
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 18 December 2008.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX


Identification number of the additive Name of the holder of authorisation Additive(trade name) Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation
CFU/kg of complete feedingstuff with a moisture content of 12 %
Category of zootechnical additives. Functional group: gut flora stabilisers
‘4b1711 LALLEMAND SAS Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20, Levucell SC10 ME) 
 Additive composition:
 Solid form:
Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 2 × 1010 CFU/g.
 Coated form:
Preparation of Saccharomyces cerevisiae CNCM I-1077 of viable dried cells with a guaranteed minimal concentration of 1 × 1010 CFU/g
 Characterisation of the active substance:
Saccharomyces cerevisiae CNCM I-1077: 80 % of viable dried cells and 14 % of not viable cells.
 Analytical method:
Pour plate method and molecular identification (PCR). Lambs — 3,0 × 109 7,3 × 109 
1. In the directions for use of the additive and premixtures, indicate the storage temperature, storage life, and stability to pelleting.

2. In complementary feedingstuffs, do not exceed 50 °C with Levucell SC20 and 80 °C with Levucell SC10ME.

3. Coated form, only for inclusion through a pelleted feed.

4. Recommended dose: 7,3 × 109 CFU/kg of complete feedingstuff.

5. If the product is handled or mixed in confined atmosphere, it is recommended to use safety glasses and masks for mixing if the mixers are not equipped with exhaust systems.
 8.1.2019

