Novel Food Applications

If your food product results from a process not previously used for food, does not have a history of safe use as a food or has been genetically modified (e.g., genetically engineered, derived from biotechnology, etc.), it may be classified as a novel food.  Health Canada must assess all novel foods prior to sale in Canada according to the Food and Drugs Act and Regulations.

The safety assessment of novel foods includes the following aspects:

  • History of use;
  • Dietary exposure;
  • Detail of novel process (if applicable);
  • History of organism(s);
  • Characterization of derived line/strain (if applicable);
  • Genetic modification considerations (if applicable);
  • Nutritional considerations;
  • Toxicology considerations;
  • Allergenicity considerations; and
  • Chemical considerations.

Our regulatory team can help you correctly classify your product as a novel food, facilitate a pre-submission consultation with the government if desired, and file an appropriate application.

Looking for more information on novel food applications? Contact a member of our team today or email us directly at You may also request a customized quote and we will contact you with details within two business days.