FDA Status
Approved
Polyethylene Glycol (400) Dioleate, CAS 977051-75-4, is a food additive additive holding a composite safety score of 4 out of 5 (Low Risk). The U.S. Food and Drug Administration currently classifies it as Approved, while the European Union lists it as not separately listed. It is most commonly used as surface-active agent.
No U.S. state has enacted specific legislation targeting Polyethylene Glycol (400) Dioleate 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 Polyethylene Glycol (400) Dioleate, which factors directly into the assigned safety score. 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 | Approved | FDA SAFFA |
| EU Status | Not separately listed | EC 1333/2008 |
| E-Number | — | EU additive register |
| CAS Number | 977051-75-4 | CAS Registry |
| Category | Food Additive | FDA functional class |
| Composite Safety Score | 4 / 5 (Low Risk) | PlainIngredients methodology |
| EFSA ADI | Not established | EFSA scientific opinion |
| U.S. State Actions | 0 states | State legislative records |
| Tracked Products | Not yet tracked | 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.
4.0 / 5
Composite Safety Low Risk
Safety Score: 4 out of 5
Safety Rating 80.0%
EU Status
Not specified
U.S. State Regulations
0 states
None enacted
Safety Assessment
Polyethylene Glycol (400) Dioleate receives a safety score of 4/5 (Low Risk) based on a composite analysis of FDA regulatory status, EU approval, scientific literature on health effects, and state-level legislative actions. The FDA has approved Polyethylene Glycol (400) Dioleate for use in food products under specified conditions.
Research has identified 1 area of health concern associated with Polyethylene Glycol (400) Dioleate. Consumers with specific health conditions should consult a healthcare provider before consuming products containing this ingredient.
What is Polyethylene Glycol (400) Dioleate?
Polyethylene Glycol (400) Dioleate (CAS 977051-75-4) is an FDA-regulated food substance used as surface-active agent.
Health Concerns
- FDA-listed substance in the Substances Added to Food (SAFFA) inventory.
Common Uses
surface-active agent
Frequently Asked Questions
Is Polyethylene Glycol (400) Dioleate safe to consume?
Polyethylene Glycol (400) Dioleate has a safety score of 4/5 (Low Risk). It is approved by the FDA for use in food. As with all food additives, moderation is advisable.
What is Polyethylene Glycol (400) Dioleate used for in food?
Polyethylene Glycol (400) Dioleate is commonly used as: surface-active agent. It belongs to the Food Additive category of food additives.
Is Polyethylene Glycol (400) Dioleate banned in any US states?
Currently, no US states have enacted specific bans or regulations targeting Polyethylene Glycol (400) Dioleate. However, state food safety legislation is evolving rapidly.
What is the difference between FDA and EU regulation of Polyethylene Glycol (400) Dioleate?
The FDA classifies Polyethylene Glycol (400) Dioleate as "Approved", and the EU may apply different standards. 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 Polyethylene Glycol (400) Dioleate?
Research has identified the following health concerns for Polyethylene Glycol (400) Dioleate: FDA-listed substance in the Substances Added to Food (SAFFA) inventory.. These findings inform its safety score of 4/5. Consult a healthcare provider for personalized guidance, especially if you have pre-existing conditions.
How is the safety score for Polyethylene Glycol (400) Dioleate calculated?
The safety score of 4/5 for Polyethylene Glycol (400) Dioleate 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
Related Data Sources
Data Sources
- FDA Substances Added to Food (SAFFA) Inventory
- EU Food Additive Regulations (EC) No 1333/2008
- State food safety legislation and bill records
Related Resources
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Read our methodology — how this data is sourced, computed, and verified.
Related
Data sourced from official EWG, FDA GRAS, and ingredient toxicology databases. See our methodology for details. Retrieved and formatted by PlainIngredients Editorial