Our Verdict: RATING UNKNOWN

Hexyl Hexanoate

CAS6378-65-0

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

Hexyl Hexanoate — food additive

Hexyl hexanoate is an ester compound used as a flavoring agent in food products to provide fruity, apple-like sensory characteristics. It is not currently approved as a food additive by the FDA under GRAS (Generally Recognized as Safe) status, though no adverse events have been reported in the agency's database.

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 Hexyl Hexanoate?

Hexyl hexanoate (CAS Number: 6378-65-0) is an organic ester compound composed of hexyl alcohol and hexanoic acid. It belongs to the class of compounds known as esters, which are commonly found in natural products and are frequently used in the food industry as flavoring agents. The compound has a characteristic fruity aroma, particularly resembling apple and other fruit notes, making it useful in food flavoring applications.

Common Uses

Hexyl hexanoate is primarily used as a flavoring agent or flavoring adjuvant in food products. Its fruity profile makes it valuable in formulations for beverages, confectionery, baked goods, and other processed foods where apple or general fruit flavoring is desired. Like other ester-based flavorings, it contributes to the sensory experience of food products by enhancing or creating specific taste and aroma profiles that appeal to consumers.

The compound is also investigated for potential use in fragrance applications due to its pleasant fruity odor profile, though food industry applications remain its primary focus.

Safety Assessment

Hexyl hexanoate has not been formally evaluated by the FDA for GRAS (Generally Recognized as Safe) status, meaning it does not have explicit regulatory approval for use in foods marketed in the United States. However, the lack of GRAS approval does not necessarily indicate a safety concern—it may reflect limited commercial use, lack of formal petition submission, or insufficient industry demand for regulatory review.

The FDA's adverse event database contains zero reported adverse events associated with hexyl hexanoate, and no food safety recalls involving this additive have been documented. This absence of reported incidents suggests that any exposure consumers may have had has not resulted in documented safety concerns.

As an ester compound, hexyl hexanoate is structurally similar to naturally occurring esters and other approved flavoring agents. Many ester-based flavorings have undergone safety evaluation by scientific bodies, though this specific compound's comprehensive toxicological profile may be limited in published literature.

Regulatory Status

In the United States, hexyl hexanoate does not hold FDA GRAS approval, which means it cannot be used as a food additive in products marketed to American consumers without prior regulatory approval or a completed GRAS petition. Food manufacturers must either obtain FDA approval through the food additive petition process or locate suppliers offering legitimately approved alternatives.

Regulatory status in other jurisdictions (European Union, Canada, Japan) may differ, as various countries maintain independent approval systems for food additives. The European Food Safety Authority (EFSA) and other international bodies may have different approval statuses for this compound.

Any use of hexyl hexanoate in food products in the United States would require either premarket approval from the FDA or an established GRAS determination supported by scientific evidence.

Key Studies

Published scientific literature specifically evaluating hexyl hexanoate's safety profile is limited. Most information available derives from general knowledge of ester compound metabolism and safety data for structurally similar approved flavorings rather than compound-specific studies.

Research on similar hexanoate esters and their metabolic pathways indicates that these compounds are typically broken down into their component alcohols and acids, which are further metabolized through normal biochemical processes. However, comprehensive toxicological studies specific to hexyl hexanoate—including acute toxicity, chronic exposure, reproductive, or developmental studies—do not appear to be readily available in public databases.

To support a GRAS petition or regulatory approval, manufacturers would typically need to compile or conduct studies addressing acute and subchronic toxicity, mutagenicity, and other endpoints relevant to food safety assessment.

Frequently Asked Questions

What is Hexyl Hexanoate?

Hexyl hexanoate is an ester compound used as a flavoring agent in food products to provide fruity, apple-like sensory characteristics. It is not currently approved as a food additive by the FDA under GRAS (Generally Recognized as Safe) status, though no adverse events have been reported in the agency's database.

Is Hexyl Hexanoate safe?

Hexyl Hexanoate 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 Hexyl Hexanoate banned in any country?

Hexyl Hexanoate 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.