Lactobacillus reuteri NBF-1 (DSM 32203) - 4b1850

In the current application authorisation is sought under Article 4(1) for Lactobacillus reuteri NBF-1 (DSM 32203) under the category / functional group 4(b) 'zootechnical additives' / 'gut flora stabilisers', according to Annex I of Regulation (EC) No 1831/2003. Authorisation is sought for the use of the feed additive for dogs. 

According to the Applicant, the feed additive contains as active substance viable cells of the strain Lactobacillus reuteri NBF-1 (DSM 32203). The feed additive is to be marketed as a lyophilised powder containing a minimum Lactobacillus reuteri NBF-1 (DSM 32203) content of 1011 Colony Forming Unit (CFU)/g. The feed additive is intended to be administered as complementary feedingstuffs with a maximum content of 6x1010 CFU/kg or to be mixed with usual feed. 

For the identification of Lactobacillus reuteri NBF-1 (DSM 32203) the Applicant applied 16S rRNA gene sequence analysis and random amplified polymorphic DNA analysis. The EURL recommends instead for official control Pulsed Field Gel Electrophoresis (PFGE), a generally recognised methodology for genetic identification of bacterial strains. 

For the enumeration of Lactobacillus reuteri NBF-1 (DSM 32203) in the feed additive and feedingstuffs, 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. 

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) 2023/256

Identification: 

DNA sequencing methods or pulsed Field Gel Electrophoresis (PFGE)

Enumeration in feed additive and compound feed: 

spread plate method on MRS agar (EN 15787)