Safety Evaluation of the Non-GMO Food Enzyme Preparation D-Allulose 3-Epimerase

The evaluation stopped before approval

If you source enzymes for rare sugar production, this one needs your attention. The EFSA panel did not complete the safety assessment. That is the key fact in this 2024 paper (DOI 10.2903/j.efsa.2024.8702). The enzyme preparation contains D-allulose 3-epimerase. It is meant to turn fructose into D-allulose. No completed opinion came out of this review.

Background: what this enzyme is for

D-allulose is a special carbohydrate. It is a low-calorie sugar with growing demand in food formulations. One route to make it is enzymatic isomerization. Fructose goes in. D-allulose comes out. The enzyme in this paper is D-allulose 3-epimerase. The preparation is non-GMO, according to the title.

The intended process uses inactive cells. Those cells carry the enzyme. A manufacturer would immobilize them and use that material in production. The recommended use level is 27 mg TOS/kg of D-fructose. That number matters for dosing. It does not mean the enzyme is approved.

What the evaluation did

This is an EFSA safety evaluation, not a fresh lab study. The abstract lays out the intended use and the endpoint. The panel reviewed the food enzyme preparation. The preparation contains D-allulose 3-epimerase and is used to isomerize fructose. The proposed immobilization uses inactive cells. The recommended level is clear.

Then comes the critical result: the panel could not complete the assessment. Let me repeat that: no final safety conclusion. For a food enzyme, an incomplete assessment leaves the regulatory file open. It is not a rejection. It is also not an acceptance.

Key findings

Factor	Finding
Enzyme	D-allulose 3-epimerase
Source description	Non-GMO food enzyme preparation
Reaction	Isomerization of fructose to D-allulose
Process form	Inactive cells, intended for immobilized use
Proposed use level	Not above 27 mg TOS/kg D-fructose
Assessment outcome	Panel could not complete the evaluation

The table tells the story. You have a clear purpose and a clear dose. You do not have a complete safety opinion. That is the single fact a formulator or ingredient buyer should record.

What it means for manufacturers

Read this paper before you commit to a supplier. The product has an intended use and a recommended maximum dose. But the scientific review did not finish. That means you cannot cite this paper as proof of a favorable EFSA safety opinion.

Ask suppliers for the full dossier. Request the final EFSA opinion if one exists. Check whether a revised assessment has been published. The DOI in this article points to a 2024 status update, not to a completed safety approval. In the specialty carbohydrate world, that distinction changes sourcing decisions.

FAQ

Why does the paper report the dose as mg TOS/kg?

TOS is a standard metric in EFSA enzyme assessments. It gives a common basis for comparing enzyme preparations. This paper uses it to set the proposed ceiling at 27 mg TOS/kg D-fructose.

Is this a negative opinion?

No. The panel simply could not complete the evaluation. A negative opinion would state reasons and risks. This abstract states an outcome of incompleteness.

What should I ask an enzyme supplier?

Ask for the completed EFSA status, the source organism, and any final safety opinion. Ask if the preparation has been cleared in your target market. The paper you are reading now does not provide that clearance.

Where this leaves formulators

A safety evaluation without a conclusion is an open file. D-allulose has real potential as a functional sweetener. Manufacturers need approved tools to make it. This non-GMO enzyme preparation has a defined job and a proposed dose. What it lacks is a completed EFSA safety assessment. Treat this paper as an update, not as approval. The file remains open until more data arrive.