The Novel Food Designation by Health Canada
Health Canada's Food and Drug Regulations classify allulose as a "novel food ingredient" because it did not have a history of widespread use in Canada before May 15, 1997. This status is not a ban, but rather a temporary restriction pending a full pre-market safety assessment. The process ensures that any new food ingredient entering the Canadian market is safe for human consumption. This is a key distinction from other jurisdictions, such as the United States, which operates under a different system.
What Constitutes a 'Novel Food'?
According to Health Canada, a food can be considered novel if it meets one of three criteria:
- It is a substance that has not previously been used as food.
- It is produced using a process that has not previously been used for food.
- It has been genetically modified in a way that creates a significant change in its nutritional composition or safety profile.
Allulose, despite being found naturally in small quantities in foods like figs and raisins, is commercially produced using a novel process that converts fructose from corn. This manufacturing method triggers the novel food classification in Canada, requiring a thorough review before it can be sold in food products.
The Rigorous Pre-Market Assessment Process
Before a novel food like allulose can be authorized for sale, its manufacturer must submit a comprehensive dossier to Health Canada's Food Directorate. This application must include extensive data covering several key areas:
- Identity and Production: A detailed description of the substance, including its source, manufacturing process, and chemical identity.
- Composition: Information on the finished food's composition, including nutritional data and levels of potential contaminants.
- Toxicology: Extensive data from toxicology studies to assess potential health risks.
- Human Tolerance: Evidence demonstrating how the human body processes the ingredient and its potential for adverse effects.
- Dietary Exposure: Estimates of consumer intake and potential exposure to the ingredient.
As of mid-2025, Health Canada's review of allulose remains ongoing, and no application has been completed and added to the official list of authorized novel foods. This lengthy, science-based process is the reason for its current unavailability in the Canadian retail market.
How Canada's Approval Differs from the United States
Canada's regulatory approach stands in contrast to that of the United States. The U.S. Food and Drug Administration (FDA) has classified allulose as "Generally Recognized as Safe" (GRAS). Under this system, manufacturers can declare an ingredient as GRAS based on scientific evidence, often through a panel of experts, and then voluntarily notify the FDA. Health Canada, however, requires its own independent, comprehensive review and authorization for any novel food, even if it has received GRAS status in the U.S..
Can I Import Allulose into Canada for Personal Use?
While commercial sale is restricted, Canadian law does not explicitly prohibit an individual from importing allulose from another country for personal consumption. Many Canadians purchase allulose online from U.S.-based retailers. However, there are important considerations for doing so:
- No Canadian Labeling: The product will likely lack bilingual Canadian packaging and labeling, as it was not intended for the Canadian market.
- Customs Issues: There is a small risk that customs officials could flag and hold a large shipment, though this is uncommon for personal-use quantities.
- Nutrient-Content Requirements: Imported food products that do not meet Canadian packaging and nutrient-content standards could be in a regulatory gray area.
Available Alternatives to Allulose in Canada
For Canadians seeking low-calorie sugar alternatives, several approved options are available in stores. While none offer the exact taste or functional properties of allulose, they provide viable substitutes depending on the application:
- Monk Fruit: A natural, zero-calorie sweetener available in extracts or blends. Health Canada has approved the use of monk fruit extract.
- Stevia: A natural, zero-calorie sweetener derived from the stevia plant. It is widely available in Canada, though some find it has a slight aftertaste.
- Erythritol: A sugar alcohol that is calorie-free and does not spike blood sugar. It's often used in ketogenic baking but can have a cooling sensation and cause digestive issues in large amounts.
- Xylitol: Another sugar alcohol with a similar sweetness to sugar, though it has some calories. Like erythritol, it can cause gastrointestinal discomfort if overconsumed.
Allulose vs. Approved Canadian Alternatives
| Feature | Allulose | Erythritol | Stevia | Monk Fruit | Xylitol |
|---|---|---|---|---|---|
| Health Canada Status | Not yet approved | Approved | Approved | Approved (extract) | Approved |
| Effect on Blood Sugar | Minimal/negligible | Minimal/negligible | Minimal/negligible | Minimal/negligible | Low glycemic index |
| Caloric Content | Approx. 0.4 kcal/g | 0.24 kcal/g | 0 kcal/g | 0 kcal/g | 2.4 kcal/g |
| Taste Profile | Very similar to sugar, no aftertaste | Clean taste, can have a cooling effect | Can have a bitter aftertaste | Clean, strong sweetness | Similar to sugar |
| Baking Properties | Browns and caramelizes like sugar | Does not brown, can crystalize | No caramelization, high concentrations can be bitter | No caramelization | Doesn't brown |
| Digestive Issues | Can occur in high doses | Can occur, especially in high doses | Rare, but possible | Rare | Can occur, especially in high doses |
Conclusion
The reason you can't buy allulose in Canada is not because it is banned, but because it has yet to be approved by Health Canada under its novel food regulations. Unlike the US, Canada requires a rigorous, independent pre-market safety assessment for any ingredient with a limited history of use. While the review process is underway, there is no set timeline for its completion. For now, Canadians must rely on other approved sweeteners or consider importing allulose for personal use, acknowledging the limitations regarding labeling and regulatory compliance. Continued advocacy from consumers and industry could potentially accelerate the process, but the final decision rests on the outcome of Health Canada's science-based review.
- For more information on the safety assessments conducted for novel foods, consult Health Canada's website: https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/safety-assessments-novel-foods.html
The Path to Allulose Approval in Canada
The future availability of allulose in Canada depends entirely on Health Canada's ongoing safety evaluation. Manufacturers, potentially through consortiums, have to provide sufficient data to satisfy Canadian regulators that allulose is safe for widespread use in food products. Until that evaluation is complete and approval is granted, allulose will not be authorized for sale in Canadian food items. The timeline remains uncertain, and consumer demand along with successful submissions will be key to its eventual entry into the Canadian market.
Current Allulose Status
It is important for consumers to understand that even if they can find allulose sold by a small, non-compliant importer online, it does not mean the product has met Canadian safety standards. Products sold outside of the official Health Canada approval process do not carry the same consumer protections. This is why official, Canadian-labeled products containing allulose will not appear on store shelves until the regulatory process is fully complete.
- Important: Always consult a healthcare professional before making significant changes to your diet, especially if you have underlying health conditions like diabetes.
What if Allulose is Never Approved in Canada?
While an outright refusal of approval is possible, it is not the most likely outcome, provided sufficient safety data is submitted. More likely, the process will continue at Health Canada's pace, with approval coming eventually. However, should the process fail, or if new safety concerns arise, Health Canada could deny approval, citing a lack of sufficient long-term data, similar to initial European reviews. In this case, other approved sweeteners will remain the primary options for Canadian consumers.
