02.10.12
Institut Rosell-Lallemand, Montreal, Quebec, Canada, has self-affirmed that its heat-stable probiotic strain Bacillus subtilis R0179 is Generally Recognized As Safe (GRAS) for use in foods and food supplements. As a result, this heat and pressure resistant probiotic can now be used as a food additive in the U.S. This strain was already approved for use in foods by local authorities in Europe (QSP status by EFSA), Canada and Japan. The GRAS approval is based on an extensive dossier incorporating a full safety profile from classic microbiological methods and state of the art genomic technologies, including sequencing of the complete bacteria genome. Additionally, the product has a good track-record of safe use in humans. This particular strain has been used for more than 15 years in Asia in a pharmaceutical to support gut health (Medilac), resulting in more than 100 post-market clinical trials published in adults and children, proving its safety.