This opinion addresses the re-e valuation of erythritol (E?968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Mo niliella pollinis BC or Mo niliella megachiliensis KW3-6, followed by purifications and drying. Erythritol is readily and dose-dependently absorbed in humans and can be me tabolised to erythro nate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise co ncerns regarding genotoxicity. The dataset e valuated co nsisted of human interventio nal studies. The Panel co nsidered that erythritol has the potential to cause diarrhoea in humans, which was co nsidered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel co nsidered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was co nsidered by the Panel to be protective for the immediate laxative effect as well as potential chro nic effects, seco ndary to diarrhoea. The highest mean and 95th percentile chro nic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel co nsidered both dietary exposure assessments an overestimation. The Panel co ncluded that the exposure estimates for both acute and chro nic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Co ncerning the new application, the Panel co ncluded that the available data do not support the proposal for exemption.

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