Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

In the current application authorisation is sought under Article 4(1) for a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM32325 and Bacillus amyloliquefaciens DSM25840 (GalliPro® Fit) under the category / functional group 4(b) 'zootechnical additives' / 'gut flora stabilisers', according to Annex I of Regulation (EC) No 1831/2003. 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 other growing poultry species. 

According to the Applicant, the feed additive contains as active substances viable spores of non-genetically modified strains Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840. The feed additive is to be marketed as a powder containing a minimum content of total active substances of 3.2x10⁹ Colony Forming Unit (CFU)/g. The feed additive is intended to be used directly in feedingstuffs or through premixtures at a minimum dose of 8x10⁸ CFU/kg complete feedingstuffs and in drinking water at a minimum dose of 2.7x10⁸ CFU/L. 

For the identification of Bacillus subtilis DSM 32324, Bacillus subtilis DSM32325 and Bacillus amyloliquefaciens DSM25840, 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 the overall Bacillus spp. (DSM 32324, DSM 32325 and DSM 25840) in the feed additive, premixtures, feedingstuffs and drinking water the Applicant submitted the ring-trial validated spread plate CEN method EN 15784. Based on the performance characteristics available, the EURL recommends this method for official control for the enumeration of the overall Bacillus spp. (DSM 32324, DSM 32325 and DSM 25840) in the feed additive, premixtures, feedingstuffs and water. 

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) 2020/1762

Enumeration in the feed additive, premixtures, feedingstuffs and water: 

• Spread plate method on tryptone soya agar (EN 15784)

Identification:

• Pulsed Field Gel Electrophoresis (PFGE) method