International Stevia Council

Statement on EFSA's Steviol Glycosides Intake Assessment Conclusions

Brussels, Belgium, 27 January 2011

On 14 April 2010, the European Food Safety Authority (EFSA) published a positive scientific opinion (1) concluding that steviol glycosides, sweeteners extracted from the stevia plant, are safe for use in food and beverages. EFSA also established an Acceptable Daily intake (ADI) (2) for their safe consumption, expressed as steviol equivalents, of 4 mg/kg bw/day, the same ADI established by the Joint FAO/WHO Expert Committee of Food Additives (JECFA) in July 2008. EFSA further expressed a concern that, at the maximum use levels proposed by the applicants (European Stevia Association, Morita, and Cargill), (3) ADI could potentially be exceeded.

In response to this opinion, the applicants submitted a revised use level proposal in September 2010, which was referred to EFSA by the European Commission for an exposure assessment. (4)

On 26 January 2011, EFSA released the statement “Revised exposure assessment for steviol glycosides for the proposed uses as a food additive”. (5) In their statement, EFSA concluded that the range of possible estimated intakes may exceed the ADI in some cases. It is important to understand, however, that EFSA’s intake assessment approach is extremely conservative and included uses not even proposed by the applicants. On its conservative approach, EFSA noted:

“When considering the results, it is important to note that these revised exposure estimates, like the ones calculated in the opinion of the ANS Panel, should be considered as conservative. Indeed an assumption made was that all processed foods and beverages contain the sweetener steviol glycosides added at the maximum proposed use levels (i.e. all beverages and not only energy-reduced beverages were considered; the latter was proposed by the applicants.)” (6)

The International Stevia Council and its members, of which two are applicants of record, will continue to work to resolve all questions during the regulatory process for the authorization of steviol glycosides in the European Union. The International Stevia Council, as the voice of the stevia industry, will be providing strong support to the regulatory process and keeping key stakeholders informed on the progress of this approval in the European Union.


2 ADI is an estimate of the amount of a food additive that can be consumed daily over an entire lifetime and is used by toxicologists and regulators to put into proper context the relationship between the doses of a food additive tested in safety studies and the amount people are expected to eat when a food additive is approved for its intended uses.

3 Morita and Cargill are both founding members of the International Stevia Council.

4 Following the scientific opinion, the European Commission requested that the EU applicants consider revising the proposed uses. The applicants responded to this request by removing and/or reducing a significant number of food categories. The applicants validated their approach using the UK’s National Diet and Nutrition Survey data which demonstrated that exposure would be expected to be below the ADI. This dataset was chosen because it is known to be comprehensive and scientifically robust. It is also the only relevant dataset that is available to the public. In support of the application, the Union of European Beverages Association submitted 2 separate intake assessment reports to EFSA. These reports also demonstrated that exposure to steviol glycosides would be below the acceptable daily intake.

5, page 13.

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