Cargill has failed in its second attempt to secure EU approval for use of bulk sweetener erythritol in soft drinks, after EFSA published a negative opinion relating to its introduction on child safety grounds.
The European Food Safety Authority (EFSA) opinion is a blow to Cargill, and other large ingredients companies, given that erythritol (E968) is used as a carrier for natural sweeteners such as stevia, and is also used for its polyol functions in drinks to improve taste and texture profiles.
Responding to EFSA's opinion, a Cargill spokesman told BeverageDaily.com that the firm would "continue to work with EU regulatory authorities to achieve approval for use of erytritol in beverages under conditions that are acceptable to them".
The spokesman said Cargill wished 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," he added.
Gastrointestinal tolerability concerns
In its negative opinion issued today, which you can access here , EFSA’s Panel on Food Additives and Nutrient Sources Added to Food (ANS) repeated its verdict on a similar submission (also made by Cargill) relating to the polyol that it delivered in July 2010.
Cargill’s European R&D Center sent EFSA new data, including a July 2012 document on total dietary exposures from E968's use as a sweetening and non-sweetening agent in drinks and foods.
Sugar alcohol Erythritol gained EU approval use in foodstuffs in 2003, and novel foods in 2006; Cargill markets its erythritol under the Zerose brand.
Based on Cargills exposure data, EFSA’s panel said the margin of safety (MOS) – calculated as the ratio between the No Observed Adverse Effect Level (NOAEL) and anticipated dietary exposure – would rise from 1.24 (the basis for the 2010 ANS panel opinion) to 1.54, but insisted this was still too low.
Given a NOAEL for laxative effects of 0.71g/kg bw and Cargill’s submission for a use level of 2.5%, EFSA’s panel said that children aged 3-9 years (weighing 22kg on average) would reach the NOAEL after drinking 630ml of soft drinks on one occasion.
Thus the panel concluded that safety concerns remained regarding the gastrointestinal tolerability of erythritol for this age group, when it was used in beverages, with the 1.54 MOS “too low to protect children adequately”.
Zero-calorie beverage blow
EFSA’s panel also noted that Cargill had not reported usage data (in its 2012 document) relating to all other foods, an omission that the authority suggested undermined the firm's exposure assessment.
The news is a blow for Cargill and other erythritol producers, as the polyol is a zero-calorie sweetener that can also ensure a sucrose-style taste profile in drinks, due to its low laxative effect vis-à-vis other polyols, while it also taps the ‘naturalness’ trend via its production: a sugar-rich substrate is fermented by a yeast-like fungus to yield erythritol.
Within the EU it is largely used in tabletop sweeteners, in some bakery products and confectionery (principally chewing gum).
Widely used in beverages outside EU
Outside Europe erythritol is used quite widely in beverages – it is accepted for use in the US and Canada at up to 3.5%, and also in Australia, Japan, Brazil, Australia, India, Korea and China at any level required to achieve the desired benefit.
"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," the spokesman said.
"Cargill will now continue to discuss and review with the European Commission and Member States to arrive at an acceptable recommendation for erythritol use in beverages," he added.
The company firmly believed that Zerose was a valuable zero-calorie sweetening and bulking agent "that could benefit calorie-conscious consumers by being available as an option for beverage formulation," the spokesman said.