Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive

Abstract

Steviol glycosides in the present evaluation are mixtures of steviol glycosides that comprise not less than 95% of stevioside and/or rebaudioside A. Stevioside as a sweetener was evaluated by the SCF in 1984, 1989 and 1999. JECFA reviewed the safety of steviol glycosides in 2000, 2005, 2006, 2007, and 2009 and established an ADI for steviol glycosides (expressed as steviol equivalents) of 4 mg/kg bw/day. The Panel considers that the results of toxicology studies on either stevioside or rebaudioside A are applicable for the safety assessment of steviol glycosides as both rebaudioside A and stevioside are metabolised and excreted by similar pathways, with steviol being the common metabolite for both. Considering the available toxicity data (in vitro and in vivo animal studies and some human tolerance studies), the Panel concludes that steviol glycosides, complying with JECFA specifications, are not carcinogenic, genotoxic or associated with any reproductive/developmental toxicity. The Panel establishes an ADI for steviol glycosides, expressed as steviol equivalents, of 4 mg/kg bw/day based on application of a 100‐fold uncertainty factor to the NOAEL in the 2‐year carcinogenicity study in the rat of 2.5% stevioside in the diet. This is equal to 967 mg stevioside/kg bw/day (corresponding to approximately 388 mg steviol equivalents/kg bw/day). Conservative estimates of steviol glycosides exposures both in adults and in children suggest that it is likely that the ADI would be exceeded at the maximum proposed use levels.

Safety of the proposed amendment of the specifications for steviol glycosides (E 960) as a food additive: Rebaudioside M produced via enzyme‐catalysed bioconversion of purified stevia leaf extract

“…In addition, in the Caco-2 cell model the apparent permeability value of steviol was found to be 200 to 300-times higher than that of stevioside or rebaudioside A. Other in vitro studies assessing the metabolic transformation of steviol showed a similar formation of hydroxy-metabolites of steviol in the presence of rat or human liver microsomes' (EFSA ANS Panel, 2010).…”

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.…”

“…The safety of steviol glycosides as a food additive was evaluated by EFSA in 2010 (EFSA ANS Panel, 2010). Following the EFSA assessment in 2015 (EFSA ANS Panel, 2015a), rebaudioside M was included in the specifications for the food additive steviol glycosides (E 960) according to the Commission Regulation (EU) No 231/2012 4 .…”

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

“…However, the Panel considers that these studies are not needed considering that the safety of these compounds can be extrapolated from the presence of sufficient amounts of the compounds in the test materials used in studies conducted to assess the safety of steviol glycosides complying with proposed specifications and/or having the same general structure as rebaudioside A. Therefore, under the conditions of intended use of steviol glycosides the related steviol glycosides and degradation products are not expected to be associated with any adverse effects following oral consumption of the steviol glycosides by humans' (EFSA ANS Panel, 2010). The Panel noted that a major uncertainty between assessment based on greater than 95% rebaudioside A or stevioside and assessment of other combinations of rebaudiosides with a lower total glycoside content would be the lack of data on minor components of stevia whose compositional levels may vary along with those of rebaudiosides.…”

“…in 1984in , 1988in (SCF, 19841989;. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) reviewed the safety of steviol glycosides in 2000, 2005, 2006and 2009(JECFA, 20002005;2006a;2010) and established an Acceptable Daily Intake (ADI) for steviol glycosides (E 960) of 4 mg/kg bw (body weight) per day, expressed as steviol equivalents.…”