FDA Status
GRAS
Emulsifier · CAS 9005-65-6 · EU E433
Polysorbate 80
FDA status: GRAS. EU: Approved. No U.S. state has enacted a specific ban yet.
3.0 / 5
Composite safety Mixed Evidence
Score 3 of 5
Polysorbate 80: 3/5 (Mixed Evidence)
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. Its composite safety score is 3 out of 5 (Mixed Evidence), and 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
FDA SAFFA additive registry desk
Row polysorbate-80 · Emulsifier
Polysorbate 80 is GRAS in FDA SAFFAand Approved in the EU register, composite score 3/5, no state actions yet, 1,575 OFF products. Derived from public FDA SAFFA + state legislative + OFF data. Not medical advice.
- FDA-GRAS GRAS
- EU-OK Approved
- SCORE-MIX 3/5
- STATE-0 0 states
- PROD-HIGH 1.6k OFF
- ADI-SET 25
- EN-NUM E433
- RANK-PV #33
- BOOK-SAFFA sorbate-80 · May 2026
Read with nearest state-action peer: Citric Acid (same state count).
U.S. state-action neighbourhood (Polysorbate 80 highlighted)
Nearest additives by distinct state statute count, same sort as the state-ban rankings, not category navigation.
Regulatory Snapshot
| Property | Value | Source |
|---|---|---|
| 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 | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | 1,575 | Open Food Facts (US) |
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.
EU Status
Approved
E433
U.S. State Regulations
0 states
None enacted
How Polysorbate 80 compares
Where a safety score of 3/5 falls among all 4,509 scored ingredients tracked on PlainIngredients.
Ingredients by safety score (Polysorbate 80 highlighted)
25 of 4,509 scored ingredients (0.6%) share a safety score of 3/5.
What is Polysorbate 80?
Synthetic emulsifier to blend oil and water.
Health Concerns
- Animal studies suggest gut microbiome effects.
Common Uses
Ice cream, salad dressing, vitamins
Compare beyond this additive
Nationwide ingredients with similar catalog profiles
Two PlainIngredients-derived peer sets for Polysorbate 80: closest on tracked product count (1,575 here) and closest on PlainIngredients safety score (3/5 here). Rows stay link-disjoint so each axis is a distinct neighborhood, not a popularity strip.
Similar product count
Nearest other additives by Open Food Facts product count (floored at ≥50).
Similar safety score
Nearest other additives by PlainIngredients safety score (floored at ≥50 tracked products), distinct from the count row.
Peer sets exclude this page and dedupe across axes so each link is a distinct nationwide neighborhood.
Frequently Asked Questions
Is Polysorbate 80 safe to consume?
Polysorbate 80 has a safety score of 3/5 (Mixed Evidence). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Polysorbate 80 used for in food?
Polysorbate 80 is commonly used as: Ice cream, salad dressing, vitamins. It belongs to the Emulsifier category of food additives.
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.
Related Emulsifier Ingredients
One of 281 Emulsifier ingredients in our database, 6 are shown here.
Similar Regulatory Profile
Different categories with the same FDA and EU status.
Same Score, Different Profile
The same PlainIngredients score, with a different FDA or EU status.
Every figure on PlainIngredients is rendered directly from FDA, EU, EFSA and U.S. state regulatory records, no number is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.