Our Verdict: SAFE

3-methylhexanal

CAS19269-28-4

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

3-methylhexanal — food additive

3-methylhexanal is a naturally-occurring organic compound used as a flavoring agent in food products. It imparts fruity and green note characteristics to beverages, baked goods, and other 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 3-methylhexanal?

3-methylhexanal (CAS Number 19269-28-4) is an organic aldehyde belonging to the class of volatile compounds commonly found in nature. It is a colorless to pale yellow liquid with a distinctive fruity aroma, often described as having green apple, pear, or herbaceous notes. The compound occurs naturally in various fruits and plant materials, making it a candidate for use as a synthetic flavoring agent that mimics naturally-occurring flavor profiles.

Common Uses

3-methylhexanal is employed in the flavor industry as a flavoring agent or adjuvant, primarily in applications requiring fruity or fresh green notes. Typical food applications include:

- Beverage flavorings (soft drinks, juices, flavored waters)

- Baked goods and confectionery products

- Dairy flavoring (yogurts, ice creams)

- Savory food applications

- Processed snack foods

As a flavoring adjuvant, it may be used in combination with other flavor compounds to enhance or modify the overall flavor profile of food products. The exact concentration levels vary depending on the intended application and desired flavor intensity.

Safety Assessment

According to FDA records, 3-methylhexanal has generated zero adverse event reports and has been involved in zero product recalls. This absence of documented safety incidents in the United States market suggests that the compound, at levels used in food applications, has not raised red flags among regulatory authorities or consumers.

The compound's safety profile is supported by its natural occurrence in food sources, which provides some basis for its use as a flavoring agent. Like many volatile organic compounds used in flavorings, 3-methylhexanal is typically used at very low concentrations—often measured in parts per million—where potential exposure is minimal.

Toxicological data on 3-methylhexanal is limited in published scientific literature, which is not uncommon for minor flavor compounds. Standard safety assessments for flavoring agents consider factors including acute toxicity, genetic toxicity, and repeat-dose toxicity studies. The lack of regulatory action or documented health concerns suggests acceptable safety margins at food-use levels.

Regulatory Status

3-methylhexanal is not on the FDA's GRAS (Generally Recognized as Safe) list. However, this designation does not necessarily indicate safety concerns. GRAS status represents formal FDA recognition through specific pathways, which many legitimate flavoring ingredients do not pursue. The compound may be used in foods under FDA regulations governing flavoring agents without explicit GRAS affirmation if it meets other regulatory requirements or is used under established flavor industry guidelines.

In the European Union, 3-methylhexanal may be regulated under the EU Flavourings Regulation (EC No 1334/2008), which establishes requirements for flavoring substances used in food production.

Manufacturers and food producers using this ingredient are responsible for ensuring compliance with all applicable food safety regulations in their respective jurisdictions.

Key Studies

Published scientific literature specifically examining 3-methylhexanal is limited. The compound is typically addressed within broader reviews of aldehyde-based flavor compounds and volatile organic compound safety in food applications. Most safety data derives from industry submissions to regulatory bodies and general toxicological data for structurally related compounds.

Research on naturally-occurring aldehydes and their flavor characteristics supports the organoleptic properties of 3-methylhexanal. Its structure and volatility characteristics are consistent with other approved flavoring aldehydes in routine food use.

Frequently Asked Questions

What is 3-methylhexanal?

3-methylhexanal is a naturally-occurring organic compound used as a flavoring agent in food products. It imparts fruity and green note characteristics to beverages, baked goods, and other processed foods.

Is 3-methylhexanal safe?

3-methylhexanal is currently rated "safe" 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 3-methylhexanal banned in any country?

3-methylhexanal 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.