SCHEDULE 5Renewal of authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 (formerly Saccharomyces cerevisiae NCYC Sc 47) (identification number 4b1702) as a feed additive for calves for rearing

Regulation 3(1)

The preparation specified in the table, 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 set out in the table15.

Additive

Saccharomyces cerevisiae CNCM I-4407

Identification number of the additive

4b1702

Authorisation holder

S.I. Lesaffre

Additive category

Zootechnical additives

Functional group

Gut flora stabilisers

Additive composition

Solid form preparation of Saccharomyces cerevisiae CNCM I-4407 containing a minimum of 5x109 CFU/g

Characterisation of the active substance(s)

Viable dried cells Saccharomyces cerevisiae CNCM I-4407

Analytical methods(1)

For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed:

  • Pour plate method using CGYE (chloramphenicol, glucose, yeast extract) agar (BS EN 15789:2021(2)).

For identification of yeast strain:

  • Polymerase chain reaction (PCR) method (DD CEN/TS 15790:2008(3)).

Species or category of animal

Calves for rearing

Maximum age

None

Minimum content(4)

1.5 x 109 CFU/kg

Maximum content(4)

None

Other provisions

In the directions of use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

(1)

Details of the analytical methods set out in the document referenced “JRC.DG.D.6/CvH/DM/mds/ARES(2010)967257” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0038.

(2)

Under reference BS EN 15789:2021 “Animal feeding stuffs: Methods of sampling and analysis. Detection and enumeration of Saccharomyces cerevisiae used as feed additive”. Published by the British Standards Institution on 30 November 2021 (ISBN 978 0 580 99832 4). Available from the British Standards Institution https://knowledge.bsigroup.com.

(3)

Under reference DD CEN/TS 15790:2008 “Animal Feeding Stuffs – PCR typing of probiotic strains of Sacccharomyces cerevisiae (yeast)”. Published by British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2). Available from the British Standards Institution https://knowledge.bsigroup.com.

(4)

Content of Saccharomyces cerevisiae CNCM I-4407 in CFU/kg of complete feed with a moisture content of 12%.