emulsifier INS 435

Polysorbate 60 E435

synthetic β€” Primarily synthetic.

πŸ‡ͺπŸ‡Ί EU: Approved
πŸ‡ΊπŸ‡Έ USA: Approved
πŸ‡―πŸ‡΅ Japan: Approved
πŸ‡¦πŸ‡Ί AU/NZ: Approved
πŸ‡¨πŸ‡¦ Canada: Approved
Scientific Name

Polyoxyethylene (20) sorbitan monostearate

CAS: 9005-67-8

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 60 is also used in cosmetics, medicine, industrial applications. Its versatility makes it one of the most multi-purpose chemical compounds in everyday life.

In the EU, Polysorbate 60 has a "quantum satis" authorization β€” Latin for "as much as needed." This means there's no specific maximum limit; manufacturers use only what's technologically necessary.

Detailed Regulatory Assessment

πŸ‡ͺπŸ‡Ί

European Union (EFSA)

approved Max: quantum satis mg/kg

Permitted in specified food categories

πŸ‡ΊπŸ‡Έ

United States (FDA)

approved GRAS

Regulated as a direct food additive under FDA CFR titles.

πŸ‡―πŸ‡΅

Japan (MHLW)

approved Cat: ζ—’ε­˜ζ·»εŠ η‰©

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 stearic acid to form sorbitan monostearate, then (2) ethoxylated with approximately 20 units of ethylene oxide. Stearic acid is typically sourced from vegetable oils or animal fats.

Applications Beyond Food

Cosmetics

Widely used in cosmetics, skincare products, and personal care items as an emulsifier.

Medical

Common in pharmaceutical formulations as an emulsifier and solubilizer.

Industrial

Used in industrial applications as a surfactant and dispersing agent.

Frequently Asked Questions

What is Polysorbate 60 (E435)?
Polysorbate 60 (E435) is a emulsifier used in food products. It is synthetic and synthetic. A synthetic emulsifier created from sorbitol, stearic acid, and ethylene oxide. The stearic acid component can be derived from vegetable oils or animal fats.
What is the ADI for Polysorbate 60?
The Acceptable Daily Intake (ADI) for Polysorbate 60 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 60?
Polysorbate 60 is used in various food categories including Edible ices, Fine bakery wares. It is used as a emulsifier in these products.
Is Polysorbate 60 the same as Tween 60?
Yes, Polysorbate 60 is also known as Tween 60, PS60, Polysorbate 60. These are different names for the same substance.