Neotame
Overview
Neotame is a high-intensity artificial sweetener structurally derived from aspartame but approximately 7,000 to 13,000 times sweeter than sucrose. Unlike aspartame, neotame does not metabolise to phenylalanine, making it safe for individuals with phenylketonuria (PKU). It is used in beverages, dairy products, frozen desserts, tabletop sweeteners, and chewing gum at extremely small concentrations that contribute negligible calories.
JECFA evaluated neotame in 2003 and established an ADI of 2 mg per kilogram of body weight per day. For a 70 kg adult this equates to 140 mg per day — an amount virtually impossible to approach through normal food consumption given the minute quantities used to achieve sweetness. Comprehensive toxicological and carcinogenicity studies conducted prior to regulatory approval showed no adverse effects at relevant doses.
Neotame is approved in the EU (E961), the United States (since 2002), Australia, and several other markets. It is considerably less common than aspartame or sucralose, appearing in a narrower range of products. Unlike aspartame, it does not require a PKU warning on labelling. For consumers seeking a well-studied artificial sweetener with no phenylalanine concerns, neotame represents a favourable safety profile among its class.
Generated from verified JECFA, EFSA, and regulatory data. All numerical values are sourced from the WHO/FAO JECFA Combined Compendium and EFSA OpenFoodTox 3.0.
Safety Assessment
| Body | Acceptable Daily Intake (ADI) | Year |
|---|---|---|
| JECFA | 0–2 mg/kg body weight/day · JECFA 2003 | 2003 |
| EFSA | — | — |
ADI = the amount of a substance a person can consume every day over a lifetime without appreciable health risk. Expressed as mg per kg body weight per day. Source: WHO/FAO JECFA Combined Compendium; EFSA OpenFoodTox 3.0.
Regulatory Status
| Jurisdiction | Status | Notes |
|---|---|---|
| United States | GRAS; FDA ADI 0.3 mg/kg/day | — |
| European Union | Approved; EFSA ADI 2 mg/kg/day | — |
| Japan | Approved with usage limits | — |
| South Korea | Approved (MFDS) | — |
| GB | FSA approved with usage limits | — |
| VN | Approved with usage limits | — |
| TH | Approved with usage limits | — |
| IN | FSSAI approved with category limits | — |
| AE | Approved (GCC/GSO standards) | — |
| CN | Approved per GB 2760 | — |
Primary Sources
Products on Looksee containing Neotame
Diet Guanabana Nectar Drink
Goya
Sparkling Water Beverage
The Kroger Co.
Sparkling Water Beverage
Kroger
Sparkling Water Beverage
The Kroger Co.
Kroger, lite nonfat yogurt, cherry cheesecake
Kroger
Kroger, lite nonfat yogurt, vanilla
Kroger
Lite nonfat yogurt
Kroger
Kroger, lite nonfat yogurt, strawberry banana
Kroger
Soda
Big K

Sugar Free Syrup
Mrs. Butterworth's
Sparkling water beverage
Kroger
Kiwi strawberry sparkling water
Kroger
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