
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 
Regulation (EC) No 1333/2004 is repealed.
Article 3 
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 11 March 2014 in accordance with the rules applicable before 11 September 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4 
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, 21 August 2013.
For the Commission
The President
José Manuel BARROSO
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: gut flora stabilisers
4b1708 Chr. Hansen A/S Enterococcus faecium(NCIMB 11181) 
 Additive composition
Preparation of Enterococcus faecium (NCIMB 11181) containing a minimum of:
 Solid form: 5 × 1010 CFU/g of additive;
 Solid water soluble form: 2 × 1011 CFU/g additive.
 Characterisation of the active substance
Viable cells of Enterococcus faecium (NCIMB 11181).
 Analytical method
Enumeration: spread plate method using Bile Esculin Azide agar (EN 15788).
Identification: Pulsed-Field Gel Electrophoresis (PFGE) Calves for rearing and for fattening 6 months 5 × 108 — 
1.. In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting and in water.
2.. May be used in milk replacers for calves for rearing and for fattening.
3.. For weaned piglets up to 35 kg.
4.. Recommended minimum doses:

— calves for rearing and for fattening: 2 × 1010 CFU/kg complete feed
— piglets (weaned): 1 × 1010 – 2 × 1010 CFU/kg complete feed
5.. The water soluble form of the preparation may be used for weaned piglets in water for drinking with a recommended minimum dose of 1 × 1010 – 2 × 1010 CFU/L
6.. For user safety: breathing protection, safety glasses and gloves should be worn during handling. 11 September 2023
Piglets (weaned) — 5 × 108 —
