Contents
Article 1Authorisation#
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 2Amendment to Regulation (EC) No 2036/2005#
In Annex I to Regulation (EC) No 2036/2005, the entry E 1713 on Enterococcus faecium CECT 4515 is deleted.
Article 3Amendment to Regulation (EU) No 887/2011#
The Annex to Regulation (EU) No 887/2011 is replaced by Annex II to this Regulation.
Article 4Transitional measures#
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 5Entry into force#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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 | ||||||||||
| 4b1713 | Evonik Operations GmbH) | Enterococcus faeciumCECT 4515 | Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive in solid formCharacterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodnoteEnumeration: 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
‘ANNEXnoteIdentification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationCFU/kg of complete feedingstuff with a moisture content of 12 %Category of zootechnical additives. Functional group: gut flora stabilisers4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additiveSolid formsCharacterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodnoteEnumeration: 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.
1.The additive may be used in water for drinking.
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.
2.In the directions for use of the additive and premixtures stability in water for drinking shall be indicated.
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.
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.
26 September 2021noteIdentification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationCFU/l of water for drinkingCategory of zootechnical additives. Functional group: gut flora stabilisers4b1713Evonik Operations GmbH)Enterococcus faeciumCECT 4515Additive compositionPreparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additiveSolid forms.Characterisation of the active substanceViable cells of Enterococcus faecium CECT 4515Analytical methodnoteEnumeration: spread plate method using bile esculin azide agar (EN 15788)Identification: Pulsed- Field Gel Electrophoresis (PFGE)Chickens for fattening—5 × 108—28 June 2027’
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.