Introduction
Calsporin contains live spores of Bacillus velezensis (formerly known as Bacillus subtilis). It is authorised for use in various animal species in the EU.
Manufacturer´s main claims
Improves daily weight gain and feed conversion
Decreases the load of pathogens
Technical specifications of Calsporin
EU category
Zootechnical additives
Functional group of additives
Gut flora stabilisers
Active substance
Bacillus velezensis (DSM 15544) (formerly known as Bacillus subtilis C-3102)
Activity in the product
1 x 1010 CFU/g product
EU approval
The minimum inclusion rate for the animal categories below:
Suckling piglets: Minimum 3 x 108 CFU/kg feed
Sows: 3 x 108 CFU/kg feed
Weaned piglets: 3 x 108 CFU/kg feed
Pigs for fattening: 1.5 x 108 CFU/kg feed
All avian species and categories: 3 x 108 CFU/kg feed
Ornamental fish: 1 x 1010 CFU/kg feed
Dogs: 1 x 109 CFU/kg feed
End of period of authorisation
Suckling piglets: 3 January 2028
Sows: 3 January 2028
Weaned piglets: 26 May 2032
Pigs for fattening: 20 August 2028
All avian species and categories: 26 May 2032
Ornamental fish: 29 June 2026
Dogs: 3 January 2028
EU code
4b1820
Product storage stability
The product was stored under two different conditions: 25°C/60% relative humidity and 40°C/75% relative humidity. When stored for 37 months at 25°C, there was no apparent loss of viability. When stored at 40°C, shelf life is limited to six months.
Storage stability in feed premix
No viability reduction was observed when the product was supplemented to a broiler vitamin/mineral premix and stored for six months at 25°C/60% relative humidity. The product's viability, when incorporated into a piglet vitamin/mineral premix, is probably similar to the data obtained with the broiler premix. There was no loss of viability when broiler feed supplemented with the product was stored for one month at 25°C/60% relative humidity.
Heat stability
The product survives pelleting at temperatures up to 90°C.
Carrier
Calcium carbonate
Package size
20 kg card box
Handling
The product is a potential respiratory sensitiser. Breathing protection and safety glasses should be used during handling.
Producer
Asahi Biocycle
List of references
EFSA (2010). Scientific Opinion on the Safety and Efficacy of Calsporin (Bacillus subtilis) as a feed additive for piglets. EFSA Journal 2010; 8(1): 1426
EU (2010). Commission Regulation (EC) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Calpis Co. Ltd. Japan, represented in the European Union by Calpis Co. Ltd. Europe Representative Office). Official Journal of the European Union. L 102/19
EU (2011). Commission Implementing Regulation (EU) 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens for laying, turkeys, minor avian species and other ornamental and game birds (holder of the authorisation Calpis Co. Ltd Japan, represented by Calpis Co. Ltd Europe Representative office). Official Journal of the European Union. L 53/33-35
EU (2016). Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation Bacillus subtilis (C3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of the authorisation Asahi Calpis Wellness Co. Ltd) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation. Official Journal of the European Union. L 152/7-10
EU (2017). Commission Implementing Regulation (EU) 2017/2312 of 13 December concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office). Official Journal of the European Union. L 331/41-43
EU (2018). Commission Implementing Regulation (EU) 2018/1081 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative office). Official Journal of the European Union. L 194/137-139
EU (2019). Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co Ltd, represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office). Official Journal of the European Union. L142/60-62
EU (2022). Commission Implementing Regulation (EU) 2022/703 of 5 May 2022 concerning the renewal of the authorisation of a preparation of Bacillus velezensis DSM 15544 as a feed additive for weaned piglets, the authorisation for all avian species and categories, amending Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2017/2312 and Implementing Regulation (EU) 2018/1081 and repealing Regulation (EU) No 333/2010, Regulation (EU) No 184/2011 and Implementing Regulation (EU) 2019/893 (holder of the authorisation: Asahi Biocycle Co. Ltd., represented in the Union by Pen & Tec Consulting S.L.U.) Official Journal of the European Union. L 132/5-9