Introduction
BioPlus 2B, the predecessor of BioPlys YC, was one of the first probiotic products to receive permanent EU authorisation. BioPlus YC contains two different strains of Bacilli: Bacillus subtilis and Bacillus paralicheniformis. The product is authorised for use in the EU in piglets, pigs for fattening and sows. It is furthermore authorised for use in calves for fattening and turkeys for fattening.
Manufacturer´s main claims
Stimulates the enzyme secretion in the intestines.
Improves digestibility and availability of nutrients.
Technical specifications of BioPlus YC
EU category
Zootechnical additives
Functional group of additives
Gut flora stabiliser
Active substance
Bacillus paralicheniformis (DSM 5749) and Bacillus subtilis (DSM 5750) in a 1:1 ratio
Activity in the product
1.6 x 109 CFU Bacillus licheniformis per g product
1.6 x 109 CFU Bacillus subtilis per g product
EU approval
No maximum inclusion for the animal categories below
All the below species: 1.3 x 109 CFU/kg feed or 6.5 x 108 CFU/l drinking water
Piglets
Pigs for fattening
Sows
Turkeys for fattening
Calves for fattening
Calves for rearing
Lambs for rearing and fattening
Minor ruminat species for rearing and fattening
Suckling piglets
End of period of authorisation
Weaned piglets
Pigs for fattening
Sows
Calves for rearing
Turkeys for fattening:
4 April 2027
Suckling piglets:
3 January 2028
Calves for fattening
Lambs for rearing and fattening
Minor ruminat species for rearing and fattening
19 December 2033
EU code
4b1700i
Recommended dosage
400 g/t feed
Product storage stability
Six batches of the product were stored at 5, 20-25 or 37°C. After 36 months of storage at temperatures not exceeding 25°C the reduction in viable bacilli was negligible.
Storage stability in pelleted feed, feed premixes and water
Three batches of the product were added to mineral/vitamin premixes. There was no significant effect on bacilli count after three months of storage at 25°C.
Several batches of the product were included in pelleted feed for piglets, pigs for fattening, sows and poultry. Samples of the pelleted were kept for up to 16 months at 20-25°C. No significant differences were observed.
The product's stability was observed when added to drinking water. After seven days of storage in water, the rate of recovery exceeded 90%.
Heat stability
Piglet feed supplemented with the product was pelleted at 75, 85, or 95°C. Regardless of temperature, the total count of bacilli was around 80%.
Carrier
Calcium carbonate and kieselgur
Compatibility claims
Compatible with formic acid, diclazuril, halofuginone, monensin sodium, robenidine, maduramicin ammonium and lasalocid sodium
Physical properties
The particle size distribution was measured using laser diffraction. The fraction of particles smaller than 50 µm was 8.7% by volume and 4.5 % was smaller than 10 µm. EFSA consider the dusting potential of 6.3 g/m3 as being high.
One batch of the product was used to test its homogeneous mixing capacity. Eight sub-samples of either mash or pelleted feed were collected. The CV in the mash feed was 9 %, and in the pelleted feed, it was 11%.
Handling
The EU states: "For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment."
Producer
Chr. Hansen
List of references
EFSA (2003). Opinion of the scientific panel of additives and products or substances used in animal feed on a request from the Commission on micro-organism product "BioPlus 2B", authorised as feed additive in accordance with Council Directive 70/524/EEC. The EFSA Journal (2003) 6,1-4
EFSA (2016). Safety and efficacy of BioPlus 2B (Bacillus subtilis DSM 5749 and Bacillus licheniformis DSM 5750) as a feed additive for sows, piglets, pigs for fattening, turkeys for fattening and calves. EFSA Journal 2016;14(9):4558
EU (2004). Commission Regulation (EC) No 1453/2004 of 16 August 2004 concerning the permanent authorisation of certain additives in feedingstuffs. Official Journal of the European Union L269/3-8
EU (2004). Commission Regulation (EC) No 2148/2004 of 16 December 2004 concerning the permanent and provisional authorisation of certain additives and the authorisation of new uses of an additive already authorised in feedingstuffs. Official Journal of the European Union. L370/24
EU (2005). Commission Regulation (EC) No 600/2005 of 18 April 2005 concerning a new authorisation for 10 years of a coccidiostat as an additive in feedingstuffs, the provisional authorisation of an additive and the permanent authorisation of certain additives in feedingstuffs. Official Journal of the European Union. L99/5-9
EU (2009). Commission Regulation (EC) No 202/2009 of 16 March 2009 amending Regulations (EC) No 600/2005 as regards the use of the preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 in compound feed containing lasalocid sodium. The official Journal of the European Union. L 71/8-10
EU (2011). Commission Regulation (EU) No 516/2011 of 25 May 2011 amending Regulation (EC) No 600/2005 as regards the use of a preparation of Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750 in feed containing formic acid. Official Journal of the European Union. L138/43-44
EU (2012). Commission Implementing Regulation (EU) No 1018/2012 of 5 November 2012 amending Regulations (EC) No 232/2009, (EC) No 188/2007, (EC) No 186/2007, (EC) No 209/2008, (EC) No 1447/2006, (EC) No 316/2003, (EC) No 1811/2005, (EC) No 1288/2004, (EC) No 2148/2004, (EC) No 1137/2007, (EC) No 1293/2008, (EC) No 226/2007, (EC) No 1444/2006, (EC) No 1876/2006, (EC) No 1847/2003, (EC) No 2036/2005, (EC) No 492/2006, (EC) No 1200/2005, and (EC) No 1520/2007 as regards the maximum content of certain micro-organisms in complete feedingstuffs. Official Journal of the European Union. L 307/56-59
EU (2017). Commission Implementing Regulation (EU) 2017/447 of 14 March 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for sows, weaned piglets, pigs for fattening, calves for rearing and turkeys for fattening and amending Regulations (EC) No 1453/2004, (EC) No 2148/2004 and (EC) No 600/2005 (holder of authorisation Chr. Hansen A/S). Official Journal of the European Union. L 69/18-22
EU (2017). Commission Implementing Regulation (EU) 2017/2308 of 13 December 2017 concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S). Official Journal of the European Union. L 331/19-22
EU (2023). COMMISSION IMPLEMENTING REGULATION (EU) 2023/2647 of 28 November 2023 concerning the authorisation of the preparation of Bacillus subtilis DSM 5750 and Bacillus paralicheniformis DSM 5749 as a feed additive for calves for fattening, lambs for rearing and for fattening and minor ruminant species for rearing and for fattening, and amending Implementing Regulation (EU) 2017/2308 as regards the terms of the authorisation of that preparation