The Feed Additives (Authorisations) (Scotland) Regulations 2022

Regulation 3(2)

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

Authorisation

1.  The preparation specified in the table in this schedule, 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 table in this schedule(1).

Table

Column 1		Column 2
Additive		Saccharomyces cerevisiae CNCM I-4407 (ACTISAF® Sc 47)
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(2)		1. For enumeration (colony count):
		Pour plate method using CGYE (yeast extract glucose chloramphenicol) agar in accordance with European standard EN 15789:2021 entitled “ Animal feeding stuffs: Methods of sampling and analysis – Detection and enumeration of Saccharomyces cerevisiae used as feed additive”(3)
		2. For identification of yeast strain:
		Polymerase chain reaction (PCR) method in accordance with DD CEN/TS 15790:2008 entitled “Animal Feeding Stuffs – PCR typing of probiotic strains of Sacccharomyces cerevisiae (yeast)”(4)
Species or category of animal		Calves for rearing
Maximum age		Not applicable
Content of Saccharomyces cerevisiae CNCM I-4407 in CFU/kg of complete feed with a moisture content of 12%	Minimum content	1.5 x 109 CFU/kg
	Maximum content	No maximum
Other provisions		In the directions of use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

(1)

This authorisation is a renewal of the authorisation granted under Commission Regulation (EU) No. 883/2010. That Regulation is revoked by regulation 11 of these Regulations, subject to the transitional provision in regulation 8.

(2)

Details of the analytical methods are set out in the document referenced “JRC.DG.D.6/CvH/DM/mds/ARES(2010)967257” and last updated on 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.

(3)

This standard was approved by the European Committee for Standardization (CEN) on 2 August 2021.

(4)

DD CEN/TS 15790:2008, published by the British Standards Institution on 31 January 2009 (ISBN 978 0 580 61806 2).