Our Verdict: SAFE

4-methylnonanoic Acid

CAS45019-28-1

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

4-methylnonanoic Acid — food additive

4-methylnonanoic acid (CAS 45019-28-1) is a branched-chain fatty acid used as a flavoring agent in food products. It contributes fruity and fatty notes to various processed foods and beverages.

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-methylnonanoic Acid?

4-methylnonanoic acid is a naturally occurring branched-chain carboxylic acid with the molecular formula C₁₀H₂₀O₂. It is classified as a flavor compound and belongs to the family of fatty acids. The compound is identified by CAS Number 45019-28-1 and exists as a clear liquid with characteristic fruity and fatty organoleptic properties. This additive is used in minute quantities in food formulations to enhance or create specific flavor profiles.

Common Uses

4-methylnonanoic acid is employed primarily as a flavoring agent in the food industry. Its applications include:

- Fruit-flavored beverages and soft drinks

- Dairy products, including flavored milk and yogurt

- Confectionery items and candy

- Baked goods and grain-based products

- Processed cheese and cheese-flavored snacks

- Flavored fats and oils

The compound is used at very low concentrations, typically in the range of parts per million (ppm), as it is a potent flavor ingredient. Like other flavoring agents, it functions to improve palatability and consumer appeal of commercial food products.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with 4-methylnonanoic acid consumption. Additionally, no food recalls have been issued related to this compound. The absence of adverse event reports and recalls indicates that when used as intended in food products at typical levels, the ingredient has not raised safety concerns in the regulatory database.

The compound's safety profile is consistent with other branched-chain fatty acids used in flavoring applications. As a naturally occurring substance found in some foods, 4-methylnonanoic acid has inherent familiarity within the food supply. Its use at flavoring levels—typically very low concentrations—further minimizes potential exposure concerns.

Direct toxicological studies specific to this compound are limited in the public domain, which is not uncommon for flavoring agents used at minimal levels. The lack of documented safety incidents provides practical evidence of its safe use history in food applications.

Regulatory Status

4-methylnonanoic acid is not listed on the FDA's Generally Recognized as Safe (GRAS) list. However, this does not indicate the substance is unsafe or prohibited. Many flavoring agents function legally in food products through the Food Additive Petition process or under the Food and Drug Administration's indirect food additive regulations, rather than through GRAS affirmation.

The lack of GRAS status means that manufacturers using this ingredient must comply with applicable FDA regulations for food additives and maintain proper documentation of its use. The compound is permitted for use in flavoring formulations under the Code of Federal Regulations Title 21, which governs food additives.

Regulatory frameworks in other jurisdictions, such as the European Union's food additive approval system, may have different classifications and usage limits for this ingredient. International food manufacturers must verify compliance with local regulations in their target markets.

Key Studies

Published scientific literature specifically examining 4-methylnonanoic acid toxicity or safety testing is limited. Most safety information derives from:

- Structural-activity relationship (SAR) assessment based on the compound's fatty acid structure

- Historical use data in food flavoring applications

- Absence of adverse event reports in regulatory databases

- Industry safety dossiers maintained in compliance with food additive regulations

The limited formal toxicological data is typical for flavor compounds used at extremely low dietary exposure levels. Regulatory agencies generally apply different evidentiary standards to substances used at minimal concentrations compared to those with higher dietary exposure. The established use history and zero adverse events provide sufficient basis for continued safe use as a flavoring agent in food products.

Frequently Asked Questions

What is 4-methylnonanoic Acid?

4-methylnonanoic acid (CAS 45019-28-1) is a branched-chain fatty acid used as a flavoring agent in food products. It contributes fruity and fatty notes to various processed foods and beverages.

Is 4-methylnonanoic Acid safe?

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

4-methylnonanoic 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.