Novel Food Notifications (NFNs) are required for foods and food ingredients classified as novel under Division 28 of Canada’s Food and Drug Regulations. Manufacturers and importers must notify Health Canada and receive written confirmation that there is no objection to the product’s sale before advertising or selling a novel food in Canada.
Companies uncertain whether their product is novel can request a Novelty Determination, for which Health Canada has established a 60-calendar-day response timeline. If the food is determined to be novel, a pre-market notification supported by appropriate scientific safety evidence is required.
Health Canada’s submission management framework establishes a 410-calendar-day performance standard for pre-market submissions, including Novel Food Notifications. This is a target for communicating a decision on 90% of submissions, not a guaranteed approval timeline. The actual duration may depend on submission completeness, scientific complexity, and additional information requests.
A successful Novel Food Notification requires appropriate evidence addressing the ingredient’s identity, manufacturing process, history of use, dietary exposure, nutritional characteristics, toxicological safety, allergenicity, and other relevant considerations.
A Novel Food Notification (NFN) is a mandatory pre-market regulatory submission required when a food or food ingredient meets the definition of a novel food under Canada’s Food and Drug Regulations, Division 28.
The notification provides Health Canada with information about the food, its intended use, manufacturing process, and scientific evidence demonstrating that it is safe for human consumption.
Under Section B.28.002, manufacturers and importers cannot sell or advertise a novel food in Canada until they have notified Health Canada and received the required written notice confirming that the submitted safety information is sufficient.
Novel Food Notifications are assessed by Health Canada’s Food Directorate through a pre-market safety assessment process.
Unlike Natural Health Product (NHP) licensing, which evaluates products under the Natural Health Products Regulations, Novel Food Notifications are intended to establish the safety of foods and food ingredients under their proposed conditions of consumption.
For example, an ingredient supplier introducing a newly developed fermentation-derived protein may need to submit scientific evidence demonstrating the ingredient’s composition, manufacturing controls, anticipated dietary exposure, and toxicological safety before commercializing it in Canada.
Health Canada’s Guidelines for the Safety Assessment of Novel Foods provide the framework for preparing the supporting scientific documentation.
Section B.28.001 of the Food and Drug Regulations defines three categories of novel foods. The definition excludes supplemental ingredients and supplemented foods.
Foods Without a History of Safe Use
This category includes substances, including microorganisms, that do not have an established history of safe use as food.
For example, a manufacturer developing a concentrated botanical extract may need to demonstrate whether the same plant part, preparation, and consumption levels have historically been used safely in foods.
Evidence that a botanical has traditionally been consumed as a tea does not necessarily establish the safety of a highly concentrated extract intended for daily consumption.
Foods Produced Through Novel Manufacturing Processes
A food may be considered novel when it is manufactured, prepared, preserved, or packaged using a process not previously applied to that food and the process causes a major change.
A major change puts the modified food outside its accepted range of natural variation in at least one area, such as composition, structure, nutritional quality, recognized physiological effects, how the body metabolizes it, microbiological or chemical safety, or safe use.
For example, an innovative extraction or processing technology that substantially changes the concentration of naturally occurring compounds may introduce safety considerations not associated with the conventional ingredient.
A new manufacturing process does not automatically make a food novel. The process must result in a major change as defined by the regulations.
Certain Genetically Modified Foods
Foods derived from genetically modified plants, animals, or microorganisms may be considered novel when the modification results in characteristics that are new, no longer present, or outside the anticipated range for the organism.
For example, a genetically modified crop developed to produce a substantially different nutritional profile may require evaluation of its composition, nutritional effects, and potential allergenicity.
However, not all genetically modified foods are automatically classified as novel. Health Canada’s updated guidance on plant breeding recognizes that certain products do not require pre-market notification when they do not meet the applicable novelty criteria.
Manufacturers should therefore assess the resulting characteristics of the food rather than assuming that a particular development technology automatically determines its regulatory status.
Before preparing a full Novel Food Notification, manufacturers should determine whether their product meets the regulatory definition of a novel food.
Health Canada offers a formal Novelty Determination process for companies uncertain about their ingredient’s classification.
