Commission Implementing Regulation (EU) 2021/367 of 1 March 2021 concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for calves for rearing and repealing Regulation (EU) No 883/2010 (holder of authorisation S.I. Lesaffre) (Text with EEA relevance)
Renewal of the authorisation
The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.
Transitional period
1. The additive specified in the Annex and premixtures containing it, which are produced and labelled before 22 September 2021 in accordance with the rules applicable before 22 March 2021 may continue to be placed on the market and used until the existing stocks are exhausted.
2. Compound feed and feed materials containing the additive specified in the Annex which are produced and labelled before 22 March 2022 in accordance with the rules applicable before 22 March 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
Repeal
Regulation (EU) No 883/2010 is repealed.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
Identification number of the additive
Name of the holder of authorisation
Additive
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
4b1702
S.I. Lesaffre
Saccharomyces cerevisiae CNCM I-4407
Additive composition
Preparation of Saccharomyces cerevisiae CNCM I-4407 containing a minimum of 5 × 10 9 CFU/g
Solid form
Calves for rearing
-
1,5 × 10 9
-
1.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
2.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.
22.3.2031
Characterisation of the active substance
Viable dried cells of Saccharomyces cerevisiae CNCM I-4407
Analytical method
( 1 )
Enumeration: pour plate method
using chloramphenicol dextrose
yeast extract agar EN 15789
Identification: polymerase chain reaction (PCR) method CEN/TS
15790.
( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.