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

Why this opinion matters

If you are evaluating enzymes for specialty carbohydrate production, this paper should be on your radar. EFSA reviewed a food enzyme preparation containing D-allulose 3-epimerase, intended to convert D-fructose into D-allulose. The conclusion is not what most suppliers want to hear. The panel could not complete the safety evaluation.

That outcome matters because D-allulose is a specialty carbohydrate. The enzyme is the production route. Before you can use the enzyme commercially in the EU, it needs a positive safety assessment. This paper does not deliver one.

Background: D-allulose and the enzyme

D-allulose is a specialty carbohydrate. Commercial production can use enzymatic isomerization of D-fructose. The enzyme in question, D-allulose 3-epimerase, catalyzes that reaction. It is the workhorse behind the process.

The enzyme preparation is described as non-genetically modified. That may appeal to some buyers, but it does not automatically clear the safety bar. The preparation contains inactive cells. In the intended process, those cells are immobilized and used to convert fructose.

The application proposed a maximum use level of 27 mg TOS/kg D-fructose. For formulators, that number gives a rough idea of the enzyme dose. But “proposed” is the key word. The panel did not validate that level.

What the evaluation covered

This is an EFSA scientific opinion, published under DOI 10.2903/j.efsa.2024.8702. The evaluation focused on the food enzyme preparation, not on D-allulose itself. EFSA’s job in this type of paper is to determine whether the enzyme preparation is safe for its intended use.

The intended use is clear from the abstract: isomerization of D-fructose to produce D-allulose. The enzyme format also matters. The active enzyme sits inside inactive cells, and the preparation is immobilized. Immobilization keeps the enzyme in the production system.

But the panel stopped. It could not complete the assessment. The abstract does not specify which data gaps caused the problem. For buyers, the status is what counts: no positive conclusion.

Key findings

The table below summarizes the core information.

Item	Detail
Enzyme	D-allulose 3-epimerase
Preparation status	Non-genetically modified
Reaction	Isomerization of D-fructose to D-allulose
Enzyme format	Inactive cells, immobilized
Proposed use level	Not more than 27 mg TOS/kg D-fructose
EFSA conclusion	Evaluation could not be completed

The most important finding is the last row. An unfinished evaluation is not the same as a negative one. It means the data package did not allow EFSA to reach a safety conclusion. For a formulator, that distinction matters less than it might seem. You still cannot cite this paper as proof of safety.

What this means for manufacturers

If you are buying D-allulose 3-epimerase, ask for the full EFSA opinion. Then ask for the additional data that addresses the panel’s concerns. A supplier may say their enzyme is “EFSA evaluated.” That is true. It is also incomplete. Evaluated and approved are different things.

This paper also highlights the difference between the enzyme and the product. D-allulose may have its own safety profile. But the enzyme used to make it must be assessed on its own. The production process, the immobilization method, and the residual enzyme activity all factor into the risk picture.

For buyers outside the EU, the paper is still useful. Many regulators look to EFSA as a reference. If EFSA could not finish the review, other jurisdictions may ask harder questions. You should, too.

The proposed dose is 27 mg TOS per kg D-fructose. That is a useful reference point, but it does not make the process safe by itself. The safety conclusion depends on the full data package. This paper shows that package was insufficient.

Frequently asked questions

Does this paper mean D-allulose is unsafe?

No. The paper evaluates the food enzyme preparation, not D-allulose. The safety of D-allulose as a food ingredient is a separate question.

Can I use this enzyme in my product based on this paper?

No. The panel could not complete the safety evaluation. Without a positive opinion, you cannot rely on this paper for regulatory approval.

What does 27 mg TOS/kg D-fructose mean?

It is a proposed dosing limit. TOS is the enzyme dose metric used in the application, and the dose is expressed relative to the fructose starting material. The applicant proposed that limit. The panel did not accept or reject it because the evaluation was not completed.

The message for the industry is straightforward. This EFSA opinion is an incomplete review, not a green light. Buyers should treat any supplier claim of approval with caution. The enzyme may eventually get a positive assessment, but this paper is not that assessment. Until then, the safe move is to demand more data and wait for a complete evaluation.