Polysorbate 80 E433
synthetic — 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.
What Is Polysorbate 80?
Polysorbate 80 (Tween 80) is a polyoxyethylene sorbitan monooleate widely used as an emulsifier in ice cream, baked goods, and salad dressings. It is the most commonly used polysorbate in food applications. Mouse studies published around 2015 raised interest in a possible link between polysorbates and gut microbiome changes, but EFSA reviewed this evidence in 2015 and concluded that current data did not support a change to the ADI of 0–25 mg/kg body weight for the polysorbate group. Approved in EU, USA, Japan, Canada, and Australia.
? 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 — Latin for "as much as needed." This means there's no specific maximum limit; manufacturers use only what's technologically necessary.
Regulatory Analysis
Polysorbate 80 (E433) attracted renewed regulatory and scientific attention following publications around 2015 that showed polysorbates (at relatively high doses in mouse models) altered gut microbiome composition and promoted low-grade intestinal inflammation. EFSA reviewed this data in 2015 and concluded that the experimental doses were far above typical human dietary exposure and that the existing group ADI of 25 mg/kg body weight per day for polysorbates (set by JECFA and adopted by EFSA) remained appropriate. The FDA maintains GRAS status under 21 CFR 172.840. The debate illustrated a broader regulatory science challenge: how to evaluate evidence from preclinical microbiome studies for which human equivalence is uncertain. No jurisdiction has moved to restrict polysorbate 80 in food applications as a result of these studies. The additive remains approved globally.
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.