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

What this EFSA opinion means

Formulators looking for an enzyme route to D-allulose just hit a regulatory wall. An EFSA expert panel evaluated a D-allulose 3-epimerase preparation for converting fructose into the specialty carbohydrate D-allulose. The panel could not complete the safety assessment.

This paper, published in 2024 under DOI 10.2903/j.efsa.2024.8702, is not an approval. It is a public record of an unfinished evaluation.

Background

D-allulose is a specialty carbohydrate that has drawn serious interest in food formulation. One production route uses D-allulose 3-epimerase to isomerize fructose. The enzyme preparation in this evaluation is non-genetically modified. That has not made the regulatory path simpler.

The process would use inactive cells containing the enzyme. Those cells would be immobilized. That is a common setup for continuous fructose processing. It also shapes how EFSA thinks about exposure.

What the safety evaluation covered

The EFSA panel reviewed the intended use of the enzyme. The substrate is D-fructose. The product is D-allulose. The proposed use level is up to 27 mg TOS/kg D-fructose. TOS stands for total organic solids, the standard benchmark EFSA uses for enzyme dose.

The dossier was assessed against the usual safety framework. That includes the identity of the enzyme, the production conditions, and the toxicological data needed to support food-use approval. The panel was not able to finish the job.

Key findings

The central finding is simple. The safety assessment is incomplete. The panel did not reach a final conclusion about the food enzyme preparation. In plain terms, the submitted information did not allow the experts to say it is safe.

What you get	What you don't get
A defined process for fructose-to-allulose isomerization	A positive safety conclusion
A proposed dose of 27 mg TOS/kg fructose	EU regulatory approval
A clear statement that the enzyme is non-GM	A complete toxicological sign-off

This is a useful data point for process design, but it is not a license to sell.

What it means for manufacturers

If you are evaluating this enzyme, treat the EFSA opinion as unfinished business. Ingredient buyers should ask suppliers for the full opinion and any follow-up submissions. One simple question works: has the assessment been completed since this paper was published?

The 27 mg TOS/kg fructose level tells you how much enzyme the applicant planned to use. It does not tell you that the panel found that level safe. That distinction matters when you talk to suppliers.

Do not assume non-GM status clears the path. Regulatory approval depends on the complete safety package, not just the absence of GM technology. This opinion shows that even a non-GM enzyme can stall at the EFSA stage.

FAQ

Why couldn’t the panel complete the assessment?

The published opinion states that the evaluation could not be completed. The abstract does not list every missing item. What is clear is that the experts did not have enough to say yes.

Is this enzyme approved for food use in the EU?

Not through this assessment. No final safety conclusion was reached. You need to check other regulatory decisions separately and ask the supplier for current status.

Should I still consider using this enzyme?

You can, but only with eyes open. It remains a candidate, not a cleared food-processing aid. Build your timeline around the possibility of more data and a resubmission.

Where that leaves you

The EFSA panel did not declare D-allulose 3-epimerase unsafe. It said the assessment is incomplete. Those are different things. For a formulator, though, the result is similar: no regulatory green light.

This is a waiting situation. A non-GM enzyme route to allulose still has appeal. But until the evaluation is complete, treat this ingredient as unresolved. The 27 mg TOS/kg fructose figure gives you a process benchmark, not a safety conclusion. That one number is useful, but it is not enough.