Food & Drink / Compounds / Neotame (E961)

Neotame (E961) in food: ingestion safety

Low risk

(People-specific data is limited; this page draws from human adult context.) Neotame presents low risk to human adults. FDA approved 2002; JECFA and EFSA ADI 2 mg/kg/day; extreme potency (7,000–13,000× sucrose) means use levels are in ppb range — estimated daily intake is a tiny fraction of the ADI even for frequent consumers. No carcinogenicity or genotoxicity. Unlike aspartame, does not release free phenylalanine — safe for PKU patients without warning. Methanol release at use concentrations is negligible. One of the most thoroughly tested sweeteners in the regulatory database.

What is neotame (e961)?

The IUPAC name is (3S)-3-(3,3-dimethylbutylamino)-4-[[(2S)-1-methoxy-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid.

Also known as: (3S)-3-(3,3-dimethylbutylamino)-4-[[(2S)-1-methoxy-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid, Neotame, N-(N-(3,3-dimethylbutyl)-L-alpha-aspartyl)-L-phenylalanine 1-methyl ester, VJ597D52EX.

IUPAC name
(3S)-3-(3,3-dimethylbutylamino)-4-[[(2S)-1-methoxy-1-oxo-3-phenylpropan-2-yl]amino]-4-oxobutanoic acid
CAS number
165450-17-9
Molecular formula
C20H30N2O5
Molecular weight
378.5 g/mol
SMILES
CC(C)(C)CCNC(CC(=O)O)C(=O)NC(CC1=CC=CC=C1)C(=O)OC
PubChem CID
9810996

Risk for people

Low risk

Neotame presents low risk to human adults. FDA approved 2002; JECFA and EFSA ADI 2 mg/kg/day; extreme potency (7,000–13,000× sucrose) means use levels are in ppb range — estimated daily intake is a tiny fraction of the ADI even for frequent consumers. No carcinogenicity or genotoxicity. Unlike aspartame, does not release free phenylalanine — safe for PKU patients without warning. Methanol release at use concentrations is negligible. One of the most thoroughly tested sweeteners in the regulatory database.

Regulatory consensus

1 regulatory bodyhas classified Neotame (E961).

AgencyYearClassificationNotes
IARC2007Not evaluated by IARC for carcinogenicity — Neotame (E961; CAS 165450-17-9; N-[N-(3,3-dimethylbutyl)-L-alpha-aspartyl]-L-phenylalanine 1-methyl ester; a chemically modified aspartame derivative) is approved by FDA (2002) and EU (E961; 2010); EFSA ADI 2 mg/kg/day (EFSA 2007; EFSA Journal 2007;5(11):581); JECFA ADI 2 mg/kg/day (JECFA 2003); no IARC, EPA, or EFSA carcinogenicity classification; neotame is approximately 7,000–13,000× sweeter than sucrose — the most potent approved sweetener at the time of its 2002 approval; despite being structurally derived from aspartame (phenylalanine + aspartic acid dipeptide methyl ester), the addition of the N-(3,3-dimethylbutyl) group to the aspartic acid nitrogen prevents the enzyme (carboxypeptidase A) that would normally cleave phenylalanine from the molecule from acting on it — consequently, neotame does not release free phenylalanine in vivo and does not require the PKU warning label required for aspartame (21 CFR 172.829); the methanol released upon ester hydrolysis is a toxicological consideration but is negligible at use levels given the extreme sweetness (required doses in ppb)

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where you encounter neotame (e961)

  • Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational Environments — Factories, Warehouses, Transportation vehicles
  • Food — processed food, beverages, candy, baked goods

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Neotame (E961):

  • Natural preservatives; Clean-label ingredients; Minimally processed food
    Trade-offs: Consumer label appeal ('clean label'); variable efficacy depending on food matrix and target pathogen; may alter flavor/color; regulatory status varies by jurisdiction; often more expensive per unit of preservation effect.
    Relative cost: 2-5× conventional

Frequently asked questions

What products contain neotame (e961)?

Neotame (E961) appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); processed food (Food).

See Neotame (E961) in the food app

Look up products containing neotame (e961), compare to alternatives, and explore the full data record.

Open in food View raw API data

Sources (1)
  1. Neotame CAS 165450-17-9 N-[N-(3,3-Dimethylbutyl)-L-alpha-Aspartyl]-L-Phenylalanine 1-Methyl Ester C20H30N2O5 7000-13000x Sucrose; FDA Approved 2002 21 CFR 172.829 All Foods; EU E961 2010; JECFA ADI 2 mg/kg/day 2003; EFSA ADI 2 mg/kg/day EFSA Journal 2007;5(11):581; No PKU Warning Required 3,3-Dimethylbutyl Steric Block Carboxypeptidase A No Free Phenylalanine; T1R2/T1R3 Heterodimer Hydrophobic Neohexyl Binding Site Extra Affinity; De-Esterified Neotame Major Metabolite Methanol Negligible at ppb Use; NutraSweet 1992 Patent 2002 FDA Approval; 80+ Study Regulatory Package No Carcinogenicity Genotoxicity Neurotoxicity; Limited Commercial Adoption vs Aspartame Sucralose Stevia (2007) — regulatory

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →