Our Verdict: SAFE

Shellac Wax

E-numberE904CAS97766-50-2FDA 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

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Shellac Wax — food additive

Shellac wax is a resinous substance derived from the lac beetle that is used as a food-grade surface-finishing agent. It creates a protective, glossy coating on candies, pills, and other foods to improve appearance and shelf life.

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 Shellac Wax?

Shellac wax (CAS Number 97766-50-2) is a natural resinous coating derived from the secretions of the lac beetle (Kerria lacca), native to India and Thailand. The raw lac resin is processed and refined to create a food-grade substance suitable for application to food products. Shellac has been used in food manufacturing and other industries for centuries, with documented use dating back to ancient times in Asia.

In its food-grade form, shellac wax serves as a surface-finishing agent that creates a thin, protective layer on food products. The coating is typically applied through spraying, dipping, or polishing processes and provides both functional and aesthetic benefits to finished food items.

Common Uses

Shellac wax is primarily used in the confectionery industry as a glazing agent for candies, including chocolate-covered items, hard candies, and gum. It is also applied to pharmaceutical tablets and capsules to improve appearance, protect contents, and facilitate swallowing. In some jurisdictions, shellac may be used as a coating on certain fruits and vegetables to enhance appearance and extend shelf life.

The coating typically forms a thin layer, usually less than 1-2% by weight of the coated product, and is approved for use in food applications under specific regulations in the United States, European Union, and other countries.

Safety Assessment

Shellac wax has an extensive history of safe use in food applications. The FDA has designated shellac as Generally Recognized As Safe (GRAS), meaning the agency has determined that the substance is safe for its intended food uses based on scientific data and expert consensus.

The FDA database records zero adverse events and zero recalls associated with shellac wax food products, indicating a strong safety profile in commercial food manufacturing. Shellac is not mutagenic, carcinogenic, or teratogenic in standard toxicological testing. The substance is largely indigestible and passes through the gastrointestinal tract without significant absorption or metabolic transformation.

Potential allergen considerations exist, as shellac is derived from an insect source. Individuals with known sensitivity to insect-derived products should exercise caution, though severe allergic reactions are rare. The European Food Safety Authority (EFSA) has similarly assessed shellac as safe for use in food applications.

Regulatory Status

In the United States, shellac is approved as a food additive and classified as GRAS under 21 CFR 182.2090. The FDA permits its use as a surface-finishing agent on candy and other foods without specific numerical limitations, provided it meets food-grade purity standards.

In the European Union, shellac is listed as a food additive (E904) and is permitted in various food categories including confectionery and bakery products. Maximum use levels are established based on good manufacturing practice.

Canada, Australia, and other regulatory jurisdictions similarly permit shellac use in food applications with appropriate quality and purity standards. The additive is not approved in all countries, and regulations vary by jurisdiction.

Key Studies

Toxicological assessments of shellac have been conducted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). These evaluations concluded that shellac poses no safety concern at current food use levels. Studies demonstrate minimal gastrointestinal absorption and rapid elimination of the substance.

Long-term feeding studies in laboratory animals have shown no adverse effects at high dose levels. Shellac's safety profile is further supported by its extensive historical use in food and non-food applications spanning multiple centuries with no documented widespread health concerns in populations with dietary exposure.

Frequently Asked Questions

What is Shellac Wax?

Shellac wax is a resinous substance derived from the lac beetle that is used as a food-grade surface-finishing agent. It creates a protective, glossy coating on candies, pills, and other foods to improve appearance and shelf life.

Is Shellac Wax safe?

Shellac Wax 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 Shellac Wax banned in any country?

Shellac Wax 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.