Commission Implementing Regulation (EU) 2023/2736 of 7 December 2023 concerning the authorisation of a preparation of Bacillus velezensis NITE BP-01844 as a feed additive for all poultry species for fattening, chickens reared for laying, turkeys reared for breeding, minor poultry species reared for laying or for breeding and ornamental birds (holder of authorisation: Toa Biopharma Co., Ltd)
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
ANNEX Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Minimum content Maximum content Other provisions End of period of authorisation CFU/kg of complete feedingstuff with a moisture content of 12 % CFU/l of water for drinking Category of zootechnical additives. Functional groups: gut flora stabilisers 4b1903 Toa Biopharma Co., Ltd., Japan, represented by Toa Biopharma Co., Ltd., Europe Representative Office Bacillus velezensis NITE BP-01844 Additive composition: Preparation of viable spores of Bacillus velezensis NITE BP-01844 with a minimum concentration of 1 × 10 8 CFU/g of additive Solid form Characterisation of the active substance: Viable spores of Bacillus velezensis NITE BP-01844 Analytical method ( 1 ) : Identification: — Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697, or — DNA sequencing methods. Enumeration in the feed additive, premixtures, compound feed and water: spread-plate method on tryptone soya agar (EN 15784). All poultry species for fattening Chickens reared for laying Turkeys reared for breeding Minor poultry species reared for laying or for breeding Ornamental birds — 2 × 10 8 — 1 × 10 8 — 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The additive may be used in compound feed containing the following coccidiostats, where authorised as feed additives for the same animal species and categories: diclazuril, decoquinate, halofuginone, monensin, salinomycin, narasin, robenidine and maduramicin. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 28 December 2033 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.