ADVANTAME

General Information


Chemical Names: N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-L-α-aspartyl]-L-phenylalanine-1-methyl ester, monohydrate
CAS number: 714229-20-6
Functional Class:
  • Food Additives
    • SWEETENER

Evaluations


Evaluation year: 2015
ADI: 0–5 mg/kg bw
Meeting: 80
Specs Code: R
Report: TRS 995-JECFA 80/36
Specification: FAO JECFA Monographs 17-JECFA 80/3

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.
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