Our Verdict: RATING UNKNOWN

10-undecen-2-one

CAS36219-73-5

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

10-undecen-2-one — food additive

10-undecen-2-one is a synthetic organic compound used as a flavoring agent in food products. It is not approved as GRAS (Generally Recognized as Safe) by the FDA, though it has generated no reported adverse events or product recalls.

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 10-undecen-2-one?

10-undecen-2-one (CAS Number 36219-73-5) is a synthetic flavoring compound classified as a ketone. Its chemical structure consists of an 11-carbon chain with a double bond between carbons 10 and 11, and a ketone functional group at carbon 2. This compound is used in the flavor industry to provide specific organoleptic characteristics to food and beverage products.

Common Uses

As a flavoring agent, 10-undecen-2-one is used to impart or enhance flavors in various food applications. The compound contributes particular sensory notes that flavor manufacturers utilize in formulations for processed foods, beverages, and other consumer products. However, due to its non-GRAS status in the United States, its use is more limited compared to approved flavoring agents. It may be available for use in certain jurisdictions or under specific regulatory frameworks that differ from FDA requirements.

Safety Assessment

The safety profile of 10-undecen-2-one remains relatively understudied in published peer-reviewed literature. The FDA has not classified this additive as GRAS, meaning it has not been formally recognized as safe for its intended use in food. However, this designation does not necessarily indicate hazard; rather, it reflects that adequate safety data meeting FDA's standards have not been submitted or reviewed.

Significantly, there are zero reported adverse events associated with 10-undecen-2-one in the FDA's adverse event reporting system, and no product recalls have been attributed to this ingredient. This absence of documented harm in regulatory databases suggests either minimal exposure in the food supply or lack of identified safety concerns at consumption levels.

As with many synthetic flavoring compounds, toxicological data would typically include acute and subchronic toxicity studies, though such information for this specific compound is not readily available in public databases.

Regulatory Status

10-undecen-2-one is not approved as GRAS by the FDA for use in food. In the United States, flavoring ingredients not on the GRAS list face more restrictive use conditions. Manufacturers seeking to use non-GRAS flavoring agents must either petition the FDA for approval or operate under regulatory pathways such as food additive petitions or color additive regulations, depending on the ingredient's classification.

Regulatory status may vary internationally. Some flavor compounds approved or permitted in certain countries may have different designations in others, reflecting varying regulatory frameworks and safety assessment standards. The European Food Safety Authority (EFSA) and other international bodies may have evaluated this or similar compounds differently.

Key Studies

Published scientific literature specifically addressing 10-undecen-2-one is limited. Most available information comes from flavor industry databases and regulatory submissions rather than independent peer-reviewed research. The lack of published safety studies in major scientific journals suggests either that formal toxicological assessments have not been conducted publicly, or that such assessments remain proprietary to ingredient manufacturers.

Flavor compounds in this chemical family have sometimes been evaluated as part of broader assessments by the Flavor and Extract Manufacturers Association (FEMA) or through industry safety programs, though specific data for this individual compound is not widely accessible.

For consumers and manufacturers seeking more detailed safety information about 10-undecen-2-one, direct inquiry with ingredient suppliers or regulatory agencies may be necessary.

Frequently Asked Questions

What is 10-undecen-2-one?

10-undecen-2-one is a synthetic organic compound used as a flavoring agent in food products. It is not approved as GRAS (Generally Recognized as Safe) by the FDA, though it has generated no reported adverse events or product recalls.

Is 10-undecen-2-one safe?

10-undecen-2-one 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 10-undecen-2-one banned in any country?

10-undecen-2-one 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.