Regulatory Status of Steviol Glycosides in France An Update 1-2 July 20093rd EUSTAS Symposium Leuven Belgium1

Introduction A difficult exercice An evolving situation A country specific situation in a complex world situation 1-2 July 20093rd EUSTAS Symposium Leuven Belgium2

Greensweet the company The company project started in 2004 after the first positive advice of JECFA The company was created in February 2006 with the objective to produce and sale stevia derived products : steviol glycosides In parallel with product and technology development Greensweet decided to apply for the authorization. 1-2 July 20093rd EUSTAS Symposium Leuven Belgium3

The Authorization How to obtain it ? – After the negative advice of JECFA in 1999 – After the negative advice of CSHPF in 1998 – After the negative advice of SCF in 1999 – With the European regulation on Novel Foods But the door started to unlock with : – The temporary positive advice of JECFA in July 20093rd EUSTAS Symposium Leuven Belgium4

The situation in 2006 Many scientific results were demonstrating the safety of steviol glycosides as a sweetener A question was remaining about the potential pharmacological effects of these products in normal patients We though that it was, at this date, possible to argue about safety of steviol glycosides and to file an application for an authorization. 1-2 July 20093rd EUSTAS Symposium Leuven Belgium5

Going through the French Channel Why ? : – Because it was possible (it will not be anymore possible in 2010) – It could be « certainly » faster than an European application (we expected 6 to 12 months). – It is less « public » and so, will try to avoid strong reaction of the opponents. – We wanted to talk only science and safety for the consumers, without any lobbying considerations ! 1-2 July 20093rd EUSTAS Symposium Leuven Belgium6

The French Procedure 1-2 July 20093rd EUSTAS Symposium Leuven Belgium7

At the End, if any ! The French authorization is temporary It is for two years The application is transferred to European Commission along with the French decision The products would also be usable by the other European countries (EU) ??? 1-2 July 20093rd EUSTAS Symposium Leuven Belgium8

The Long Endless Story Application Filed in June 2006 (DGCCRF) AFSSA asked for more data in January 2007 – Not enough data to demonstrate the total safety of steviol glycosides – First additional information from our side AFSSA asked again for more information in June 2007 – Second additional information from our side 1-2 July 20093rd EUSTAS Symposium Leuven Belgium9

The Long Endless Story 2 AFSSA first advice published in October 2007, the conclusion was negative : – No demonstration of the « perfect safety » of the products – JECFA has extended its temporary positive advice and ADI – …. 1-2 July 20093rd EUSTAS Symposium Leuven Belgium10

The Long Endless Story 3 Meeting the AFSSA experts (who also work for JECFA) in order to have a clear scientific explanation of this advice (December 2007) New additional information in March 2008 (scientific and economic data) New additional information in May 2008 based on the published results in the issue of Food & Chemical Toxicology 1-2 July 20093rd EUSTAS Symposium Leuven Belgium11

The Long Endless Story 4 June 2008 : final definitive advice and ADI from JECFA in Roma. Second AFSSA advice : « positive » but for the rebaudioside A 97% only, in September 2008 Redaction of the legal text (DGCCRF) based on the JECFA specifications and ADI AFSSA negative advice on this text in December (the 16 th ), back to rebaudioside A 1-2 July 20093rd EUSTAS Symposium Leuven Belgium12

The Long Endless Story 5 New legal text written by DGCCRF for rebaudioside A only (February 2009) AFSSA Agreement but with some modifications in the authorized final products and the maximal quantities allowed A new Go and Return exchange between DGCCRF and AFSSA…. Final text accepted by AFSSA in June July 20093rd EUSTAS Symposium Leuven Belgium13

The Long Endless Story 6 Text today on the way for signature by the Ministers (three of them) ……… BUT : Is it really finished ? And when do we will have the final signature : one day, one year ??? 1-2 July 20093rd EUSTAS Symposium Leuven Belgium14

Questions raised Why such a decision only for Reb A ? – Scientific results in Food & Chem. Tox. ? – French « principe de précaution » applied to the excess ? – Any other unknown reason (farmers, sugar industry, chemical industry….) ? The consequences of this decision : – A bad sign for EFSA ? – A distortion in the stevia economic competition ? 1-2 July 20093rd EUSTAS Symposium Leuven Belgium15

A non satisfactory situation Facing this decision for only Rebaudioside A, EUSTAS helped our application with new data and contacts with French authorities (thanks to EUSTAS). For the moment this didn’t change the AFSSA position… 1-2 July 20093rd EUSTAS Symposium Leuven Belgium16

Today Rebaudioside A 97 % purity could be authorized in France in the coming days (if not already done today !) This authorization is temporary for two years We wait for the text to « discover » the final products in which the sweetener will be allowed and in which maximum quantities 1-2 July 20093rd EUSTAS Symposium Leuven Belgium17

And Now ? Our objective is to give consumers a safe fully natural product based on EUSTAS quality standards The choice of the product as to be determined by organoleptic and economic considerations as all steviol glycosides have the same safety features 1-2 July 20093rd EUSTAS Symposium Leuven Belgium18

DON’T GIVE UP We will continue to act for an authorization based on the JECFA and CODEX specifications for the whole steviol glycosides family. SO WE DON’T GIVE UP Thank you for your attention 1-2 July 20093rd EUSTAS Symposium Leuven Belgium19