LegalizeCommission Implementing Regulation (EU) No 887/2011 of 5 September 2011 concerning the authorisation of a preparation of Enterococcus faecium CECT 4515 as feed additive for chickens for fattening (holder of the authorisation Norel SA) Text with EEA relevance
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
This Regulation shall enter into force on the 20th day following 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.
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 Operations GmbH | Enterococcus faecium CECT 4515 | Additive composition Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive Solid forms Characterisation of the active substance Viable cells of Enterococcus faecium CECT 4515 Analytical method (1) 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 |
| (1) Details of the analytical methods are available at the following address of the Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports | |||||||||
| 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 Operations GmbH) | Enterococcus faecium CECT 4515 | Additive composition Preparation of Enterococcus faecium CECT 4515 containing a minimum of 1 × 109 CFU/g additive Solid forms. Characterisation of the active substance Viable cells of Enterococcus faecium CECT 4515 Analytical method (1) 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 |
| (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports |
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