All additives
E961·sweetener

Neotame

Safe

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

BodyAcceptable Daily Intake (ADI)Year
JECFA0–2 mg/kg body weight/day · JECFA 20032003
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

JurisdictionStatusNotes
United StatesGRAS; FDA ADI 0.3 mg/kg/day
European UnionApproved; EFSA ADI 2 mg/kg/day
JapanApproved with usage limits
South KoreaApproved (MFDS)
GBFSA approved with usage limits
VNApproved with usage limits
THApproved with usage limits
INFSSAI approved with category limits
AEApproved (GCC/GSO standards)
CNApproved per GB 2760

Primary Sources

Products on Looksee containing Neotame

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