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This is the original version (as it was originally made).
Regulation 3(1)
SCHEDULE 8Renewal of authorisation of a preparation of Clostridium butyricum FERM BP-2789 (identification number 4b1830) as a feed additive for chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species, and its authorisation as a feed additive for chickens for fattening, suckling piglets and suckling minor porcine species
The preparation specified in the table, 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().
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Additive | Clostridium butyricum FERM BP-2789 |
Identification number of the additive | 4b1830 |
Authorisation holder | Miyarisan Pharmaceutical Co Ltd |
Additive category | Zootechnical additive |
Functional group | Gut flora stabilisers |
Additive composition | Solid form preparation of Clostridium butyricum FERM BP-2789 containing a minimum of 5 × 108 CFU/g of additive |
Characterisation of the active substance(s) | Viable spores of Clostridium butyricum FERM BP-2789 |
Analytical methods | For enumeration (colony count) in the feed additive, premixtures, feed materials and compound feed:
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For identification of bacterial strain:
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Species or category of animal | Chickens for fattening
Chickens reared for laying
Turkeys for fattening
Turkeys reared for breeding
Minor avian species (excluding laying birds)
Piglets (suckling and weaned)
Minor porcine species (suckling and weaned)
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Maximum age | None |
Minimum content | For turkeys for fattening and turkeys reared for breeding: 1.25 x 108 CFU/kg |
For the other species/categories: 2.5 x 108 CFU/kg |
Maximum content | None |
Other provisions | 1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated. |
2. If 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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