Allulose isn’t technically banned in Europe. It’s classified as a “novel food,” which means it can’t be sold until it passes the EU’s safety authorization process. That process has stalled, leaving allulose in regulatory limbo while it’s freely available in the United States, Japan, South Korea, and other countries.
Novel Food, Not Banned Substance
The EU draws a legal distinction between banning a substance and simply not authorizing it. A ban means regulators reviewed something and determined it’s unsafe. With allulose, the situation is different: the European Food Safety Authority (EFSA) hasn’t completed its review, so the sweetener sits in a gray zone where it can’t legally be sold as food but hasn’t been declared dangerous either.
Under EU Regulation 2015/2283, any food that wasn’t commonly consumed in Europe before May 1997 needs formal authorization before it can reach store shelves. Allulose, a rare sugar found naturally in tiny amounts in figs, raisins, and wheat, wasn’t part of the European diet before that cutoff. So it triggers the novel food process, which requires a company to submit a detailed safety dossier, then wait for EFSA to evaluate it.
What Went Wrong With the Application
A company called CJ-Tereos Sweeteners Europe submitted an application to approve allulose as a novel food ingredient in April 2018. EFSA began its safety review and identified gaps in the data the applicant provided. This is routine. What happened next is not: despite being contacted multiple times, the applicant never responded to EFSA’s requests for additional information.
In 2025, EFSA published its final opinion. The conclusion was blunt: “the safety of the novel food, i.e. D-allulose, cannot be established.” That language doesn’t mean allulose is dangerous. It means EFSA didn’t receive enough data to say it’s safe, because the applicant went silent. The review essentially collapsed due to an unresponsive company rather than a finding of harm.
Why the US Approved It Years Ago
The FDA operates on a fundamentally different model. In the United States, companies can self-determine that an ingredient is “Generally Recognized as Safe” (GRAS) and notify the FDA. Allulose received its first GRAS designation in 2012, with additional notices following in 2014 and 2017. The FDA reviewed these submissions and raised no objections.
The practical difference comes down to who carries the burden. In the US system, the company asserts safety and the FDA can challenge it. In the EU system, the company must prove safety to EFSA’s satisfaction before selling anything. Neither approach is inherently better, but the EU path takes significantly longer. Novel food applications in the EU average about 2.5 years from submission to a published opinion, with some stretching past six years. When an applicant stops cooperating, the timeline effectively becomes infinite.
Allulose provides roughly 0.2 calories per gram, compared to 4 calories per gram for regular sugar. It has a negligible effect on blood glucose and insulin levels, which is why it has attracted so much commercial interest as a sugar substitute. The FDA even allows manufacturers to exclude allulose from total and added sugar counts on nutrition labels. None of these properties matter to EU regulators until the authorization process is complete.
The UK Is Moving Independently
Since Brexit, the United Kingdom runs its own novel food process through the Food Standards Agency (FSA). A German company called Savanna Ingredients submitted an allulose application to the FSA in June 2021, and the UK’s Advisory Committee on Novel Foods discussed it at a meeting in November 2024. The committee is evaluating whether the safety data is sufficient to recommend approval. If the UK authorizes allulose, it would create an unusual situation where a product is available in Britain but not across the English Channel.
What the Safety Data Actually Shows
The irony of allulose’s European situation is that a fair amount of human safety data already exists from research conducted elsewhere. Clinical studies on gastrointestinal tolerance found that healthy adults can consume about 0.4 grams per kilogram of body weight in a single sitting without digestive problems. For a person weighing around 130 pounds, that works out to roughly 24 grams at once. Severe diarrhea only appeared at higher doses, around 0.5 grams per kilogram. Researchers have suggested a maximum daily intake of 0.9 grams per kilogram of body weight, which for that same person would be about 54 grams spread across the day.
A meta-analysis of clinical trials in people with type 2 diabetes found that allulose had a negligible effect on blood sugar and a modest, statistically non-significant reduction in insulin response. These findings align with the basic biochemistry: the human body absorbs allulose in the small intestine but lacks the enzymes to metabolize it for energy, so most of it passes through and is excreted in urine.
None of this evidence was enough for EFSA, partly because the agency never got to evaluate it properly. The data gaps EFSA identified remain unknown publicly, but the core problem was the breakdown in communication with the applicant rather than alarming safety signals.
What It Would Take to Change
For allulose to become legal in the EU, a company would need to submit a new novel food application with a complete safety dossier and actually respond when EFSA asks follow-up questions. Given the average timeline of 2.5 years for novel food approvals, even an ideal scenario would put European availability several years out. The failed 2018 application doesn’t prevent a new one, but it does mean the process starts from scratch.
The commercial incentive is clearly there. Allulose has become one of the fastest-growing sweetener ingredients in the US market, showing up in everything from protein bars to ice cream. European food manufacturers and consumers are aware of its existence but have no legal way to use or buy it. Until a company commits to shepherding a complete application through EFSA’s process, that gap will persist.