Cargill Welcomes Positive EFSA Opinion on Steviol Glycosides

The opinion is based on a rigorous safety assessment by EFSA's ANS expert panel of the scientific dossiers submitted by several applicants including Cargill, maker of Truvia sweetener, a great-tasting, zero-calorie sweetener derived from the leaf of the stevia plant.

15 Apr 2010 --- The European Food Safety Authority (EFSA) published a Scientific Opinion, which confirms that steviol glycosides, sweeteners extracted from the stevia plant, are safe for use in foods and beverages and establishes an Acceptable Daily Intake (ADI) for their safe consumption.

In its published Scientific Opinion, EFSA's Panel on Food Additives and Nutrient Sources Added to Foods (ANS) concludes that, considering the available toxicity data, "steviol glycosides complying with JECFA1 specifications are not carcinogenic, genotoxic or associated with any reproductive / development toxicity". The ANS Panel also establishes an ADI for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg bw/day, the same ADI as previously established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

The opinion is based on a rigorous safety assessment by EFSA's ANS expert panel of the scientific dossiers submitted by several applicants including Cargill, maker of Truvia sweetener, a great-tasting, zero-calorie sweetener derived from the leaf of the stevia plant. The Scientific Opinion applies to steviol glycosides including stevioside, rebaudioside A, rebaudioside C, dulcoside A, rubusoside, steviolbioside, rebaudioside B, rebaudioside D and rebaudioside F.

Truvia tabletop sweetener, the U.S. market leader in the new category of stevia-based sweeteners is made with rebiana, which is 97% pure rebaudioside A, the best-tasting part of the stevia leaf and one of the steviol glycosides assessed by EFSA. Truvia rebiana, which is 200 times sweeter than sugar, opens up a whole new range of choices for food and beverage companies to create products with sweetness from a natural source without calories.

Zanna McFerson, Assistant Vice President, Cargill Health and Nutrition, said: "This is a very important milestone in the path of European regulatory approval of steviol glycosides. We look forward to offering our food and beverage customers Truvia rebiana for use in foods, beverages and confectionary products as an innovation for their brands. Consumers in Europe will benefit by having more choice as they look to manage sugars and calories in their lives. Our Truvia product will initially be available in France where it is already allowed for use." EFSA's ANS Panel also stated that, based on conservative estimates, the ADI would be exceeded at the maximum proposed use levels for steviol glycosides. For comparison, the ADI is equivalent to approximately 23 teaspoons of Truvia tabletop sweetener every day over the course of a lifetime. Projected use levels were based on provisional industry estimates. In

practice, maximum use limits in certain food and beverage categories may need to be adjusted before a final regulation is issued by the European Union.

In May 2008 Cargill published the results of the Truvia rebiana research programme in the journal Food and Chemical Toxicology. This research is the only peer-reviewed, published comprehensive safety programme and was pivotal for substantiating the safe use of steviol glycosides, of which rebaudioside A is one, in food and beverages.

Professor Andrew Renwick OBE, Emeritus Professor of the School of Medicine of the University of Southampton UK, who contributed to the Truvia rebiana research programme, commented: "EFSA's positive Scientific Opinion affirms that the extensive research performed on rebiana has established its safety for use in foods and beverages."

In July 2008, the Joint FAO/WHO Expert Committee on Food Additives found steviol glycosides safe for use and the U.S. Food & Drug Administration responded favourably to Generally Recognised As Safe notifications (GRAS) in December 2008. In September 2009, France authorised the use of rebaudioside A as a sweetener at the national level as the result of a positive safety opinion issued by the Agence Française de Sécurité Sanitaire des Aliments.

Steviol glycosides are also permitted for use in foods and beverages in Argentina, Australia, Brazil, China, Columbia, France, Japan, Korea, Malaysia, Mexico, New Zealand, Paraguay, Peru, Russia, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay.

In the U.S., since its introduction, Truvia tabletop sweetener has achieved a 7.6 percent market share of the sugar substitute category and Truvia rebiana launched in more than a dozen food and beverage products. In France, Fanta Still juice drinks made with Truvia rebiana were recently launched.

Meanwhile the Functional Ingredients laboratory at Reading Scientific Services Ltd (RSSL) has developed and validated a new HPLC method for Rebaudoside A, one of the active components of the natural sweetener stevia. The test can be used on the raw ingredient and in a few finished products such as soft drinks and confectionery. Other matrices are being worked on and will be added soon. Reb A has recently received approval for use in France, and there is strong expectation that the rest of Europe will soon follow suit and permit its use. Reb A is already approved for use in many other countries including Japan and USA.

"Companies are already coming to us for advice and support in reformulating products to use Reb A," says Sarah Marshall of RSSL's Product and Ingredient Innovation Department.

RSSL's new analytical method will help in this development work, as it is important to know how Reb A levels are affected by processing and storage.

The method is sensitive and accurate, having a limit of detection down to 1mg/100g of raw material. "We will be able to give clients the evidence to support labelling claims, and to make the best use of the Reb A in formulations," adds Marta Ahijado Fernandez, manager of RSSL's Functional Ingredients laboratory.