Saccharomyces cerevisiae CNCM I- 4407 - 4b1702

In the current application authorisation is sought under Article 10 (2) for Actisaf Sc 47 under the category / functional group 4(b) 'zootechnical additives' / 'gut flora stabilisers', according to Annex I of Regulation (EC) No 1831/2003. Authorisation is sought for the use of the feed additive for weaned piglets, sows, dairy cows and cattle for fattening. 

According to the Applicant, the feed additive contains as active substance viable cells of the non-genetically modified strain Saccharomyces cerevisiae NCYC Sc 47. The feed additive is marketed in powder form containing a minimum Saccharomyces cerevisiae NCYC Sc 47 concentration of 5x10⁹ Colony Forming Unit (CFU)/g. The feed additive is to be used directly in feedingstuffs or through premixtures at minimum doses ranging from 4x10⁸ to 5x10⁹ CFU/kg complete feedingstuffs, depending on the animal species of concern. 

For the identification of Saccharomyces cerevisiae NCYC Sc 47, the EURL recommends for official control Polymerase Chain Reaction (PCR), a generally recognised standard methodology for genetic identification of yeasts. 

For the enumeration of Saccharomyces cerevisiae NCYC Sc 47 in feed additive, premixtures and feedingstuffs, the Applicant submitted the ring-trial validated pour plate method EN 15789. Based on the performance characteristics available, the EURL recommends this method for official control. 

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) is not considered necessary.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2020/147

Enumeration: 

- pour plate method using chloramphenicol dextrose yeast extract agar (EN 15789:2009) 

Identification: 

- polymerase chain reaction (PCR) method CEN/TS 15790:2008