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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)

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)

Implementing Regulation (EU) 2021/367 · Regulation · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Renewal of the authorisation

Article 1

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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

Article 2

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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.

Entry into force

Article 4

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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

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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

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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