EFSA finds erythritol safety margin for beverages too slim

11-Jul-2010 - Last updated on 12-Jul-2010 at 14:34 GMT

The use of erythritol in beverages at a proposed level of 2.5 per cent could cause a safety concern for small children, EFSA says, as the margin between estimated daily intake and the no-observed-adverse-effects-level (NOAEL) is too small.

EFSA gave a positive safety opinion on the use of erythritol, a zero calorie four-carbon polyol, in foods in 2003, and it received novel foods approval in 2006. It has not been approved for use in beverages, however, as the opinion stated that the laxative threshold may be exceeded.

Erythritol does have a higher laxative threshold than other polyols, and the NOAEL for laxation has been calculated at between 0.5 and 1.0 g/kg bw/day.

Last July, however, Cargill, which supplies erythritol, filed an application for erythritol to be used in beverages at a maximum level of 2.5 per cent. It is already permitted for use in beverages in the United States at up to 3.5 per cent, and in Australia and Japan in unlimited percentages (within the context of good manufacturing practices).

However the new opinion was based on data from a new pediatric study, provided by Cargill, to establish the maximum does level that is well-tolerated by young children aged 4-6 years in a single drinking occasion. It observed a greater incidence of diarrhoea or gastrointestinal symptoms at the 25g dose level, while 5g and 15g doses did not cause problems.

If erythritol were used at a level of 2.5 per cent in cordials and diet soft drinks (carbonated and non-carbonated), the highest-consuming children in the 4 to 6 year age bracket could consume as much as 11.6g per person a day. For 1.5 to 4.5 year olds the level was 1.4g per person, and for teenagers aged 15 to 18 years it was 8.8g per person.

For the 4 to 6 year olds, a more precise NOAEL has been established at 0.71 g/kg bw/day. The safety margin between this and the estimated daily intake of the highest consuming 4 to 6 year olds is 1.24 per cent.

This, EFSA’s panel said, is “too low to ensure that children are adequately protected taking into account that erythritol is also used in other food categories”.

It added that there may be a synergism with the gastrointestinal effects of other polyols, too.

“It’s very important to be clear that, despite the title of the report, EFSA is not saying that there are any safety issues per se with the use of erythritol in beverages,” said Henry Hussell, head of marketing – sweetness, Cargill EMEA.

“What’s at issue is the level of erythritol that can be incorporated into beverages without risking inconvenient – but not harmful – laxation effects.”

He said it is not possible to possible to predict whether children would actually exceed the NOAEL threshold in practice and that the company is not aware of any evidence that the use of erythritol in beverages in the USA, Japan and Australia has been accompanied by a significant incidence of excessive laxation among children.

Cargill will continue to liaise with EFSA over erythritol, and thinks it is possible that in future EFSA may decide in favour of a beverage incorporation level lower than 2.5 per cent for the EU.