Status in the EU

Preface:

In South America Stevia rebaudiana has been used as a sweetener since time immemorial. In Japan extracts of that plant (steviol glycoside) have had about 40% of the sweetener market for decades. Also, in Europe Stevia has been used as a non-calorie replacement for sugar.

In 1997 an application for the permission for the sweet contents of the Stevia plant as "Novel Food" has been put to the SCIENTIFIC COMMITTEE ON FOOD (SCF) of the European Commission. The "Novel Food Regulation" determines that foodstuff from other cultural backgrounds has to be proven completely harmless to the health before being approved of as foodstuff.
Especially for a complex natural product such as Stevia it is almost impossible to provide such evidence, as the costs for the research are very high. Because such a raw material can not be monopolized, no enterprise can be found for financial sponsorship.

In 1999 the application was turned down with the following reasoning: 'The data was not sufficient to guarantee complete harmlessness to the health.' The disapproval from Brussels does, by the way, contain some factual and argumentative errors.

From 2000, Stevia has been ruled under the EU regulation § No 258/97 (Novel Food regulation) and the marketing as foodstuff in Europe has been prohibited (source: EU Gazette; L 61/14 ).

Since then numerous scientific studies have been done, proving the complete harmlessness. 2004 a provisional ADI value for Stevia and its isolated contents: Steviosid and Rebaudiosid A, has been established by JECFA, hence the complete harmlessness to the health proven. To accomplish a definite ADI value JECFA has requested the following:

• Analytical data on distribution and concentrations of all component steviol glycosides, including those that are not identified in these tentative specifications.
• Method of analysis for the determination of all component steviol glycosides, including those that are not identified in these tentative specifications;
• The nature and concentration of the fractions that do not contain steviol glycosides.
• The quantities of residual solvents from isolation and purification steps of the manufacturing process.
• The hydrolytic stability of the steviol glycosides in acidic foods and beverages.

The recommendation of JECFA, concerning Stevia rebaudiana and its contents, have no meaning for approval from the EU. In Europe, only the SCIENTIFIC COMMITTEE ON FOOD decides on the approval of new foodstuff. In order to get an assessment, a new application for Stevia rebaudiana as Novel Food has to be put to the SCIENTIFIC COMMITTEE ON FOOD.

Professor Dr. Jan Geuns of KULeuven, Belgium and President of EUSTAS has already put the scientific part of the application together.

The EU considers Stevia, the living plants, dried leaves and crude extracts as "Novel Food". To obtain an authorization for the EU market, the Novel Food procedure has to be followed. The purified steviol glycosides (stevioside and rebaudioside A) are considered as Food Additives, and a new application has to be sent to EFSA in Parma, not anymore to the Scientific Committee.
More information about this can be found at the website of the EU: 

a) about Novel Food: http://ec.europa.eu/food/food/biotechnology/novelfood/legisl_en.htm 

b) about the review of the regulation and comments by member countries:
http://ec.europa.eu/food/food/biotechnology/novelfood/initiatives_en.htm

c) Food chain, general information:
http://ec.europa.eu/food/food/foodlaw/guidance/guidance_rev_7_en.pdf 

According to the "guidance on submissions for food additive evaluations by the scientific committee on food (SCF/CS/ADD/GEN/26 Final (12 July 2001)", data about cultivation and production processes has to be provided too.

EUSTAS depends on cooperation with producers in China, Japan, Brazil, Paraguay and Malaysia. The confidential handling of production data is guaranteed by EUSTAS.