sweetener INS 961

Neotame E961

artificial — Primarily synthetic.

🇪🇺 EU: Approved

🇺🇸 USA: Approved

🇯🇵 Japan: Approved

🇦🇺 AU/NZ: Approved

🇨🇦 Canada: Approved

Scientific Name

N-[N-(3,3-Dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester

CAS: 165450-17-9

Data verified: 2026-04-04

Factual Regulatory Reference

This database provides factual regulatory information compiled from official government sources. It does not constitute medical, nutritional, or safety advice. Regulatory status varies by country and is subject to change. Always refer to your local regulatory authority for the most current information.

? Did You Know?

Neotame isn't just a food additive — it's also used in medicine.

To reach the Acceptable Daily Intake limit, a 60kg adult would need to consume approximately ~171 cans of neotame-sweetened beverage (355ml) in a single day. (This is a mathematical illustration, not a safety recommendation.)

Neotame is fully synthetic — it doesn't exist in nature and is manufactured entirely through chemical processes.

Detailed Regulatory Assessment

🇪🇺

European Union (EFSA)

approved Max: varies by food category (2-33 mg/kg) mg/kg

Very low maximum levels due to high sweetness intensity

Official EFSA Link

🇺🇸

United States (FDA)

approved Approved food additive

Approved in 2002; no PKU warning required unlike aspartame

🇯🇵

Japan (MHLW)

approved Cat: 指定添加物

Approved with maximum use levels

Acceptable Daily Intake (ADI)

International Standard (JECFA)

0–2 mg/kg bw/day

mg/kg body weight per day

European Standard (EFSA)

2 mg/kg bw/day

Everyday Perspective

For a 60kg adult, this limit is roughly equivalent to consuming:

~171 of cans of neotame-sweetened beverage (355ml)

~0.7mg per serving

~240 of pieces of neotame-sweetened gum

~0.5mg per serving

Natural Occurrence

This additive is not known to occur naturally in significant quantities.

Manufacturing

Method: chemical synthesis

Synthesized from aspartame by adding a 3,3-dimethylbutyl group. This modification makes it much sweeter and eliminates the need for phenylketonuria (PKU) warnings.

Applications Beyond Food

Medical

Sweetener in chewable tablets and liquid medicines

Frequently Asked Questions

What is Neotame (E961)?

Neotame (E961) is a sweetener used in food products. It is artificial and synthetic. A synthetic high-intensity sweetener derived from aspartame. About 7,000-13,000 times sweeter than sucrose. Chemically similar to aspartame but does not require PKU warning.

What is the ADI for Neotame?

The Acceptable Daily Intake (ADI) for Neotame is 0–2 mg/kg bw/day as established by JECFA (Joint FAO/WHO Expert Committee on Food Additives). ADI represents the amount that can be consumed daily over a lifetime without appreciable health risk.

What foods contain Neotame?

Neotame is used in various food categories including Other non-alcoholic beverages, Confectionery. It is used as a sweetener in these products.

Primary Research & Evidence