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)

• CELEX: Implementing Regulation (EU) 2021/367
• Articles: 5

Article 1 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.

Article 2 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.

Article 3 Repeal

Regulation (EU) No 883/2010 is repealed.

Article 4 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.

Schedules & Appendices

ANNEX

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