Requesting a novelty determination for a food or food ingredient
On this page
- About novel food determinations
- How to submit a request for a novelty determination
- Review process
- Outcomes of novelty determinations
About novel food determinations
You can ask Health Canada for a novelty determination if you are unsure if your food or food ingredient is novel. This applies whether you are a:
- Canadian interested in food production
- food manufacturer
- food importer or their representative
Novel foods are outlined in Division 28 of the Food and Drug Regulations, which is also known as the Novel Foods Regulations. The regulations prohibit the advertisement or sale of a novel food before a notification is made to Health Canada by a petitioner. As part of the pre-market notification, you, as the petitioner, must provide information about the novel food so Health Canada can conduct a pre-market safety assessment of the product.
Once Health Canada has determined a novel food is safe for consumption, the Department will inform you by writing that the product can be advertised and sold in Canada. It is important for you to understand whether your products are subject to these regulations to ensure they comply with all statutory and regulatory requirements of the Food and Drugs Act and Regulations.
How to submit a request for a novelty determination
You can send your requests to:
Submission Management and Information Unit
Food Directorate, Health Products and Food Branch, Health Canada
251, Sir Frederick Banting Driveway, Postal Locator: 2202E
Ottawa, Ontario K1A 0K9
For food or food ingredients that are not genetically modified (non-GM), you must complete a Novelty Determination Information Form. You can request this form by sending an email to: firstname.lastname@example.org.
For genetically modified (GM) foods and food ingredients, you can contact Health Canada for assistance on the information required at the email above.
There are 2 steps to the review process:
- Step 1: Health Canada reviews the form and information to ensure they are complete.
- If the form and information are complete, we will determine the product’s novelty status.
- If a minor clarification is needed, we will send a letter asking for clarification and give you 15 calendar days to provide a sufficiently detailed response.
- We will close the requests if the response is still incomplete and the information is not sufficient to make a determination, or the response is received after the deadline. Upon closure, Health Canada will detail what information (if any) was missing
- Health Canada will accept a resubmission when you have provided all the required information.
- Step 2 (if needed): Health Canada reviews the information supplied following a clarification request, and provides a determination.
You will receive a written response on the novelty status of the food or food ingredient within 60 calendar days of receipt of the request.
Outcomes of novelty determinations
Health Canada will determine that the food or food ingredient is novel or non-novel, based on the information received at the time of the request.
Outcome 1: Novel
Health Canada will inform you by email that your novel food(s) or food ingredient(s) requires a pre-market safety assessment to be sold in Canada.
If you decide to proceed with a novel food submission, the foods or food ingredients will undergo a pre-market safety assessment. You can request a pre-submission consultation with Health Canada for assistance on how to make a submission.
Outcome 2: Non-novel
If a food or food ingredient is non-novel, we will:
- inform you by email that we will issue a Letter of Non-novelty for the product
- publish the non-novel determination on the List of Non-novel Determinations for Food and Food Ingredients.
You may request a new determination if new information becomes available. If you have concerns regarding the determination outcome, please contact us at the email above.
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