Our Verdict: RATING UNKNOWN

Hexanal Dihexyl Acetal

CAS33673-65-3

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 Dihexyl Acetal — food additive

Hexanal dihexyl acetal is a synthetic flavoring compound used to impart fruity and floral notes in food and beverage products. It functions as a flavoring agent that enhances taste profiles in various 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
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 Dihexyl Acetal?

Hexanal dihexyl acetal (CAS Number 33673-65-3) is a synthetic organic compound belonging to the acetal class of chemical compounds. It is derived from hexanal, a naturally occurring aldehyde found in some fruits, combined with hexyl alcohol through an acetalization reaction. The resulting compound is a colorless to pale yellow liquid with fruity and floral aromatic characteristics.

Common Uses

This flavoring agent is primarily used in the food and beverage industry to create or enhance fruity and floral flavor profiles. It appears in applications such as beverages, confectionery, baked goods, and other processed foods where fruity notes are desirable. The compound's sensory properties make it useful for formulating complex flavor systems that mimic natural fruit flavors. Like many synthetic flavoring compounds, it is used at very small concentrations—typically measured in parts per million (ppm)—to achieve the desired taste impact.

Safety Assessment

Hexanal dihexyl acetal has not been formally approved by the FDA as Generally Recognized as Safe (GRAS). However, the absence of GRAS status does not necessarily indicate safety concerns; rather, it reflects that the compound has not undergone the formal GRAS notification process or determination. According to FDA records, there are zero reported adverse events associated with this additive and zero product recalls linked to its use. This absence of adverse event reports suggests no documented safety issues in actual food applications.

The compound's safety profile should be understood in context: synthetic flavoring agents used in food are typically employed at extremely low concentrations. The toxicological relevance of a substance depends not only on its intrinsic properties but also on the dose of exposure. At the trace levels used in food flavoring applications, many compounds present minimal risk.

Limited published scientific literature specifically addresses this particular compound, which is common for specialized synthetic flavoring agents. Many such compounds are produced by established flavor manufacturers using established chemical synthesis methods with known reaction chemistry.

Regulatory Status

In the United States, hexanal dihexyl acetal is not listed on the FDA's GRAS list and has not received an official GRAS determination. This means it cannot be used as an additive in foods under the GRAS exemption. However, it may be used in foods under FDA's Food Additive Regulations if it has been approved through the food additive petition process or if it meets criteria for indirect additives.

The European Food Safety Authority (EFSA) maintains different regulatory pathways for flavoring substances. Regulatory status in Europe may differ from the United States, as each jurisdiction maintains independent safety assessment and approval systems.

Manufacturers wishing to use this compound in food applications in the United States would need to ensure compliance with applicable FDA regulations regarding food additives and their permitted uses.

Key Studies

Specific peer-reviewed studies exclusively examining hexanal dihexyl acetal are limited in the published scientific literature. Safety data for this compound may exist in proprietary toxicological reports submitted to regulatory agencies or held by manufacturers, which are not always publicly available.

When evaluating the safety of synthetic flavoring agents generally, regulatory agencies and researchers consider acute toxicity studies, subchronic toxicity data, and the compound's metabolic fate in the body. The acetal functional group itself is found in many food-approved flavoring compounds, suggesting this chemical class has an established history of safe use at appropriate concentrations.

Prospective users or those seeking detailed safety information should consult directly with flavor manufacturers or regulatory agencies for specific technical data.

Frequently Asked Questions

What is Hexanal Dihexyl Acetal?

Hexanal dihexyl acetal is a synthetic flavoring compound used to impart fruity and floral notes in food and beverage products. It functions as a flavoring agent that enhances taste profiles in various processed foods.

Is Hexanal Dihexyl Acetal safe?

Hexanal Dihexyl 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 Dihexyl Acetal banned in any country?

Hexanal Dihexyl 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.