What Is Polysorbate 80 (Tween 80)? Safety, Risks & Alternatives
β‘ Quick Facts
E-Number
E433
FDA Status
FDA-approved as GRAS (Generally Recognized As Safe). Listed in 21 CFR 172.840. Permitted as an emulsifier, dispersant, oβ¦
EFSA Status
EFSA evaluated in 2015 and 2018. Approved as E433 with an ADI of 25 mg/kg body weight/day. EFSA noted that at the approvβ¦
ADI
25 mg/kg body weight/day (EFSA/JECFA)
Severity
Moderate Risk (6/10)
What Is Polysorbate 80 (Tween 80)?
A synthetic emulsifier derived from sorbitol and oleic acid. It is used in food to stabilize emulsions, prevent separation, and improve texture. Found in ice cream, sauces, baked goods, and supplements. Also widely used in pharmaceuticals and vaccines as a solubilizer.
Mechanism of Action
Acts as a surfactant that reduces surface tension between oil and water phases. Research published in Nature (2015) found that dietary emulsifiers including polysorbate 80 can alter gut microbiota composition, promote intestinal inflammation, and potentially contribute to metabolic syndrome in mouse models.
Why People Avoid Polysorbate 80 (Tween 80)
2015 Nature study linked polysorbate 80 to gut inflammation and metabolic changes in mice (Chassaing et al.)
Concerns about impact on gut microbiome diversity
Some individuals report digestive sensitivity
Derived from petroleum-based ethylene oxide, which some consumers prefer to avoid
Used in vaccines, leading to allergic reaction concerns in sensitive individuals
Regulatory Status
πΊπΈ FDA
FDA-approved as GRAS (Generally Recognized As Safe). Listed in 21 CFR 172.840. Permitted as an emulsifier, dispersant, or stabilizer in food at concentrations up to 1% in most applications.
πͺπΊ EFSA
EFSA evaluated in 2015 and 2018. Approved as E433 with an ADI of 25 mg/kg body weight/day. EFSA noted that at the approved levels, polysorbate 80 is not of safety concern.
Regulatory Timeline
1962FDA grants GRAS status for polysorbate 80
2005JECFA re-evaluates and confirms ADI of 25 mg/kg/day
2015Chassaing et al. publish Nature study linking dietary emulsifiers to gut inflammation in mice
2017Follow-up human study shows emulsifiers may alter gut microbiome composition
2018EFSA re-evaluation confirms safety at current usage levels
2022Additional human clinical trials begin investigating emulsifier impact on IBD patients
A synthetic emulsifier derived from sorbitol and oleic acid. It is used in food to stabilize emulsions, prevent separation, and improve texture. Found in ice cream, sauces, baked goods, and supplements. Also widely used in pharmaceuticals and vaccines as a solubilizer.
Is Polysorbate 80 (Tween 80) safe?
Polysorbate 80 (Tween 80) is FDA-approved as GRAS (Generally Recognized As Safe). Listed in 21 CFR 172.840. Permitted as an emuls. EFSA evaluated in 2015 and 2018. Approved as E433 with an ADI of 25 mg/kg body weight/day. EFSA note.
Where is Polysorbate 80 (Tween 80) banned?
Polysorbate 80 (Tween 80) is not currently banned in any major market according to our database.
What are alternatives to Polysorbate 80 (Tween 80)?
Download CheckIt AI and scan any product's barcode or ingredient label. The app will flag Polysorbate 80 (Tween 80) and suggest safer alternatives.
What foods contain Polysorbate 80 (Tween 80)?
Polysorbate 80 (Tween 80) is commonly found in: Ice cream, Mayonnaise, Vaccines, Cosmetics, Vitamin supplements, Salad dressings, Shortening. Our database has flagged it in 7 products.
What are the side effects of Polysorbate 80 (Tween 80)?
Concerns about Polysorbate 80 (Tween 80) include: 2015 Nature study linked polysorbate 80 to gut inflammation and metabolic changes in mice (Chassaing et al.); Concerns about impact on gut microbiome diversity; Some individuals report digestive sensitivity.
Is Polysorbate 80 (Tween 80) natural or artificial?
Polysorbate 80 (Tween 80): Acts as a surfactant that reduces surface tension between oil and water phases. Research published in Nature (2015) found that dietary emulsifiers inc.
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βοΈ This page provides ingredient information for educational purposes only. It is not medical advice. Consult a healthcare professional for personalized dietary guidance. This information is for educational purposes only. Some studies cited were conducted in animal models and may not directly translate to human health effects at typical dietary exposure levels.