Scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive
food additive, sweetener, steviol glycosides, E 960, rebaudioside M, technical specifications
First published in the EFSA Journal:
8 December 2015
17 November 2015
Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion regarding the safety of an amendment of the specifications for the food additive steviol glycosides (E 960). It was requested that rebaudioside M be added to the list of steviol glycosides as an authorised component of the mixture and that the minimum amount of 75% of stevioside and/or rebaudioside A be deleted. The ANS Panel received a dossier from the applicant and subsequently requested additional data. The Panel noted that for all stevioside and any rebaudioside following intestinal degradation, only steviol would be available in the plasma. The toxicological conclusions made by the ANS Panel in 2010 were also based on the conversion to steviol in the intestine and that steviol was the only compound systemically available. Further to this, the Panel considered that the toxicological studies performed with stevioside and rebaudioside A were relevant for assessing the safety of any steviol glycoside degraded in the intestine. The ANS Panel therefore concluded that extending the current specifications to include rebaudioside D and M as alternatives to rebaudioside A in the predominant components would be of no safety concern. The Panel also concluded that provided that the total amount of steviol glycosides (stevioside; rebaudioside, A, B, C, D, E, F and M; steviolbioside; rubusoside and dulcoside) were greater than 95% which are all converted to steviol and given that there was no evidence of absorption for intact glycosides at realistic use levels, the specific steviol glycosides (E 960) composition would not be of safety concern. Finally it was considered that the ADI of 4 mg/kg bw/day can also be applied where total steviol glycosides comprise more than 95% of the material.
© European Food Safety Authority, 2015
Panel members at the time of adoption:
The Panel wishes to thank the members of the Working Group on Applications: Maria Jose Frutos, David Gott, Lieve Herman, Claude Lambré, Jean-Charles Leblanc, Peter Moldeus, Alicja Mortensen, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo and Camilla Smeraldi for the support provided to this scientific output.
Panel on Food Additives and Nutrient Sources Added to Food
fip [at] efsa.europa.eu
EFSA Journal 2015;13(12):4316 [29 pp.].
On request from: