Details
- Publication date
- 12 February 2020 (Last updated on: 4 May 2020)
Description
In the current application authorisation is sought under Article 4(1) for a preparation of Lactobacillus parafarraginis DSM 32962 under the category / functional group 1(k) 'technological additives' / 'silage additives', according to Annex I of Regulation (EC) No 1831/2003. Authorisation is sought for the use of the feed additive for all animal species and categories.
According to the Applicant, the active substance in the feed additive consists of viable cells of the non-genetically modified strain Lactobacillus parafarraginis DSM 32962. The feed additive is to be marketed as a powder preparation containing a minimum Lactobacillus parafarraginis DSM 32962 content of 5×1011 Colony Forming Unit (CFU)/g. The feed additive is intended to be added to silage at a minimum dose of 1x105 CFU/kg fresh silage.
For the enumeration of Lactobacillus parafarraginis DSM 32962 in the feed additive and silage, the Applicant submitted the ring-trial validated spread plate method EN 15787 (Animal feeding stuffs, Isolation and enumeration of Lactobacillus spp) which was already evaluated by EURL in the frame of previous Lactobacillus spp. dossiers. Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated EN 15787 method for the enumeration of Lactobacillus parafarraginis DSM 32962 in the feed additive.
Since the unambiguous determination of the content of Lactobacillus parafarraginis DSM 32962 initially added to silage is not achievable by analysis, the EURL cannot evaluate nor recommend any method for official control to determine the feed additive in silage.
For the identification of Lactobacillus parafarraginis DSM 32962, the EURL recommends for official control Pulsed Field Gel Electrophoresis (PFGE), a generally recognised methodology for genetic identification of bacterial strains.
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.
Recommended Method
as of:
- Commission Implementing Regulation (EU) 2021/346
Identification: Pulsed Field Gel Electrophoresis (PFGE)
Enumeration in the feed additive: Spread plate method on MRS agar (EN 15787)