Preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856

In the current application an authorisation is sought under Article 4(1) for a preparation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 under the category / functional group 1(k) 'technological additives' / 'silage additives', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for all animal species. According to the Applicant, the feed additive contains Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as an active substance at a minimum amount of 7.20 x 10¹⁰ and 2.88 x 10¹¹ Colony Forming Unit (CFU) / g feed additive, respectively. The feed additive is intended to be added to the forage, used for ensiling process at a recommended dosage of 1 x 10⁵ CFU / g fresh silage. For the identification of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 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 33862 and Lentilactobacillus buchneri DSM 12856 in the feed additive, the EURL recommends for official control the ring-trial validated CEN methods (EN 15784 and EN 15787), respectively. As the unambiguous determination of Bacillus subtilis DSM 33862 or Lentilactobacillus buchneri DSM 12856 added to silage is not achievable by analysis, the EURL cannot evaluate nor recommend the two above mentioned CEN methods, or any other methods for official control to enumerate Bacillus subtilis DSM 33862 or Lentilactobacillus buchneri DSM 12856 in silage. 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.