Safety Evaluation of the Non-Genetically Modified Food Enzyme D-Allulose 3-Epimerase

If you are buying D-allulose enzyme, check the EFSA opinion before you commit. The paper in front of you is a safety evaluation of a food enzyme containing D-allulose 3-epimerase. It was published with DOI 10.2903/j.efsa.2024.8702. The intended use is straightforward: convert D-fructose into D-allulose. The outcome is not. The expert panel could not complete the assessment.

Why this enzyme matters

D-allulose 3-epimerase is the enzyme used for the isomerization of fructose to produce the specialty carbohydrate D-allulose. For formulators, that reaction is the heart of D-allulose production. For ingredient buyers, the regulatory status of that enzyme is just as important as its activity.

The preparation in this paper is presented as non-genetically modified. It contains non-viable cells. Those cells are immobilized and intended for use in the production of D-allulose. The suggested use level is no more than 27 mg TOS per kg of D-fructose. TOS means total organic solids. 27 mg is a specific, low number. But it was not enough to settle the safety question.

What the study did

This is an EFSA safety evaluation, not a lab experiment. The panel reviewed the food enzyme preparation containing D-allulose 3-epimerase. They looked at the intended use in fructose isomerization. The preparation is non-genetically modified. It is meant to work as immobilized, non-viable cells.

The panel had one task: decide whether the data support a conclusion of safety. They could not do it. The paper reports that the expert panel was unable to complete the evaluation. There is no approval. There is no “safe as used” finding. There is only an incomplete assessment.

Key findings

Here is what the paper actually says, in condensed form.

Parameter	Finding
Enzyme	D-allulose 3-epimerase
Production strain	Non-genetically modified
Reaction	Isomerization of D-fructose to produce D-allulose
Form	Non-viable cells, immobilized
Proposed use level	Not more than 27 mg TOS/kg D-fructose
Assessment outcome	Expert panel unable to complete safety evaluation

That last line is the one that matters most. An incomplete evaluation is not a safety defect finding. But it is also not a safety pass. For a regulatory professional, it means the data package has gaps. For a formulator, it means the enzyme lacks the official green light you might need for a market launch.

What this means for manufacturers

Do not treat this paper as a rejection of D-allulose. Treat it as a flag on the enzyme itself. The panel could not finish the job with the data provided. That is a solvable problem, but the supplier must solve it. Until then, the enzyme preparation carries regulatory risk.

Ask your supplier about EFSA status first. Then ask about the production strain. Then ask for the recommended use level and compare it to the 27 mg TOS/kg figure in this paper. If the supplier cannot show a completed safety evaluation, you are carrying that risk in your supply chain.

The EU is not the only market, but it is a demanding one. A positive EFSA opinion is a baseline for many buyers around the world. An incomplete one is not. If you are sourcing D-allulose enzyme, make sure you know which version of the dossier you are buying.

FAQ

What is D-allulose 3-epimerase?

It is the food enzyme used to convert D-fructose into the specialty carbohydrate D-allulose. It catalyzes the isomerization reaction that makes D-allulose production possible.

Did EFSA approve this enzyme?

No. The expert panel could not complete the safety evaluation of this food enzyme preparation. No final safety conclusion was reached.

What should I ask an enzyme supplier before buying?

Ask about the EFSA assessment status. Ask whether the production organism is genetically modified. Then ask for the recommended use level in mg TOS per kg of substrate and compare it with the 27 mg TOS/kg level in this paper.

This paper does not mean D-allulose is off the table. It does not mean the enzyme is unsafe. It means the evidence is incomplete. That is a different problem, and it is one a supplier can fix. Until the panel can finish its work, this specific preparation stays in regulatory limbo. Make sure you know exactly what you are buying.