Novel foods: Overview
On this page
- Novel food
- Genetically modified (GM) food
- Health Canada's role in bringing novel foods to market
- Working together
- Guidelines and policies
Novel food
Simply put, novel foods are food products that are new or changed compared to existing foods. We review novel foods for their safety before they can be sold in Canada.
A novel food is:
- a substance, including a microorganism (a living thing so small you need a microscope to see it), that does not yet have a history of safe use as a food
- a food that has been manufactured, prepared, preserved or packaged by a process that:
- has not been previously used for that food, and
- causes the food to undergo a major change
- a food that comes from a plant, animal or microorganism that has been genetically modified so that the plant, animal or microorganism:
- shows characteristics that it didn't before
- doesn't show characteristics that it did before
- has 1 or more characteristic that no longer falls within the expected range
Genetically modified (GM) food
A genetically modified (GM) food is a food that comes from an organism (plant, animal or microorganism) that has had 1 or more of its characteristics changed on purpose. Organisms can be modified by different processes, including:
- conventional breeding techniques, like cross-breeding or mutagenesis (a change in the genetic make-up of an organism caused by chemicals or radiation)
- modern biotechnology techniques, such as genetic engineering
- gene editing
Genetic modification has been used to produce crops that are better at:
- resisting disease
- resisting pests that destroy crops
- tolerating the herbicides used to kill weeds
- delaying the ripening process to allow them to be transported long distances
- surviving drought conditions where water is scarce.
The next generation of GM foods may have direct benefits for consumers, such as:
- better taste
- improved nutrition
The majority of GM foods approved for sale in Canada are from plants, along with a few produced using GM microorganisms. We approved the first GM animal, AquAdvantage salmon, for sale in 2016.
Health Canada's role in bringing novel foods to market
Health Canada assesses the safety of all novel foods proposed for sale or advertising in Canada.
Manufacturers are required to submit detailed scientific data for review by Health Canada before such foods can be authorized for sale.
A team of Health Canada scientists carries out the assessment. The team includes:
- chemists
- nutritionists
- toxicologists
- microbiologists
- molecular biologists
The Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms outlines the specific criteria for the safety assessment of novel foods.
Health Canada also:
- stays up to date on all new scientific advances involving GM foods
- maintains a complete list of assessed novel foods (including novel GM foods)
- administers the provisions of the Food and Drug Regulations relating to novel foods
Working together
Health Canada has developed new guidance for novel foods. All correspondence and documents from meetings with stakeholders on this process are available online on our meetings and correspondence table.This includes meetings and correspondence in which opinions and information (including requests for information) are relayed with the intent to inform the development of the new regulatory guidance for novel foods.
Please sign up to our Consultation and Stakeholder Information Management System (CSIMS) to stay engaged with:
- meetings
- webinars
- publications
- consultations
- policy documents
If you want to know more please visit the transparency and privacy page.
Guidelines and policies
- Health Canada-FSANZ shared assessment process: Information for applicants
- Health Canada Guidance on the Novelty Interpretation of Products of Plant Breeding (Appendix 1 of the Guidelines for the Safety Assessment of Novel Foods)
- Health Canada Guidance on the Pre-Market Assessment of Foods Derived from Retransformants (Appendix 2 of the Guidelines for the Safety Assessment of Novel Foods)
- Pre-submission consultation procedures for novel foods, novel feeds and plants with novel traits
- The Food Directorate's Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods
- Guidance for Submitting Whole Genome Sequencing (WGS) Data to Support the Pre-Market Assessment of Novel Foods, Novel Feeds and Plants with Novel Traits
- Food Directorate Interim Policy on Foods from Cloned Animals
- Health Canada Position - High Pressure Processing (HPP) Is No Longer a Novel Process
Related links
- Share your thoughts: Foods derived from somatic cell nuclear transfer clones and their offspring policy update
- 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]
- Health Canada Scientific Opinion on the Regulation of Gene-edited Plant Products within the context of the Novel Food Regulations
- List of non-novel products of plant breeding for food use
- Biotechnology Notices of Submission
- Public Opinion Research Report on Consumers Views of Genetically Modified Foods
- Codex Alimentarius International Food Standards
- OECD Working Group on Safety of Novel Foods and Feeds
- FAO GM Foods Platform
- World Health Organization Genetically modified food
- ARCHIVED - Comments on the United States Food and Drugs Administration's Center for Veterinary Medicine's Animal Cloning: a Draft Risk Assessment
- Health Canada and Canadian Food Inspection Agency statement on the Séralini et al. (2012) publication on a 2-year rodent feeding study with glyphosate formulations and GM maize NK603
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