Saccharomyces cerevisiae Y1242

In the current application an authorisation is sought under Article 4 (1) for Saccharomyces cerevisiae Y1242 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 cattles for fattening, cows for milk production, piglets (suckling and weaned), dairy sheeps, lambs for fattening, dairy goats, goats for fattening, horses and buffalo. The active substance of the feed additive is viable cells of Saccharomyces cerevisiae strain Y1242 with a minimum content of 2.0 x 10¹⁰ Colony Forming Unit (CFU) / g feed additive. The feed additive is intended to be used directly in compound feed or through premixtures. The Applicant proposed the following minimum doses of the active substance / additive in compound feed: 3 g / animal / day (for dairy cows and other dairy ruminants); 1.5 g / animal / day (for cattle for fattening, other growing ruminants, horses and other Equidae); and 0.5 g / kg compound feed (for piglets and other growing Suidae). For the identification of Saccharomyces cerevisiae Y1242, 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 the identification of probiotic yeast. This method was ring-trial validated and became the CEN technical specification CEN/TS 15790.
For the enumeration of Saccharomyces cerevisiae Y1242 in the feed additive, premixtures and compound feed the Applicant proposed the ring-trial validated EN 15789 method, which was recently revised by CEN resulting in 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 YGC agar, after logarithmic transformation of CFU values ranging from 7.13 to 7.48 log¹⁰ CFU/g: a standard deviation for repeatability (S_r) ranging from 0.17 to 0.36 log¹⁰ CFU/g and a standard deviation for reproducibility (S_R) 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 Y1242 in the feed additive, premixtures and compound feed. 

Note: The EN 15789 method is not applicable to mineral feeds containing at least 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.