Commission Implementing Regulation (EU) 2024/1200 of 18 April 2024 concerning the renewal of the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying or breeding, the authorisation of that preparation as a feed additive for use in feed and in water for drinking for chickens reared for breeding, turkeys for fattening and turkeys reared for breeding (holder of authorisation: Biomin GmbH) and repealing Implementing Regulations (EU) No 544/2013 and (EU) 2015/1105

• CELEX: Implementing Regulation (EU) 2024/1200
• Articles: 6

Article 1 Renewal of the authorisation

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, for use in feed and water for drinking for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying or breeding, is renewed subject to the conditions laid down in that Annex.

Article 2 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised for use in feed and water for chickens reared for breeding, turkeys for fattening and turkeys reared for breeding, subject to the conditions laid down in that Annex.

Article 3 Repeals

Implementing Regulations (EU) No 544/2013 and (EU) 2015/1105 are repealed.

Article 4 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that preparation, which are intended for use in feed and water for drinking for chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying or breeding, and which are produced and labelled before 12 November 2024 in accordance with the rules applicable before 12 May 2024 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 chickens for fattening, chickens reared for laying and minor poultry species for fattening and reared for laying or breeding, and which are produced and labelled before 12 May 2025 in accordance with the rules applicable before 12 May 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 5 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

Minimum content

Maximum content

Other provisions

End of period of authorisation

CFU/kg of complete feedingstuff with a moisture content of 12%

CFU/l of water for drinking

Category: zootechnical additives. Functional group: gut flora stabilisers

4b1890

Biomin GmbH

Bifidobacterium animalis ssp. animalis DSM 16284 , Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913

Additive composition

Preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913 containing a minimum of 10 × 10 9 CFU/g additive

(3:1:6 ratio)

Solid form

Characterisation of the active substance

Viable cells of Bifidobacterium animalis ssp. animalis DSM 16284, Ligilactobacillus salivarius DSM 16351 and Enterococcus faecium DSM 21913

Analytical method

( 1 )

Identification: DNA sequencing methods or Pulsed Field Gel Electrophoresis (PFGE) - CEN/TS 17697.

Enumeration in the feed additive, premixtures, compound feed and water of:

—

Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785

—

Ligilactobacillus salivarius DSM 16351: spread plate method EN 15787

—

Enterococcus faecium DSM 21913: spread plate method EN 15788

All poultry species for fattening

All poultry species reared for laying

All poultry species reared for breeding

-

1 × 10 8

-

5 × 10 7

-

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

The additive may be used via water for drinking.

3.

The additive may be used simultaneously with the following coccidiostats, in accordance with their respective conditions of authorisation as feed additives: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin, a combination of narasin with nicarbazin.

4.

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.

12.5.2034

( 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 .