Safety evaluation of the food enzyme d-allulose 3-epimerase from the genetically modified Corynebacterium glutamicum strain FIS002

What this paper gives you

If you buy d-allulose, you should know how the enzyme behind it was assessed. This EFSA opinion does exactly that. It evaluates d-allulose 3-epimerase, an enzyme made by a genetically modified Corynebacterium glutamicum strain. The enzyme converts fructose into the rare sugar d-allulose.

Background

D-allulose is a special carbohydrate. It is also called D-psicose. To produce it, processors use enzymes to rearrange fructose into allulose. The enzyme in this paper is d-allulose 3-epimerase. Because the enzyme comes from a GM production strain, EFSA needed to confirm its safety for food processing. They also checked whether anything from the enzyme production process ends up in the final sweetener.

What the study did

The EFSA panel evaluated the safety data for this enzyme. The core question was simple. At what dose would you see harm? No harm appeared. The panel set the no-observed-adverse-effect level at 1796 mg TOS per kilogram of body weight per day. That was the highest dose tested.

TOS stands for Total Organic Solids. It is the standard way to measure enzyme exposure in food safety assessment.

Key findings

The enzyme does its job. It acts on fructose to produce d-allulose. The next part matters for buyers. Purification removes TOS during d-allulose production. The final d-allulose contains no detectable recombinant DNA.

Parameter	Finding
Production organism	Genetically modified Corynebacterium glutamicum
Reaction	Fructose to d-allulose (D-psicose)
NOAEL	1796 mg TOS/kg body weight/day, highest dose tested
Enzyme carryover	TOS removed during processing
Residual DNA	Not detected in d-allulose

What it means for manufacturers and buyers

Use this paper as a benchmark. It gives you a documented safety reference for a specific enzyme route. When a supplier says their d-allulose is made with a well-characterised enzyme, ask which strain and which assessment they mean. The answer should line up with a paper like this one. If not, ask for their own dossier.

The 1796 mg figure is useful. It gives formulators a concrete number to reference. But it applies to this enzyme and this production strain. A different strain means a different risk assessment.

This also helps with technical files. You can point to a published EFSA opinion showing that TOS are removed and that recombinant DNA is absent from the finished ingredient. That makes customer questionnaires easier.

FAQ

What is TOS? Total Organic Solids. It measures the non-water organic fraction of an enzyme preparation. Regulators use TOS to calculate exposure and set safe intake levels.

Does this process leave GM material in d-allulose? The EFSA opinion says no recombinant DNA was detected in d-allulose. TOS are removed during production. The strain used to make the enzyme is genetically modified, but the final sweetener does not contain detectable GM DNA.

Does this paper approve d-allulose itself? No. It is a safety evaluation of the enzyme. D-allulose may need separate regulatory handling depending on your market. The paper gives you the enzyme safety baseline.

Read the full opinion when you write supplier specifications or update your risk files. The DOI is 10.2903/j.efsa.2021.6870. A clear enzyme safety record makes sourcing decisions easier. This one gives you that.