Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms

Health Canada is responsible for establishing standards and policies governing the safety and nutritional quality of foods sold in Canada. Health Canada controls the sale of novel foods in Canada via a mandatory pre-market notification procedure described under Division 28 of the Food and Drugs Regulations, known as the Novel Foods Regulation.

These guidelines assist the petitioner in preparing a novel food notification and explain what information is considered sufficient for a safety assessment. Novel food safety assessments are conducted by Health Canada's Food Directorate.

This document encompasses all novel foods derived from plant or microbial sources, whether whole foods, food products, or food ingredients. Safety assessment criteria for novel foods derived from animals are under development. Manufacturers or importers of novel foods derived from animal sources should consult with the Food Directorate to discuss what information is appropriate to the evaluation of the safety of a particular product.

  • The guidelines were updated in July 2022.

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