Biomin® C5

In the current application an authorisation is sought under Article 4 for Biomin® C5 under the category/functional group 4(b) "zootechnical additives"/"gut flora stabilisers", according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor avian species other than laying species.
According to the Applicant, the feed additive contains as active substances Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351. The feed additive is intended to be marketed in non-coated and coated formulations that have a total contain of viable cells of the microorganisms respectively of 1.0 x 1011 and 4.0 x 1010 Colony Forming Unit (CFU) / g product. The feed additive is intended to be used in complete feed (coated formulation) or in water for drinking (non-coated formulation). The Applicant proposed a minimum dosage of the product corresponding to 1.0 x 108 CFU / kg complete feed and 5.0 x 107 CFU / L water for drinking.
For the enumeration of Enterococcus faecium DSM 33761 in the feed additive, premixtures, compound feed and water the Applicant proposed for official control to apply the ring-trial validated method EN 15788. The standard, recently revised by CEN, describes a spread plate (or pour plate) method on bile esculin azide agar or, alternatively, on enterococcus selective medium Slanetz and Bartley agar. For the enumeration of Pediococcus acidilactici DSM 33758 in the feed additive, premixtures, compound feed and water the Applicant proposed for official control to apply the ring-trial validated method EN 15786. The standard, recently revised by CEN, describes a spread plate (or pour plate) method on MRS (de Man, Rogosa, Sharp) agar. For the enumeration of Bifidobacterium animalis DSM 16284 in the feed additive, premixtures, compound feed and water the Applicant proposed for official control to apply the ring-trial validated spread plate (or pour plate) method on MRS agar EN 15785. For the enumeration of Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351 in the feed additive, premixtures, compound feed and water the Applicant proposed for official control to apply the ring-trial validated method EN 15787. The standard, recently revised by CEN, describes a spread plate (or pour plate) method on MRS agar.
Based on the available performance characteristics, the EURL recommends for official control the ring-trial validated EN 15788, EN 15786, EN 15785 and EN 15787 methods for the enumeration of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751 and Ligilactobacillus salivarius DSM 16351, respectively, in the feed additive, premixtures, compound feed and water. For the taxonomic identification of the five bacterial strains contained in the product, the Applicant did not proposed any analytical method suitable for official control. However, 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 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.