Our Verdict: RATING UNKNOWN

Hexanal Octane-1,3-diol Acetal

CAS202188-46-3

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

Hexanal Octane-1,3-diol Acetal โ€” food additive

Hexanal octane-1,3-diol acetal (CAS 202188-46-3) is a synthetic flavoring agent used to provide fruity and floral notes in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, though it has generated no reported adverse events or 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
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 Hexanal Octane-1,3-diol Acetal?

Hexanal octane-1,3-diol acetal is a synthetic organic compound classified as a flavoring agent. It belongs to the acetal family of flavor compounds, which are formed through the condensation of aldehydes with diols. This particular compound combines hexanal (a six-carbon aldehyde) with octane-1,3-diol to create a volatile flavor molecule. The chemical structure allows it to contribute fruity and floral flavor characteristics to food and beverage products.

Common Uses

Hexanal octane-1,3-diol acetal is used as a flavoring agent in various food and beverage applications, typically in very small concentrations. Its fruity and floral profile makes it suitable for use in confectionery, beverages, baked goods, and other processed foods where such flavor notes are desired. Like most synthetic flavoring agents, it would be used at levels well below those that would have any nutritional or caloric significance. The exact concentration used in commercial products varies depending on the specific application and desired flavor intensity.

Safety Assessment

Hexanal octane-1,3-diol acetal has not been designated as Generally Recognized as Safe (GRAS) by the FDA. This designation, however, does not necessarily indicate an unsafe substance; rather, it means the compound has not completed the GRAS approval process or has not been widely adopted for use in the United States food supply. According to FDA records, there have been zero reported adverse events associated with this additive and zero recalls involving this substance. This absence of reported harm indicates no identified safety issues in actual use.

The lack of adverse event reports and recalls provides some reassurance regarding the safety profile of this compound in food applications. However, the absence of a GRAS determination means that its use in foods may be limited or restricted in certain jurisdictions, particularly in the United States where GRAS status is typically required or strongly preferred for food additives.

Regulatory Status

In the United States, hexanal octane-1,3-diol acetal is not listed as a GRAS substance by the FDA. This means it cannot be used as a food additive in the U.S. without prior FDA approval through the food additive petition process. The compound may, however, be approved or permitted for use in other jurisdictions. The European Food Safety Authority (EFSA) and other regulatory bodies maintain separate approval lists, and approval status may differ by region.

Manufacturers seeking to use this flavoring agent in the United States would need to file a food additive petition with the FDA, providing toxicological data, manufacturing specifications, and proposed use levels. This regulatory framework ensures that flavor compounds undergo appropriate safety review before market introduction.

Key Studies

Limited published scientific literature is available specifically evaluating hexanal octane-1,3-diol acetal. The lack of formal FDA approval and the limited use history of this particular compound mean that comprehensive long-term safety studies may not have been conducted or published in peer-reviewed journals. Safety evaluation of similar acetal-based flavoring compounds has generally supported their safety when used at typical flavor levels. The chemical stability and metabolism of related compounds suggests hexanal octane-1,3-diol acetal would likely be rapidly metabolized and excreted, though specific data for this compound would be needed to confirm this assumption.

Future safety assessments would likely focus on acute and subchronic toxicity studies, genotoxicity testing, and reproductive/developmental toxicity evaluationโ€”standard endpoints for flavor compound evaluation.

Frequently Asked Questions

What is Hexanal Octane-1,3-diol Acetal?

Hexanal octane-1,3-diol acetal (CAS 202188-46-3) is a synthetic flavoring agent used to provide fruity and floral notes in food products. It is not currently approved as Generally Recognized as Safe (GRAS) by the FDA, though it has generated no reported adverse events or recalls.

Is Hexanal Octane-1,3-diol Acetal safe?

Hexanal Octane-1,3-diol Acetal 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 Hexanal Octane-1,3-diol Acetal banned in any country?

Hexanal Octane-1,3-diol Acetal 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.