Statement on a refined dietary exposure assessment of erythritol (E 968) taking into account additional data provided

Erythritol, laxation, gastrointestinal tolerability.
First published in the EFSA Journal
12 March 2013
20 February 2013
Scientific Opinion


Following a request by the European Commission, the Scientific Panel on Food Additives and Nutrient Sources added to Foods (ANS) carried out an assessment of the dietary exposure to erythritol and concluded on the safety of the proposed use in beverages at a maximum use level of 2.5 %, taking into account additional exposure data provided to the Panel. Anticipated exposure to erythritol from its use as food additive including soft-drinks containing a mean concentration of 2.5 % erythritol would be in the range of 0.004-0.04 g/kg bw/day for toddlers, 0-0.05 g/kg bw/day for children, 0-0.08 g/kg bw/day for adolescents, 0-0.14 g/kg bw/day for adults, and 0-0.01 g/kg bw/day for the elderly. At high level, exposure estimates would be in the range of 0.29-0.48 g/kg bw/day (toddlers), 0.13-0.76 g/kg bw/day (children), 0.04-0.50 g/kg bw/day (adolescents), 0.05-0.43 g/kg bw/day (adults), and 0.01-0.25 g/kg bw/day (the elderly). The main categories contributing to the exposure to erythritol were table-top sweeteners and soft drinks for all age groups except toddlers where soft drinks were the only main contributor. The Panel concluded that based on the new data provided on use levels of erythritol in foods and on the basis of the extension of the authorisation for the use of erythritol to soft drinks at a use level of 2.5 % the Margin of Safety of 1.54 is too low to protect children adequately.

Panel members at the time of adoption

Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert-Remy, Jürgen König, Claude Lambré, Jean-Charles Leblanc, Alicja Mortensen, Pasquale Mosesso, Agneta Oskarsson, Dominique Parent-Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright.
Panel on Food Additives and Nutrient Sources Added to Food
ans [at]
EFSA Journal 2013;11(3):3121
Question Number
On request from
European Commission