France's decision to approve Rebaudioside-A as safe for human consumption is, without doubt, the best news stevia processors have had since the sweetener was accorded Generally Recognised as Safe (GRAS) status in the US last December.
The industry agrees the decision by French food-industry regulator Agence Français de Sécurité Sanitaire Des Aliments (AFSSA) brings EU-wide approval a step closer. But the champagne is staying on ice for now. For myriad reasons, the ruling — though notable — represents only a partial success.
The French approval followed an application by a hitherto little-known stevia manufacturer called Greensweet, based in Auvergne in the south of France. The company was founded at the beginning of 2006 by Joel Perret, who spotted an opportunity for stevia when, in 2004, the FAO/WHO Joint Expert Committee on Food Additives recommended the plant should be considered safe. At that stage, he said, it appeared likely that global approvals would soon follow.
In mid 2006, Perret applied to the French authorities for permission to market steviol glycosides extracted from the stevia plant in France as a sweetener. He did so under a legal instrument that exists in the current EU additives regulations. This allows individual member states to give an ingredient temporary approval within their own borders, even if it is not approved across the EU.
The application required a fair amount of persistence and tenacity on Perret's part. "For three years I had to fight with the experts at the French food-safety agency to demonstrate these products have no effect on human health," he recalled. "Each time I replied to their questions I would get another set of questions."
Finally, in September this year, there was good news: AFSSA had given Greensweet's application the nod. But there was a catch. The approval was for 97 per cent purity Reb-A only, not steviol glycosides. Perret said he believes that by approving only the purest available form of Reb-A, AFSSA was applying a 'precautionary principle' to the process.
The limited approval poses Greensweet — and other stevia producers, who also stand to benefit — a range of potential problems. One is that Reb-A 97 — at about E350 per kg — is many times more expensive than steviol glycosides, which sell for just E70 to E80 per kg. Reb-A is costly to extract because it is only one small component of the whole stevia leaf. Steviol glycosides, on the other hand, are a mixture of several components.
Another issue is that some taste tests have found consumers prefer products sweetened with steviol glycosides over those sweetened with pure Reb-A 97. Lastly, Reb-A 97 is not so easy to use in industrial food-manufacturing applications.
On the upside, Greensweet's application succeeded just in time. The ability to grant this kind of special dispensation for an ingredient expires in January, when new additive regulations are implemented that will harmonise the ingredient-approvals process across the whole of the EU. For this reason, AFSSA's decision was a surprise to Nigel Baldwin, senior scientific and regulatory consultant at Cantox International.
"Member states, up until fairly recently, were very reluctant to do what has just happened," he said. "As of January the new additive regulations will do away with the two-year provisional approval. Most member states have been reluctant to grant it because it goes against the spirit of the new regulations."
The French decision falls outside of the scope of the new Mutual Recognition Regulation, said Brussels-based regulatory experts EAS. That means the industry must now wait to find out if separate attempts to prove the safety of stevia-based sweeteners are successful before EU-wide trade can be envisaged.
The European Stevia Association (EUSTAS) is pursuing an application for steviol glycosides through the EU's food-additives approval process, and hopes there may be an opinion from the European Food Safety Authority as early as next March.
EUSTAS has also lodged a Novel Foods application for the whole stevia plant — though Jan Geuns, co-founder of the organisation, admits this has been fraught with technical difficulties. The organisation changed tactics recently — and its lawyers are currently attempting to prove stevia was in use in the EU before 1997, the legal start point for the Novel Foods Regulation. If successful, Novel Foods approval will not be required.
For now, though, stevia suppliers desperate to break into the potentially lucrative EU market will have to cling to developments in France. "It's the first step," said Geuns of Greensweet's success. "And I hope it will lead to general authorisation of steviol glycosides in Europe."