
Article 1 
The preparation specified in Annex I, 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 
In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.
Article 3 
The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.
Article 4 
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 28 December 2017 in accordance with the rules applicable before 28 June 2017 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, 7 June 2017.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

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
4b1713 Evonik Nutrition & Care GmbH) Enterococcus faeciumCECT 4515 
Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid form

Viable cells of Enterococcus faecium CECT 4515

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

Identification: Pulsed-Field Gel Electrophoresis (PFGE)
 Weaned piglets  1 × 109 — 5 × 108 — 
1.. The additive may be used in water for drinking.
2.. In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.
3.. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
4.. For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.
5.. For use in weaned piglets up to 35 kg of body weight.
6.. 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, including breathing protection and skin protection. 28 June 2027

ANNEX II

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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
4b1713 Evonik Nutrition & Care GmbH) Enterococcus faeciumCECT 4515 
Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive

Solid forms

Viable cells of Enterococcus faecium CECT 4515

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

Identification: Pulsed-Field Gel Electrophoresis (PFGE)
 Chickens for fattening — 1 × 109 — 
1.. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
2.. The use is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium.
3.. 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, including breathing protection and skin protection. 26 September 2021

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
Category of zootechnical additives. Functional group: gut flora stabilisers
4b1713 Evonik Nutrition & Care GmbH) Enterococcus faeciumCECT 4515 
Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive

Solid forms.

Viable cells of Enterococcus faecium CECT 4515

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

Identification: Pulsed- Field Gel Electrophoresis (PFGE)
 Chickens for fattening — 5 × 108 — 
1.. The additive may be used in water for drinking.
2.. In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.
3.. For use of the additive in water for drinking a homogeneous dispersion of the additive shall be ensured.
4.. The use is compatible in feed containing one of the following authorised coccidiostats: monensin sodium, diclazuril, nicarbazin, decoquinate, robenidine hydrochloride, semduramycin sodium, narasin, salinomicin sodium, lasalocid A sodium, narasin/nicarbazin or maduramycin ammonium.
5.. 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, including breathing protection and skin protection. 28 June 2027
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