Details
- Publication date
- 22 May 2024 (Last updated on: 6 February 2025)
- Author
- Joint Research Centre
Description
In the current application an authorisation is sought under Article 4(1) for a preparation of Bacillus velezensis ATCC PTA-6737, Bacillus velezensis ATCC PTA-127114 and Bacillus licheniformis ATCC-127113 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 all growing avian species. According to the Applicant, the feed additive contains Bacillus velezensis ATCC PTA-6737, Bacillus velezensis ATCC PTA-127114 and Bacillus licheniformis ATCC-127113 as active substances at a minimum total content of 1.0 x 1011 Colony Forming Unit (CFU) / g feed additive. The feed additive is intended to be added to compound feed through premixtures at a minimum recommended dosage of the total content of the actives substances of 3.0 x 108 CFU / kg compound feed. For the identification of Bacillus velezensis ATCC PTA-6737, Bacillus velezensis ATCC PTA-127114 and Bacillus licheniformis ATCC-127113 at strain level, the EURL recommends for official control DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) (CEN/TS 17697). For the enumeration of total content of Bacillus velezensis ATCC PTA-6737, Bacillus velezensis ATCC PTA-127114 and Bacillus licheniformis ATCC-127113 in the feed additive, premixtures and compound feed, 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.