Understanding the 'Novel Food' Classification
The primary reason for allulose's restricted status in certain countries is its designation as a 'novel food.' The European Union, Canada, and other jurisdictions have a rigorous process for approving any food or food ingredient that was not widely consumed by their citizens prior to a specific date (May 15, 1997, for the EU).
This novel food framework mandates that manufacturers submit extensive data demonstrating the ingredient's safety for human consumption before it can be sold. The assessment can take several years to complete, and approval is only granted if the relevant food safety authority—such as the European Food Safety Authority (EFSA) or Health Canada—is satisfied that there are no public health and safety concerns.
The Allulose Regulatory Landscape: A Global Comparison
Regulatory bodies around the world take different approaches to evaluating new food ingredients. This difference in methodology explains why a substance like allulose can be available in one country but not another.
- United States: The U.S. Food and Drug Administration (FDA) follows a system known as 'Generally Recognized As Safe' (GRAS). Under this system, manufacturers can submit a dossier of scientific evidence to the FDA, or even self-affirm the GRAS status based on publicly available data and expert consensus. The standard for demonstrating safety is generally less time-intensive than the EU's novel food process.
- European Union (EU) and United Kingdom (UK): The EU's Novel Food Regulation requires a full pre-market authorization process overseen by the EFSA. The UK operates under similar assimilated regulations post-Brexit. As of late 2024, despite applications, allulose has not yet received a final authorization for use in the EU.
- Canada: Health Canada also considers allulose a novel food and requires a pre-market safety assessment. While it may be permitted in some Natural Health Products, it is not yet approved for general use as a food ingredient.
- Australia and New Zealand: These countries have a joint food standards code managed by FSANZ (Food Standards Australia New Zealand). After a multi-year review, FSANZ recently approved D-allulose as a novel food, permitting its sale within specified food categories.
Potential Health Concerns and Ongoing Research
Although non-approval is primarily a regulatory issue, some safety concerns have been raised. Critics point to the fact that while some short-term human and animal studies exist, there is limited long-term research on allulose's effects, especially regarding consumption in children or specific populations.
Gastrointestinal Side Effects
One of the most common issues cited with excessive allulose consumption is gastrointestinal distress. Like other sugar alcohols, it can cause bloating, gas, and diarrhea, especially at high doses. The Center for Science in the Public Interest (CSPI) has previously urged the FDA to require warning labels regarding this effect.
Other Unexplored Areas
Research is still evolving on allulose's full metabolic impact. Some scientists have raised cautious comparisons to other sweeteners like erythritol and xylitol, which have faced scrutiny over potential long-term health risks, although any similar link to allulose is not yet known. The high percentage of allulose that is excreted unchanged by the kidneys has also raised potential, though unproven, concerns regarding urinary tract health in specific contexts.
The Road to Global Approval
For companies seeking broader market access, navigating these differing regulatory systems is a major challenge. The Allulose Novel Food Consortium (ANFC), formed by manufacturers, is actively working to speed up the approval process in the EU and UK by compiling and submitting the necessary safety data. The recent approval in Australia and New Zealand is a positive sign for manufacturers and consumers, showing that a data-driven path to global availability is possible.
| Feature | US (FDA) | EU (EFSA) | Canada (Health Canada) | Australia/NZ (FSANZ) |
|---|---|---|---|---|
| Approval Status | Approved (GRAS) | Not yet approved | Awaiting approval (Novel Food) | Approved (Novel Food 2024) |
| Assessment Process | GRAS (Self-affirmed or notified) | Novel Food Regulation | Novel Food Assessment | Novel Food Assessment |
| Timeline | Less onerous | Multi-year assessment | Multi-year assessment | Multi-year assessment |
| Key Concern | Potential GI effects at high doses | Lack of full safety dossier | Lack of full safety dossier | Labeling requirements |
Conclusion: A Matter of Regulation, Not Safety Concerns
The perception that allulose is 'banned' is a misunderstanding rooted in the complex, country-specific world of food regulations. The lack of market authorization in regions like the EU and Canada is not an indictment of its safety but rather a reflection of differing regulatory frameworks and the extensive review period required for 'novel' ingredients. In countries where allulose is approved, such as the U.S., Japan, and recently Australia and New Zealand, regulatory bodies have determined it is safe for consumption within specified levels based on the available scientific evidence. While minor side effects can occur at high intakes, consumers can use allulose with confidence, mindful of their individual tolerance and the regulatory status in their location.
Visit the European Food Safety Authority for updates on their assessments.
Note: While not a ban, the status of non-approval prevents the commercial sale of allulose as a food ingredient within these regions. Consumers should always check local food and drug laws.
