emulsifier INS 436

Polysorbate 65 E436

synthetic — Primarily synthetic.

🇪🇺 EU: Approved

🇺🇸 USA: Approved

🇯🇵 Japan: Approved

🇦🇺 AU/NZ: Approved

🇨🇦 Canada: Approved

Scientific Name

Polyoxyethylene (20) sorbitan tristearate

CAS: 9005-71-4

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?

Beyond food, Polysorbate 65 is also used in cosmetics, medicine. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.

In the EU, Polysorbate 65 has a "quantum satis" authorization — Latin for "as much as needed." This means there's no specific maximum limit; manufacturers use only what's technologically necessary.

Detailed Regulatory Assessment

🇪🇺

European Union (EFSA)

approved Max: quantum satis mg/kg

Permitted in specified food categories

🇺🇸

United States (FDA)

approved GRAS

Regulated as a direct food additive under FDA CFR titles.

🇯🇵

Japan (MHLW)

approved Cat: 既存添加物

Compliant with Japanese food sanitation law.

Acceptable Daily Intake (ADI)

International Standard (JECFA)

0-25 mg/kg body weight (for all polysorbates combined)

mg/kg body weight per day

European Standard (EFSA)

Not specified

Natural Occurrence

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

Manufacturing

Method: chemical synthesis

Produced in two steps: (1) sorbitan (from sorbitol) is reacted with three molecules of stearic acid to form sorbitan tristearate, then (2) ethoxylated with approximately 20 units of ethylene oxide. The tri-ester structure makes it more lipophilic (fat-loving) than other polysorbates.

Applications Beyond Food

Cosmetics

Used in cosmetic formulations as an emulsifier, particularly in high-fat products.

Medical

Used in pharmaceutical formulations as an emulsifying agent.

Frequently Asked Questions

What is Polysorbate 65 (E436)?

Polysorbate 65 (E436) is a emulsifier used in food products. It is synthetic and synthetic. A synthetic emulsifier created from sorbitol, stearic acid (three molecules), and ethylene oxide. Unlike other polysorbates which are mono-esters, this is a tri-ester with three stearic acid chains. The stearic acid can be derived from vegetable oils or animal fats.

What is the ADI for Polysorbate 65?

The Acceptable Daily Intake (ADI) for Polysorbate 65 is 0-25 mg/kg body weight (for all polysorbates combined) 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 Polysorbate 65?

Polysorbate 65 is used in various food categories including Fine bakery wares, Edible ices. It is used as a emulsifier in these products.

Is Polysorbate 65 the same as Tween 65?

Yes, Polysorbate 65 is also known as Tween 65, PS65, Polysorbate 65. These are different names for the same substance.