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

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.

© European Food Safety Authority, 2010

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources (ANS) was asked to deliver an opinion in relation to the safety of erythritol (E 968) in light of new data, including a new paediatric study on the gastrointestinal (GI) tolerability of erythritol.

Erythritol is a four-carbon polyol that is well-tolerated and permitted for use in foods and beverages in many countries around the world including the USA, China, Japan, Russia, Canada, Australia, New Zealand, Brazil, Argentina, Uruguay, Mexico, Korea, Thailand, Singapore, Taiwan, Hong Kong, Philippines, Israel and South Africa.

In 1999, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated erythritol and assigned an Acceptable Daily Intake (ADI) “not specified”. In 2003, the EU Scientific Committee on Food (SCF) reviewed the acceptability of erythritol for human consumption and concluded that it 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 of 2003 stated that the laxative threshold may be exceeded, especially by young consumers and through ingestion of erythritol in beverages. Human studies on GI tolerance of erythritol indicated that the No-Observed-Adverse-Effect Level (NOAEL) for laxation is between 0.5 and 1.0 g/kg bw/day.

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. This was a double-blind, randomised, controlled GI tolerance study utilising a cross-over design. Children aged 4 – 6 years were enrolled from multiple sites in France. The cross-over design allowed the incidence of GI-related adverse events following consumption of erythritol to be compared with those following consumption of a placebo (saccharose). Since each child served as its own control, differences in sensitivity between subjects did not affect the evaluation. Three doses of erythritol (5, 15, 25 g) versus an isosweet control (saccharose) were evaluated in 128 children. The primary outcome variable was an estimate of GI tolerability as measured by the incidence of diarrhoea and/or significant GI symptoms following consumption of the study products. Subjects were categorised according to whether or not (yes versus no) they experienced diarrhoea and/or significant GI symptoms during the test periods. The study lasted 27 months. There were no differences between the 3 test groups for gender (42-57% female), age (4.4 to 4.9 years old), weight (21 kg), height (113-114 cm) or BMI (16 kg/m2). For the 5 g and 15 g erythritol test groups, there was no significant difference in the incidence of diarrhoea or significant GI symptoms between the erythritol-sweetened test beverages and the saccharose sweetened (control) product. For the 25 g dose, a greater incidence of diarrhoea and/or significant GI symptoms was observed following consumption of the erythritol-sweetened beverage (32%) versus the control (3.5%) (p =0.0002). This result met the study stopping criteria, thus a higher dose of 35 g erythritol was not tested.

The intake of erythritol from its proposed use in beverages (2.5%), in particular diet concentrated soft drinks (cordials), diet ready-to-drink soft drinks and diet carbonated soft drinks, per drinking occasion, is estimated to range from a mean of 2.4 g/person in 1.5 to 4.5 year old children, to 8.8 g/person in teenagers (15 to 18 years old). Subjects most exposed to erythritol on a g/kg bw basis are 4 to 6-year-old children. At the 97.5^th percentile beverage consumption level, the maximum erythritol intake in children 4 to 6 years old is estimated to be 11.6 g/person.

The Panel noted that the results of the paediatric study demonstrate that ingestion of 15 g (0.71 g/kg bw) of erythritol in a beverage consumed by children aged 4-6 years in a single drinking occasion within 15 minutes, indicate a NOAEL for laxation in these young children amounting to 0.71 g/kg bw/day.

The margin of safety 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 at the 97.5^th percentile) is 1.24.

Given that:

• The NOAEL is based on a study population that consists of a limited number of selected children in the low-dose group and a limited statistical power
• Erythritol is also allowed for use in other food categories,
• There may be synergism with GI effects due to intake of other polyols,

the Panel concludes that this margin of safety is too low to ensure that children are adequately protected taking into account that erythritol is also used in other food categories.

Therefore, the Panel concludes based on the available data that there is a safety concern with respect to the GI tolerability for the use of erythritol in beverages at a maximum use level of 2.5% for non-sweetening purposes.
 

Erythritol, laxation, gastrointestinal tolerability, paediatric study