Commission Implementing Regulation (EU) 2024/2185 of 3 September 2024 concerning the authorisation of a preparation of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 as a feed additive for all poultry species for fattening, all poultry species reared for laying or 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. This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX Identification number of the feed 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: zootechnical additives. Functional groups: gut flora stabilisers 4b1895 Toa Biopharma Co., Ltd., Japan, represented by Toa Biopharma Co., Ltd., Europe Representative Office Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 Additive composition Preparation of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 containing a minimum of 12 × 10 8 CFU/g additive (1:10:1 ratio) Solid form Characterisation of the active substance Viable spores of Bacillus subtilis FERM BP-07462, Enterococcus lactis FERM BP-10867 and Clostridium butyricum FERM BP-10866 Analytical method ( 1 ) Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697. Enumeration in the feed additive, premixtures, compound feed and water of: Bacillus subtilis FERM BP-07462: Spread plate method on tryptone soya agar (EN 15784) Enterococcus lactis FERM BP-10867: Spread plate method using bile esculin azide agar (EN 15788) Clostridium butyricum FERM BP-10866: Pour plate method using iron sulfite agar (ISO 15213) All poultry species for fattening All poultry species reared for laying All poultry species reared for breeding - 2,4 × 10 8 - 1,2 × 10 8 - 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. The additive may be used via water for drinking. 3. The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: diclazuril, decoquinate and halofuginone. 4. 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 and skin protective equipment. 24 September 2034 Ornamental birds Point of lay 2,4 × 10 8 - 1,2 × 10 8 - ( 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.