Detailed Description
Give a thorough description of your new food—where it comes from, how it's made, and what you plan to use it for.
Novel food is any food that hasn’t been widely eaten in Canada before. If you plan to introduce a new type of food to the market, Health Canada must verify its safety and proper labeling.
A Novel Food Submission is a process to get Health Canada approval to sell a new food product in Canada. Health Canada regulates the safety of food products and considers a food novel if it doesn’t have a history of safe use in Canada. So, if your food product is new to the Canadian market, you need to submit a Novel Food Notification before introducing it to the marketplace.
You’d need to file a Novel Food Submission if you’re one of the following:
Basically, anyone introducing a food that hasn’t been previously consumed to a significant degree in Canada needs to go through this process.
To process a novel food submission with Health Canada, follow these steps:
Give a thorough description of your new food—where it comes from, how it's made, and what you plan to use it for.
Provide scientific proof that your new food is safe for people to eat.
Explain what's in your food—like its vitamins, minerals, and other nutritional details.
If your food could trigger allergies, you need to list those potential allergens.
Explain how you're planning to use your food. Explain if there are any special rules or limits for how it should be used.
Finally, send all this info to Health Canada and wait for them to give you the green light before you start selling your new food in Canada.
Navigate the complex regulatory landscape with confidence and ensure your product’s safety and market readiness with GRAS Experts.
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Regulations can change. We’ll keep you compliant for the long haul.
Health Canada defines a novel food as one that has not been significantly consumed in Canada, has undergone a substantial change in its nutritional composition or safety profile, or is produced using innovative processes not previously applied to similar foods. These criteria ensure that any food introduced into the Canadian market meets the highest safety and regulatory standards before approval.
Health Canada requires a range of testing to evaluate the safety and quality of a novel food before it can be approved for sale. This includes toxicology studies, which assess potential health risks, and nutritional analysis to determine the food’s contribution to a balanced diet and to identify any changes in nutrient levels compared to conventional counterparts.
Allergen identification is also critical, especially for ingredients that may be new to the Canadian food supply. If your product contains proteins from novel sources, you’ll need to assess allergenic potential to protect consumers with sensitivities.
Microbiological safety testing is a separate and equally important component. This confirms that the food is free from harmful pathogens and meets hygiene standards during production and storage.
All of this testing supports compliance with Health Canada’s food safety and quality assurance standards. Having this data prepared and validated helps streamline the review process and build confidence in your submission.
Yes, GRAS-certified ingredients can be included in a novel food submission to support their safety. However, Health Canada may require additional evidence, such as specific toxicology studies or Canadian safety evaluations, to ensure the ingredient meets national standards. Certification of GRAS ingredients strengthens the submission but does not replace the need for a complete evaluation.
The timeline for Health Canada’s review of a novel food submission depends on the complexity of the food and the quality of the provided data. Typically, the process takes several months. Ensuring that all safety, nutritional, and allergen data are thoroughly documented, and following Health Canada’s guidelines precisely, can significantly reduce delays. GRAS Experts can assist in preparing a comprehensive submission to streamline the process.
If Health Canada identifies gaps or inconsistencies in your submission, they may request additional data or clarification. This could involve providing more detailed safety studies, revisiting allergen testing, or supplying further toxicology data. Promptly addressing these requests helps avoid delays. GRAS Experts can support you in preparing supplementary materials to meet Health Canada’s stringent standards efficiently.
A food safety audit is not mandatory but can strengthen a novel food submission by confirming compliance with safety and quality assurance certification standards. These audits provide a comprehensive review of production processes, ingredient handling, and potential contamination risks, ensuring your food meets Health Canada’s rigorous safety requirements. GRAS Experts offer tailored guidance to align your food safety practices with regulatory expectations.
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