Introduction
Bacillus subtilis (DSM 25841) is a single-strain probiotic authorised for use in pigs in the EU. The DSM 25841 Bacillus subtilis is used as a component in the SolPreme® product.
Technical specifications of Bacillus subtilis, DSM 25841
EU category
Zootechnical additives
Functional group of additives
Gut flora stabilisers
Active substance
Bacillus subtilis (DSM 25841)
Activity in the product
Activity stated in the EU authorisation: 1.25 x 1010 CFU/g
EU approval
No maximum inclusion for the animal categories below
All porcine species, including sows, other than lactating sows, in order to have a benefit in suckling piglets
5 x 108 CFU/kg feed or 1.7 x 108 CFU/l of drinking water
End of period of authorisation
16 December 2030
EU code
4b1902
Recommended dosage
Minimum dosage authorised in EU: For all the above species, a minimum of each strain: 0.5 x 108 CFU/kg feed or 1.7 x 108 CFU/l drinking water
Product storage stability
Three batches of the product were used to test its stability when stored at 25, 30, or 37°C for one year. Storage at these temperatures did not affect spore count.
Storage stability in feed premix
Two vitamin-mineral premixes were supplemented with the product and stored for six months at 20-25°C. No reductions in viable spores could be detected.
The stability of the product, when added to meal or pelleted feed and stored for six months at 20-25°C, was also tested. More than 90% of the residual activity remained in the meal feed. In the pelleted feed, 80% of the activity could be detected.
Samples of the product from three different product batches were dissolved in drinking water. The water was stored at 20-25°C and analysed after one and two days. No viability losses could be detected at either time point.
Heat stability
The product´s heat stability was studied using three different pelleting temperatures: 75, 85 and 95°C. The recovery rate was higher than 9% for the low temperatures and 78% at 95°C
Physical properties
Laser diffraction was used to determine the particle size distribution. Nine per cent of the particles were smaller than 50 µm, and 4 % were smaller than 10 µm. A dusting potential test showed that the product has a dusting potential of 2 g/m3
Ten subsamples of a batch of pelleted feed with the product were analysed to test the capacity to mix homogeneously. The analytical results showed a CV of 0.9%.
Handling
The European Commission states: "For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection."
Producer
Chr. Hansen A/S
List of references
EFSA (2018). Safety and efficacy of EB15 10 (Bacillus subtilis DSM 25841) as a feed additive for weaned piglets and minor porcine species. EFSA Journal 2018;16(4):5199
EU ( 2020). COMMISSION IMPLEMENTING REGULATION (EU) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S). Offiicial Journal of the European Union, L 397/6-8
EU (2022). COMMISSION IMPLEMENTING REGULATION (EU) 2022/271 of 23 February 2022 correcting Implementing Regulation (EU) 2020/1760 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S). Official Journal of the European Union. L 43/10-13