Scientific opinion on the safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive

Abstract

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.

Safety evaluation of steviol glycoside preparations, including rebaudioside AM, obtained by enzymatic bioconversion of highly purified stevioside and/or rebaudioside A stevia leaf extracts

“…Data on absorption, distribution, metabolism and excretion (ADME) of some of steviol glycosides currently listed in the EU specifications have been considered and summarised in previous EFSA opinions (EFSA ANS Panel, 2010, 2015aEFSA FAF Panel, 2020). According to these opinions, stevioside and rebaudioside A are not hydrolysed by digestive enzymes of the upper gastrointestinal tract due to the presence of b-glycosidic bonds.…”

Safety of the proposed amendment of the specifications of the food additive steviol glycosides (E 960)

“…The available information was not sufficient to assess the safety of the proposed amendment of the specifications of the food additive steviol glycosides (E 960) and the conclusions on the previous assessments on steviol glycosides (EFSA ANS Panel, 2010, 2015a) cannot be extrapolated to any other mixture of steviol glycosides extracted from S. rebaudiana Bertoni leaves and complying with the proposed specification of containing not less than 95% of any steviol glycosides.…”

Neuroendocrine and Metabolic Effects of Low-Calorie and Non-Calorie Sweeteners

“…Stevia has a strong sweetening power, 200-to 400-fold higher than that of sucrose (94). Its maximal recommended daily intake is 4 mg/kg, and it is considered unsafe at higher doses (EU regulation 1129/2011) (95). This quantity corresponds to approximately nine tablets per day.…”