Statement in relation to the safety of erythritol (E 968) in light of new data, including a new paediatric study on the gastrointestinal tolerability of erythritol EFSA Panel on Food Additives and Nutrient Sources (ANS)

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of erythritol (E 968) in light of a paediatric study on the gastrointestinal (GI) tolerability of erythritol. In 1999, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated erythritol and assigned an ADI "not specified". In 2003, the EU Scientific Committee on Food (SCF) concluded that erythritol is safe for use in foods. Erythritol is approved in the EU for the same uses as other polyols, but EU approval does not yet cover its use in beverages because the SCF opinion stated that the laxative threshold may be exceeded, especially by young consumers and through ingestion of erythritol in beverages. A paediatric study on the GI tolerability of erythritol was conducted with the goal to determine the maximum dose level of erythritol that is well- tolerated by young children aged 4-6 years old, in a single drinking occasion. The Panel noted that erythritol intake resulting from an incorporation rate of 2.5% in beverages (i.e. 0.59 g/kg bw) is below the No-Observed-Adverse-Effect Level (NOAEL) for laxative effects (i.e. 0.71 g/kg/bw/day). The Panel noted that the margin of safety (MOS) between this NOAEL and the estimated daily intake of erythritol resulting from an incorporation rate of 2.5% in beverages (0.59 g/kg bw) is 1.24. The Panel concludes that this MOS is too low to ensure that children are adequately protected taking into account the fact that erythritol is also used in other food categories. The Panel concludes that there is a safety concern with respect to GI tolerability for the use of erythritol in beverages at a maximum use level of 2.5% for non-sweetening purposes.