EU green light for stevia could take years, predicts professor

Manufacturers keen to use extracts of the much-hyped stevia leaf as a sweetener are unlikely to get the green light from EU regulators for at least a year, while novel food approval for the dried leaves of the plant is likely to take even longer, experts have predicted.Although an application to gain EU approval for steviol glycosides as food additives (sweeteners) was submitted in September 2007, the European Food Safety Authority (EFSA) was not even likely to start looking at it until after June 2009, claimed professor Jan Geuns.

Geuns, who is head of the functional biology laboratory at the Katholieke Universiteit Leuven in the Netherlands, filed the application on behalf of the European Stevia Association. However, he stressed that Rebaudioside A, the purified steviol glycoside produced by stevia supplier PureCircle, is also included in the application. Other key players in the market were also involved, he said: "We have a meeting in January with Cargill and Morita to combine the three applications that were submitted to EFSA. The sheet of specifications will then be the same for everybody."

Frustratingly, said Geuns, who also submitted a novel food application for dried stevia leaves in August 2007, the German authorities were adopting an "overly cautious" approach, which meant approval could take years. "There is not even any consensus about the type of safety data needed that might be different for various types of novel food. For example, the BfR [German Federal Institute for Risk Assessment] has asked for stability studies of stevia, without explaining exactly what should be measured. Each leaf contains thousands of different compounds; it is impossible to measure all of them."

He added: "The uncertainties and lack of consensus make the Novel Food Regulation an expensive toy for those who abuse food safety as a pretext to keep good products off the EU market. When a food is consumed daily by over 164M people without harmful effects, it should be authorised without further expensive and unnecessary research." It would be "impossible to do the research required by BfR as the budget required would be 2M euro", he claimed.

Although several countries including Brazil, New Zealand, Australia and Japan have authorised the use of stevia extracts as sweeteners, they are currently only allowed in dietary supplements and not as sweeteners in the US.

However, GRAS (generally recognised as safe) approval is expected shortly in the US.