Our Verdict: RATING UNKNOWN

Isobutyl 10-undecenoate

CAS5421-27-2

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

Isobutyl 10-undecenoate — food additive

Isobutyl 10-undecenoate is a synthetic ester compound used as a flavoring agent in food products. It provides fruity and waxy sensory characteristics and is employed in small quantities to enhance food flavors.

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
Not EvaluatedHealth 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 Isobutyl 10-undecenoate?

Isobutyl 10-undecenoate (CAS Number: 5421-27-2) is a synthetic ester chemical compound composed of isobutanol and 10-undecenoic acid. It belongs to the class of organic compounds used primarily as a flavoring agent or flavor adjuvant in the food industry. The compound is characterized by a fruity and slightly waxy odor profile, making it useful in creating or enhancing specific flavor notes in processed foods and beverages.

Common Uses

Isobutyl 10-undecenoate is utilized in food manufacturing as a flavoring agent, typically in very small concentrations. Its primary applications include enhancing fruity and waxy flavor notes in:

- Beverages (both alcoholic and non-alcoholic)

- Confectionery products

- Baked goods

- Dairy products

- Flavor formulations for processed foods

As with most synthetic flavor compounds, it is used at levels well below those that would have any nutritional impact, functioning purely for sensory enhancement purposes.

Safety Assessment

Isobutyl 10-undecenoate has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA. However, this designation status does not necessarily indicate a safety concern. The FDA has received zero adverse event reports associated with this compound and has initiated zero recalls involving its use. The absence of reported adverse events or regulatory actions suggests that as currently used in food products, it has not been associated with consumer health incidents.

The compound's safety profile appears to be based on its chemical structure and the limited exposure levels from typical food applications. Ester compounds of this type are generally metabolized through standard digestive pathways in the human body.

Regulatory Status

While isobutyl 10-undecenoate does not hold FDA GRAS status, it may be used in foods under other regulatory frameworks. In the European Union, it may be listed in flavor compound registries and databases used by the fragrance and flavor industry. The lack of GRAS status does not prohibit its use; rather, it indicates that formal FDA review or industry petition for GRAS status has not been completed or approved.

Manufacturers using this compound in food products are responsible for ensuring its safety and compliance with applicable regulations in their respective markets. Food products containing this ingredient must comply with ingredient labeling requirements.

Key Studies

Limited peer-reviewed scientific literature is publicly available specifically addressing isobutyl 10-undecenoate. The compound's use in food is based primarily on its chemical properties, structural similarity to other approved ester flavorings, and the absence of reported adverse effects. Research on related ester compounds and broader ester chemistry provides context for understanding this additive's behavior in food systems.

The lack of extensive published research should be interpreted in context: many synthetic flavor compounds used in food have limited published literature because they are used safely at very low levels and rarely present regulatory or safety concerns that would warrant investigation.

Frequently Asked Questions

What is Isobutyl 10-undecenoate?

Isobutyl 10-undecenoate is a synthetic ester compound used as a flavoring agent in food products. It provides fruity and waxy sensory characteristics and is employed in small quantities to enhance food flavors.

Is Isobutyl 10-undecenoate safe?

Isobutyl 10-undecenoate 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 Isobutyl 10-undecenoate banned in any country?

Isobutyl 10-undecenoate 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.