Our Verdict: RATING UNKNOWN

2-undecanol

CAS1653-30-1

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

2-undecanol โ€” food additive

2-Undecanol is a naturally-occurring fatty alcohol used as a flavoring agent and flavor enhancer in food products. This C11 alcohol compound is employed in small quantities to provide fruity, citrus, or waxy sensory notes in beverages, confections, and other 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 2-Undecanol?

2-Undecanol (CAS Number 1653-30-1) is an 11-carbon secondary alcohol classified as a flavoring agent and flavor enhancer. The chemical structure consists of a straight-chain hydrocarbon with a hydroxyl group (-OH) attached to the second carbon position. This compound occurs naturally in various fruits and plant materials, contributing to their characteristic aromatic profiles. In food manufacturing, 2-undecanol is synthesized for use as a food flavoring ingredient.

Common Uses

2-Undecanol is utilized in the food industry primarily as a flavoring component in processed foods and beverages. Its typical applications include:

- Fruit-flavored beverages and juice products

- Confectionery items such as candies and chocolate products

- Baked goods and desserts

- Dairy products and flavor systems

- Alcoholic beverages

The compound is used in very small concentrations, typically measured in parts per million (ppm), to achieve desired flavor profiles without contributing substantially to caloric intake or nutritional content. Its role as a flavor enhancer allows it to amplify existing flavors or create complex flavor combinations.

Safety Assessment

2-Undecanol has not been formally designated as Generally Recognized As Safe (GRAS) by the FDA, which means it has not undergone the specific FDA GRAS petition process. However, this designation does not indicate safety concernsโ€”rather, it reflects that formal GRAS status has not been sought or established through official channels.

According to available FDA data, there are zero reported adverse events associated with 2-undecanol consumption, and no product recalls have been issued due to this ingredient. This absence of reported safety incidents suggests a favorable safety profile in historical use.

The chemical structure of 2-undecanol as a medium-chain fatty alcohol suggests it would be metabolized similarly to other aliphatic alcohols in the human body. Its use in minute quantities in food products means systemic exposure would be minimal under normal consumption patterns.

Regulatory Status

2-Undecanol operates in a regulatory framework where its GRAS status remains unestablished with the FDA. In the United States, flavoring agents may be used in food products under FDA regulations when they meet safety standards, even without formal GRAS designation, provided they are used in accordance with Good Manufacturing Practices (GMP) and at levels that achieve the intended flavoring effect without creating safety concerns.

The European Union's approach to flavorings is governed by Regulation (EC) No. 1334/2008, which establishes a positive list of approved flavorings. The regulatory status of 2-undecanol in the EU may differ from that in the United States, and manufacturers must ensure compliance with local regulations in their respective markets.

International regulatory bodies including those in Japan, Canada, and other countries maintain their own evaluations of food flavorings. The absence of restrictions or bans on 2-undecanol in major regulatory jurisdictions suggests widespread acceptance for use in food applications.

Key Studies

Limited published peer-reviewed research specifically examines 2-undecanol in isolation as a food additive. However, scientific literature on medium-chain fatty alcohols generally demonstrates low toxicity profiles. Studies on structurally similar compounds provide supporting evidence for the safety of this class of ingredients when used in appropriate food applications.

The flavor and fragrance industry has extensive data on 2-undecanol's organoleptic properties and stability, though much of this information exists in proprietary manufacturer databases rather than public scientific literature. Acute toxicity data for 2-undecanol in animal models indicates low inherent toxicity, consistent with its chemical classification as a simple fatty alcohol.

Further formal safety evaluation through standardized toxicology testing would be necessary to formally establish GRAS status if sought by manufacturers or regulatory bodies.

Frequently Asked Questions

What is 2-undecanol?

2-Undecanol is a naturally-occurring fatty alcohol used as a flavoring agent and flavor enhancer in food products. This C11 alcohol compound is employed in small quantities to provide fruity, citrus, or waxy sensory notes in beverages, confections, and other processed foods.

Is 2-undecanol safe?

2-undecanol 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 2-undecanol banned in any country?

2-undecanol 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.