
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 252/2006 is amended as follows:

((1)) Article 1 is deleted;
((2)) Annex I is deleted.
Article 3 
Regulation (EC) No 943/2005 is amended as follows:

((1)) Article 1 is deleted;
((2)) Annex I is deleted.
Article 4 
In Annex II to Regulation (EC) No 1200/2005, the entry E 1705 on Enterococcus faecium NCIMB 10415 is deleted.
Article 5 
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 24 July 2019 in accordance with the rules applicable before 24 January 2019 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 6 
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, 3 January 2019.
For the Commission
The President
Jean-Claude JUNCKER
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 
Preparation of Enterococcus faecium

NCIMB 10415 containing a minimum of:


— coated form (with shellac):
2 × 1010 CFU/g additive, or
— other coated forms:
1 × 1010 CFU/g additive, or
— granulated non-coated form:
3,5 × 1010 CFU/g additive.

Viable cells of Enterococcus faecium

NCIMB 10415

Enumeration: spread plate method using bile esculin azide agar (EN 15788)

Identification: Pulsed- Field Gel Electrophoresis (PFGE)
 Sows — 7 × 108 — 
1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

2. The additive shall be administered to pregnant and lactating sows and simultaneously to the suckling piglets

3. For use in weaned piglets until approximately 35 kg.

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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.
 24 January 2029
Suckling piglets 1 × 109 —
Weaned pigletsPigs for fattening 3,5 × 108 —
