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

Allulose enzyme safety gets a clean EFSA review

If you buy or formulate with allulose, the enzyme behind it just passed a major safety check. The European Food Safety Authority (EFSA) assessed the food enzyme D-allulose 3-epimerase, also called D-psicose 3-epimerase, produced by a genetically modified Corynebacterium strain. This is the enzyme that converts fructose into D-allulose. The published opinion gives formulators and ingredient buyers a concrete safety reference.

Why this enzyme matters

Allulose is a rare sugar with the taste and texture of sucrose but very few calories. Producing it at scale usually means enzymatic conversion. The enzyme D-allulose 3-epimerase rearranges fructose into D-allulose. That reaction turns a cheap sugar into a specialty sweetener.

Regulators need to know if the enzyme itself is toxic, if it shows up in the final ingredient, and if workers are exposed during production. EFSA’s 2021 opinion addressed all of those points.

What the EFSA evaluation covered

EFSA’s panel assessed the enzyme preparation from a genetically modified Corynebacterium strain. They looked at the chemical identity of the enzyme, the production organism, and potential toxicity. They also estimated dietary exposure. The key measure was TOS, or total organic solids. TOS represents the enzyme-related material after you ignore added water, salts, and other formulation ingredients. It is a standard way to compare enzyme preparations across studies.

The panel ran toxicity tests and determined a no-observed-adverse-effect level, or NOAEL. That level was 1796 mg TOS per kilogram of body weight per day. It was the highest dose tested. No adverse effects appeared at that dose.

Key findings from the safety assessment

The core conclusion is straightforward: under the intended use, the enzyme is safe. The table below shows the evidence that matters most.

Parameter	Finding
NOAEL	1796 mg TOS/kg body weight per day, highest dose tested
Adverse effects	None reported at any dose
TOS in finished D-allulose	Removed during production
Recombinant DNA in D-allulose	Not detected

The last two rows matter for anyone buying allulose. Even though the enzyme is produced by a genetically modified organism, the finished sweetener does not contain the enzyme’s organic solids or the recombinant DNA from the production strain.

What this means for formulators and buyers

For ingredient buyers, this opinion gives you a benchmark. When an enzyme supplier presents a D-allulose 3-epimerase product, you can ask whether the production strain and process match the one in this EFSA review. If yes, you have a published safety endpoint to cite in your own documentation.

For formulators, the clean final-product profile is the key point. No TOS carries over. No recombinant DNA shows up. That means the enzyme can be treated as a processing aid rather than an ingredient in most regulatory frameworks, but check your target market’s specific rules before labeling.

This opinion also helps in customer conversations. If a brand asks for reassurance about allulose’s production, this EFSA evaluation gives you something concrete to share.

FAQ

Is D-allulose 3-epimerase safe to use in food production? Yes. EFSA’s panel set a NOAEL at 1796 mg TOS/kg body weight per day, the highest dose tested. No adverse effects appeared at any dose.

Does the final allulose contain enzyme residue or DNA from the GMO? No. TOS is removed during D-allulose production, and recombinant DNA was not detected in the finished D-allulose.

Why does the production organism matter? The safety assessment applies to the enzyme produced by that specific genetically modified Corynebacterium strain. If a supplier uses a different host strain or a different genetic modification, the safety profile might not match.

What to do next

Keep this opinion in your supplier qualification file. It is a public document with a clear toxicological endpoint and a clean final-product story. When you evaluate allulose or the enzyme used to make it, this EFSA review is the kind of evidence that separates a credible ingredient from an unsupported one. Use it as a reference, and keep asking for strain-level details.