Our Verdict: SAFE

Dimethylpolysiloxane

E-numberE900CAS9016-00-6FDA GRAS

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

5

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Dimethylpolysiloxane — food additive

Dimethylpolysiloxane is a silicone-based lubricant and release agent approved by the FDA as Generally Recognized as Safe (GRAS). It is used in food processing to prevent foaming and reduce sticking in cooking oils and other food applications.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

5

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 Dimethylpolysiloxane?

Dimethylpolysiloxane (DMPS) is a synthetic silicone polymer composed of repeating dimethylsiloxane units. It is a colorless, odorless, viscous liquid that belongs to the class of surface-active agents. The chemical is identified by CAS Number 9016-00-6 and functions primarily as a lubricant and anti-foaming agent in food manufacturing.

Common Uses

Dimethylpolysiloxane is primarily used as a processing aid in food preparation, particularly in cooking oil and frying applications. Its main function is to reduce foaming during high-temperature food processing, such as deep frying. The additive helps prevent overflow in fryers and other cooking vessels by breaking down foam that naturally forms when foods are cooked in oil. It is also utilized as a release agent in baking and food processing to prevent sticking of foods to equipment surfaces. Small amounts are typical in finished food products, as it is considered a processing aid rather than an ingredient intended to remain in significant quantities in the final product.

Safety Assessment

Dimethylpolysiloxane has been granted GRAS (Generally Recognized as Safe) status by the FDA, indicating that the agency has determined the substance is safe for its intended uses in food. The FDA database shows zero reported adverse events specifically linked to this additive, suggesting a strong safety profile in actual use. The silicone compound is poorly absorbed by the human digestive system and is largely excreted unchanged, which contributes to its favorable safety assessment.

While the additive itself has no documented adverse events in the FDA system, there have been 5 recalls involving products containing dimethylpolysiloxane. These recalls appear to be related to other contamination issues or unrelated safety concerns rather than toxicity from the silicone itself, though the specific details of individual recalls vary. It is important to note that product recalls can involve multiple ingredients and causes, and the presence of an additive in a recalled product does not necessarily indicate the additive caused the recall.

Toxicological studies have generally found dimethylpolysiloxane to have low toxicity when ingested. Its chemical structure makes it resistant to breakdown in the gastrointestinal tract, meaning it passes through the system largely unchanged. This characteristic actually contributes to its safety profile, as the body does not metabolize it into potentially harmful metabolites.

Regulatory Status

In the United States, dimethylpolysiloxane is regulated by the FDA and holds GRAS status under 21 CFR 182.70 for use as a release agent and anti-caking agent. The European Food Safety Authority (EFSA) has also evaluated silicon dioxide and silicone-based compounds, with generally favorable assessments for food contact applications. The compound is permitted in numerous countries' food systems, including Canada and Australia.

The FDA permits dimethylpolysiloxane in specific food applications at levels determined to be safe. As a processing aid, it is not required to be listed on ingredient labels in all cases, depending on the amount remaining in the finished food and regulatory jurisdiction. When used appropriately, the levels present in final food products are minimal.

Key Studies

Limited human studies directly address dimethylpolysiloxane consumption, as the compound's inert nature and poor absorption have made extensive safety testing unnecessary. Animal studies, primarily conducted in rats and dogs, have demonstrated the safety of ingested silicone polymers at levels well above typical food exposure. These studies showed no evidence of organ toxicity, reproductive effects, or developmental toxicity at tested doses.

The poor bioavailability of dimethylpolysiloxane—meaning the body absorbs very little of it—suggests that local gastrointestinal effects are the primary concern, and research has found no significant adverse local effects at food-use levels. The additive's use history in food processing for several decades without documented safety concerns provides additional reassurance of its practical safety in commercial food applications.

Frequently Asked Questions

What is Dimethylpolysiloxane?

Dimethylpolysiloxane is a silicone-based lubricant and release agent approved by the FDA as Generally Recognized as Safe (GRAS). It is used in food processing to prevent foaming and reduce sticking in cooking oils and other food applications.

Is Dimethylpolysiloxane safe?

Dimethylpolysiloxane is currently rated "safe" 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 Dimethylpolysiloxane banned in any country?

Dimethylpolysiloxane 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.