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Regulation 3(2)
1. The preparation specified in the table in this schedule, 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 set out in the table in this schedule(1).
Column 1 | Column 2 | |
---|---|---|
Additive | Clostridium butyricum (FERM BP-2789) | |
Identification number of the additive | 4b1830 | |
Authorisation holder | Miyarisan Pharmaceutical Co. Ltd | |
Additive category | Zootechnical additives | |
Functional group | Gut flora stabilisers | |
Additive composition | Solid form preparation of Clostridium butyricum (FERM BP-2789) containing a minimum of 5 x 108 CFU/g additive | |
Characterisation of the active substance(s) | Viable spores of Clostridium butyricum FERM BP-2789 | |
Analytical methods(2) | 1. For enumeration (colony count): | |
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2. For identification of bacterial strain: | ||
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Species or category of animal | Turkeys for fattening; turkeys reared for breeding; chickens for fattening; chickens reared for laying; minor avian species (excluding laying birds); piglets and piglets of minor porcine species | |
Maximum age | Not applicable | |
Content of Clostridium butyricum (FERM BP-2789) in CFU/kg of complete feed with a moisture content of 12% | Minimum content | Turkeys: 1.25 x 108 CFU/kg Chickens, minor avian species, piglets and minor porcine species: 2.5 x 108 CFU/kg |
Maximum content | All species and categories of animal as provided for above: no maximum | |
Other provisions | 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. Where Clostridium butyricum (FERM BP-2789) is to be used in feed containing coccidiostats, this feed additive is authorised for use with the following coccidiostats only, and in accordance with their individual authorisation criteria: | |
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This authorisation is a renewal of the authorisations granted under Commission Implementing Regulations (EU) No. 373/2011, 374/2013 and 1108/2014. Those Regulations are revoked by regulation 11 of these Regulations.
Details of the analytical methods are set out in the document referenced “JRC.DG.D.6.CvH/DM/hn/ARES (2010)-355411” and last updated on 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2010-0005.
ISO standards are published in Geneva by the International Organisation for Standardisation, and are available on their website (www.iso.org) or at ISO Central Secretariat, International Organization for Standardization (ISO), 1 rue de Varembé, Case postale 56, CH-1211, Geneva 20, Switzerland. Under reference BS ISO 15213:2003, it was published as a UK standard by the British Standards Institution on 16 May 2003 (ISBN 0 580 41892 8).
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