Lactobacillus buchneri DSM 29026 - 1k20759

In the current application authorisation is sought under Article 4(1) for a preparation of Lactobacillus buchneri DSM 29026 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 in silage for all animal species. 

According to the Applicant, the feed additive contains as active substance viable spores of the non-genetically modified strain Lactobacillus buchneri DSM 29026. The feed additive is to be marketed as a powder preparation containing a minimum Lactobacillus buchneri DSM 29026 content of 2x10¹⁰ Colony Forming Unit (CFU)/g. The feed additive is intended to be added to silage at a minimum dose of 5x10⁵ CFU/g of fresh silage if used alone, or at a minimum dose of 5x10⁴ CFU/g of fresh silage if combined with other microorganisms. 

For the identification of Lactobacillus buchneri DSM 29026, the EURL recommends for official control Pulsed Field Gel Electrophoresis (PFGE), a generally recognised methodology for the genetic identification of bacterial strains. 

For the enumeration of Lactobacillus buchneri DSM 29026 in the feed additive, the Applicant submitted the ring-trial validated spread plate method EN 15787. Based on the performance characteristics available, the EURL recommends this method for official control.

The Applicant did not provide any experimental method or data for the quantification of Lactobacillus buchneri DSM 29026 in silage. Since the unambiguous enumeration of Lactobacillus buchneri DSM 29026 initially added to silage is not achievable by analysis. Therefore, the EURL cannot evaluate nor recommend any method for official control to quantify the active substance 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.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2021/343

Identification: Pulsed Field Gel Electrophoresis (PFGE)

Enumeration in the feed additive: Spread plate method on MRS agar (EN 15787)