BIO-CAT Microbials submitted an NHP-Master File to Health Canada in December 2017 for OPTI-BIOME®. Access to this Master File can be used to support the complete submission (safety, efficacy and quality) of a customer’s Product License Application in Canada.
All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004.
The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality.
OPTI-BIOME® Bacillus Subtilis MB40 is a naturally occurring, non-GMO, shelf stable probiotic strain. It has been GRAS reviewed by an expert panel. This strain is naturally protected by its spore coating, which provides resistance to pH and temperature extremes and ensures long term stability. This added feature allows you to skip the microencapsulation process, which is commonly practiced to ensure your product survives and is delivered in the proper location. These features make it an ideal probiotic ingredient for dietary supplements and foods typically associated with non-spore-forming probiotics such as Lactobacillus.