Commission Implementing Regulation (EU) 2023/2734 of 7 December 2023 concerning the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, dairy ruminants and pigs (holder of authorisation: Mazzoleni S.p.A.)

• CELEX: Implementing Regulation (EU) 2023/2734
• Articles: 3

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘digestibility enhancers’ and ‘other zootechnical additives’, 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 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: digestibility enhancers

4d24

Mazzoleni S.p.A.

Saccharomyces cerevisiae DBVPG 48 SF

Additive composition

Preparation of Saccharomyces cerevisiae DBVPG 48 SF with a minimum concentration of:

1 × 10 9 CFU/g of additive.

Solid forms.

Characterisation of the active substance

Viable cells of Saccharomyces cerevisiae DBVPG 48 SF.

Analytical method

( 1 )

—

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

—

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

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 and skin protective equipment.

28 December 2033

Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d24

Mazzoleni S.p.A.

Saccharomyces cerevisiae DBVPG 48 SF

Additive composition

Preparation of Saccharomyces cerevisiae DBVPG 48 SF with a minimum concentration of:

1 × 10 9 CFU/g of additive.

Solid forms.

Characterisation of the active substance

Viable cells of Saccharomyces cerevisiae DBVPG 48 SF.

Analytical method

( 1 )

—

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

—

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

Dairy cows

All minor dairy ruminants

-

4 × 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 and skin protective equipment.

28 December 2033

Pigs for fattening

Piglets (suckling and weaned)

Minor porcine species (suckling piglets, weaned piglets and pigs for fattening)

4 × 10 9

Sows for reproduction

Minor porcine species (sows for reproduction)

6 × 10 9

( 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