
Article 1 
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 
The Annex to Regulation (EU) No 544/2013 is amended as follows:

((1)) In the eighth column, ‘Maximum content’, the text ‘1 × 109’ is deleted.
((2)) In the ninth column, ‘Other provisions’, paragraph 2 is replaced by the following:
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2. The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.
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Article 3 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 8 July 2015.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

PART A

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 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 of zootechnical additives. Functional group: gut flora stabilisers.
4b1890 Biomin GmbH Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 
Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive

Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive

Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive

Solid preparation (ratio 3:1:6)

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

For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)
 Chickens reared for laying, minor poultry species other than laying  1 × 108 — 5 × 107 — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

2. The use is permitted in feed containing the following coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.

3. For safety: breathing protection, glasses and gloves shall be used during handling.

4. The additive may be used also via water for drinking.

5. For use of the additive in water for drinking the homogeneous dispersion of the additive shall be ensured.

6. The simultaneous use with antibiotic shall be avoided.
 29 July 2025



PART B

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/l of water for drinking

4b1890 Biomin GmbH Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 
Preparation of Bifidobacterium animalis ssp. animalis DSM 16284 containing a minimum of 3 × 109 CFU/g additive

Lactobacillus salivarius ssp. salivarius DSM 16351 containing a minimum of 1 × 109 CFU/g additive

Enterococcus faecium DSM 21913 containing a minimum of 6 × 109 CFU/g additive

Solid preparation (ratio 3:1:6)

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

For the enumeration of: Bifidobacterium animalis ssp. animalis DSM 16284: spread plate method EN 15785 Lactobacillus salivarius ssp. salivarius DSM 16351: spread plate method EN 15787 Enterococcus faecium DSM 21913 spread plate method EN 15788 For the identification: Pulsed Field Gel Electrophoresis (PFGE)
 Chickens for fattening — 5 × 107 — 
1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.

2. The water for drinking containing the additive may be used simultaneously with feed containing the following permitted coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.

3. For safety: breathing protection, glasses and gloves shall be used during handling.

4. The homogeneous dispersion of the additive shall be ensured in the water for drinking.

5. The simultaneous use with antibiotic shall be avoided.
 29 July 2025


