The Feed Additives (Authorisations) (Wales) Regulations 2022

Regulation 3(1)

SCHEDULE 8 Renewal 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(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: Pour plate method based on BS ISO 15213:2003(2).
	For identification of bacterial strain: Pulsed-field gel electrophoresis (PFGE).
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)
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: Decoquinate Diclazuril Lasalocid A sodium Maduramicin ammonium Monensin sodium Narasin Narasin/Nicarbazin (as combined use) Robenidine hydrochloride Salinomycin sodium Semduramicin sodium

(1)

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.