STEVIOL GLYCOSIDES

Comments:

Considered for specification only.

Meeting:

96

Specs Code:

R

Report: 

Specification: 

ADI:

0-4 mg/kg bw

Comments:

Considered for specification only.

Meeting:

91

Specs Code:

R

Specification: 

ADI:

0–4 mg/kg bw

Comments:

At the present meeting, the Committee determined that no safety issues exist for steviol glycosides produced by any one of four methods (see FAO JECFA Monograph) resulting in products with ≥95% steviol glycosides as per existing specifications. The Committee indicated that the ADI of 0–4 mg/kg bw established at the sixty-ninth meeting of JECFA for steviol glycosides (expressed as steviol) applies to steviol glycosides produced by the four methods indicated in the annexes of the specifications monograph produced at the current meeting.

Meeting:

87

Specs Code:

R

Report: 

Specification: 

ADI:

0–4 mg/kg bw

Comments:

Considered for specification only.

Meeting:

84

Specs Code:

R

Report: 

Specification: 

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: 

Tox Monograph: 

Specification: 

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: 

Tox Monograph: 

Specification: 

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: 

Tox Monograph: 

Specification: 

Previous Years: