Our Verdict: RATING UNKNOWN

Methyl 3-hydroxyhexanoate

CAS21188-58-9

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

Methyl 3-hydroxyhexanoate — food additive

Methyl 3-hydroxyhexanoate is a synthetic flavoring compound used to create fruity and creamy taste profiles in processed foods. It functions as both a flavoring agent and flavor enhancer in various food and beverage applications.

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 Methyl 3-hydroxyhexanoate?

Methyl 3-hydroxyhexanoate (CAS Number: 21188-58-9) is a synthetic organic compound classified as a flavoring agent. It belongs to the class of esters and is characterized by a hydroxyl group on its carbon chain. This compound is primarily used in the food industry to impart fruity and creamy flavor notes to products. The molecule's structure allows it to interact with taste and smell receptors, contributing to the overall sensory profile of foods and beverages.

Common Uses

Methyl 3-hydroxyhexanoate is utilized as a flavoring ingredient in various processed food and beverage applications. It appears in formulations designed to create fruit flavors, particularly those with tropical or berry characteristics, as well as in creamy or dairy-like flavor profiles. The compound is typically used in small concentrations in products such as flavored beverages, confectionery, dairy products, and other processed foods where flavor enhancement is desired. Its use is part of the broader category of synthetic flavoring agents that food manufacturers employ to achieve consistent and desired taste experiences.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with methyl 3-hydroxyhexanoate, and no food recalls have been linked to this additive. The absence of documented health complaints or safety incidents provides baseline reassurance regarding its use in food products. However, it is important to note that the lack of adverse event reports does not necessarily indicate comprehensive safety approval, as many synthetic flavoring agents have limited comprehensive toxicological data available in the public domain.

As a synthetic flavoring agent, methyl 3-hydroxyhexanoate falls within a regulatory category where food manufacturers are generally responsible for ensuring safety through appropriate testing and proper use levels. The compound's structural similarity to naturally occurring esters and its use at low concentrations in food products suggest a generally recognized safety profile for typical intended uses, though extensive peer-reviewed safety studies may not be widely published.

Regulatory Status

Methyl 3-hydroxyhexanoate has not received FDA GRAS (Generally Recognized As Safe) status. This designation indicates that while the compound is used in foods, it has not gone through the formal GRAS notification process with the FDA. GRAS status is not required for all food additives to be legally used; it is one pathway to regulatory acceptance. The absence of GRAS status does not indicate safety concerns but rather reflects whether manufacturers have pursued or obtained this specific formal FDA acknowledgment.

The compound's regulatory status may vary in different countries and regions. Food manufacturers using this ingredient must ensure compliance with applicable regulations in their target markets, as different jurisdictions maintain different lists of approved flavoring agents.

Key Studies

Published scientific literature specifically focused on methyl 3-hydroxyhexanoate is limited in the publicly available domain. Most safety information regarding synthetic flavoring agents in this category derives from structural analysis, in vitro studies, and broader evaluations of ester compounds used in flavorings. The FDA's Generally Recognized As Safe (GRAS) program and the European Food Safety Authority (EFSA) maintain databases of approved flavoring substances with supporting toxicological data, though specific comprehensive studies on this individual compound may not be extensively documented in peer-reviewed literature.

Research on similar hydroxylated ester compounds and their metabolic fate suggests that such molecules are typically metabolized through standard xenobiotic pathways in the body. The structural characteristics of methyl 3-hydroxyhexanoate suggest it would follow similar metabolic patterns, though specific pharmacokinetic data would require review of proprietary safety dossiers maintained by manufacturers or regulatory agencies.

Frequently Asked Questions

What is Methyl 3-hydroxyhexanoate?

Methyl 3-hydroxyhexanoate is a synthetic flavoring compound used to create fruity and creamy taste profiles in processed foods. It functions as both a flavoring agent and flavor enhancer in various food and beverage applications.

Is Methyl 3-hydroxyhexanoate safe?

Methyl 3-hydroxyhexanoate 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 Methyl 3-hydroxyhexanoate banned in any country?

Methyl 3-hydroxyhexanoate 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.