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
The verdict
Polysorbate 80 is classified GRAS by the FDA, and no U.S. state has moved to restrict it.
- 3/5
- Mixed Evidence
- GRAS
- FDA status
- Approved
- EU status
- 0
- state regulations
Polysorbate 80 (E433), CAS 9005-65-6, is a emulsifier additive holding a composite safety score of 3 out of 5 (Mixed Evidence). The U.S. Food and Drug Administration currently classifies it as GRAS, while the European Union lists it as Approved. This ingredient appears in approximately 1,575 tracked food products across our database. It is most commonly used as Ice cream, salad dressing, vitamins.
No U.S. state has enacted specific legislation targeting Polysorbate 80 to date, keeping federal FDA classification as the operative standard. State-level food safety legislation remains active nationally, and that picture may shift as new bills advance.
Peer-reviewed research has flagged 1 distinct area of health concern for Polysorbate 80, which factors directly into the assigned safety score. The European Food Safety Authority has published an evaluation dated 2015-07-17, with an Acceptable Daily Intake (ADI) of 25. EFSA has noted an overexposure risk classification of "moderate" for typical consumption patterns. All figures above draw on FDA SAFFA inventory records, EU food additive regulation (EC) No 1333/2008, EFSA scientific opinions where published, and legislative records from individual U.S. states.
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
Safety Assessment
Polysorbate 80 receives a safety score of 3/5 (Mixed Evidence) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA classifies Polysorbate 80 as "Generally Recognized As Safe" (GRAS), meaning qualified experts consider it safe under intended conditions of use.
Research has identified 1 area of health concern associated with Polysorbate 80. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
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
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.
Is Polysorbate 80 banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Polysorbate 80. However, state food safety legislation is evolving rapidly.
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 FDA and EU use separate evaluation frameworks, the EU often applies the precautionary principle, sometimes banning additives that remain approved in the US. Always check both jurisdictions when evaluating food additive safety.
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.
How is the safety score for Polysorbate 80 calculated?
The safety score of 3/5 for Polysorbate 80 is a composite assessment based on FDA regulatory status, EU approval status, published scientific research on health effects, and state-level legislative actions. A score of 1 means "Banned / Avoid" and 5 means "Generally Safe." The score is updated as new regulatory actions or scientific evidence emerge.
Explore PlainIngredients
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Read our methodology - how this data is sourced, computed, and verified.
Related
What to do about Polysorbate 80
Use the regulatory picture, not a single score, to decide.
- Check the FDA status (GRAS) and EU status (Approved) before assuming it is risk-free. How we score
- Compare it against the most-restricted additives in the U.S. supply. View rankings
- Scan a whole ingredient label at once to flag the concerning entries. Label checker
Safety scores summarise regulatory status and published concerns; they are not medical or dietary advice.
Data sourced from the FDA Substances Added to Food (SAFFA) inventory, EU food-additive regulation (EC) No 1333/2008, EFSA scientific opinions, and U.S. state legislation. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial.