- Publication date
- 2 December 2022 (Last updated on: 28 February 2023)
- Joint Research Centre
In the current application an authorisation is sought under Article 4 for a preparation of Lentilactobacillus buchneri BioCC 203 DSM 32650 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 as active substance viable cells of the non-genetically modified strain Lentilactobacillus buchneri BioCC 203 DSM 32650. The feed additive is to be marketed as a preparation with a minimum content of 1.0 x 1010 Colony Forming Unit (CFU) / g product. The feed additive, after water addition, is intended to be sprayed homogeneously directly on fresh forage. The Applicant proposed a minimum dosage of the active substance of 1.0 x 105 CFU / g fresh forage, corresponding to 1.0 g of product to be distributed on one ton of fresh forage.
For the enumeration of Lentilactobacillus buchneri BioCC 203 DSM 32650 in the feed additive and water the Applicant presented for official control the ring-trial validated spread plate (or pour plate) method EN 15787.
Based on the performance characteristics, as already concluded for similar Lactoplantibacilli reports, the EURL recommends for official control the ring-trial validated EN 15787 method for the enumeration of Lentilactobacillus buchneri BioCC 203 DSM 32650 in the feed additive and water.
Furthermore, for the identification of Lentilactobacillus buchneri BioCC 203 DSM 32650, the Applicant proposed Enterobacterial Repetitive Intergenic Consensus - Polymerase Chain Reactions (ERIC-PCR). In former reports for similar dossiers, the EURL recommended for official control DNA sequencing methods or Pulsed-Field Gel Electrophoresis (PFGE). The EURL considers that all the above-mentioned methodologies are fit-for-purpose for the bacterial identification of authorised additives at a strain level.
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.