
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘gut flora stabilisers’ and ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2 
Regulation (EC) No 102/2009 is repealed.
Article 3 
In Annex I to Regulation (EC) No 1288/2004 the entry on E 1705, Enterococcus faecium NCIMB 10415 is deleted.
Article 4 
The preparation specified in Annex as far as its use for calves is concerned, and feed containing that preparation, which are produced and labelled before 19 May 2014 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
The preparation specified in Annex as far as its use for cats and dogs is concerned, and feed containing that preparation, which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 November 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 5 
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, 29 October 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
4b1705 DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o Enterococcus faeciumNCIMB 10415 
 Additive composition
Preparation of Enterococcus faecium
NCIMB 10415 containing a minimum of: microencapsulated form with shellac and other microencapsulated forms:
1 × 1010 CFU/g additive;
non-coated granulated forms:
3,5 × 1010 CFU/g additive
 Characterisation of the active substance
Viable cells of Enterococcus faecium
NCIMB 10415
 Analytical method
Enumeration: spread plate method using bile esculin azide agar (EN 15788)
Identification: Pulsed-Field Gel Electrophoresis (PFGE) CalvesKids — 1 × 109 — In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. 19 November 2023
4b1705 DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o Enterococcus faeciumNCIMB 10415 
 Additive composition
Preparation of Enterococcus faecium
NCIMB 10415 containing a minimum of: 5 × 109 CFU/g of additive;
Microencapsulated forms (shellac).
 Characterisation of the active substance
Viable cells of Enterococcus faecium
NCIMB 10415
 Analytical method
Enumeration: spread plate method using bile esculin azide agar (EN 15788)
Identification: Pulsed-Field Gel Electrophoresis (PFGE) Cats — 7 × 109 — In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. 19 November 2023
Category of zootechnical additives. Functional group: other zootechnical additives (improvement of gut conditions)
4b1705 DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o Enterococcus faeciumNCIMB 10415 
 Additive composition
Preparation of Enterococcus faecium
NCIMB 10415 containing a minimum of 5 × 109 CFU/g of additive.
Microencapsulated forms (shellac).
 Characterisation of the active substance
Viable cells of Enterococcus faecium
NCIMB 10415
 Analytical method
Enumeration: spread plate method using bile esculin azide agar (EN 15788)
Identification: Pulsed-Field Gel Electrophoresis (PFGE) Dogs — 2,5 × 109  In the directions for use of the additive and premixture, indicate the storage conditions and stability to pelleting. 19 November 2023
