# Polyethylene Glycol (400) Dioleate (E1521)

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**Safety rating:** UNKNOWN
**E-number:** E1521
**CAS number:** 977051-75-4
**Category:** other
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Polyethylene Glycol (400) Dioleate is a synthetic surface-active agent derived from polyethylene glycol and oleic acid. It functions as an emulsifier and solubilizing agent in food and pharmaceutical applications, helping to blend ingredients that don't naturally mix.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | approved |
| Canada | approved |
| Australia | approved |
| Japan | approved |
| South Korea | approved |
| Brazil | approved |
| China | approved |
| India | approved |

## Detailed analysis

## What is Polyethylene Glycol (400) Dioleate?

Polyethylene Glycol (400) Dioleate is a non-ionic surfactant synthesized from polyethylene glycol (PEG-400) and dioleic acid. It belongs to the class of polyethylene glycol esters, which are widely used in industrial and food applications. The compound functions as a surface-active agent, meaning it reduces surface tension between different substances and facilitates the mixing of incompatible ingredients.

## Common Uses

Polyethylene Glycol (400) Dioleate is primarily used in the food industry as an emulsifier and solubilizer. Its applications include:

- Emulsification of oils and water-based ingredients in food products
- Solubilization of flavoring compounds and essential oils
- Stabilization of food emulsions to prevent separation
- Use in pharmaceutical and cosmetic formulations alongside food applications

While specific food products containing this additive are not widely documented in consumer-facing databases, it is used in specialized food manufacturing where emulsification and solubilization are critical process requirements.

## Safety Assessment

Polyethylene Glycol (400) Dioleate has not received Generally Recognized as Safe (GRAS) status from the FDA, which means it has not undergone the standard GRAS notification process. However, this designation does not indicate that the substance is unsafe; rather, it reflects that formal GRAS documentation has not been submitted to or accepted by the FDA.

The FDA's Adverse Events database contains zero reported adverse events associated with this additive, and there have been no FDA recalls linked to its use. This absence of reported incidents suggests that if the compound is being used in food products, it has not generated safety concerns significant enough to warrant formal complaints or enforcement actions.

Safety data on polyethylene glycol-based compounds is generally reassuring. Related PEG compounds have been extensively studied and are used across food, pharmaceutical, and cosmetic industries. However, specific toxicological studies on this particular dioleate ester formulation are limited in publicly available literature, which contributes to the lack of GRAS status.

## Regulatory Status

In the United States, Polyethylene Glycol (400) Dioleate does not have FDA GRAS status. This means that any use of this additive in food would technically require either pre-market approval as a food additive or qualification under alternative regulatory pathways. The absence of GRAS status may limit its commercial use in mainstream food applications, particularly in products intended for the U.S. market.

The FDA maintains authority to restrict or prohibit the use of substances in food if safety concerns emerge. The current lack of adverse events or recalls suggests this additive is either used minimally in the U.S. food supply or that its use has not raised regulatory red flags.

Regulatory status in other jurisdictions, including the European Union and other countries, may differ. The European Food Safety Authority (EFSA) maintains separate assessments of food additives authorized for use in EU member states.

## Key Studies

Publicly available peer-reviewed research specifically focused on Polyethylene Glycol (400) Dioleate is limited. Most available data on safety comes from broader assessments of polyethylene glycol compounds and their metabolic fate. General toxicological profiles of PEG-based compounds suggest low systemic absorption when ingested and relatively low toxicity.

The lack of extensive published research on this specific compound reflects either limited commercial use or the proprietary nature of formulation data held by manufacturers. Interested parties seeking detailed safety information should consult the specific manufacturer's technical data sheets and safety documentation.

## Brands using Polyethylene Glycol (400) Dioleate

- Nature Made (2 products)
- Bayer (1 product)
- Equate (1 product)
- Kirkland (1 product)
- citracal (1 product)
- kirkland (1 product)

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Polyethylene Glycol (400) Dioleate (E1521) — Safety, regulation, and evidence." https://additivefacts.com/additives/polyethylene-glycol-400-dioleate. Accessed 2026-05-20.