| Evaluation year: | 2013 |
| ADI: | 0–5 mg/kg body weight (bw) |
| Comments: | The Committee established an acceptable daily intake (ADI) of 0–5 mg/kg body weight (bw) for advantame on the basis of a no-observed-adverse-effect level (NOAEL) of 500 mg/kg bw per day for maternal toxicity in a developmental toxicity study in rabbits and application of a 100-fold safety factor to account for interspecies and intraspecies variability.
The Committee agreed that the ADI also applies to those individuals with phenylketonuria, as the formation of phenylalanine from the normal use of advantame would not be significant in relation to this condition.
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| Intake: | Using the proposed maximum use levels and conservative assumptions, the maximum mean dietary exposure to advantame would be 1.45 mg/kg bw per day (29% of the upper bound of the ADI), and the maximum high-percentile dietary exposure would be 2.16 mg/kg bw per day (43% of the upper bound of the ADI). |
| Specs Code: | N |
| Report: | TRS 983 JECFA 77 |
| Tox Monograph: | FAS 68 JECFA 77 |
| Specification: | Compendium of food additive specifications. FAO JECFA Monographs 14, 2013 |
