Our Verdict: RATING UNKNOWN

4-methyloctanoic Acid

CAS54947-74-9

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

4-methyloctanoic Acid — food additive

4-methyloctanoic acid is a branched-chain fatty acid used as a flavoring agent in food products. It contributes a cheese-like, fatty aroma and is employed in various processed foods to enhance flavor profiles.

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 4-methyloctanoic Acid?

4-methyloctanoic acid, also known as 4-methyl octanoic acid, is a naturally occurring branched-chain carboxylic acid with the CAS number 54947-74-9. This organic compound belongs to the class of aliphatic fatty acids and is characterized by a straight-chain structure with a methyl branch at the fourth carbon position. The compound has a molecular formula of C9H18O2 and exists as a colorless to pale yellow liquid with a distinct fatty, cheese-like odor.

Common Uses

4-methyloctanoic acid is primarily used in the food industry as a flavoring agent and flavor adjuvant. Its characteristic aroma makes it valuable in formulating dairy flavors, cheese flavors, and fermented food products. The compound can be found in small quantities in certain fermented foods naturally, including some cheeses and dairy products, where it contributes to their distinctive sensory profiles. In food manufacturing, it is added to processed cheese products, dairy-based beverages, seasonings, and various snack foods to enhance or replicate cheese-like flavoring notes. The compound is also utilized in non-food applications within cosmetics and fragrance industries.

Safety Assessment

According to FDA records, there are zero adverse events reported for 4-methyloctanoic acid and zero recalls associated with this substance. The compound has not been formally reviewed under the FDA's GRAS (Generally Recognized as Safe) program, meaning it does not carry explicit GRAS status. However, the absence of adverse event reports and recalls indicates no documented safety issues in food applications as currently used.

As a branched-chain fatty acid, 4-methyloctanoic acid shares structural similarities with compounds that occur naturally in foods and are metabolized through standard fatty acid pathways in the body. The toxicological profile of branched-chain fatty acids has been studied, with most showing low acute toxicity. Typical use levels in food applications are minimal, further reducing potential exposure concerns.

The European Food Safety Authority (EFSA) has evaluated various flavoring compounds, though specific comprehensive assessments of 4-methyloctanoic acid may be limited in publicly available literature. The compound's chemical structure suggests it would undergo normal lipid metabolism when ingested in the small quantities typical of food flavoring applications.

Regulatory Status

4-methyloctanoic acid is not approved under the FDA's GRAS program, which means manufacturers using this ingredient in food products must comply with FDA regulations for food additives. In the United States, its use is restricted and must be evaluated on a case-by-case basis or through food additive petitions. Different regulatory frameworks exist globally, with some countries potentially allowing its use under flavor regulations while others may have different classification requirements.

The lack of GRAS status does not automatically indicate safety concerns but rather indicates that the specific approval pathway and formal evaluation process have not been completed. Manufacturers intending to use this ingredient in the U.S. market would need to ensure compliance with applicable food additive regulations or seek appropriate regulatory clearance.

Key Studies

Limited peer-reviewed literature specifically addressing 4-methyloctanoic acid safety exists in the public domain. Most information about this compound comes from flavor industry databases and technical specifications. General toxicology studies on branched-chain fatty acids provide a foundation for safety assessment, indicating that compounds in this class typically exhibit low acute toxicity when evaluated through standard testing protocols.

The natural occurrence of 4-methyloctanoic acid in fermented foods suggests long-term human dietary exposure at trace levels, though systematic epidemiological studies specifically examining this compound are not readily available in scientific literature. Safety assessments would typically rely on chemical structure-activity relationship analysis, comparative toxicology of similar compounds, and intended use levels in food applications.

Frequently Asked Questions

What is 4-methyloctanoic Acid?

4-methyloctanoic acid is a branched-chain fatty acid used as a flavoring agent in food products. It contributes a cheese-like, fatty aroma and is employed in various processed foods to enhance flavor profiles.

Is 4-methyloctanoic Acid safe?

4-methyloctanoic Acid 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 4-methyloctanoic Acid banned in any country?

4-methyloctanoic Acid 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.