Novel foods: Transparency initiative

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About the transparency initiative (TI) process

Many plant varieties developed using gene editing technologies don’t meet the definition of a “novel food” and therefore aren’t subject to pre-market notification. However, there is interest in greater transparency regarding all products developed using these technologies that are present in the Canadian food supply. This increased transparency would benefit:

To address this interest, Health Canada introduced a voluntary transparency initiative (TI) process for gene-edited plants developed for food use that are not novel foods. The department invites developers to provide it with concise information about their product. The department will publish this information online for public access.

The goal of this initiative is to provide people in Canada with information on the types of gene-edited plant products that may be used as food in the Canadian market. This initiative will also help developers:

This initiative enhances public trust in these products and the regulatory system.

How the TI process is different than the novelty determination process

The TI process is specifically for gene-edited plant products:

As the product is non-novel, it doesn’t require a pre-market assessment per Division 28, Part B of the Food and Drug Regulations. However, the developer is informing Health Canada that their product will be used as a food in Canada to increase transparency regarding the food use of gene-edited plant products.

The novelty determination process is for any food or food ingredient (including gene-edited plant products) where a developer would like Health Canada to determine if their product meets the definition of a novel food. Based on the information the developer provides about the product, the department will:

If a developer submits a gene-edited plant product through the TI process, they are not expected to submit through the novelty determination process and vice versa.

How to notify a gene-edited plant product for the TI process

To notify Health Canada of a non-novel gene-edited plant product, please complete our TI product information form. You can request this form by sending an email to Health Canada’s Submission Management and Information Unit (SMIU):

Submission Management and Information Unit
Food Directorate, Health Products and Food Branch, Health Canada
251, Sir Frederick Banting Driveway, Postal Locator: 2202E
Ottawa, ON K1A 0K9
Email: smiu-ugdi@hc-sc.gc.ca

Plant developers are encouraged to provide their completed TI product information form to Health Canada’s SMIU at least 90 calendar days prior to commercialization of their product. While developers aren’t limited by how far in advance of commercialization they inform Health Canada, for the purposes of the TI process a developer should be able to provide an ‘earliest entry to market’ date. The TI process isn’t intended for theoretical products or products in early stages of development.

TI process

Health Canada will publish a summary of information regarding a product on its website within 60 calendar days from the date of receiving a completed TI product information form.

There are 2 steps in the TI process:

Step 1: Health Canada reviews the TI product information form and the submitted information to ensure completeness.

Step 2: Health Canada publishes the information for a non-novel gene-edited plant product.

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