Safety Assessment of the Food Enzyme D-Psicose 3-Epimerase from Genetically Modified Escherichia coli

The Safety Signal

If your formulation uses D-allulose, the enzyme behind it just became easier to defend. In 2021, EFSA evaluated the food enzyme D-psicose 3-epimerase from a genetically modified Escherichia coli strain. The panel concluded there are no safety concerns when the enzyme is used in immobilized form to produce D-allulose from fructose.

That conclusion matters. D-allulose is a specialty carbohydrate. It is made by converting fructose. The enzyme flips the structure of fructose around one carbon. The result is D-psicose, better known to formulators as D-allulose.

Background

The enzyme is produced by a genetically modified Escherichia coli. That alone raises questions for many formulators. But safety depends on what remains in the finished ingredient, not only on the production organism. Here, the process is designed around an immobilized enzyme.

Immobilization means the enzyme is held on a solid support. The fructose stream passes over it. The enzyme does not dissolve into the syrup. That changes the risk profile.

What the Study Did

The evaluation looked at the immobilized enzyme. EFSA’s panel asked whether any enzyme-derived material could carry over into the final D-allulose product.

The answer was no. The purification steps after the enzymatic reaction remove the residual total organic solids. Those solids are the biological material that could contain enzyme protein or production organism remnants. Once they are gone, the enzyme is not present in the product in a measurable way.

Because of that, dietary exposure was not calculated. The panel did not see a route for the consumer to ingest enzyme-derived material. The number of toxicological studies required: zero. That is a strong outcome for a food enzyme.

Key Findings

Here is what the assessment came down to.

Evaluation point	EFSA finding
Production organism	Genetically modified E. coli
Enzyme form	Immobilized
Application	Fructose conversion to D-allulose
Purification after reaction	Removes residual total organic solids
Dietary exposure	Not calculated
Toxicological studies	Not considered necessary
Overall conclusion	No safety concern when used in immobilized form

What It Means for Manufacturers

For ingredient buyers, this is a useful reference point. It means the regulatory path for enzyme-made D-allulose is clearer than many people expect. You can point to the EFSA opinion when a customer asks about enzyme safety.

But read the details carefully. The opinion is specific to the immobilized form. A soluble version of the enzyme would not be covered by the same conclusion. If you are sourcing D-allulose, ask your supplier whether the enzyme is used immobilized and whether the downstream purification matches the process described in the EFSA evaluation.

Keep the documentation. Your supplier should be able to provide the EFSA opinion reference, the production organism, and information about the purification steps. That will satisfy most technical reviews.

FAQ

Is D-psicose the same as D-allulose? Yes. D-psicose is another name for D-allulose. The enzyme D-psicose 3-epimerase converts fructose into this specialty sugar.

Does this mean the enzyme is safe in every product? No. The conclusion only applies to the immobilized enzyme under the assessed conditions of use. If the process changes, the safety case needs to be re-examined.

Do I need to worry about residual enzyme in the finished ingredient? The EFSA panel concluded that the purification steps remove the residual total organic solids. Dietary exposure was not calculated because the enzyme was not expected to remain in the final product.

That is the kind of clarity formulators want when they build a new product around an alternative sweetener. The enzyme technology is proven. The safety record is now on paper.