This process is optional and separate from the mandatory pre-market notification required for foods determined to be novel.
| Requirement | Novelty Determination | Novel Food Notification |
| Purpose | Determine whether a food is novel or non-novel | Establish the safety of a novel food before sale |
| Regulatory status | Optional classification process | Mandatory for foods meeting the novel food definition |
| Evidence required | Product identity, manufacturing information, history of use, and novelty rationale | Scientific safety data package appropriate to the product |
| Review timeline | 60 calendar days | 410-calendar-day overall performance standard |
| Favourable outcome | Letter of Non-novelty | Letter of No Objection |
| Market access | No NFN required if non-novel, subject to other requirements | Sale permitted following a favourable decision, subject to other requirements |
Under Health Canada’s Novelty Determination guidance, companies requesting a determination for a non-genetically modified food must complete a Novelty Determination Information Form.
Health Canada reviews the submitted information and provides a written determination within 60 calendar days of receiving the request.
If Health Canada determines that a food or ingredient is non-novel, it issues a Letter of Non-novelty. Health Canada maintains a separate public list for non-novel products of plant breeding intended for food use.If the ingredient is novel, a pre-market safety assessment is required before the product can be sold in Canada.
A novelty determination is not a substitute for a Novel Food Notification, and a Letter of Non-novelty does not exempt a product from other applicable food regulations.
Canada’s Novel Foods Regulations establish a mandatory pre-market notification process designed to ensure that novel foods are evaluated for safety before entering the Canadian marketplace.
Under Sections B.28.002 and B.28.003, manufacturers and importers must submit prescribed information to Health Canada and receive written confirmation before selling or advertising a novel food.
The process involves three principal stages.
1. Pre-Market Notification
The manufacturer or importer submits a Novel Food Notification containing the information prescribed under Section B.28.002(2).
The notification must identify the food, describe how it is produced, explain its intended use, and provide scientific evidence establishing its safety.
The prescribed information includes:
2. Pre-Market Safety Assessment
Health Canada evaluates the submitted scientific evidence to determine whether the novel food presents unacceptable risks under its proposed conditions of use.
The assessment may involve specialists in toxicology, nutrition, chemical safety, microbiology, and other relevant scientific disciplines.
Where the evidence is insufficient, Health Canada may request additional information or testing.
3. Regulatory Decision
If Health Canada determines that the submitted evidence establishes the food’s safety, it issues a Letter of No Objection.
This letter confirms that Health Canada has no objection to the sale of the novel food under the conditions evaluated.
If the evidence does not adequately establish safety, the submission may require further information or may be closed without a favourable decision.
Importantly, submitting an NFN does not itself authorize commercialization. The manufacturer or importer must receive the required written notice before selling or advertising the novel food.
Novel Food Notifications must include sufficient scientific information to demonstrate that the proposed food is safe for consumption.
Health Canada’s safety assessment guidelines establish evidence categories based on the product’s origin, characteristics, manufacturing process, and intended use.
Not every submission requires the same studies. Applicants should identify which evidence is relevant to their specific ingredient and provide a scientific justification where particular assessment categories do not apply.
History of Safe Use
A history of safe use assessment examines whether the ingredient has been consumed as food under comparable conditions without identified safety concerns.
Supporting evidence may include historical consumption records, scientific publications, traditional preparation methods, serving sizes, and documented exposure.
For example, an ingredient traditionally consumed in small quantities may require additional safety justification when proposed for use at substantially higher concentrations.
The evidence should establish comparability between the historically consumed material and the proposed commercial ingredient.
Dietary Exposure Assessment
Dietary exposure assessments estimate how much of the ingredient consumers may ingest through their normal diets.
Applicants may need to evaluate proposed food categories, ingredient concentrations, serving sizes, consumption frequency, and exposure among different population groups.
For example, an ingredient intended for beverages, snack foods, and nutritional products may require an assessment of cumulative intake across multiple food categories.
Higher-consumption scenarios should also be considered where relevant.
Nutritional Considerations
Nutritional evidence evaluates whether the novel food introduces meaningful changes to nutrient intake, nutrient availability, or nutritional quality.
Relevant information may include macronutrient composition, vitamins, minerals, amino acids, fatty acids, anti-nutritional factors, and other constituents.
For example, an alternative protein ingredient intended to replace conventional protein sources may require an assessment of amino acid composition and nutritional suitability.
Toxicological Considerations
Toxicological evidence evaluates whether consumption of the novel food could present unacceptable health risks.
