Polysorbate 80 E433
synthetic β Primarily synthetic.
Polyoxyethylene (20) sorbitan monooleate
CAS: 9005-65-6
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 80 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 80 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
European Union (EFSA)
Permitted in specified food categories
United States (FDA)
Regulated as a direct food additive under FDA CFR titles.
Japan (MHLW)
Compliant with Japanese food sanitation law.
Acceptable Daily Intake (ADI)
International Standard (JECFA)
mg/kg body weight per day
European Standard (EFSA)
Natural Occurrence
This additive is not known to occur naturally in significant quantities.
Manufacturing
Produced in two steps: (1) sorbitan (from sorbitol) is reacted with oleic acid to form sorbitan monooleate, then (2) ethoxylated with approximately 20 units of ethylene oxide. Oleic acid is typically sourced from vegetable oils.
Applications Beyond Food
Extensively used in cosmetics, lotions, creams, and personal care products.
Widely used in pharmaceutical formulations, vaccines, injectable medicines, and drug delivery systems. Can help drugs cross the blood-brain barrier in research.
Used in industrial applications as a surfactant, dispersing agent, and wetting agent.