Re-evaluation of neotame (E 961) as food additive

Area of Science:

• Food Additive Safety
• Toxicology
• Nutritional Science

Background:

• Neotame (E 961) is a manufactured sweetener, N-[N-(3,3-dimethylbutyl)-l-α-aspartyl]-l-phenylalanine 1-methyl ester.
• Its primary impurity and metabolite is N-[N-(3,3-dimethylbutyl)-l-α-aspartyl]-l-phenylalanine (NC-00751).
• Previous safety assessments were conducted by EFSA in 2007.

Purpose of the Study:

• To re-evaluate the safety of neotame (E 961) as a food additive.
• To establish a revised Acceptable Daily Intake (ADI) for neotame.
• To assess dietary exposure to neotame in various population groups.

Main Methods:

• Review of available toxicological studies from EFSA (2007) and literature.
• Assessment of genotoxicity, aneugenic potential, and other toxicological endpoints.
• Calculation of ADI based on NOAEL from chronic and carcinogenicity studies in rats.

Main Results:

• No genotoxicity concerns were identified for neotame (E 961).
• No adverse effects were observed at the highest doses tested in available toxicological studies.
• A new ADI of 10 mg/kg bw per day was established, based on a NOAEL of 1000 mg/kg bw per day.
• Dietary exposure estimates did not exceed the new ADI across all population groups and scenarios.

Conclusions:

• Neotame (E 961) is considered safe at current permitted and reported use levels.
• The established ADI of 10 mg/kg bw per day replaces the 2007 ADI of 2 mg/kg bw per day.
• Recommendations include revising EU specifications for neotame (E 961).