This Statement is the result of Cargill’s most recent application to extend the use of erythritol (marketed by Cargill under the Zerose brand) into beverages at a maximum use level of 2.5%. This application does not affect the existing food approval and zero-calorie status for erythritol which remains in place.
Cargill wishes to reinforce the well established position that erythritol is a safe ingredient. What’s at issue is the level of erythritol that can be incorporated into beverages without risking inconvenient—but not harmful—laxation effects.
Cargill will continue to work with EU Regulatory Authorities to achieve approval for use of erythritol in beverages under conditions that are acceptable for them.
In a previous Statement, EFSA concluded that a Margin of Safety (MOS) for laxation of 1.24 was too low to adequately protect children taking into account the fact that erythritol is also used in other food categories. Its conclusion was based on the possibility that if children were consuming other foods containing erythritol concurrently with beverages containing up to 2.5% of erythritol, there would be a risk of them exceeding the No Observed Adverse Effect Level (NOAEL) for laxation.
In Cargill’s most recent submission to the EU regulatory authorities, based on the latest UK intake surveys and EFSA criteria, it was demonstrated that the MOS was in fact nearer to 1.54—after taking concurrent consumption of other erythritol-containing foods into account. However EFSA’s Statement concludes that the use of erythritol in soft drinks (at a use level of 2.5%) gives a total MOS of 1.54, and that this is too low to protect children (3-9 years) adequately.
Cargill notes that in all territories outside the EU where erythritol is approved for use in foods, erythritol is also permitted for use in beverages at a maximum level up to 3.5% in countries such as the US and Canada, or at any level required to achieve the desired benefit such as in Brazil, Australia, India, Korea, China and Japan. In those territories, Cargill is not aware of any evidence that the availability of beverages containing up to 2.5% erythritol has been accompanied by a significant incidence of excessive GI intolerance among children.
Cargill will now continue to discuss and review together with the European Commission and Member States to arrive at an acceptable recommendation for erythritol use in beverages, in the firm belief that Zerose erythritol is a valuable zero-calorie sweetening and bulking agent that could benefit calorie-conscious consumers by being available as an option for beverage formulation.
