STEVIOL GLYCOSIDES

General Information


Synonyms: DULCOSIDE A, REBAUDIOSIDE A, REBAUDIOSIDE C, STEVIOSIDE
Chemical Names: STEVIOSIDE: 13-[(2-O-beta-D-GLUCOPYRANOSYL-beta-D-GLUCOPYRANOSYL) OXY] KAUR-16-EN-18-OIC ACID beta-D-GLUCOPYRANOSYL ESTER; REBAUDIOSIDE A: 13-[(2-O-beta -D-GLUCOPYRANOSYL-3-O-beta-D-GLUCOPYRANOSYL-beta-D-GLUCOPYRANOSYL)OXY] KAUR-16-EN-18-OIC ACID beta-D-GLUCOPYRANOSYL ESTER; REBAUDIOSIDE C: 13-[(2-O-alpha-L-RHAMNOPYRANOSYL-3-O-beta-D-GLUCOPYRANOSYL-beta-D-GLUCOPYRANOSYL)OXY] KAUR-16-EN-18-OIC ACID beta-D-GLUCOPYRANOSYL ESTER; DULCOSIDE A: 13-[2-O-alpha-L-RHAMNOPYRANOSYL-beta-D-GLUCOPYRANOSYL]OXY] KAUR-16-EN-18-OIC ACID beta-D-GLUCOPYRANOSYL ESTER
INS: 960
Functional Class:
  • Food Additives
    • SWEETENER

Evaluations


Evaluation year: 2016
ADI: 0–4 mg/kg bw
Comments: The Committee confirmed the ADI of 0–4 mg/kg bw, expressed as steviol. The Committee also confirmed that rebaudioside A from multiple gene donors expressed in Yarrowia lipolytica is included in the ADI. The Committee concluded that it was not necessary to make the ADI temporary because the requested information to complete the specifications refers only to an update of the method and has no safety implication. The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0–4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (up to 110%), but the ADI was not exceeded for other age groups. Considering the conservative nature of the dietary exposure estimate, based on maximum use levels applied to all food consumed from categories with permissions for use in the countries assessed, steviol glycosides are not likely to present a health concern for any age group.
Meeting: 82
Specs Code: N, T
Report: TRS 1000-JECFA 82/54
Specification: FAO JECFA Monographs 19/106

Evaluation year: 2008
ADI: 0-4 mg/kg bw
Comments: ADI of 0–4 mg/kg bw expressed as steviol, based on a NOEL of 970 mg/kg bw per day from a long-term experimental study with stevioside (383 mg/kg bw per day expressed as steviol) and a safety factor of 100. The results of the new studies presented tothe Committee at its present meeting have shown no adverse effects of steviol glycosides when taken at doses of about 4 mg/kg bw per day, expressed as steviol, for up to 16 weeks by individuals with type 2 diabetes mellitus and individuals with normal or low-normal blood pressure for 4 weeks. The Committee concluded that the new data were sufficient to allow the additional safety factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0– 4 mg/kg bw expressed as steviol.
Report: TRS 952-JECFA 69/50
Tox Monograph: FAS 60-JECFA 69/183
Specification: FAO JECFA Monographs 5/75

Evaluation year: 2007
ADI: 0-2 mg/kg bw
Comments: The temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol was extended until 2008, pending submission of the results of the ongoing studies. The Committee considered that the newly available data did not raise additional concerns regarding the safety of steviol glycosides, but that the results of ongoing clinical studies, which more closely address the requirements specified at the sixty-third meeting, would be essential to its evaluation. The specifications were revised and the tentative assignation was removed. The method of assay includes a minimum requirement of 95% of the total of 7 steviol glycosides.
Report: TRS 952-JECFA68/
Tox Monograph: FAS 59-JECFA68/
Specification: FAO JECFA Monographs 4/ . R
Previous Years: 2007, TRS 947 -JECFA68/50, FAO JECFA Monographs 4/61. R, FAS 59-JECFA68/?.
2004, TRS 928-JECFA 63/34, COMPENDIUM ADDENDUM 12/FNP 52 Add. 12/47. N,T; FAO JECFA Monographs 1 vol.3/433, FAS 54-JECFA 63/117. 0-2 (TEMPORARY, EXPRESSED AS STEBIOL). TE, N,T