Answer given by Mr Dalli on behalf of the Commission
On the basis of an application, the Commission has in the past requested the Scientific Committee on Food (SCF) to examine the safety of stevioside as a sweetener. The most recent opinions of the Scientific Committee date from June 1999.
The SCF expressed concerns regarding the absence of safety data about the genotoxic potential of a metabolite of stevioside, about the impurities in the compound and about possible effects on human fertility. The Committee concluded that ‘the substance is not acceptable as a sweetener on the presently available data’. Therefore, the Commission did not propose the authorisation of this substance under Directive 94/35/EC(1) on sweeteners for use in foodstuffs.
Since July 2007, the Directorate-General for Health and Consumers has received three new applications for the authorisation of steviol glycosides from Stevia rebaudiana as a sweetener. The European Food Safety Authority (EFSA) is currently performing a combined safety assessment of steviol glucosides, on the basis of the three applications, which will be completed by March 2010. In case of a favourable opinion by EFSA, the Commission will propose a measure for the inclusion of steviol glycosides in the Community list of sweeteners.
Foods from Stevia rebaudiana not covered by the food additives legislation require authorisation under the Novel Food Regulation (Regulation (EC) No 258/97 of the Parliament and of the Council(2) concerning novel foods and novel food ingredients). Currently an application for using the dried leaves of Stevia rebaudiana as a novel food ingredient is pending in Germany. However, this application is stalled as the applicant is not responding to questions.