Saccharomyces cerevisiae DSM34246

In the current application an authorisation is sought under Article 4 for Saccharomyces cerevisiae DSM34246 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 pets and other non-food producing animals (cats and dogs). According to the Applicant, the feed additive contains as active substance viable cells of a not genetically modified Saccharomyces cerevisiae DSM34246 with a minimum content of 2 x 1010 Colony Forming Unit (CFU) / g product. The feed additive is proposed to be directly included in the compound feed with a minimum level of inclusion corresponding to 5 x 109 CFU / kg. For the enumeration of Saccharomyces cerevisiae DSM34246 in the feed additive, and compound feed the Applicant proposed the recently revised ring-trial validated EN 15789 method dedicated for the enumeration of Saccharomyces cerevisiae in feed additives, premixtures and compound feed (with exclusion of mineral feed) containing Saccharomyces cerevisiae as a single microorganism or in a mixture with other microorganisms. The following performance characteristics are reported in the frame of the ring-trial validation studies when using pour plate method with yeast extract dextrose chloramphenicol (YGC) agar after logarithmic transformation of CFU values ranging from 7.13 to 7.48 log10 CFU / g: a standard deviation for repeatability (Sr) ranging from 0.17 to 0.36 log10 CFU / g and a standard deviation for reproducibility (SR) ranging from 0.55 to 0.60 log10 CFU / g. In addition, a limit of quantification (LOQ) of 3 x 105 CFU / kg can be derived using the
considerations of EN ISO 7218 standard. Based on the performance characteristics available, the EURL recommends for official control the ring-trial validated EN 15789 method for the enumeration of Saccharomyces cerevisiae DSM34246 in the feed additive and compound feed. For the identification of Saccharomyces cerevisiae DSM34246, the Applicant applied whole genome sequencing (WGS). However, the EURL recommends for official control the polymerase chain reaction (PCR) amplification method, a generally recognised methodology for microbial identification. This method was ring-trial validated and became the CEN
technical specification CEN/TS 15790. 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.