Saccharomyces cerevisiae DBVPG 48 SF

Executive Summary

In the current application an authorisation is sought under Article 4(1) for Saccharomyces cerevisiae DBVPG 48SF under the category / functional group 4(a, d) 'zootechnical additives' / 'digestability enhancers', 'other zootechnical additives', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for the use of the feed additive for sows, piglets, pigs for fattening and minor growing and reproductive porcine species, dairy ruminants, ruminants for fattening, other minor growing and reproductive ruminants and horses.
The feed additive is intended to be marketed under 3 different forms such as powder (BioCell® P), microspheres (BioCell® S12) and micropellets (BioCell® M16). The active substance of the feed additive are viable cells of Saccharomyces cerevisiae strain DBVPG 48 SF with a minimum content of 1.0x109, 1.2x1010 and 1.6x1010 Colony Forming Unit (CFU) / g products, respectively.
The feed additive is intended to be used in feedingstuffs and premixtures. The Applicant proposed the minimum doses of the active substance in feedingstuffs ranging from 4.0x108 CFU/kg to 6.0x109 CFU/kg, depending on the animal species.
For the identification of Saccharomyces cerevisiae DBVPG 48SF, the Applicant applied whole genome sequencing (WGS). However, the EURL recommends for oficial 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.
For the enumeration of Saccharomyces cerevisiae DBVPG 48SF in the feed additive, premixtures and feedingstuffs the Applicant submitted the ring-trial validated EN 15789 method for the enumeration of yeast probiotic strains, which was recently revised by CEN resulting in an updated 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 3x105 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 DBVPG 48SF in feed additive, premixtures and feedingstuffs.

Note: The EN 15789 method is not applicable to mineral feeds containing at least of 40 % (w/w) of crude ash. For these matrices laboratories may consider the validated 28.2.6.VDLUFA method.
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.