Introduction
Clostat contains live spores of Bacillus subtilis. The product is authorised for use in the EU in piglets, chickens for fattening and other avian species.
Manufacturer´s main claims
Reduces the number of pathogens in the intestines
Improves gut health
Technical specifications of Clostat
EU category
Zootechnical additives
Functional group of additives
Gut flora stabilisers
Active substance
Bacillus velezensis (ATCC PTA-6737) (formerly known as Bacillus subtilis ATCC PTA-6737)
Activity in the product
1 x 1010 CFU/g product
EU approval
No maximum inclusion for the animal categories below
Piglets: 1 x 107 CFU kg feed
Sows: 1 x 108 CFU/kg feed
Chickens for fattening: 1 x 107 CFU/kg feed
Chickens reared for laying: 1 x 107 CFU/kg feed
Minor poultry species except minor poultry for laying: 1 x 107 CFU/kg feed
Ornamental birds: 1 x 107 CFU/kg feed
Laying hens: 1 x 108 CFU/kg feed
Minor poultry species for laying: 1 x 108 CFU/kg feed
Turkeys for fattening: 1 x 108 CFU/kg feed
Turkeys reared for breeding: 1 x 108 CFU/kg feed
End of period of authorisation
Weaned piglets: 23 April 2023*
Sows: 29 December 2027*
Chickens for fattening: 9 March 2033
Chickens reared for laying: 9 March 2033
Minor poultry species except minor poultry for laying: 9 March 2033
Ornamental birds: 9 March 2033
Laying hens: 20 July 2025*
Minor poultry species for laying: 20 July 2025*
Turkeys for fattening: 6 September 2023*
Turkeys reared for breeding: 6 September 2023*
*: Following the provisions of Art. 14 of Reg. (EC) No 1831/2003, an application, in accordance with Article 7, has been submitted
EU code
4b1823i
Product storage stability
The product was stored at 5°C or 25°C for one year. After one year of storage, viability did not significantly decrease.
Storage stability in feed premix
Storage stability in feed and premix The product was added to a vitamin/mineral premix and stored for six months at room temperature. At the end of the storage period, viability remained intact.
Heat stability
Pelleting temperatures up to 95°C did not affect the viability of the product
Carrier
Calcium carbonate, soybean oil and maltodextrin
Handling
The product is not supposed to give concerns about sensitisation via the respiratory route. No signs of dermal or eye irritation have been observed in various tests.
Producer
Kemin
List of references
EFSA (2009). Scientific Opinion on the Safety and Efficacy of Bacillus subtilis PB6 (Bacillus subtilis) as a feed additive for chickens for fattening. EFSA Journal 2009; 7(9):1314
EU (2011). Commission Regulation (EU) No 168/2011 of 23 February 2011 amending Regulation (EU) No 107/2010 as regards the use of the feed additive Bacillus subtilis ATCC PTA-6737 in feed containing maduramycin ammonium, monensin sodium, narasine or robenidine hydrochloride. Official Journal of the European Union. L 49/4-5
EU (2011). Commission Regulation (EU) No 885/2011 of 5 September 2011 concerning the authorisation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for chickens reared for laying, ducks for fattening, quails, pheasants, partridges, guinea fowl, pigeons, geese for fattening and ostriches (holder of the authorisation Kemin Europa N.V.). Official Journal of the European Union. L 229/3-4
EU (2013). Commission Regulation (EU) No 787/2013 of 16 August 2013 concerning the authorisation of a preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for turkeys for fattening and turkeys reared for breeding (holder of authorisation Kemin Europa N.V.). Official Journal of the European Union. L 220/15-17
EU (2015). Commission Implementing Regulation (EU) 2015/1020 of 29 June 2015 concerning the authorisation of the preparation of Bacillus subtilis (ATCC PTA-6737) as a feed additive for laying hens and minor poultry species for laying (holder of the authorisation Kemin Europe NV). Official Journal of the European Union. L 163/22-24
EU (2017). Commission Regulation (EU) No 2017/2276 of 8 December 2017 concerning the authorisation of a new use of the preparation Bacillus subtilis (ATCC PTA-6737) as a feed additive for sows (holder of the authorisation Kemin Europe N.V.). Official Journal of the European Union. L 326/50-52
EU (2023). Commission Implementing Regulation (EU) 2023/366 of 16 February 2023 concerning the renewal of the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species except for laying purposes, its authorisation for ornamental birds, amending Implementing Regulation (EU) No 306/2013, Implementing Regulation (EU) No 787/2013, Implementing Regulation (EU) 2015/1020, Implementing Regulation (EU) 2017/2276 and repealing Regulation (EU) No 107/2010 and Implementing Regulation (EU) No 885/2011 (holder of authorisation Kemin Europe N.V.). Official Journal of the European Union. L 50/59-64