Erythritol is a zero-calorie polyol that occurs at low levels in many fruits and at higher levels in fermented foods such as soy sauce, cheese, wine and beer. In Europe, it gained novel foods approval for use in foods in 2006 – but concerns of a potential laxative effect, especially for children, held back approval for beverages.
EFSA’s positive opinion relates to a dossier submitted by Cargill, which supplies erythritol under its Zerose brand name. The dossier included new clinical data from a 27-month trial, which examined tolerance of the sweetener in soft drinks among 4-6 year olds.
“The Panel concluded that…consumption of erythritol via non-alcoholic beverages at a maximum level of 1.6 % would not raise concerns for laxation,” EFSA said in its opinion.
EFSA said its conclusion took into account new information on estimated exposure, history of use, absorption characteristics and lack of adverse findings, including laxation, at a level of 1.6% in soft drinks.
Studies had shown a laxative effect in adults and children at 0.78 g and 0.71 g per kg of bodyweight respectively, it said. EFSA considered that using erythritol at 2.5% did not provide an adequate safety margin, but the maximum 1.6% level would lead to an intake from all food and drink of about 0.3 g per kg of bodyweight at the highest consumption levels.
“Cargill welcomes the EFSA opinion supporting the safety of erythritol in beverages, and looks forward to the day when our customers can offer European consumers new innovations in better-tasting, non-caloric beverages,” Cargill’s global nutrition innovation leader, erythritol, Peter De Cock said in a statement.
Although the EFSA opinion is a critical step toward approval of erythritol in soft drinks, the European Commission still needs to give its approval before companies can start using it in beverages.
Erythritol is already approved for use in foods and drinks in more than 60 countries, including the US, Argentina, Australia, Brazil, China, Japan and India.