Our Verdict: SAFE

Cetyl Alcohol

CAS36653-82-4

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

Cetyl Alcohol — food additive

Cetyl alcohol is a long-chain fatty alcohol derived from natural sources or synthesized chemically, used as a flavoring agent and adjuvant in food products. It functions to enhance flavor delivery and improve product texture in various food formulations.

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
Not EvaluatedUK FSA
Canada
ApprovedHealth Canada
Australia
Not EvaluatedFSANZ
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 Cetyl Alcohol?

Cetyl alcohol (CAS Number 36653-82-4) is a saturated fatty alcohol with 16 carbon atoms in its molecular chain. Despite its name, it is not an intoxicating alcohol but rather a waxy, white solid at room temperature. Cetyl alcohol can be derived from natural sources such as sperm whale oil or palm oil, though modern production typically uses synthetic methods or sustainable vegetable sources. It is chemically stable and odorless, making it suitable for food applications where it does not contribute taste or aroma itself.

Common Uses

In the food industry, cetyl alcohol serves primarily as a flavoring agent adjuvant, meaning it functions as a supporting ingredient to enhance or stabilize flavoring compounds rather than provide flavor directly. It is used in food products to improve the delivery and distribution of flavor compounds throughout the product. Additionally, cetyl alcohol functions as an emollient and texture modifier in food formulations, helping to create smoother mouthfeel and improving product consistency. It appears in a variety of processed foods, though typically in small quantities due to its functional properties.

Safety Assessment

Cetyl alcohol demonstrates a strong safety profile based on available data. The FDA has recorded zero adverse events associated with cetyl alcohol consumption, and no food recalls have been linked to this ingredient. The additive has been used in food products for decades without documented safety concerns in normal use conditions.

Toxicological studies on cetyl alcohol show it is poorly absorbed when ingested orally, with most of the compound passing through the gastrointestinal tract without significant systemic exposure. Animal studies have not identified concerning effects at relevant exposure levels. Dermal and inhalation exposure studies indicate low toxicity via these routes as well. The compound does not exhibit mutagenic, carcinogenic, or reproductive toxicity in standard testing protocols.

Cetyl alcohol is recognized as safe for use in cosmetic and personal care products by regulatory agencies, where it has been used extensively for decades. Its safety margin appears substantial given the minimal systemic exposure following oral ingestion.

Regulatory Status

Cetyl alcohol is not on the FDA's Generally Recognized as Safe (GRAS) list, which means it has not undergone the formal GRAS notification process. However, this designation does not indicate safety concerns; rather, it reflects that the ingredient may not have been submitted for GRAS review or that manufacturers have chosen alternative regulatory pathways. The ingredient is permitted in food use in various countries, including European Union member states, where it is listed in food additive inventories.

In the European Union, cetyl alcohol is approved as a food additive under specific conditions. Its use is regulated and limited to certain food categories at established maximum levels. The European Food Safety Authority (EFSA) has reviewed cetyl alcohol and determined it acceptable for food use under current regulatory frameworks.

Key Studies

Limited published research specifically focuses on cetyl alcohol as a food additive, reflecting its long history of safe use and minimal regulatory attention. Available toxicological data comes primarily from cosmetic industry research, where the ingredient has been extensively studied. These studies consistently demonstrate low oral bioavailability and absence of systemic toxicity at exposure levels relevant to food use. The lack of adverse event reports and recalls in food applications, combined with decades of historical use, provides additional evidence supporting its safety profile in food products.

Frequently Asked Questions

What is Cetyl Alcohol?

Cetyl alcohol is a long-chain fatty alcohol derived from natural sources or synthesized chemically, used as a flavoring agent and adjuvant in food products. It functions to enhance flavor delivery and improve product texture in various food formulations.

Is Cetyl Alcohol safe?

Cetyl Alcohol 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 Cetyl Alcohol banned in any country?

Cetyl Alcohol 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.