Safety Evaluation of the Food Enzyme D-Psicose 3-Epimerase from Genetically Modified Corynebacterium

Opening

You are sourcing allulose. The enzyme that converts fructose into allulose has to pass regulatory scrutiny. This EFSA opinion is one of the cleaner reviews you will find.

The European Food Safety Authority published this safety evaluation in 2021. It covers a food enzyme called D-psicose 3-epimerase, also known as D-allulose 3-epimerase. The enzyme comes from a genetically modified Corynebacterium. Its job is to turn fructose into D-allulose, the special carbohydrate buyers know as allulose.

Background

Allulose is a rare sugar. It is produced enzymatically, not chemically. The enzyme rearranges a hydroxyl group on fructose, converting it into allulose. This particular enzyme is produced inside a GM bacterial host. That sounds like a red flag to some consumers. The paper looks directly at that question.

EFSA evaluated the enzyme preparation, not just the final sweetener. They needed to know whether the production organism, the enzyme itself, or any residual DNA posed a risk.

What the study did

The panel used standard food enzyme safety assessment. They identified the source organism, examined the genetic modification, and considered the manufacturing process. Then they looked at toxicological data.

The key figure is the NOAEL—no observed adverse effect level. The panel set it at 1796 mg TOS per kilogram of body weight per day. That was the highest dose tested. No adverse effects appeared even there.

TOS means Total Organic Solids. It is the part of the enzyme preparation that matters for exposure. Using TOS avoids confusion from added carriers or diluents.

Key findings

The results are straightforward. The table below shows the main points.

Parameter	Finding
Enzyme	D-psicose 3-epimerase (D-allulose 3-epimerase)
Production organism	Genetically modified Corynebacterium
Application	Conversion of fructose to D-allulose
NOAEL	1796 mg TOS/kg body weight per day, the highest dose tested
TOS in finished allulose	Removed during D-allulose production
Recombinant DNA in finished allulose	Not present

Two findings matter most for buyers. First, the toxicology looks clean. The enzyme did not cause adverse effects at the top dose. Second, the enzyme does not end up in your ingredient. TOS is removed during production. No recombinant DNA is detected in the finished allulose.

What it means for manufacturers

This EFSA opinion gives you a regulatory anchor. If you sell in markets that rely on EFSA assessments, this paper supports the safety case for allulose produced with this enzyme. It also helps when talking to retail customers who ask about GM technology.

The enzyme is a processing aid. It acts on fructose, then gets cleaned out. The final sweetener is not a GM food. That may simplify labeling and approval discussions.

But do not treat this as a blanket approval. The opinion covers a specific enzyme from a specific GM Corynebacterium. Your supplier must use the same production process and meet the same purity specs. Ask for their enzyme preparation details. Confirm that their finished allulose has no detectable recombinant DNA and no residual TOS.

FAQ

Is allulose made with this GM microorganism itself a GM food?

No. The GM organism is only used to produce the enzyme. During production, the enzyme is purified, and the finished allulose is separated from the enzyme. In this assessment, no recombinant DNA was found in the finished D-allulose.

What does the NOAEL number mean in practice?

The experts fed animals up to 1796 mg TOS per kg of body weight per day. That was the highest dose in the study. They saw no adverse effects. It is a strong safety margin, not a cause for concern.

Should I ask my supplier for more data?

Yes. This EFSA opinion covers the enzyme in a specific production setup. You still need certificates of analysis, allergen statements, and local regulatory opinions for your target markets.

Closing

Safety data for allulose is still catching up with demand. This EFSA review gives formulators a solid reference point. The enzyme works, the toxicology is clean, and the final ingredient carries no recombinant DNA. That is one less question to answer.