Commission Implementing Regulation (EU) 2023/1170 of 15 June 2023 concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for dairy cows, cattle for fattening, minor ruminant species for fattening and camelids for fattening (holder of the authorisation: Danstar Ferment AG represented by Lallemand SAS) and repealing Regulation (EC) No 1200/2005 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1170
• Articles: 5

Article 1 Authorisation

The preparation specified in the Annex, 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 laid down in that Annex.

Article 2 Repeal of Regulation (EC) No 1200/2005

Regulation (EC) No 1200/2005 is repealed.

Article 3 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that substance, which are intended for dairy cows and cattle for fattening and are produced and labelled before 6 January 2024 in accordance with the rules applicable before 6 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparation specified in the Annex, which are intended for dairy cows and cattle for fattening and are produced and labelled before 6 July 2024 in accordance with the rules applicable before 6 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

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 groups: gut flora stabilisers

4b1711

Danstar Ferment AG represented by Lallemand SAS

Saccharomyces cerevisiae CNCM I-1077

Additive composition

Preparation of Saccharomyces cerevisiae CNCM I-1077 with a minimum concentration of:

—

1 × 10 10 CFU/g of additive (coated form);

—

2 × 10 10 CFU/g of additive (not-coated form).

Characterisation of the active substance

Viable dried cells of Saccharomyces cerevisiae CNCM I-1077

Analytical method

( 1 )

Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789) Identification: polymerase chain re action (PCR) method CEN/TS 15790

Cattle for fattening

All minor ruminant species for fattening

Camelids for fattening

-

5 × 10 8

-

1.

In the directions for use of the additive and premixture, 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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal eye protective equipment.

6 July 2033

Dairy cows

4 × 10 8

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en