Novel Food Notifications and Food Additive Submissions

Novel Food Notifications must be completed and submitted to Health Canada prior to selling a novel food in the Canadian marketplace. The advancements in the food industry and the global nature of food supply means that the introduction of foods not previously available in the Canadian marketplace is inevitable. However, before a novel food can be sold on the Canadian market it must first go through Health Canada’s mandatory pre-market notification requirement.

Food Additive Submissions are required to be completed to permit a new food additive or new uses of already approved food additives to be used in retail food in Canada.

Our Services for Novel Food Notifications and Food Additive Submissions Include:

  • Review your product for regulatory strategy (to determine if product or ingredient is novel or can be established to be non-novel)
  • Arrange pre-submission meetings with the Food Directorate
  • Prepare a safety data package for notification submission, such as: history of use, dietary exposure, detail of novel process, history of organism(s), characterization, genetic modification considerations, nutritional considerations, toxicology considerations, allergen considerations, chemical considerations and microbiological considerations
  • Prepare statutory requirements for submissions on food additives, such as: description of the food additive, including chemical properties, purpose and level of use, efficacy, residue data and proposed maximum level of use, analytical method, safety data, and label content
  • Prepare other supporting information, such as: consumer benefits and food quality considerations, and compiling information on evaluations, approvals, and authorizations of other health authorities
  • Correspond with Food Directorate regarding novel food approval
  • Respond to government clarification requests (CRs) and information request notices (IRNs)