Processing a Novel Food Notification/Submission in the Food Directorate

Standard Operating Procedure

• As the coordinating office, the Novel Foods Section (formerly Office of Food Biotechnology) is responsible for communicating with petitioners and receiving novel foods notifications and submission material and initiating the review process.
• The Novel Foods Section distributes the submission material to relevant Food Directorate bureaux, namely the Bureau of Chemical Safety, the Bureau of Nutritional Sciences, and the Bureau of Microbial Hazards for their respective reviews.
• In some cases, an environmental assessment of novel foods is conducted under proposed Environmental Assessment Regulations.
• Evaluators will review the novel food notification package and determine whether or not the product is considered novel under section B.28.001 of the Novel Foods Regulations. If considered novel, a safety assessment is then conducted as outlined in the Guidelines for the Safety Assessment of Novel Foods. Evaluators may make requests for additional information if relevant data has not been included in the original notification/submission package.
• At the completion of the safety assessment, if and only if all members of the evaluation team agree there are no health risks associated with the consumption of the novel food product in question, a proposal is drafted and presented to the Food Rulings Committee.
• If found acceptable by the Committee, the petitioner is notified in writing by the Director General that, based on the evaluation of the submitted data, Health Canada has no objection to the sale of the novel food product as human food in Canada as specified in the letter.