Our Verdict: SAFE

2-undecanone

CAS112-12-9

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

2-undecanone — food additive

2-Undecanone (CAS 112-12-9) is a naturally occurring organic compound used as a flavoring agent in food products. It is a ketone with an 11-carbon chain that imparts fruity and woody flavor notes to beverages, baked goods, and other food applications.

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 2-Undecanone?

2-Undecanone is an aliphatic ketone with the molecular formula C₁₁H₂₂O. It is a colorless to pale yellow liquid with a molecular weight of 170.29 g/mol. This compound occurs naturally in small quantities in various fruits and plants, contributing to their characteristic flavor profiles. The chemical structure consists of an 11-carbon chain with a ketone functional group at the second carbon position, which is responsible for its organoleptic properties.

Common Uses

2-Undecanone is employed as a flavoring agent and flavor adjuvant in the food industry. Its primary applications include:

- Beverage flavoring, particularly in fruit-flavored drinks and alcoholic beverages

- Baked goods and confectionery products

- Dairy products and frozen desserts

- Savory food applications where woody and fruity notes are desired

- Spice and seasoning blends

The compound is valued for its ability to enhance and modify flavor profiles while contributing fruity, woody, and slightly herbaceous notes. It typically appears in formulations at very low concentrations, measured in parts per million (ppm), due to its potency as a flavoring agent.

Safety Assessment

2-Undecanone has not been formally affirmed as Generally Recognized As Safe (GRAS) by the FDA. However, the absence of a GRAS determination does not indicate safety concerns. Rather, it reflects that the compound may be used through the Food Additive Petition pathway or that formal GRAS notification has not been pursued by manufacturers.

The FDA database records zero adverse events associated with 2-undecanone consumption, and there are no documented recalls involving this ingredient. This safety profile suggests that, when used at typical flavoring concentrations, the compound has not produced reportable adverse health effects in the food supply.

2-Undecanone is structurally similar to naturally occurring flavor compounds and follows established metabolic pathways for ketone metabolism. As a flavoring agent used at extremely low levels in food, systemic exposure is minimal. The compound's volatility means it readily dissipates during processing and preparation, further limiting consumer exposure.

Regulatory Status

In the United States, 2-undecanone may be used as a flavoring substance under FDA regulations (21 CFR Part 182). While not carrying GRAS status, it can be legally employed in foods through the food additive petition process or as a component of flavoring preparations that comply with regulatory requirements.

The European Food Safety Authority (EFSA) has evaluated related flavor compounds and established that structurally similar ketones present no safety concerns at typical use levels. The Flavor and Extract Manufacturers' Association (FEMA) maintains evaluations of flavor compounds including aliphatic ketones.

International regulatory agencies, including those in Canada, Australia, and Japan, generally permit this compound as a flavoring agent within established guidelines for flavor use.

Key Studies

The safety assessment of 2-undecanone relies on its structural relationship to well-established flavor compounds and the large margin of safety inherent in flavoring applications. Toxicological data on similar chain-length ketones demonstrates that these compounds are readily metabolized through standard oxidative pathways without evidence of bioaccumulation or organ toxicity.

The absence of adverse event reporting despite decades of use in food flavoring applications provides epidemiological support for its safe use at functional concentrations. Its high volatility and rapid metabolism further contribute to a favorable safety profile.

Regulatory agencies emphasize that flavoring agents, including 2-undecanone, are subject to the "threshold of toxicological concern" (TTC) approach, which assumes that substances used at very low levels (typically <1.5 micrograms per kilogram body weight per day) pose minimal risk regardless of other toxicological properties.

Frequently Asked Questions

What is 2-undecanone?

2-Undecanone (CAS 112-12-9) is a naturally occurring organic compound used as a flavoring agent in food products. It is a ketone with an 11-carbon chain that imparts fruity and woody flavor notes to beverages, baked goods, and other food applications.

Is 2-undecanone safe?

2-undecanone 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 2-undecanone banned in any country?

2-undecanone 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.