Bacillus velezensis NITE BP-01844

In the current application an authorisation is sought under Article 4(1) for Bacillus amyloliquefaciens TOA5001 (NITE BP-01844)[1] under the category / functional group 4(b) 'zootechnical additives' / 'gut flora stabilisers', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and all minor avian species. According to the Applicant, the feed additive contains as active substance viable spores of the non-genetically modified strain Bacillus amyloliquefaciens TOA5001. The feed additive is to be marketed as a preparation (BA-KING®) containing a minimum content of active substance of 1 x 10⁸ Colony Forming Unit (CFU)/g. The feed additive is intended to be added directly in feedingstuffs or through premixtures at a minimum dose of 5 x 10⁷ CFU/kg complete feedingstuffs and in water for drinking at a minimum dose of 2.5 x 10⁷ CFU/L. For the identification of Bacillus amyloliquefaciens TOA5001, the EURL recommends for official control Pulsed Field Gel Electrophoresis (PFGE), a generally recognised methodology for genetic identification of bacterial strains. For the enumeration of Bacillus amyloliquefaciens TOA5001 in the feed additive, premixtures, feedingstuffs and water the EURL recommends for official control the ring-trial validated spread-plate method EN 15784. Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005), as last amended by Regulation (EU) 2015/1761) is not considered necessary.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2023/2736

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)

[1] New name: Bacillus velezensis NITE BP-01844