Preparation of Bacillus velezensis (amyloliquefaciens) NRRL B-67647, Bacillus pumilus NRRL B-67648, Bacillus licheniformis NRRL B-67649 (Microsaf®)

In the current application an authorisation is sought under Article 4(1) for the preparation of Bacillus velezensis (amyloliquefaciens) NRRL B-67647, Bacillus pumilus NRRL B-67648, Bacillus licheniformis NRRL B-67649 (Microsaf®) under the category / functional groups 4(b, d) 'zootechnical additives' / 'gut flora stabilisers', '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 chickens for fattening, and other poultry for fattening (e.g. turkeys, ducks, geese, pheasants, quail, guinea fowl, ostrich) and ornamental birds.
According to the Applicant, the feed additive contains as active substances the non-genetically modified Bacillus velezensis (amyloliquefaciens) NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649.
The feed additive is to be marketed as two powder formulations containing a minimum total content of the active substances of 2.0 x 108 and of 5.0 x 109 Colony Forming Unit (CFU) / g, respectively. The feed additive is intended to be used in premixtures and feedingstuffs at a minimum dose of 3.0 x 107 CFU / kg complete feedingstuffs.
For the identification of Bacillus velezensis (amyloliquefaciens) NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 at a strain level, the EURL recommends for official control DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE).
For the enumeration of total Bacilli spp. (Bacillus velezensis (amyloliquefaciens) NRRL B-67647, Bacillus pumilus NRRL B-67648 and Bacillus licheniformis NRRL B-67649 in the feed additive, premixtures and feedingstuffs, 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.