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Products that may be classified as novel foods in Canada can include those resulting from a manufacturing process not previously used for that food, those without a history of safe use as a food, or those that have been genetically modified. Before a novel food can be sold in Canada, Health Canada conducts a premarket assessment to evaluate its safety and compliance with applicable regulatory requirements.
The first step in the regulatory process is determining whether a product may be considered novel and submitting a Novelty Determination Information Form (NDIF) to Health Canada. Health Canada then determines whether the product meets the criteria for a novel food. If the product is determined to be novel, a premarket safety assessment is required before it can be marketed in Canada. Our team can support you throughout this process, from preparing the NDIF and managing the project through to facilitating a pre-submission consultation with Health Canada, providing strategic regulatory guidance, and preparing a comprehensive premarket safety assessment tailored to Canadian requirements.
Learn how we can help you navigate the complexities of the Canadian regulatory process and bring your novel food to market with confidence.