FAD-2009-0028 — Saccharomyces Cerevisiae MUCL39885

Details

Identification: 4b1710
Publication date: 3 February 2010 (Last updated on: 16 October 2025)

Description

In the current application a re-evaluation of an authorised additive (Article 10(2)) is sought for the microbial feed additive Saccharomyces cerevisiae MUCL 39885 under the category 'zootechnical additives', functional group 'gut flora stabilizers' according to Annex I of Regulation (EC) No 1831/2003. Specifically, authorization is sought for the use of Saccharomyces cerevisiae MUCL 39885 for piglets (weaned). The feed additive is intended to be mixed at a minimum dose of 3x10⁹CFU/kg of feedingstuffs.

For the enumeration of the yeast probiotic strain Saccharomyces cerevisiae MUCL 39885 in feed additive, premixtures and feedingstuffs, the applicant proposes the ring-trial validated CEN method -EN 15789:2009. This pour plate method was ring-trial validated using feed samples containing 10⁹ to 10¹³ CFU Saccharomyces cerevisiae /kg.

The performance characteristics of the CEN method using CGYE (yeast extract glucose chloramphenicol) agar - reported after logarithmic transformation (CFU) - are:

- a repeatability standard deviation (s_r) ranging from 0.17 to 0.36 log₁₀CFU/g,

- - a reproducibility standard deviation (s_R) ranging from 0.55 to 0.60 log₁₀CFU/g, and,

- a limit of detection (LOD) of 1x10⁵CFU/kg, well below the minimum dose proposed by the applicant.

Based on these acceptable performance characteristics, the CRL recommends for official control the CEN method EN 15789:2009 for the determination of the Saccharomyces cerevisiae MUCL 39885 in feed additive, premixtures and feedingstuffs.

Molecular methods were used by the applicant for strain identification. The CRL recommends for official control PCR typing, a generally recognised standard methodology for microbial identification, for the yeast Saccharomyces cerevisiae strain.

Further testing or validation is not considered necessary.