Weizmannia faecalis DSM 32016

In the current application authorisation is sought under Article 4(1) for Bacillus coagulans DSM 32016¹ 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 piglets (suckling and weaned), other growing Suidae, chickens for fattening, other poultry for fattening and ornamental birds.

According to the Applicant, the feed additive contains viable spores of the non-genetically modified strain Bacillus coagulans DSM 32016 as an active substance. The feed additive is to be marketed as a powder (under the trade name - TechnoSpore®) containing a minimum content of the active substance of 2x10¹⁰ Colony Forming Unit (CFU)/g TechnoSpore®. The feed additive is intended to be used in feedingstuffs and premixtures at a minimum dose of 1x10⁹ CFU/kg complete feedingstuffs.

For the identification of Bacillus coagulans DSM 32016, the EURL recommends for the official control Pulsed Field Gel Electrophoresis (PFGE), a generally recognised methodology for the genetic identification of bacterial strains. 

For the enumeration of Bacillus coagulans DSM 32016 in the feed additive, premixtures and feedingstuffs the Applicant submitted the slightly modified method based on ring-trial validated spread plate method EN 15787, where Tween® 80 is added at 1 % in buffer and diluent in the case of all matrices and where the final dilution is heated. Based on the performance characteristics and experimental data available, the EURL recommends the modified method EN 15787 for the official control for the enumeration of Bacillus coagulans DSM 32016 in the feed additive, premixtures and feedingstuffs.

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.

¹ New name: Weizmannia faecalis DSM 32016

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2024/1054

Identification: 

• DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) – CEN/TS 17697

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

• Spread plate method on MRS agar (based on EN 15787 method)