Depending on the ingredient, Health Canada may consider:
The need for additional toxicological studies depends on the available evidence and the specific safety questions associated with the ingredient.
Allergenicity Considerations
Allergenicity assessments evaluate whether the novel food may introduce new allergens or increase exposure to known allergenic substances.
Relevant evidence may include the source organism’s allergenic history, protein characterization, sequence comparisons, and the effects of processing.
For genetically modified foods, assessments may also consider newly expressed proteins and their potential allergenicity.
Chemical and Microbiological Considerations
Chemical safety assessments may examine contaminants, processing residues, naturally occurring toxins, heavy metals, or other relevant chemical hazards.
For foods derived from microorganisms, additional evidence may be required concerning organism identity, pathogenicity, toxigenicity, microbiological stability, and the safety of the production strain.
For example, a fermentation-derived ingredient may require characterization of both the production microorganism and the final ingredient to establish that the manufacturing process does not introduce unacceptable safety risks.
Health Canada’s review process includes administrative verification, scientific screening, detailed safety assessment, and regulatory decision-making.
The Food Directorate’s pre-market submission management guidance establishes a performance standard of 410 calendar days for communicating a decision on 90% of submissions.
This broader performance standard operates alongside the statutory notification review periods established under Division 28.
Novel Food Notification Review Timelines
| Review Stage | Timeline | Description |
| Novelty Determination | 60 calendar days | Written determination of novel or non-novel status |
| Administrative verification | 10 calendar days | Verification of required submission components |
| Scientific screening | 45 calendar days from the date Health Canada issues the Letter of Acknowledgment. | Initial assessment for major scientific deficiencies |
| Screening deficiency response | 14 calendar days | Applicant response period for significant gaps identified during screening |
| Scientific review | Up to 368 calendar days | Includes scientific screening and the safety assessment. |
| Information request response | Up to 90 calendar days | Applicant response period for additional scientific information |
| Overall performance standard | 410 calendar days | Target for communicating a decision on 90% of submissions |
These periods are not necessarily sequential or additive. Administrative and scientific review stages form part of the broader submission process, while applicant response periods and other interruptions can affect the total elapsed time.
Statutory Review Requirements Under Division 28
Section B.28.003 of the Food and Drug Regulations establishes two important statutory periods:
Initial 45-day review: Within 45 days of receiving the notification, Health Canada must review the submitted information and either provide written notice that the safety information is sufficient or request additional scientific information.
Additional 90-day assessment: Where further scientific information is requested, Health Canada has 90 days after receiving that information to assess it and provide written notice if the evidence establishes that the food is safe for consumption.
These statutory provisions should not be interpreted as a guarantee that every novel food will receive a favourable decision within 45 or 135 days.
Health Canada’s broader submission management framework accounts for administrative processing, scientific evaluation, clarification requests, and internal decision-making.
Manufacturers should also allow time before submission for literature reviews, ingredient characterization, scientific testing, and preparation of the safety dossier.
Preparing a Novel Food Notification involves determining the correct regulatory pathway, evaluating available scientific evidence, and compiling a complete safety assessment package.
Step 1: Confirm the Product’s Novelty Status
Review the ingredient’s identity, manufacturing process, composition, history of consumption, and intended use.
Companies should consult Health Canada’s published novel food decisions and List of Non-novel Determinations.
Where the regulatory classification remains uncertain, applicants may request a formal Novelty Determination before preparing a full NFN.
Step 2: Conduct a Scientific Evidence Gap Assessment
Evaluate whether the available evidence adequately supports the proposed ingredient’s safety.
This may involve reviewing historical consumption data, published toxicological studies, ingredient specifications, dietary exposure estimates, and relevant manufacturing information.
For example, a company developing a new microbial ingredient may have extensive safety information on the source organism but limited data characterizing the final commercial ingredient.
An evidence gap assessment can identify whether additional analytical testing, toxicological studies, or other research is necessary.
Step 3: Prepare the Safety Assessment Data Package
Compile the administrative information prescribed under Section B.28.002(2), together with the scientific evidence relevant to the product.
The safety dossier should clearly identify the ingredient, explain how it is manufactured, describe its intended uses, and demonstrate how the available evidence supports safe consumption.
Applicants should organize their scientific documentation according to Health Canada’s safety assessment guidelines.
Where existing studies involve different ingredient preparations or manufacturing processes, a scientific rationale may be needed to demonstrate comparability.
