Why Allulose Is Banned in the EU: Novel Food Rules and EFSA 2025

Allulose is not sold in the European Union because it has never been authorized under the bloc’s novel food rules, and in June 2025 the European Food Safety Authority (EFSA) concluded that its safety “cannot be established” from the data on file.1 So the short answer to why allulose is banned in the EU is that it was never approved in the first place, and the last application under review collapsed when the applicant stopped responding to EFSA’s requests for information.

Not Banned, But Not Authorized

The distinction is technical, and for a shopper it makes no difference. Allulose is not on a list of prohibited substances. It is simply absent from the list of foods and ingredients that are legally allowed to be placed on the EU market. Under EU food law, that absence is itself the prohibition: if a novel food has not been authorized, it cannot be sold, used as an ingredient, or marketed anywhere in the Union.

That is why you will not find allulose in European supermarkets, in packaged products made for the EU market, or in bakery ingredients sold to European food manufacturers. Companies that place an unauthorized novel food on the EU market face product seizures, mandatory recalls, and penalties under the national laws that implement the Novel Food Regulation.

What EFSA Concluded in June 2025

The immediate cause of allulose’s continued absence is a specific scientific opinion. In June 2025, EFSA’s Panel on Nutrition, Novel Foods and Food Allergens published its assessment and concluded that “the safety of the NF, i.e. D-allulose, cannot be established.”

Read that phrasing carefully. EFSA did not find allulose dangerous. It found the evidence too thin to confirm it is safe, which under the EU’s precautionary approach produces the same result. The reason the evidence was thin is procedural. EFSA had identified gaps in the applicant’s dossier covering:

  • the sweetener’s identity and specifications
  • the production process
  • proposed uses and use levels
  • genotoxicity data
  • human studies supporting safety at intended intake levels

These are standard requirements for any novel food application. EFSA sent a formal request for the missing information. The applicant did not respond, and EFSA closed out its assessment with the only conclusion available to it on an incomplete file.

Why Allulose Falls Under Novel Food Rules

The EU regulates unfamiliar food ingredients through Regulation (EU) 2015/2283, known as the Novel Food Regulation. Any food not consumed to a significant degree in the EU before 15 May 1997 is a “novel food” and cannot be sold until it clears a centralized safety review. Allulose was virtually unknown in Europe before that date, so it falls squarely inside the category.

Getting out of that category requires a company to submit a detailed dossier to the European Commission covering the food’s identity, production, composition, intended uses, and safety evidence. The Commission asks EFSA to run an independent risk assessment. Only after a favorable EFSA opinion can the Commission authorize the ingredient.

The system is deliberately cautious. When scientific evidence is incomplete, the default answer is no. That is the precautionary principle in action, and it explains why substances cleared elsewhere can sit unavailable in Europe for years.

Approved Almost Everywhere Else

The EU’s position is unusual among major markets. Several regulators have looked at allulose and cleared it:

  • In the United States, the FDA has accepted allulose as Generally Recognized as Safe for use as a sweetener in a wide range of foods and beverages, and allows manufacturers to exclude it from the “Total Sugars” and “Added Sugars” lines on Nutrition Facts labels.
  • Japan, Mexico, Singapore, and South Korea have all approved allulose for food use.
  • Food Standards Australia New Zealand approved allulose as a novel food, permitting its sale as a tabletop sweetener and as an ingredient in manufactured foods. Products in certain categories must carry a warning that excess consumption may have a laxative effect.
  • In the United Kingdom, which runs its own novel food process through the Food Standards Agency since Brexit, an application from Savanna Ingredients is at the risk assessment stage. No authorization has yet been granted.
  • Health Canada classifies allulose as a novel food and has not published a completed safety assessment, so it cannot legally be sold as a food ingredient in Canada.

Between 2018 and 2020, several companies filed EU applications, including CJ-Tereos Sweeteners Europe, Petiva Europe, Samyang Corp., Tate & Lyle, and Savanna Ingredients. The regulators in the U.S., Japan, and Australia looked at broadly the same underlying science and reached a favorable conclusion. The EU never got that far. It did not reject allulose on the merits; the review stalled when the applicant stopped engaging with EFSA’s data requests.

What It Means If You Live in the EU

You will not find allulose on shelves, and you will not find it listed as an ingredient in products made for the European market. EU-based food manufacturers cannot use it. Imports for commercial sale are not allowed.

Products containing allulose sometimes appear on European e-commerce platforms shipped from outside the EU. Customs authorities do not routinely screen for allulose, and the legal prohibition targets commercial sale rather than personal consumption. The products themselves, however, are technically non-compliant with EU food law, so ordering from abroad sits in a regulatory gray zone rather than a clearly permitted one.

Could Allulose Be Approved Later?

Yes, in principle. The June 2025 opinion closed out the application that was under review, but it does not prevent new submissions. A company would need to file a fresh dossier addressing every gap EFSA identified: full identity and specifications, a complete production description, defined uses and use levels, genotoxicity studies meeting EFSA’s standards, and human clinical data at the intended intake levels.

Future applicants may be able to draw on the FSANZ record from Australia and New Zealand, which set specific maximum permitted levels for different food categories and an energy factor of 2 kilojoules per gram for labeling. Those figures could serve as reference points for an EU submission.

Timelines are uncertain. EFSA typically takes 9 to 18 months to deliver an opinion once it has a complete dossier, and Commission authorization adds more time after that. Until a new applicant carries a full file across the finish line, allulose will stay off the European market, not because the science says it is harmful, but because the paperwork was never finished.

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