Re-evaluation of erythritol (E 968) as a food additive

If you formulate with erythritol, the 2023 EFSA re-evaluation changes how you should think about intake. The agency set an acceptable daily intake (ADI) of 0.5 grams per kilogram of body weight per day. That number now anchors safety discussions in Europe and may influence regulators elsewhere.

Why EFSA re-opened the file

Erythritol is a polyol, not a typical sugar. It has almost no calories and does not spike blood glucose the way sucrose does. That makes it popular in keto, low-sugar, and diabetic-friendly products. But polyols have a known catch: they can cause gastrointestinal distress. EFSA’s latest review puts that catch at the center of the safety assessment.

The review covers production, human metabolism, and gut effects. It also sets a clear reference point for the first time.

What the study did

EFSA evaluated multiple human intervention studies. Researchers measured blood glucose, insulin, and gut hormones such as CCK, PYY, and GLP-1. They also recorded gastrointestinal symptoms after erythritol consumption. This was not just a chemical safety check. It was a physiological review.

The agency also confirmed how erythritol is made. Manufacturers produce it through fermentation using Moniliella pollinis BC or Moniliella megachiliensis KW3-6. The process includes purification and drying. That part did not change.

Key findings

The most important outcome is the ADI. EFSA identified a no-observed-adverse-effect level (NOAEL) range from human studies. The lower bound of that range, 0.5 g/kg body weight, became the reference point. The agency then set the ADI at exactly that value.

Area	Finding
ADI	0.5 g/kg body weight/day
Reference point	Lower bound of NOAEL range: 0.5 g/kg body weight
Main adverse effect	Possible diarrhea in humans
Metabolic effects	Blood glucose, insulin, and gut hormone changes studied
Production method	Fermentation with M. pollinis BC or M. megachiliensis KW3-6, then purification and drying

The table looks simple, but the implications are not. For a 70 kg adult, the ADI equals 35 grams per day. For a 20 kg child, it equals 10 grams per day. A single serving of some sugar-free candies or baking blends can contain 10 to 15 grams of erythritol. That means one serving can put a small child at or above the daily ADI.

What it means for manufacturers

Formulators need to shift from “safe because natural” to “safe at this dose.” Erythritol is still usable. But portion size and daily intake now matter much more.

Start by calculating how much erythritol is in a realistic serving, not a laboratory serving. Then multiply by expected daily consumption. If you market to children, run that number against body weight. A product that works for an adult may fail for a child.

You should also consider cumulative exposure. Consumers rarely eat only one erythritol-containing product per day. A protein bar, a flavored drink, and a sugar-free cookie can add up quickly. The ADI applies to total intake, not just your product.

Labeling strategy may need adjustment too. If a package suggests a serving that pushes intake close to the ADI for a small adult, that package now carries more risk. You can use erythritol in smaller doses or blend it with other sweeteners. Either way, the burden falls on the formulator.

FAQ

Does this mean erythritol is banned?
No. EFSA did not ban erythritol. It set a daily intake limit. The additive remains available, but product developers must respect the ADI.

How do I apply the ADI to my product?
Convert your erythritol content per serving to grams. Divide by a range of body weights, such as 20 kg for children and 70 kg for adults. Compare that number to 0.5 g/kg/day.

Will other regions adopt this ADI?
Not automatically. But EFSA opinions often influence JECFA and national regulators. If you export to Europe, this ADI already matters.

Erythritol still offers real advantages in sugar replacement. The new safety limit does not erase that. It simply forces sharper thinking about doses, serving sizes, and total daily exposure. The ADI is a practical tool. Use it early in development, not after the label is printed.