Consultation: Proposed new guidance for Novel Food Regulations focused on plant breeding

Health Canada is seeking feedback on two new pieces of guidance for the Novel Food Regulations, focused on plant breeding. Our intent is to ensure the guidance:

• provides greater clarity, predictability and transparency regarding the regulation of novel foods derived from plants, including those developed using gene editing technologies
• provides an efficient and predictable pathway to commercialization for new products

How to participate

Review the summaries of the proposed new pieces of guidance for the Novel Food Regulations, focused on plant breeding:

• Proposed Changes to Health Canada Guidance on the interpretation of Division 28 of Part B of the Food and Drug Regulations (the Novel Food Regulations): When is a food that was derived from a plant developed through breeding a “novel food”?
• Proposed Health Canada Guidance on the pre-market assessment of foods derived from Retransformants under Division 28 of Part B of the Food and Drug Regulations (the Novel Food Regulations).

To obtain a copy of each guidance piece, please send a request by e-mail to bmh-bdm@hc-sc.gc.ca.

We welcome your feedback by e-mail or mail by May 24, 2021.

Please note: The Canadian Food Inspection Agency (CFIA) will be consulting soon on new guidance for the environmental release of new plant varieties as part of a separate public consultation process.

Who is the focus of this consultation

Health Canada wants to hear from:

• regulated parties
• interested stakeholders
• general Canadian public

Key questions for discussion

For each new piece of guidance, we would like commenters to consider the following:

• Does this new guidance improve clarity, helping plant developers and interested parties determine which plant-derived foods are, and are not, novel foods?
• Is it clear that plant developers and interested parties can consult with Health Canada to help make this determination?
• Does the guidance reference the most useful and appropriate resources for plant characterization? Are there alternative or additional resources you would recommend?
• Does the guidance align with the goal of a regulatory approach that is based on the level of food safety risk posed by specific products of plant breeding?
• Does the voluntary transparency initiative serve its purpose to inform Canadians what non-Novel gene-edited products are on the market? Can we do more to achieve this objective?
• Does the guidance on the pre-market assessment of foods derived from retransformants clearly describe the information requirements for the assessment of these products?

Related Information

• Division 28, Part B of the Food and Drug Regulations
• Guidance for the Safety Assessment of Novel Foods

Contact Us

Bureau of Microbial Hazards
Food Directorate
Health Canada
251 Sir Frederick Banting Driveway
Ottawa, Ontario K1A 0K9

Email: bmh-bdm@hc-sc.gc.ca