Our Verdict: RATING UNKNOWN

Polyoxyethylene (600) Dioleate

CAS977028-99-1

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Polyoxyethylene (600) Dioleate โ€” food additive

Polyoxyethylene (600) Dioleate is a synthetic surfactant derived from oleic acid and polyethylene glycol. It functions as a surface-active agent in food products to improve texture, stability, and ingredient mixing.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Polyoxyethylene (600) Dioleate?

Polyoxyethylene (600) Dioleate is a non-ionic surfactant created through the chemical reaction of oleic acid (a naturally occurring fatty acid) with polyethylene glycol chains containing approximately 600 ethylene oxide units. The resulting compound has both hydrophobic (water-repelling) and hydrophilic (water-attracting) properties, making it effective at reducing surface tension between ingredients that normally do not mix well.

Common Uses

This additive is primarily used in food manufacturing as a surface-active agent and emulsifier. Its main applications include:

- Improving the texture and mouthfeel of processed foods

- Stabilizing emulsions in sauces, dressings, and spreads

- Enhancing ingredient dispersal in baked goods and confectionery

- Facilitating uniform distribution of oils and water-based components

- Improving the stability of whipped products and foams

Polyoxyethylene (600) Dioleate is typically used in very small concentrations, measured in parts per million or as a percentage of total product weight.

Safety Assessment

Polyoxyethylene (600) Dioleate has not been approved by the FDA as a Generally Recognized As Safe (GRAS) substance, indicating that it lacks formal GRAS status in the United States. However, the absence of GRAS designation does not indicate that the substance is unsafeโ€”rather, it means that a formal regulatory pathway has not been established or completed for this particular compound.

The FDA database shows zero reported adverse events and zero product recalls specifically associated with this additive, suggesting no documented safety incidents in food products currently on the U.S. market. The additive is structurally related to other polyoxyethylene surfactants that have undergone toxicological evaluation.

As a polyoxyethylene-based compound, Polyoxyethylene (600) Dioleate would be expected to exhibit similar safety profiles to related substances. Polyoxyethylene surfactants are generally recognized as having low toxicity via oral consumption, with the body's ability to absorb and eliminate these compounds being a key factor in their safety profile.

Regulatory Status

In the United States, Polyoxyethylene (600) Dioleate does not have FDA GRAS status. This means it is not authorized for use in foods under the GRAS provision of the Federal Food, Drug, and Cosmetic Act without prior FDA approval or a completed GRAS notification that has received no objection from the agency.

The European Union maintains the E-number system for food additives. While related polyoxyethylene compounds appear in various approved additive lists in different countries, Polyoxyethylene (600) Dioleate's specific regulatory status varies by jurisdiction.

If this ingredient is being used in food products in the United States, manufacturers must either have obtained FDA pre-market approval, submitted a successful GRAS notification, or be operating under an existing regulatory authorization.

Key Studies

While no specific human clinical trials appear dedicated solely to Polyoxyethylene (600) Dioleate, toxicological data on chemically related polyoxyethylene surfactants suggest these compounds have low acute and chronic toxicity profiles. Studies on similar polyoxyethylene emulsifiers have demonstrated that they are poorly absorbed in the gastrointestinal tract and are largely excreted unchanged.

The safety of structurally similar compounds has been reviewed by regulatory bodies including the FDA and the European Food Safety Authority (EFSA). These reviews have generally found that polyoxyethylene-based surfactants used in food do not present significant toxicological concerns at typical use levels.

Further specific safety data on Polyoxyethylene (600) Dioleate would depend on manufacturer-conducted studies or regulatory submissions that may not be publicly available.

Frequently Asked Questions

What is Polyoxyethylene (600) Dioleate?

Polyoxyethylene (600) Dioleate is a synthetic surfactant derived from oleic acid and polyethylene glycol. It functions as a surface-active agent in food products to improve texture, stability, and ingredient mixing.

Is Polyoxyethylene (600) Dioleate safe?

Polyoxyethylene (600) Dioleate is currently rated "unknown" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Polyoxyethylene (600) Dioleate banned in any country?

Polyoxyethylene (600) Dioleate is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.