Commission Implementing Regulation (EU) 2025/1426 of 17 July 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for ruminants (other than lambs) and camelids reared for milk production or reared for reproduction, young ruminants for fattening other than calves and lambs, camelid calves for fattening, and Equidae other than horses (holder of authorisation: Lallemand SAS) and amending Implementing Regulation (EU) 2020/149 as regards the terms of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for lambs

• CELEX: Implementing Regulation (EU) 2025/1426
• Articles: 5

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘digestibility enhancers’ and ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Amendment to Implementing Regulation (EU) 2020/149

In the Annex to Implementing Regulation (EU) 2020/149 in the column ‘minimum content’ regarding lambs the value is replaced by ‘1 × 10 9 ’.

Article 3 Transitional measures

1.   The feed additive Saccharomyces cerevisiae CNCM I-1077, as authorised by Implementing Regulation (EU) 2020/149 and premixtures containing that additive, which are intended for lambs, and which are produced and labelled before 7 February 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted.

2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are intended for lambs, and which are produced and labelled before 7 August 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned 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: zootechnical additives. Functional group: gut flora stabilisers

4b1711

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 cells of Saccharomyces cerevisiae CNCM I-1077

Analytical method

( 1 )

Enumeration in the feed additive, premixtures and compound feed: pour or spread plate method using chloramphenicol dextrose yeast extract agar (EN 15789)

Identification: polymerase chain reaction (PCR) method (CEN/TS 15790)

Ruminants (other than lambs) and camelids reared for milk production or reared for reproduction

-

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 breathing, eye (only for the coated formulation) and skin protective equipment.

7 August 2035

Young  ( 2 )

ruminants for fattening other than calves and lambs

Camelid calves for fattening

1 × 10 9

Category: zootechnical additives. Functional group: digestibility enhancers

4b1711

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 cells of Saccharomyces cerevisiae CNCM I-1077

Analytical method

( 1 )

Enumeration in the feed additive, premixtures and compound feed: pour or spread plate method using chloramphenicol dextrose

yeast extract agar (EN 15789)

Identification: polymerase chain reaction (PCR) method (CEN/TS 15790)

Equidae other than horses

-

3 × 10 9

-

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 breathing, eye (only for the coated formulation) and skin protective equipment.

7 August 2035

( 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 .

( 2 )   Animals at the similar developmental stage as ‘calves’.