Novel foods: Transparency initiative
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- About the transparency initiative (TI) process
- How the TI process is different than the novelty determination process
- How to notify a gene-edited plant product for the TI process
- TI process
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:
- the public
- plant developers
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:
- better understand how the novel foods regulatory framework applies to different types of gene-edited plant products
- ensure that gene-edited products which meet the definition of a novel food are notified to Health Canada for pre-market assessment
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:
- that do not meet the definition of a novel food
- for which no novelty determination has been sought from Health Canada
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:
- determine whether the product is or is not novel
- communicate this determination to the developer in writing
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
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.
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.
- If the form and information are complete, the department will determine if they agree with the developer that the foods derived from the gene-edited plant product aren’t novel.
- Please note: The department’s decision about a product’s status is not a safety assessment of the product. It is a review of the product descriptions/rationales provided by the developer to support the non-novel status of their product. The department will conclude whether or not these descriptions/rationales correctly support that the product is not novel.
- It’s unlikely that regulators and a developer would differ in their determination of a product’s novelty status, based on the Health Canada Guidance on the Novelty Interpretation of Products of Plant Breeding. However, the department reserves the right to request additional information if it believes that such foods meet the “novel food” definition. If the department determines the product meets this definition, a pre-market safety assessment would be required for the sale of that product in Canada. This not only applies to foods made from gene-edited plants, but all foods intended for sale in Canada.
- If the form and information aren’t complete, the department will send a letter to the developer indicating what information is missing. Developers are encouraged to resubmit their completed information form when ready.
Step 2: Health Canada publishes the information for a non-novel gene-edited plant product.
- Prior to publication, the department will send a written response to the developer, indicating that the confidential business information (CBI)-free information provided by the developer on their product will be published on Health Canada’s list of non-novel products of plant breeding for food use.
- As part of the TI product information form, the department instructs developers on how to prepare the specific CBI-free information as it will appear on the list.
- Health Canada will publish the CBI-free information for the specific non-novel gene-edited plant product on the list.
- Health Canada Guidance on the Novelty Interpretation of Products of Plant Breeding (Appendix 1 of the Guidelines for the Safety Assessment of Novel Foods)
- Notice to industry – Implementation for Health Canada's new guidance for novel food regulations focused on plant breeding
- Notice of intent to propose amendments to Division 28 of the Food and Drug Regulations (Novel Foods)
- Consultation: Proposed new guidance for Novel Food Regulations focused on plant breeding [2021-03-25]
- Consultation summary: Proposed guidance for Novel Food Regulations focused on plant breeding
- Scientific opinion on the regulation of gene-edited plant products within the context of Division 28 of the Food and Drug Regulations (Novel Foods)
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