Our Verdict: RATING UNKNOWN

Undecanoic Acid

CAS112-37-8

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

Undecanoic Acid — food additive

Undecanoic acid is an 11-carbon straight-chain fatty acid used as a flavoring agent and adjuvant in food products. It occurs naturally in some plants and is utilized to provide fatty, waxy, and slightly fruity flavor notes 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
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 Undecanoic Acid?

Undecanoic acid, also known as hendecanoic acid, is a saturated fatty acid with the molecular formula C₁₁H₂₂O₂ and CAS number 112-37-8. It is a straight-chain (linear) fatty acid containing eleven carbon atoms. The compound exists as a white to off-white crystalline solid at room temperature with a characteristic fatty, waxy odor. Undecanoic acid can be derived from natural sources, including certain plant oils and animal fats, though it can also be synthesized chemically for industrial use.

Common Uses

In the food industry, undecanoic acid functions as a flavoring agent and flavoring adjuvant. Its primary application is in creating complex flavor profiles that require fatty or waxy notes. It is used in various food categories including beverages, baked goods, dairy products, confectionery, and meat products. The compound contributes subtle fruity and buttery undertones that enhance overall flavor complexity. As a flavoring adjuvant, it may also help stabilize or carry other flavor compounds in food formulations. The specific concentrations used in food applications are typically very small, measured in parts per million (ppm).

Safety Assessment

Undecanoic acid has not received formal FDA GRAS (Generally Recognized As Safe) status, though this absence does not indicate the substance is unsafe. The FDA has recorded zero adverse events associated with undecanoic acid and zero recalls linked to this ingredient. Undecanoic acid is structurally similar to other fatty acids that are common in food and have established safety profiles. As a naturally occurring compound found in various foods, it has a history of consumption in the human diet.

The compound is lipophilic (fat-soluble) and would be metabolized similarly to other dietary fatty acids in the body. No significant toxicological concerns have been identified in available literature. The lack of reported adverse events and recalls suggests that current usage levels in food products have not raised safety concerns among regulatory agencies or consumers.

Regulatory Status

In the United States, undecanoic acid is not approved as a food additive under FDA regulations and has not been granted GRAS status. However, it may be used in certain food applications under different regulatory pathways or in specific jurisdictions. The European Food Safety Authority (EFSA) maintains separate regulatory frameworks for food additives, and undecanoic acid's status in Europe may differ from its status in the United States.

Manufacturers using undecanoic acid in food products must comply with applicable national and regional regulations regarding food additives and flavoring substances. Regulatory classification and permitted uses vary by country, and food producers should verify compliance with local requirements before use.

Key Studies

Limited published peer-reviewed research specifically addresses undecanoic acid as a food additive. Most scientific literature on undecanoic acid focuses on its antimicrobial properties in pharmaceutical and cosmetic applications rather than its flavor properties. The compound has been studied for potential therapeutic applications, but these investigations are outside the scope of food additive safety assessment. The absence of adverse event reports and recalls suggests that the compound has an adequate safety profile at levels used in food flavoring, though formal toxicological studies specific to food use may be limited in public literature. Further research or formal safety assessments may be warranted if regulatory approval is pursued.

Frequently Asked Questions

What is Undecanoic Acid?

Undecanoic acid is an 11-carbon straight-chain fatty acid used as a flavoring agent and adjuvant in food products. It occurs naturally in some plants and is utilized to provide fatty, waxy, and slightly fruity flavor notes in various food formulations.

Is Undecanoic Acid safe?

Undecanoic Acid 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 Undecanoic Acid banned in any country?

Undecanoic Acid 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.