Notice of intent to propose amendments to Division 28 of the Food and Drug Regulations (Novel Foods)
The purpose of this notice is to inform Canadians and interested stakeholders of Health Canada’s intention to develop and propose amendments to Division 28 of the Food and Drug Regulations (Novel foods). These proposed amendments are a result of Health Canada’s recent work to update its guidance on the Novel Food Regulations, specifically related to products of plant breeding. The primary objective of this work is to improve the clarity, predictability, and transparency of Division 28.
Under Division 28 of the Food and Drug Regulations, a food with no history of safe use, or a food produced using a novel process that causes a major change to the food, or a food that has been genetically modified to add, remove, or change a characteristic falls within the definition of a “novel food.” The Food and Drug Regulations prohibit the sale of novel foods unless they have undergone a mandatory pre-market safety assessment and are determined to be safe for consumption.
During 2020 and 2021, Health Canada undertook a project to clarify the interpretation of the definition of a novel food found in Division 28 for products of plant breeding. The result of this work was new guidance that serves to improve the clarity, predictability, and transparency of the requirements for industry stakeholders that are developing new food products from plants, including plants that have been developed using gene (genome) editing technologies. As the full scope of Division 28 covers a variety of products, the guidance on products of plant breeding was intended to be followed by complementary phases related to the remaining areas covered under the Novel Food Regulations.
In developing the new guidance it was determined that it is consistent with the scope of the regulation, but that amendments to Division 28 could help to more clearly define “novel food” in the regulations to reflect the interpretation reflected in the guidance. Given Health Canada’s intent to develop similar guidance for the remaining areas covered by the regulation (e.g., animals and microorganisms), the Department is seeking to develop and propose amendments that will provide clarity, predictability, and transparency for stakeholders, thereby reducing the need for additional amendments as new guidance is developed.
The guidelines on how the Department conducts pre-market assessments (Guidelines for the Safety Assessment of Novel Foods) was last updated in 2006. In light of Government commitments for regulatory modernization specifically to provide better clarity, predictability, and transparency for the agricultural industry, new and updated Guidelines for the Safety Assessment of Novel Foods will be developed. These new guidelines will follow as an additional phase that will occur once Division 28 has been amended.
While first and foremost maintaining the health and safety of Canadians and the Canadian food supply, the proposed regulatory amendments will be intended to:
- Support innovation and the introduction of new technologies which result in the production of safe food
- Maintain the product-based regulatory framework
- Better facilitate a risk-based approach where oversight is commensurate to the level of risk posed by a product
To achieve these aims, Health Canada will seek engagement from stakeholders across the food system to identify where Division 28 might benefit from amendments and key issues that need to be considered as part of the development of the proposed amendments. While Health Canada is engaged in the development of the proposed amendments, the newly developed guidance regarding products of plant breeding will be implemented by the Department. To facilitate the implementation of this guidance in the absence of regulatory amendments, the Canadian Food Inspection Agency (CFIA) has published a Notice to Industry – Implementation for Health Canada’s New Guidance for Novel Foods Regulations Focused on Plant Breeding, which summarizes the CFIA’s compliance and enforcement approach to Division 28.
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