Is Allulose Approved in Europe? The Official Regulatory Update (2025)

As of June 2025, the European Food Safety Authority (EFSA) concluded that it could not establish the safety of allulose, effectively halting its approval for the European market. The question, is allulose approved in Europe, is often asked by consumers and food manufacturers, but the answer remains a firm 'no,' based on the EU's strict Novel Food Regulation.

Quick Summary

Allulose is not approved for use in Europe as a food ingredient. A June 2025 EFSA opinion found insufficient data to confirm its safety, stalling its authorization under EU Novel Food regulations.

Key Points

• Not Approved: Allulose is not a legally authorized food ingredient in the European Union.

• Novel Food Status: It is classified as a 'novel food' under EU law and requires a formal safety assessment.

• EFSA Denied Authorization in 2025: The EFSA issued a negative opinion in June 2025, citing insufficient data to establish long-term safety.

• Data Gaps: The rejection stemmed from missing data, notably a long-term chronic toxicity and carcinogenicity study.

• Application Incomplete: The applicant failed to provide additional requested information.

• New Application Needed: To gain approval, a new application with complete safety data is required.

• Contrasts with US Approach: The EU's stance differs significantly from the US FDA's 'Generally Recognized as Safe' (GRAS) status.

Allulose’s Failed Attempt at European Approval

The regulatory journey for allulose in the European Union has encountered a significant roadblock. For ingredients not widely consumed before May 1997, the EU's Novel Food Regulation (EU) 2015/2283 requires a comprehensive safety assessment. While allulose is approved in other regions, like the United States and Japan, the European pathway is more demanding.

The EFSA’s Negative 2025 Opinion

A key development occurred on June 5, 2025, when the European Food Safety Authority's (EFSA) Panel on Nutrition, Novel Foods and Food Allergens (NDA) issued a scientific opinion stating it could not establish the safety of D-allulose. This decision was based on limitations in the toxicological data and other deficiencies identified during the review of the application.

Reasons cited for the negative safety opinion included the absence of a reliable chronic toxicity and carcinogenicity study and insufficient human data to assess potential long-term health risks.

Frequently Asked Questions

Is allulose approved for sale in Europe?

No, allulose is not currently approved for sale as a food ingredient in Europe. Its application for market authorization was denied by the European Food Safety Authority (EFSA) in June 2025.

Why did the EFSA deny allulose's approval?

The EFSA denied the application because the submitted data was insufficient to establish the ingredient's safety. Critical gaps included the lack of a long-term toxicity and carcinogenicity study and insufficient human data.

Is allulose banned in Europe, or just not approved?

Allulose is not 'banned' but is unauthorized because it failed the required pre-market safety assessment as a novel food ingredient.

Can I import and use allulose for my own baking in the EU?

The sale of allulose-containing products within the EU is not authorized. Personal importation for consumption is a grey area and not recommended as customs could seize unauthorized products.

Is allulose considered a novel food in Europe?

Yes, it is classified as a 'novel food' because it was not widely consumed in the EU before May 1997 and requires authorization.

What is the difference between allulose's status in the US and Europe?

In the US, the FDA recognizes allulose as 'Generally Recognized as Safe' (GRAS). The EU requires a stringent EFSA safety assessment, which found the submitted data incomplete.

Could allulose be approved in Europe in the future?

Yes, it is possible if a new application with a comprehensive safety dossier is submitted and passes EFSA's review.

How does the EU review process for novel foods work?

An applicant submits a dossier for EFSA review. Based on EFSA's scientific opinion, the European Commission makes the final authorization decision.