Regulatory

The Regulatory Department at BIO-CAT Microbials supports our customers with regulation review and assistance, product and consumer safety information, import/export support, and other ad hoc services. Specifically, the services include the provision of documentation to customers to support their regulatory compliance files:

  • GRAS Statements
  • Allergen Statements
  • Certificates of Origin
  • Animal Derivative, BSE/TSE Statements
  • Composition Statements
  • GMO Statements
  • HALAL certification; as issued under Islamic Laws by the Islamic Food and Nutrition Council of America (IFANCA®)
  • Kosher Status certification; as issued by the Kashruth Division of the Orthodox Union (OU)
  • Harmonized Tariff Schedule
  • Irradiation/Ionization Statement
  • Melamine Statements
  • Nutritional Statements
  • Organic Statements
  • Vegetarian/Vegan Statements
  • Safety Data Sheets

BIO-CAT Microbials supports our customers with registration processes to relevant regulatory bodies. Regulatory authorities that we have worked with recently include the Canadian Health Authorities, OMRI, Environmental Protection Agency and TGA. Additionally, we have experience in managing clinical trials with the generation of Good Clinical Practice Technical Agreements as per ICH Q6 R1 both for BIO-CAT and our customers where needed.

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.

The Regulatory team at BIO-CAT Inc/BIO-CAT Microbials work closely with various industry groups such as the Enzyme Technical Association (ETA), the American Feed Industry Association (AFIA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) to name a few.