Step 4: Submit the Novel Food Notification
Novel Food Notifications are submitted electronically through Health Canada’s pre-market submission system.
Applicants should follow the Guidance on Completing the Online Application and Transport Forms.
Following receipt, Health Canada assigns a case number and verifies that the submission contains the necessary administrative components.
Once accepted for scientific review, the applicant receives a Letter of Acknowledgment.
Step 5: Respond to Health Canada’s Information Requests
During scientific review, Health Canada may request additional information concerning ingredient identity, manufacturing processes, dietary exposure, toxicology, or other safety considerations.
For example, reviewers may question whether safety studies conducted on one ingredient preparation adequately support a commercially manufactured version with a different chemical profile.
Applicants should address each deficiency with relevant scientific evidence and provide a complete response within the specified deadline.
Step 6: Receive the Letter of No Objection
If Health Canada concludes that the novel food is safe under its proposed conditions of use, it issues a Letter of No Objection.
The product may then be sold in Canada under the conditions assessed, provided all other applicable regulatory requirements are satisfied.
Health Canada may also publish a decision document summarizing the scientific safety assessment and its conclusions.
Novel Food Notifications may experience delays or unfavourable outcomes when the scientific evidence does not adequately establish safety or when the submitted information is incomplete.
| Deficiency | Potential Consequence | Recommended Approach |
| Insufficient history of safe use | Novelty or safety questions remain unresolved | Provide documented evidence relevant to the proposed ingredient |
| Incomplete ingredient characterization | Uncertainty about product identity and composition | Include specifications, analytical data, and manufacturing information |
| Inadequate dietary exposure assessment | Potential consumer exposure cannot be evaluated | Assess intended food uses and cumulative intake |
| Insufficient toxicological evidence | Additional testing or scientific justification requested | Evaluate available studies and identify outstanding safety questions |
| Missing allergenicity information | Potential allergen risks remain unresolved | Provide an appropriate allergenicity assessment |
| Manufacturing inconsistencies | Existing safety evidence may not apply to the commercial ingredient | Establish comparability between tested and marketed materials |
| Incomplete information responses | Extended review or submission closure | Address every deficiency within Health Canada’s deadlines |
Companies can reduce avoidable delays by evaluating these issues before submission and ensuring that the scientific evidence directly supports the proposed commercial ingredient.
Not necessarily. Health Canada applies a case-by-case approach to evaluating the safety of novel foods.
The type and extent of evidence required depend on the ingredient’s characteristics, manufacturing process, history of consumption, anticipated exposure, and available scientific literature.
For example, a food ingredient supported by extensive published safety evidence and well-characterized manufacturing information may not require an entirely new toxicological testing program.
Conversely, a newly developed fermentation-derived ingredient with limited human consumption history may require additional studies to establish its safety.
Existing evidence must be scientifically relevant to the proposed commercial ingredient. Differences in composition, concentration, manufacturing methods, or exposure may limit the applicability of published studies.
A regulatory and scientific evidence gap assessment can help manufacturers determine whether additional research is necessary before committing to an extensive testing program.
Novel Food Notifications require specialized regulatory and scientific expertise to establish the appropriate submission strategy, evaluate supporting evidence, and prepare a complete safety assessment package.
With more than two decades of experience and over 24,000 regulatory and compliance projects, dicentra supports food manufacturers, ingredient suppliers, and brand owners seeking access to the Canadian market.
Our regulatory and scientific specialists assist with novelty determinations, history of safe use assessments, scientific literature reviews, ingredient characterization, dietary exposure evaluations, toxicological assessments, and preparation of Novel Food Notifications.
dicentra can also coordinate pre-submission consultations with Health Canada, prepare supporting scientific documentation, and respond to clarification requests and additional information requirements during regulatory review.
Where evidence gaps are identified, our team can help develop an appropriate scientific strategy to generate the additional data needed to support the submission.
Whether you’re introducing a new food ingredient, developing an innovative manufacturing process, or seeking Canadian market access for an ingredient already sold internationally, understanding Health Canada’s Novel Food Notification requirements is essential to an effective regulatory strategy.
Contact dicentra’s regulatory experts to discuss your Novel Food Notification, evaluate your supporting scientific evidence, and determine the appropriate regulatory pathway for the Canadian market.