Introduction
Miya-Gold® contains spores of Clostridium butyricum. The product is approved in the EU for piglets, chickens for fattening and other avian species.
Manufacturer´s main claims
Inhibits the growth of pathogens, e.g. E. coli, Campylobacter jejuni, Salmonella typhimurium etc.
Technical specifications of Miya-Gold® S and Miya-Gold® EU
EU category
Zootechnical additive
Functional group of additives
Gut flora stabiliser
Active substance
Clostridium butyricum (FERM BP 2789)
Activity in the product
Miya-Gold® S: 5 x 108 CFU/g
Miya-Gold® EU: 1 x 1010 CFU/g
EU approval, minimum content
No maximum content is specified for the animal categories below
Piglets and piglets of minor porcine species: 2.5 x 108 CFU/kg feed
Chickens for fattening: 2.5 x 108 CFU/kg feed
Chickens reared for laying: 2.5 x 108 CFU/kg feed
Turkeys for fattening: 1.25 x 108 CFU/kg feed
Turkeys reared for breeding: 1.25 x 108 CFU/kg feed
Minor avian species (excluding laying birds): 2.5 x 108 CFU/kg feed
End of period of authorisation
Piglets and piglets of minor porcine species: 19 September 2031
Chickens for fattening: 19 September 2031
Chickens reared for laying: 19 September 2031
Turkeys for fattening: 19 September 2031
Turkeys reared for breeding: 19 September 2031
Minor avian species (excluding laying birds): 19 September 2031
EU code
4b1830
Product storage stability
EFSA concludes that a shelf life of at least 24 months was demonstrated.
Storage stability in feed premix
When the product was added to a vitamin/mineral premix and stored for six months at 20-25°C and 40-60% relative humidity, it was stable. The product was stable for at least three months when added to mash or pelleted feed and stored at similar conditions.
Heat stability
EFSA states that 50% of the viability is lost during pelleting; however, no pelleting temperature is indicated.
Carrier
Miya-Gold S: Killed brewers yeast, glucose, corn starch and aluminium silicate
Miya-Gold EU: Lactose or calcium carbonate
Compatibility claims
Compatible with monensin sodium, robenidine, maduramicin ammonium, lasalocid sodium or diclazuril
Handling
During handling, breathing protection and safety glasses should be used
Producer
Huvepharma
List of references
EFSA (2009). Safety and efficacy of Miya-Gold®S (Clostridium butyricum) as feed additive for chickens for fattening. The EFSA Journal (2009) 1039, 1-16
EU (2009). Commission Implementing Regulation (EC) No 903/2009 of 28 September 2009 concerning the authorisation of the preparation of Clostridium butyricum MIYAIRI 588 (FERM-P 1467) as a feed additive for chickens for fattening (holder of the authorisation Miyarisan Pharmaceuticals Co. Ltd, represented by Mitsui & Co Deutschland GmbH). Official Journal of the European Union. L 256/26-27
EFSA (2014). Scientific Opinion on the safety and efficacy of Miya-Gold® (Clostridium butyricum) for turkeys for fattening and turkeys for breeding. EFSA Journal 2014;12(3):3603
EU (2011). Commission Implementing Regulation (EU) No 373/2011 of 15 April 2011 concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for minor avian species except laying birds, weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 903/2009 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd, represented by Miyarisan Pharmaceutical Europe S.L.U.). Official Journal of the European Union. L 102/10-12
EU (2013). Commission Implementing Regulation (EU) No 357/2013 of 18 April 2013 Amending Regulation (EC) No 903/2009 and implementing Regulation (EU) 373/2011 as regards the minimum content of the preparation of Clostridium butyricum (FERM BP 2789) as a feed additive for chickens for fattening and minor avian species (excluding laying birds) (holder of authorisation Miyarisan Pharmaceutical Co. Ltd. represented by Miyarisan Pharmaceutical Europe S.L.U.) Official Journal of the European Union. L 109/22
EU (2013). 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 Miyarisan Pharmaceutical Europe S.L.U.). Official Journal of the European Union. L 112/13-14
EU (2014). Commission Implementing Regulation (EU) No 1108/2014 of 20 October 2014 concerning the authorisation of a preparation of Clostridium butyricum (FERM BP-2789) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of the authorisation Miyarisan Pharmaceutical Co. Ltd represented by Miyarisan Pharmaceutical Europe S.L.U.). Official Journal of the European Union. L 301/16-18
EU (2021). Commission Implementing Regulation (EU) 2021/1411 of 27 August 2021 concerning the renewal of the authorisation of Clostridium butyricum FERM BP-2789 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, its authorisation for chickens for fattening, suckling piglets and suckling minor porcine species, and repealing Implementing Regulations (EU) No 373/2011, (EU No 374/2013 and (EU) No 1108/2014 (holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium). Official Journal of the European Union. L 304/11-13