Our Verdict: SAFE

Hydroxypropyl Methylcellulose

E-numberE464CAS9004-65-3

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

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Hydroxypropyl Methylcellulose — food additive

Hydroxypropyl methylcellulose (HPMC) is a semi-synthetic polymer derived from cellulose, a natural plant fiber. It functions as a versatile food additive that improves texture, stability, and moisture retention in various processed foods.

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 Hydroxypropyl Methylcellulose?

Hydroxypropyl methylcellulose (HPMC) is a cellulose derivative created by chemically modifying natural plant cellulose through hydroxypropylation and methylation processes. The resulting compound is a white to off-white powder that is soluble in cold water but forms a gel when heated—a unique property that distinguishes it from many other food additives. CAS Number 9004-65-3 identifies this specific chemical substance.

Common Uses

HPMC is widely used in the food industry across multiple applications. As an emulsifier, it helps stabilize mixtures of oil and water that would normally separate. Its thickening and stabilizing properties make it valuable in sauces, dressings, and gravies. In baked goods, HPMC acts as a texturizer and processing aid, improving dough handling and final product quality. The additive also functions as a humectant, helping retain moisture in products to extend shelf life. Additionally, it serves as an anticaking or free-flow agent in dry products, preventing clumping. Its surface-finishing properties make it useful in glazes and coatings for confectionery and other food products.

Safety Assessment

Hydroxypropyl methylcellulose is generally recognized as a safe food additive by regulatory authorities worldwide. The FDA has documented zero adverse events and zero recalls associated with HPMC, indicating a strong safety profile during decades of use in food applications. The additive is poorly absorbed by the human digestive system and is largely excreted unchanged, minimizing systemic exposure.

Toxicological studies have established that HPMC has low acute toxicity. Animal studies examining long-term consumption have not identified carcinogenic, mutagenic, or reproductive effects at typical exposure levels. The European Food Safety Authority (EFSA) has also reviewed HPMC and determined it to be safe for consumption at permitted use levels.

Because HPMC is derived from cellulose, a common dietary fiber, it shares structural similarities with naturally occurring compounds. It does not accumulate in body tissues and has no known bioaccumulation potential. Individuals with cellulose sensitivity are extremely rare, and the chemical modification process creates a compound distinct from pure cellulose.

Regulatory Status

While HPMC is not on the FDA's Generally Recognized as Safe (GRAS) list, this does not indicate safety concerns. Rather, it means the additive is approved as a food additive through the formal regulatory pathway (21 CFR 172.874). This distinction is procedural; approval through the food additive petition process is equally rigorous as GRAS status.

HPMC is approved for food use in the European Union, Canada, Australia, Japan, and most other developed food regulatory jurisdictions. It appears in food regulations in numerous countries as an approved food additive with specified maximum usage levels that vary by food category.

Key Studies

Multiple peer-reviewed studies have evaluated HPMC safety. Acute toxicity studies establish an LD50 (lethal dose for 50% of test subjects) well above typical human exposure levels. Subchronic and chronic feeding studies in laboratory animals have shown no concerning effects at doses substantially higher than anticipated human consumption. In vitro and in vivo genotoxicity assays have shown negative results, indicating no genetic damage potential.

Obesrvational studies of human consumption have not identified any adverse health associations with HPMC exposure from food sources. The compound's poor bioavailability—meaning most of it passes through the digestive system unabsorbed—further supports its safety profile for food use.

Frequently Asked Questions

What is Hydroxypropyl Methylcellulose?

Hydroxypropyl methylcellulose (HPMC) is a semi-synthetic polymer derived from cellulose, a natural plant fiber. It functions as a versatile food additive that improves texture, stability, and moisture retention in various processed foods.

Is Hydroxypropyl Methylcellulose safe?

Hydroxypropyl Methylcellulose 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 Hydroxypropyl Methylcellulose banned in any country?

Hydroxypropyl Methylcellulose 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.