Skip to main content

Regulatory Support

Providing Exceptional Regulatory Guidance for Every Customer

Our Regulatory Team at BIO-CAT are responsible for providing customers with a detailed overview of their ingredient/s thus demonstrating that their ingredient meets all FDA requirements as laid out in the Code of Federal Regulations (CFR).

Our Regulatory Experts are Here to Assist You

BIO-CAT and BIO-CAT Microbials are both individually registered as food facilities with the FDA. Section 415(a)(3) of the FD&C Act, as amended by section 102 of FSMA, requires a food facility to renew its registration with the FDA every other year. The renewal process changed slightly in 2020 in that a unique facility identifier (UFI) recognized as acceptable by the FDA had to be included in the application. The UFI will be used to verify that the facility specific address associated with the UFI is the same address associated with the facility’s registration.

Support Provided:

  • GRAS Status
  • Allergen Information
  • Country of Origin
  • Animal Derivative, BSE/TSE
  • GE/GMO and non-GMO
  • Halal certifications
  • Kosher certifications
  • Organic
  • SDS
  • USMCA documentation

Extraordinary Regulatory Expertise

The BIO-CAT Regulatory team is well known for its commitment and delivery of fast turnaround time for requests, processing 12,000 queries annually.

Experience and contacts with US FDA, Health Canada and other international markets.

Learn About Our Services

Custom Formulation

The right enzyme or microbial for your precise application

Custom Blending

Large blending capacity, production and packaging

Custom Product Development

Your partner in innovating new products

Custom R&D Projects

From basic research through development and tech support

Quality Assurance & Control Support

Every product rigidly tested in our in-house lab

Regulatory Support

Regulation review, safety, import/export and more

Explore our Resources

Learn about enzymes, probiotics and microbials in our resource library.

Binders in a row

Let’s Develop Something Together

We’re as passionate as you are about scientific innovation that matters

Learn More