Our Verdict: RATING UNKNOWN

5-methylhexyl Acetate

CAS72246-17-4

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

5-methylhexyl Acetate — food additive

5-methylhexyl acetate is a synthetic flavoring compound used to impart fruity and floral notes in processed foods and beverages. It functions as a flavoring agent or adjuvant and is not currently on the FDA's GRAS (Generally Recognized as Safe) list.

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 5-methylhexyl Acetate?

5-methylhexyl acetate (CAS Number: 72246-17-4) is a synthetic organic compound belonging to the ester family of flavor chemicals. It is composed of a branched-chain alcohol (5-methylhexanol) esterified with acetic acid. The compound is a colorless to pale yellow liquid with characteristic fruity and slightly floral aromatic properties.

Common Uses

This flavoring agent is utilized in the food and beverage industry to create or enhance fruity flavor profiles, particularly in products where apple, pear, or tropical fruit notes are desired. It may be found in applications such as flavored beverages, confectionery, baked goods, and other processed foods where synthetic flavoring is permitted. The compound's specific organoleptic properties make it useful in complex flavor compositions designed to replicate natural fruit essences.

Safety Assessment

According to FDA records, there are no reported adverse events associated with 5-methylhexyl acetate, and no product recalls have been linked to this additive. The absence of adverse event reports and recalls suggests that, based on available post-market surveillance data, this compound has not been associated with documented consumer harm at current usage levels.

However, it is important to note that the lack of adverse events does not constitute formal FDA approval for safety. The compound's limited regulatory history means that comprehensive toxicological and safety evaluation data may be restricted or not publicly available. Most synthetic flavoring agents in this chemical class undergo safety assessments through established toxicological testing protocols, though specific published studies on this particular compound may be limited in public databases.

Regulatory Status

5-methylhexyl acetate is not listed on the FDA's GRAS (Generally Recognized as Safe) list, which means it has not received this designation of recognized safety status. In the European Union, this additive is not listed in the current EU regulation for food flavorings, indicating it is not approved for use in EU food products. The regulatory distinction is important: not being on the GRAS list does not necessarily mean the additive is unsafe, but rather that it has not undergone or received the formal approval process in the United States.

For a flavoring agent to be used in FDA-regulated food products without GRAS status, it must be approved through the Food Additive Petition (FAP) process, which requires submission of safety and technical data for FDA review. The absence of GRAS status suggests this compound may not have pursued or completed this approval pathway in the U.S. market.

Key Studies

Public scientific literature on 5-methylhexyl acetate is limited. Most safety evaluations for synthetic flavoring compounds in this chemical class are conducted by the Flavor and Extract Manufacturers Association (FEMA) and evaluated by the FEMA Expert Panel, which assesses flavoring safety data. Individual published peer-reviewed studies specifically examining 5-methylhexyl acetate's toxicological profile are not readily available in major public health databases.

Safety assessments for structurally similar acetate esters indicate that compounds in this chemical family are typically rapidly metabolized and do not bioaccumulate. However, compound-specific data would be necessary to make definitive safety conclusions about 5-methylhexyl acetate itself.

Frequently Asked Questions

What is 5-methylhexyl Acetate?

5-methylhexyl acetate is a synthetic flavoring compound used to impart fruity and floral notes in processed foods and beverages. It functions as a flavoring agent or adjuvant and is not currently on the FDA's GRAS (Generally Recognized as Safe) list.

Is 5-methylhexyl Acetate safe?

5-methylhexyl Acetate 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 5-methylhexyl Acetate banned in any country?

5-methylhexyl Acetate 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.