# Neotame (E961)

> Source URL: https://additivefacts.com/additives/neotame
> Markdown URL: https://additivefacts.com/additives/neotame.md

**Safety rating:** SAFE
**E-number:** E961
**CAS number:** 165450-17-9
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Neotame is a non-nutritive sweetener and flavor enhancer derived from aspartame. It is approximately 7,000-13,000 times sweeter than sugar and is used in small quantities to enhance sweetness and flavor in various food and beverage products.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | approved |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is Neotame?

Neotame (CAS Number: 165450-17-9) is a high-intensity non-nutritive sweetener belonging to the class of compounds known as dipeptide methyl esters. It is chemically derived from aspartame through the addition of a neohexyl group, which creates a distinct molecule with different metabolic properties. Neotame provides sweetness without contributing calories to foods, making it suitable for use in reduced-calorie and sugar-free products.

## Common Uses

Neotame is used as a sweetening and flavor-enhancing agent in a wide variety of food and beverage applications. These include:

- Carbonated and non-carbonated soft drinks
- Tabletop sweeteners and sugar substitutes
- Dairy products including yogurt and ice cream
- Baked goods and desserts
- Confectionery products
- Dietary supplements and nutritional beverages
- Flavored water and juice drinks

The compound's high sweetness intensity means that only small quantities are required to achieve desired sweetness levels, which can improve product formulation flexibility for manufacturers.

## Safety Assessment

Neotame has been subjected to extensive safety evaluations. The FDA has not classified neotame as Generally Recognized As Safe (GRAS), instead approving it as a food additive through the formal petition process. The agency has reviewed comprehensive toxicological studies including acute toxicity, chronic toxicity, reproductive and developmental toxicity, and genotoxicity assessments.

According to FDA records, there are zero reported adverse events associated with neotame consumption and zero recalls related to this additive. This indicates a strong safety profile in real-world use since its approval.

The European Food Safety Authority (EFSA) has also evaluated neotame and established an acceptable daily intake (ADI). The ADI represents the amount of a substance that can be safely consumed daily over a lifetime without appreciable health risk.

## Regulatory Status

Neotame is approved for use as a food additive in multiple jurisdictions:

- **United States**: Approved by the FDA as a food additive (not GRAS-designated) for use in specific food categories
- **European Union**: Authorized as food additive E961 under Regulation (EC) No 1333/2008
- **Other countries**: Approved in Canada, Australia, New Zealand, and numerous other countries

While neotame is not on the FDA's GRAS list, this does not indicate a safety concern. The GRAS designation and formal food additive approval represent different regulatory pathways, both of which require demonstrated safety.

## Key Studies

The safety database for neotame includes:

- **Absorption and Metabolism**: Studies demonstrate that neotame is rapidly absorbed and metabolized, with the compound being broken down into aspartame and other metabolites similar to those produced from aspartame consumption.
- **Chronic Toxicity Studies**: Long-term animal studies have not identified adverse effects at levels significantly higher than expected human exposure.
- **Reproductive/Developmental Toxicity**: Adequate data support the safety of neotame for use during pregnancy and lactation at approved levels.
- **Genotoxicity**: Standard genotoxicity assays have not demonstrated mutagenic or clastogenic potential.

The FDA's approval was based on a comprehensive review of these studies, and the absence of adverse event reports in post-market surveillance further supports the established safety profile.

## Brands using Neotame

- Ice Breakers (1 product)
- Icebreakers (1 product)
- The Hershey Company (1 product)

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Neotame (E961) — Safety, regulation, and evidence." https://additivefacts.com/additives/neotame. Accessed 2026-05-19.