Notice of Intent: To develop and publish new guidance for the Novel Food Regulations, focussed on plant breeding
The purpose of this notice is to inform Canadians and interested stakeholders of Health Canada’s intention to develop and publish new regulatory guidance for novel foods. New guidance will provide clarity and predictability regarding the regulatory interpretation and oversight of novel products of plant breeding.
Under Division 28 of Part B of the Food and Drug Regulations, a food with no history of safe use, or a food produced using a process that causes a major change, or a food that has been genetically modified to add, remove, or change a trait falls within the definition of a “novel food”. Division 28 of Part B of the Food and Drug Regulations prohibits the sale of novel foods unless they have undergone a mandatory pre-market safety assessment and are determined to be safe for consumption. Plant breeders can use a range of techniques to achieve desired characteristics in their crops. Depending on the characteristics of the final product, crops developed by plant breeders could be considered novel and therefore require a mandatory pre-market safety assessment prior to sale. The development of new guidance will serve to improve the transparency and predictability of the requirements for industry stakeholders that are developing new food products from plants, including plants that have been gene-edited.
Guidelines on how the Department conducts pre-market assessments (B.28.002) was last updated in 2006. In light of Government commitments for regulatory modernization specifically to provide better clarity and predictability for the agricultural industry, new and updated guidelines for novel foods will be developed.
While first and foremost maintaining health and safety, the revised regulatory guidance is intended to:
- Support innovation and the introduction of new technologies which result in the production of safe food
- Maintain the product-based system
- Better facilitate a risk-based approach where oversight (i.e., level of review, data requirements, etc.) is commensurate to the level of risk
The full scope of Division 28 of the Food and Drug Regulations covers plants, animals and microorganisms. This guidance will be focussed on plant breeding, and will be followed in the future by complementary phases related to the remaining areas covered under the Regulations.
Health Canada will work closely with the Canadian Food Inspection Agency, and Agriculture and Agri-Food Canada during the development of the draft guidance.
Health Canada will be publishing the draft guidance online for a 60-day consultation period in January 2021.
Health Canada will engage experts from industry, academia and other sectors to provide scientific information and advice to inform the development of the guidance. As this work will be aligned with Health Canada’s Regulatory Transparency and Openness Framework initiative, all meetings and correspondence as well as all documents shared between Health Canada and experts from industry, academia and other sectors will be published online. All scientific information and advice submitted to Health Canada in order to inform the development of the guidance will not be considered confidential.
Any comments regarding the above Notice should be directed to:
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