Ingredient Index · E433

Is Polysorbate 80 banned in Europe?

Legal in both

No: polysorbate 80 is authorized in both the EU and the US with broadly similar treatment: an approved emulsifier with maximum levels per food category.

E-number: E433CAS: 9005-65-6 Also seen as: Tween 80, E433

What the EU does

Authorized. Polysorbate 80 (E433) is a permitted emulsifier under Regulation (EC) No 1333/2008 with maximum levels per food category. EFSA re-evaluated the polysorbate group (E432–436) in 2015 and set a group acceptable daily intake of 25 mg per kilogram of body weight.

When the answer is boring, we say so: this is one where Brussels and Washington substantially agree.

Citation Regulation (EC) No 1333/2008, Annex II (E433); EFSA group ADI 25 mg/kg (2015)

What the US does

Legal under 21 CFR 172.840 with per-category limits, and ubiquitous: ice cream is the classic use, where it keeps fat droplets from clumping and gives slow-melt texture. It is also a standard pharmaceutical excipient, including in vaccines, at doses far below food exposure.

The research wrinkle: 2015 mouse studies found that emulsifiers including polysorbate 80 altered gut microbiota and promoted inflammation in mice at high doses. Human trials are underway; no regulator on either side has changed the additive's status, and EFSA's re-evaluation took the data into account.

Citation 21 CFR 172.840 (polysorbate 80)

Products that commonly contain it

Polysorbate 80 makes oil and water cooperate. It appears in:

Ice cream and frozen desserts
Pickles and relishes
Salad dressings and sauces
Whipped toppings
Shortening and cake mixes
Vitamins, medicines, and vaccines (as an excipient)

What to look for on a label

Identification is straightforward:

"Polysorbate 80" in the ingredient list, or "E433" on EU labels
"Tween 80" in technical or supplement contexts
Siblings polysorbate 60 and 65 (E435, E436) are regulated the same way

Or skip the squinting: paste the whole ingredient list into our checker and it flags everything in our database. Nothing you paste leaves your browser.

Frequently asked questions

Is polysorbate 80 banned in Europe?

No. E433 is authorized under Regulation (EC) No 1333/2008 with category-specific maximum levels, and EFSA reaffirmed a group ADI of 25 mg/kg body weight in 2015.

Is polysorbate 80 legal in the United States?

Yes, under 21 CFR 172.840 with per-category limits. It is one of the most common emulsifiers in US processed food.

What about the gut microbiome studies?

High-dose mouse studies in 2015 linked emulsifiers including polysorbate 80 to microbiome changes and gut inflammation. The findings are taken seriously enough to fund human trials, but no EU or US regulatory limit has changed because of them.

Why is polysorbate 80 in vaccines?

It is a standard stabilizer that keeps vaccine components dissolved, used in quantities orders of magnitude below daily food exposure. Its presence there is unrelated to the food-additive debate.

Related ingredients

Primary sources

Last reviewed June 10, 2026 · How we assign statuses