Commission Implementing Regulation (EU) 2025/154 of 29 January 2025 concerning the authorisation of a preparation of Saccharomyces cerevisiae DSM 34246 as a feed additive for dogs and cats (holder of authorisation: ACEL pharma s.r.l.)

• CELEX: Implementing Regulation (EU) 2025/154
• Articles: 3

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 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 feed 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

4b1873

ACEL pharma S.r.l.

Saccharomyces cerevisiae DSM 34246

Additive composition

Preparation of Saccharomyces cerevisiae DSM 34246

containing a minimum of 2 × 10 10 CFU/g

Solid form.

Characterisation of the active substance

Viable cells of Saccharomyces cerevisiae DSM 34246

Analytical method

( 1 )

Enumeration in the feed additive and compound feed: Pour or spread plate method (EN 15789)

Identification: Polymerase Chain Reaction (PCR) – CEN / TS 15790

Dogs and cats

—

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 their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.

19 February 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 .