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Document 02013R0374-20170714
Commission Implementing Regulation (EU) No 374/2013 of 23 April 2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying ( holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ) (Text with EEA relevance)
Consolidated text: Commission Implementing Regulation (EU) No 374/2013 of 23 April 2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying ( holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ) (Text with EEA relevance)
Commission Implementing Regulation (EU) No 374/2013 of 23 April 2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying ( holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ) (Text with EEA relevance)
No longer in force
02013R0374 — EN — 14.07.2017 — 001.001
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COMMISSION IMPLEMENTING REGULATION (EU) No 374/2013 of 23 April 2013 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying ( ►M1 holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ◄ ) (OJ L 112 24.4.2013, p. 13) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) 2017/1126 of 23 June 2017 |
L 163 |
13 |
24.6.2017 |
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COMMISSION IMPLEMENTING REGULATION (EU) No 374/2013
of 23 April 2013
concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for chickens reared for laying ( ►M1 holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ◄ )
(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 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.
ANNEX
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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 |
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CFU/kg of complete feedingstuff with a moisture content of 12 % |
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Category of zootechnical additives. Functional group: gut flora stabilisers |
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4b1830 |
►M1 Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium ◄ |
Clostridium butyricum (FERM BP-2789) |
Additive composition Preparation of Clostridium butyricum (FERM BP-2789) containing in solid form a minimum of 5 × 108 CFU/g additive. Characterisation of the active substance Viable spores of Clostridium butyricum FERM BP-2789. Analytical method (1) Quantification: pour plate method based on ISO 15213 standard. Identification: pulsed-field gel electrophoresis (PFGE) method. |
Chickens reared for laying |
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2,5 × 108 |
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1. In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. 2. The use is allowed in feed containing the authorised coccidiostats: monensin sodium, diclazuril, salinomycin sodium or lasalocid sodium. 3. For safety: breathing protection and safety glasses shall be used during the handling. |
14 May 2023 |
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(1) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/crl-feed-additives |
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