Safety evaluation of the food enzyme D-psicose 3-epimerase from genetically modified Corynebacterium

Why this opinion matters

If you buy allulose for low-sugar formulations, the enzyme behind it just passed a major safety review. In 2021, EFSA published a safety evaluation of the food enzyme D-psicose 3-epimerase, produced by a genetically modified strain of Corynebacterium. That enzyme is what converts fructose into the rare sugar D-allulose, also called D-psicose.

For formulators, this opinion settles a key supply chain question. The enzyme is safe. And the final sweetener carries none of the production organism’s DNA.

What EFSA evaluated

EFSA does not evaluate the final allulose ingredient. It evaluates the food enzyme preparation as a processing aid. The panel looked at the production strain, the enzyme’s function, and the toxicological data submitted by the applicant.

The enzyme works by epimerizing fructose. During manufacturing, the enzyme is immobilized or used in a bioreactor. The allulose product is then purified. That purification step matters. It removes the enzyme preparation solids that EFSA measures and regulates.

Those solids are called Total Organic Solids, or TOS. The safety assessment uses TOS as the standard measure. When EFSA sets an acceptable dose, it expresses that dose in milligrams of TOS per kilogram of body weight per day.

Key findings from the 2021 opinion

The panel’s central finding was straightforward. The no-observed-adverse-effect level, or NOAEL, was 1796 mg TOS per kg body weight per day. That was the highest dose tested in the study.

In other words, at every dose the animals received, there were no adverse effects. The panel could not identify a level where harm appeared.

Two other findings matter just as much for buyers. During allulose production, TOS is removed. And the final allulose contains no recombinant DNA from the production organism.

Finding	What it means
NOAEL = 1796 mg TOS/kg bw/day	No adverse effects at the highest test dose
TOS removed during production	The enzyme preparation does not carry into final allulose
No recombinant DNA in allulose	The GM production strain leaves no trace in the sweetener

What this means for manufacturers

You can formulate with allulose without treating the enzyme as a carryover risk. EFSA’s review confirms that the processing enzyme does not end up in the finished ingredient at levels that matter for consumer exposure.

That gives you a cleaner story for customers who ask about GMOs. The production organism is genetically modified, yes. But the final allulose contains no recombinant DNA. Purification strips it out. So the sweetener itself is not a GMO ingredient.

It also simplifies your documentation. When a supplier sends an allulose specification sheet, you can point to the EFSA opinion and the process controls behind it. The safety conclusion is not based on vague assumptions. It is based on a specific NOAEL and on verified removal of enzyme solids.

Questions buyers keep asking

Is the enzyme preparation safe to use? EFSA concluded yes. The NOAEL was the highest dose tested at 1796 mg TOS/kg bw/day. No adverse effects appeared at that level.

Does allulose contain GMO material? No. The final allulose contains no recombinant DNA. The enzyme and its production organism are removed during purification.

What does TOS-free mean in practice? EFSA’s safety evaluation is based on TOS, the organic solids from the enzyme preparation. That TOS is removed during allulose production. So the final product sits far below any toxicological concern.

The practical picture

This opinion removes a regulatory hurdle for allulose suppliers. It also gives you confidence as a buyer. You are not importing a GM enzyme into your final product. The purification step handles that.

For new product launches, the EFSA evaluation is a useful piece of evidence for your own safety review. It gives you a clear number, a clean process story, and a final ingredient free of recombinant DNA. That is exactly what a food formulator needs when scaling up a low-sugar formulation.