Neotame as a sweetener and flavour enhancer

The Panel noted that the additional phenylalanine intake expected from ingestion of neotame as a general purpose sweetener represents a relatively small increment in the exposure to phenylalanine of the phenylketonuric homozygous child. The hypothetical formation of nitrosamines in the gastrointestinal tract from reaction of nitrite with neotame and its major degradation product and/or metabolite NC-00751 has been considered by the Panel. No nitrosated neotame (N-nitroso-(3,3-dimethyl)-L-aspartyl-Lphenylalanine methyl ester, N-nitrosoneotame; NC-00799) and no nitrosated de-esterified neotame (N-nitroso-(3,3-dimethylbuthyl)-L-aspartyl-L-phenylalanine, NC- 00800) could be detected under simulated gastric juice conditions. Furthermore, both compounds were synthesised and shown to be without mutagenic activity in the Ames test. In view of the high sensitivity of the Ames test to genotoxic nitrosocompounds, the Panel considered that nitrosation of neotame, should it occur, is not a matter of safety concern. After considering all the data on stability, degradation products and toxicology, the Panel concluded that neotame is not of safety concern with respect to the proposed uses as a The Panel established an Acceptable Daily Intake (ADI) of 0-2 mg/kg bw/day based on the application of a 100-fold safety factor to the NOAEL of 200 mg/kg bw from a 52-week dog. Conservative estimates of dietary exposure both in adults and children suggest that it is very unlikely that the ADI would be exceeded at the proposed use levels.