Lentilactobacillus buchneri BioCC 228 DSM 32651

In the current application an authorisation is sought under Article 4(1) for Lentilactobacillus buchneri BioCC 228 DSM 32651 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 the non-genetically modified Lentilactobacillus buchneri BioCC 228 DSM 32651 as an active substance at a minimum concentration of 1 x 1011 Colony Forming Unit (CFU) / g. 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 Lentilactobacillus buchneri BioCC 228 DSM 32651, the Applicant proposed Enterobacterial Repetitive Intergenic Consensus - Polymerase Chain Reactions (ERIC-PCR) and Pulsed-Field Gel Electrophoresis (PFGE). In former reports for similar dossiers, the EURL recommended for official control DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE) described in CEN Technical Specification (CEN/TS 17697). The EURL considers that all the above-mentioned methodologies are suitable for official control for the bacterial identification of Lentilactobacillus buchneri BioCC 228 DSM 32651 at strain level. For the enumeration of Lentilactobacillus buchneri BioCC 228 DSM 32651 in the feed additive the Applicant proposed the ring-trial validated EN 15787 method. Based on the available information, the EURL recommends for official control the ring-trial validated EN 15787 method for the enumeration of Lentilactobacillus buchneri BioCC 228 DSM 32651 in the feed additive.
As the unambiguous determination of Lentilactobacillus buchneri BioCC 228 DSM 32651 added to silage is not achievable by analysis, the EURL cannot evaluate nor recommend any method for official control. 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.