Emulsifier · CAS 9005-65-6 · EU E433
Polysorbate 80
FDA status: GRAS. EU: Approved. No U.S. state has enacted a specific ban yet.
According to the U.S. Food and Drug Administration, Polysorbate 80 is classified GRAS by the FDA, and no U.S. state has moved to restrict it independently of federal policy. The European Union separately classifies it as approved. By tracked product count it ranks #33 of 417.
- #33 of 417 by tracked product prevalence
The verdict
Polysorbate 80 is classified GRAS by the FDA, and no U.S. state has moved to restrict it. By Open Food Facts product count it sits #33 of 417 among additives with tracked product presence (92nd percentile).
- 3/5
- Mixed Evidence
- GRAS
- FDA status
- #33 of 417
- product-prevalence rank
- 0
- state regulations
How widely this ingredient shows up, and its regulatory record
Polysorbate 80: 1,575 tracked U.S. products (common band, #33 of 417) frame how often this additive appears on shelves.
| Property | Value | Source |
|---|---|---|
| Tracked Products | 1,575 · #33 of 417 | Open Food Facts (US) |
| FDA Status | GRAS | FDA SAFFA |
| EU Status | Approved | EC 1333/2008 |
| E-Number | E433 | EU additive register |
| CAS Number | 9005-65-6 | CAS Registry |
| Category | Emulsifier | FDA functional class |
| Composite Safety Score | 3 / 5 (Mixed Evidence) | PlainIngredients methodology |
| EFSA ADI | 25 mg/kg body weight a day | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
Values reflect official agency classifications as published by the U.S. Food and Drug Administration and the European Union's regulatory framework. See our methodology for scoring details.
Polysorbate 80: what it is
Synthetic emulsifier to blend oil and water.
Health Concerns
- Animal studies suggest gut microbiome effects.
Common Uses
Shelf-footprint peer axes
Nationwide peers for a common OFF footprint
Nearest OFF product-count peers (1,575 tracked here); safety-score column omitted on prevalence-led pages.
Nearest OFF product count to 1,575
Nearest other additives by Open Food Facts product count (floored at ≥50).
Frequently Asked Questions
Is Polysorbate 80 safe to consume?
Polysorbate 80 scores 3/5 (Mixed Evidence). FDA status is GRAS. On the Open Food Facts U.S. sample it is a common additive (1,575 tracked products, #33 of 417), so product footprint, not just the score label, frames how widely a shopper will meet it.
What is Polysorbate 80 used for in food?
Polysorbate 80 shows up as Ice cream, salad dressing, vitamins in the Emulsifier class, and the OFF sample puts it in the common footprint band (1,575 products).
Where does Polysorbate 80 sit among food additives PlainIngredients tracks?
Among additives with at least one tracked product, it ranks #33 of 417 by Open Food Facts product count. See /methodology#corpus-placement for the ranking bases.
What is the difference between FDA and EU regulation of Polysorbate 80?
The FDA classifies Polysorbate 80 as "GRAS" while the EU status is "Approved" (E433). The EU often applies the precautionary principle, sometimes restricting additives that remain approved in the US.
What health concerns are associated with Polysorbate 80?
Research has identified the following health concerns for Polysorbate 80: Animal studies suggest gut microbiome effects.. These findings inform its safety score of 3/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.