Safety Evaluation of the Food Enzyme Preparation D-Allulose 3-Epimerase from a Non-Genetically Modified Source

EFSA cannot clear D-allulose 3-epimerase yet. The safety assessment is still open. That matters if you make or buy enzymes for D-allulose production.

The European Food Safety Authority published this scientific opinion in 2024 under DOI 10.2903/j.efsa.2024.8702. The enzyme converts D-fructose into D-allulose. The report title describes it as non-genetically modified. The preparation contains inactive cells. Those cells are intended for use in an immobilized form. The proposed working level is no more than 27 mg TOS per kg of D-fructose.

Why this affects formulators

D-allulose is a specialty carbohydrate. It comes from an isomerization reaction. That reaction needs an enzyme with the right specificity and process stability. If the enzyme cannot get a clean safety opinion, product development stalls. You may have great pilot results, but no regulatory green light. This EFSA opinion is a gate, not a footnote.

What the assessment covered

The panel looked at a food enzyme preparation containing D-allulose 3-epimerase. The enzyme source is non-genetically modified. The active enzyme sits inside inactive cells. Those cells are immobilized for the production process. That format keeps the catalyst in place and allows repeated use.

The proposed use level is limited to 27 mg TOS/kg D-fructose. TOS matters because it forms the basis for dietary exposure estimates.

The panel's job was safety evaluation. It did not judge yield, conversion rate, or process economics. It asked one question: is this enzyme safe under the intended conditions of use? The answer is not finalized.

Key findings

The central finding is straightforward. The EFSA panel could not complete the assessment. It did not conclude that the enzyme is safe under the proposed conditions. It also did not say the enzyme is unsafe. It said the data do not support a finished evaluation.

Parameter	Reported detail
Reaction	Isomerization of D-fructose to D-allulose
Enzyme	D-allulose 3-epimerase
Source status	Non-genetically modified
Form	Immobilized inactive cells
Proposed use level	≤ 27 mg TOS/kg D-fructose
EFSA outcome	Evaluation not completed

That table is the whole story in six rows. For a B2B buyer, the missing row is "approved." Without that, you are working with conditional risk.

What this means for manufacturers

Treat this dossier as incomplete. Verify what your supplier has submitted to EFSA. Ask if additional toxicology or exposure data are expected. Ask if the proposed use level matches yours. If your process uses more than 27 mg TOS/kg D-fructose, you need a different safety argument. This EFSA opinion does not cover that scenario.

You also need a market strategy. A pending safety opinion blocks full EU authorization. That may not stop production in every region, but it will limit your options. Good suppliers will share the regulatory status openly. Silence is a red flag.

FAQ

Does an incomplete evaluation mean the enzyme is dangerous?
No. It means the evidence package was insufficient. Dangerous would be a different conclusion.

Will this enzyme get approved?
Probably, if the missing data get submitted. But "probably" is not an approval. Wait for the next EFSA statement.

What should I ask before buying?
Ask for the EFSA submission number. Ask whether the supplier provided new toxicology studies after this opinion. Ask for the exact TOS calculation at your production scale.

Allulose demand is growing. The enzyme side of the market needs clarity. This 2024 opinion does not give that clarity. Watch the dossier and ask sharp questions. That is the best way to protect your formulation timeline and your purchase contract.