Bacillus subtilis DSM 34755

In the current application an authorisation is sought under Article 4(1) for a preparation of Bacillus subtilis DSM 34755 under the category / functional group 4(d) 'zootechnical additives' / other zootechnical additives', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for all aquatic species.
According to the Applicant, the feed additive contains viable spores of Bacillus subtilis DSM 34755 as active substance at a minimum amount of 10⁹ Colony Forming Unit (CFU) / g feed additive.
The feed additive is intended to be added to compound feed at a minimum dose of 1.0 x 10⁹ CFU/ kg compound feed.
For the identification of Bacillus subtilis DSM 34755 at a strain level, the EURL recommends for official control DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) (CEN/TS 17697).
For the enumeration of Bacillus subtilis DSM 34755 in the feed additive, premixtures and compound feed the EURL recommends for official control the ring-trial validated CEN 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.