B. subtilis
Lallemand > Media center > Press releases > Heat stable probiotic strain Bacillus subtilis R0179 receives self-affirmed GRAS status in the USA

Institut Rosell-Lallemand is pleased to announce that the heat-stable probiotic strain Bacillus subtilis R0179 has been deemed safe for use in foods and food supplements by US experts: the strain has gained the self-affirmed GRAS (Generally Recognized As Safe) status. As a result, this heat and pressure resistant probiotic can now be used as a food additive in the United States. This strain is also already approved for use in foods by local authorities in Europe (QSP status by EFSA), Canada and Japan.

Because B. subtilis R179 combines good probiotic features with resistance to high stress conditions such as heat, acid, pressure and lack of nutrients, it is the perfect candidate to be incorporated into long-life foods including baked goods such as muffins and bread, and drinks such as shelf-stable juices. It is also well adapted to formulate a variety of stable food supplements: solid in sachets, capsules, tablets, or liquid in bottles, and it can be mixed with various ingredients.

B. subtilis R0179 self-affirmed GRAS status is based on an extensive dossier incorporating the strain full safety profile based on classic microbiological methods and state of the art genomic technologies (Tompkins et al., 2008.), including sequencing of the complete bacteria genome. To this was added a good track-record of safe used in human. Indeed, this particular strain has been used for over 15 years in Asia in a pharmaceutical to support gut health (Medilac®), resulting in over 100 post-market clinical trials published in adults and children, proving its safety (Tompkins et al., 2010).

B. subtilis R0179 (CNCM I-3471) benefits from good probiotic features. Indeed, this strain secretes antimicrobial compounds, is naturally part of the human microflora, and survives well the digestion process. The IViDiS in vitro digestion model showed at least 80% recovery of live bacteria after passage through the stomach and duodenum, hence a greatest number of the friendly bacteria can reach their site of action and exert their benefits.

B. subtilis R0179 is produced by Institut Rosell-Lallemand, an expert in probiotics, according to the highest bacteria production standards (Drug GMP- Division 2 GUI0001, Health Canada). It is available in its heat-stable sporulated form as freeze dried powder.

Tompkins, T.A., Hagen, K.E., Wallace, T.D. and Fillion-Forte, V., 2008. Safety evaluation of two bacterial strains used in Asian probiotic products. Canadian Journal of Microbiology 54: 391-400.

Tompkins, T.A., Xu, X. and Ahmarani, J., 2010. A comprehensive review of post-market clinical studies performed in adults with an Asian probiotic formulation. Beneficial Microbes, 2010; 1(1): 93-106

Contact for the Food and Drink market:

Joanie Dion

Technical Representative

Tel.: +1 514-858-4655 – jdion@lallemand.com

Contact for the food supplements market:

Isabelle Champié

Deputy Manager / Global Marketing Director

Tel.: +33 (5)62 74 5555- human@institut-rosell.com