory sensitiser. Polish recital 3 assigns the new use to “technological additives”, while the English text and Article 2 say zootechnical.
- Methods in the annex: enumeration — spread plate on tryptone soya agar (EN 15784); identification — PFGE to CEN/TS 17697 or DNA sequencing. The reference laboratory considered its earlier conclusions still valid (Article 5(4)(a), (b) and (c) of Regulation (EC) No 378/2005). Additive: at least 8 × 10¹⁰ CFU/g (previously 1 × 10¹⁰), minimum dose 1 × 10⁸ CFU/kg complete feed for poultry for laying or breeding; information on storage conditions and stability to heat treatment; respiratory and skin protection.
- Composition according to EFSA: spore concentrate approx. 5–25 % and sodium bicarbonate 75–95 %; five batches — 1.06 × 10¹¹ CFU/g on average (1.0–1.1 × 10¹¹). Lead < 0.20–1.3, mercury < 0.01–0.011, cadmium < 0.05–0.43, arsenic < 0.20–0.48 mg/kg, fluoride 49.8–152 mg/kg (three batches), dioxins with DL-PCBs 0.13–0.14 ng WHO2005-TEQ/kg. Of thirteen mycotoxins, twelve (including aflatoxins G1, B2 and G2, DON, nivalenol, T-2, HT-2, cytochalasin E, ochratoxin A) below the LOQ, aflatoxin B1 up to 1 — the unit in the EFSA table is written as “µg/mg”.
- The strain was isolated from the intestinal tract of a chicken; the genome (ResFinder, CARD) gave three hits above the EFSA thresholds, none of which was an acquired resistance gene after analysis, so the QPS approach still applies. Microbiology: Salmonella not detected in 25 g (10 batches), coliforms, E. coli and Staphylococcus aureus not detected in 10 g, yeasts and moulds < 10 CFU/g, B. cereus < 100 CFU/g. No adverse events have been reported since the 2015 authorisation.
- Efficacy in laying hens was demonstrated in 2015; for other birds for laying and breeding EFSA extended that conclusion in line with its guidance at the same dose of 1 × 10⁸ CFU/kg. Transitional periods: additive and premixtures for laying hens labelled before 4 August 2026, compound feed and feed materials before 4 February 2027. The same strain is also authorised for poultry for fattening, turkeys, ornamental birds and pigs (EFSA opinion, section 3).