Safety evaluation of the non-genetically modified food enzyme D-allulose 3-epimerase

If you work with D-allulose

Need a reason to check your enzyme supply paperwork? Here it is. EFSA published a safety evaluation for a D-allulose 3-epimerase food enzyme preparation. The expert panel could not complete the assessment. That is not a rejection. It is also not a green light.

Background: D-allulose and this enzyme

D-allulose is a specialty carbohydrate. Producers make it by isomerizing D-fructose, and that reaction uses an enzyme called D-allulose 3-epimerase. In this evaluation, the enzyme comes from a non-genetically modified source. The applicant planned to supply it in immobilized form as non-viable cells. The proposed use level topped out at 27 mg TOS per kg of D-fructose.

TOS stands for total organic solids. Enzyme suppliers use it to standardize doses. If you compare enzyme products, compare them on TOS. Otherwise you are comparing apples to oranges.

What the evaluation covered

The paper appears in the EFSA Journal under DOI 10.2903/j.efsa.2024.8702. It reports a safety evaluation of this specific food enzyme preparation. EFSA’s framework for food enzymes looks at the source, production process, toxicological data, dietary exposure, and potential allergenicity. The report covers the intended use: the isomerization of D-fructose to produce D-allulose.

Then the panel weighed the evidence. That is where things stalled.

Key findings

The headline result is simple. The panel could not complete the evaluation.

Assessment item	Finding
Source type	Non-genetically modified
Enzyme	D-allulose 3-epimerase
Intended reaction	Isomerization of D-fructose to D-allulose
Proposed use level	Up to 27 mg TOS/kg D-fructose
EFSA conclusion	Evaluation not completed

No one said the enzyme is dangerous. The issue is that the data did not allow the panel to finish its safety assessment. For a food ingredient, that matters. Regulatory approval does not happen without a complete opinion.

What it means for manufacturers

If you formulate with D-allulose, this affects your supply chain. Any enzyme used to make that D-allulose has to stand up to regulatory review. An unfinished EFSA evaluation leaves that review open.

Ask suppliers for the full dossier. Ask how they handled EFSA’s concerns. Ask for additional toxicology or exposure studies. If they cannot point to a path toward authorization, treat that as a supply risk.

Do not assume a supplier’s enzyme is the same as this one. Different production strains and different preparations have different safety profiles. You need to know exactly which enzyme and which dossier sit behind the powder you buy.

FAQ

Does this mean the enzyme is unsafe? No. The evaluation did not conclude that. It said the panel could not complete the assessment. That is different from finding a safety problem.

Why couldn’t EFSA finish the evaluation? The abstract does not specify the missing data. It simply states that the expert panel could not complete the evaluation. Suppliers may have more detail, so ask them directly.

What does 27 mg TOS/kg mean? It is the proposed maximum dose. It means 27 milligrams of total organic solids per kilogram of D-fructose substrate. That is the dose EFSA was asked to assess.

What to watch next

Watch for a revised application. EFSA can update an opinion if new data arrive. Until then, treat this evaluation as an open question. Your purchasing decision should reflect that. You want an enzyme with a clear regulatory future. This one does not have one yet.