Safety Evaluation of a Non-Genetically Modified Food Enzyme Preparation Containing D-Allulose 3-Epimerase

Safety assessment stalls at EFSA

EFSA's latest safety assessment of a D-allulose 3-epimerase food enzyme ended without a conclusion. That matters to anyone sourcing enzymes for allulose production. Here's what you need to know.

Background

European food enzyme approvals follow a strict review process. EFSA evaluates safety, allergenicity, and toxicological data. This particular enzyme preparation came from a non-GMO production route. It catalyzes the isomerization of D-fructose into D-allulose.

D-allulose is a specialty carbohydrate. Demand for it keeps rising in reduced-calorie formulations. That puts pressure on suppliers to deliver proven, approved enzymes.

The applicant proposed using inactive cells in immobilized form. Those cells contain the enzyme. This approach fits continuous allulose production systems.

What the study did

The assessment focused on a single food enzyme preparation. EFSA's panel reviewed the submitted toxicological data, compositional information, and exposure estimates. The intended use level was specific: no more than 27 mg TOS/kg D-fructose.

The applicant submitted a dossier with compositional data and toxicological studies. The panel examined all of it. That's where things stalled.

Key findings

The panel could not complete the evaluation. The data package was not sufficient. EFSA neither confirmed the enzyme's safety nor rejected it outright. The application remains open but incomplete.

Parameter	Application detail
Enzyme	D-allulose 3-epimerase
Production route	Non-GMO
Reaction	Isomerization of D-fructose to D-allulose
Delivery form	Immobilized inactive cells
Proposed maximum dose	27 mg TOS/kg D-fructose
EFSA outcome	Evaluation incomplete

The 27 mg TOS/kg figure stands out. It is the proposed ceiling for enzyme loading. Without a full safety conclusion, formulators cannot cite an EFSA opinion in their regulatory filings. The outcome is not a rejection. It is a pause.

What it means for manufacturers

For ingredient buyers, this is a waiting game. The enzyme has no authorized status in the EU until EFSA closes the data gaps. If you're developing allulose products for the European market, you cannot assume this enzyme will gain approval soon.

Ask your supplier three questions. Which data gaps did EFSA flag? What is their timeline for resubmission? Do they have alternative enzymes with completed EFSA assessments?

Product developers elsewhere should still pay attention. EFSA's review process is rigorous. A stalled dossier raises questions that other regulators may ask too. Non-GMO status does not change that. Regulatory acceptance depends on the full evidence package, not just the production route. For non-EU buyers, the immediate impact may be smaller, but regulatory signals travel across borders.

FAQ

Why did EFSA stop the assessment? The panel found the submitted data insufficient for a safety conclusion. The specific deficiencies were not detailed in the public abstract.

Can I use this enzyme in my products? Outside the EU, that depends on local regulations. Within the EU, no. Without a completed EFSA assessment, the enzyme lacks authorized food-processing status.

What does 27 mg TOS/kg D-fructose mean? It is the proposed maximum enzyme dose per kilogram of fructose substrate. TOS means total organic solids, a standard EFSA measure for comparing enzyme preparations.

Closing

EFSA left the door open for resubmission. That's the normal pathway. The applicant can supply additional data and try again. Buyers should monitor EFSA's public register for updates. Regulatory status can change quickly. Your sourcing strategy should be ready to move with it.