- Y Diweddaraf sydd Ar Gael (Diwygiedig) - Saesneg
- Y Diweddaraf sydd Ar Gael (Diwygiedig) - Cymraeg
- Gwreiddiol (Fel y'i Gwnaed) - Saesneg
- Gwreiddiol (Fel y'i Gwnaed) - Cymraeg
There are currently no known outstanding effects for the The Feed Additives (Authorisations) (Wales) Regulations 2022, SCHEDULE 8.
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Regulation 3(1)
Commencement Information
I1Sch. 8 in force at 24.11.2022, see reg. 1(2)(c)
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(1).
(1) Details of the analytical methods set out in the document referenced “JRC.DG.D.6.CvH/DM/hn/ARES (2010)-355411” and last updated 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. | |
(2) Under reference BS ISO 15213:2003 “Microbiology of food and animal feeding stuffs – Horizontal method for the enumeration of sulfite-reducing bacteria growing under anaerobic conditions”. Published by the British Standards Institution on 16 May 2003 (ISBN 0 580 41892 8). Available from the British Standards Institution https://knowledge.bsigroup.com. | |
(3) Content of Clostridium butyricum FERM BP-2789 in CFU/kg of complete feed with a moisture content of 12%. | |
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(1) | 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 |
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Maximum age | None |
Minimum content(3) | 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(3) | 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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This authorisation is a renewal of the authorisations granted under Commission Implementing Regulations (EU) No 373/2011, No 374/2013 and No 1108/2014. Those Regulations are revoked by regulation 8 of these Regulations.
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