Is Erythritol (E 968) as a Food Additive Safe for Consumption?

According to the European Food Safety Authority (EFSA) announcement on December 20, 2023, the EFSA Panel on Food Additives and Flavorings (FAF) has conducted a re-evaluation of erythritol (E 968) as a food additive and an application for its exemption from the laxative warning label requirement established under Regulation (EU) No 1169/2011.

Erythritol is a polyol obtained through fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3-6, followed by purification and drying. It is readily and dose-dependently absorbed in humans and can be metabolized to erythronate to a small extent. Erythritol is excreted unchanged in the urine and does not raise concerns regarding genotoxicity.

The evaluation was based on human interventional studies, and the Panel identified that erythritol has the potential to cause diarrhea in humans, which was considered adverse due to its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhea, at 0.5 g/kg body weight (bw), was established as the reference point. The Panel determined that setting a numerical acceptable daily intake (ADI) at the level of the reference point would be appropriate. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective against both the immediate laxative effect and potential chronic effects secondary to diarrhea.

The evaluation also estimated dietary exposure to erythritol. The highest mean and 95th percentile chronic exposure were observed in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). The maximum acute exposure for children at the 99th percentile was 3531 mg/kg bw per meal. The Panel considered these exposure assessments to be overestimations.

In conclusion, the Panel found that both acute and chronic dietary exposures to erythritol (E 968) exceeded the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Regarding the application for exemption, the available data did not support the proposal.

Considering these findings, the question arises: Is erythritol (E 968) as a food additive safe for consumption? The EFSA's re-evaluation suggests that while erythritol is readily absorbed and metabolized in humans, it has the potential to cause diarrhea, which is considered adverse. An ADI of 0.5 g/kg bw per day was established to protect against both immediate and potential chronic effects. However, dietary exposure assessments indicated that individuals with high intake may exceed the ADI, putting them at risk of adverse effects. These findings emphasize the need for careful consideration of erythritol intake and highlight the importance of labeling and regulatory measures to ensure consumer safety.