- 16 Mai 2022 (Viimati ajakohastatud: 8 juuli 2022)
- Teadusuuringute Ühiskeskus
In the current application an authorisation is sought under Article 4 for a preparation of Lactiplantibacillus plantarum DSM 11520 under the category / functional group 1(j) 'technological additives' / 'acidity regulators' and 1(o) 'other technological additives' / 'starter cultures', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for horses, dogs, cats and non-food producing rabbits (pets).
According to the Applicant, the feed additive contains as active substance viable cells of the non-genetically modified strain Lactiplantibacillus plantarum DSM 11520. The feed additive is to be marketed as a preparation with a minimum content of 1.33x1010 Colony Forming Unit (CFU) / g product. The product is intended to be added to feed materials of plant origin with high moisture content, including liquid feedingstuffs, with a minimum proposed dose of the active substance of 8.0x1010 CFU / kg feed material.
For the enumeration of Lactiplantibacillus plantarum DSM 11520 in the feed additive and feedingstuffs 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 Lactiplantibacillus plantarum DSM 11520 in the feed additive and feedingstuffs.
Furthermore, for the identification of Lactiplantibacillus plantarum DSM 11520, the EURL recommends for official control (i) DNA sequencing methods such as Whole Genome Sequencing (WGS) or (ii) Pulsed-Field Gel Electrophoresis (PFGE). The EURL considers that both 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.