Preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 (Bovacillus)

In the current application an authorisation is sought under Article 4(1) for a preparation of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 (BovacillusTM) 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 in compound feed and water for all dairy ruminants.
According to the Applicant, the feed additive contains as active substances viable spores of non-genetically modified strains of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903.
The feed additive is to be marketed as two solid formulations having a minimum total content of both microorganisms of 3.2 x 1010 Colony Forming Unit (CFU)/g. The feed additive is intended to be used directly in compound feed or into water at a minimum dose of 3.2 x 1010 CFU / kg and 7.4 x 107 CFU / L, respectively.
For the identification of Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903 at strain level, the EURL recommends for official control DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) described in CEN Technical Specification (CEN/TS 17697).
For the enumeration of total Bacilli spp. (Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903) in the feed additive, compound feed and water, the EURL recommends for official control the ring-trial validated EN 15784 method.
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.