Our Verdict: RATING UNKNOWN

2-methylbutyric Acid

CAS116-53-0

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

2-methylbutyric Acid — food additive

2-methylbutyric acid is an organic carboxylic acid used as a flavoring agent in food products. It occurs naturally in some foods and provides a fruity, cheese-like aroma in small quantities.

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 2-methylbutyric Acid?

2-methylbutyric acid, also known as 2-methylbutanoic acid, is a short-chain carboxylic acid with the chemical formula C5H10O2 (CAS Number 116-53-0). It is a colorless to pale yellow liquid with a characteristic pungent, fruity odor often described as apple-like or cheese-like. The compound occurs naturally in small quantities in various foods including fruits, vegetables, and fermented products.

Common Uses

In the food industry, 2-methylbutyric acid functions primarily as a flavoring agent and flavor adjuvant. It is used in very small quantities to enhance or modify the flavor profiles of processed foods. Common applications include dairy products, baked goods, beverages, confectionery, and savory snacks. The acid contributes fruity and slightly tangy notes that enhance the sensory appeal of products. Because it occurs naturally in foods, it is sometimes considered part of natural flavor systems, though synthetic versions are also produced for food use.

Safety Assessment

The FDA has recorded zero adverse events and zero recalls associated with 2-methylbutyric acid. However, the compound has not received GRAS (Generally Recognized As Safe) status from the FDA, which means it does not have formal regulatory approval in the United States for direct use as a food additive. This status does not indicate a safety concern but rather reflects that formal safety dossiers and approvals were not pursued or completed through FDA channels.

The compound has not been the subject of significant safety concerns in published scientific literature. As a short-chain organic acid, its toxicological profile is consistent with other similar compounds used in food flavoring. Exposure levels through food consumption are typically minimal, measured in parts per million in finished food products.

Unlike some flavor compounds, 2-methylbutyric acid does not appear on lists of banned or restricted substances in major regulatory jurisdictions. It has been evaluated as part of natural flavor composition assessments in various countries.

Regulatory Status

In the United States, while not GRAS-approved, 2-methylbutyric acid can be used as a food additive under FDA regulations for flavoring purposes, though with limited direct regulatory oversight compared to approved additives. In the European Union, it is listed in the FLAVIS database (Flavor Information System) as a flavor substance. Different countries maintain varying regulatory frameworks for flavor chemicals, and approval status may differ by region.

Because it does not have formal U.S. GRAS status, manufacturers using 2-methylbutyric acid should verify current regulations with the FDA and may need to document its use as a food ingredient according to applicable food labeling requirements.

Key Studies

Limited published clinical or toxicological studies specifically examine 2-methylbutyric acid in isolation. The compound's safety assessment generally relies on structural similarity to approved short-chain carboxylic acids, its occurrence in nature, and the absence of adverse reports in decades of food industry use. As a natural constituent of foods and a component of microbial metabolism, it has likely been present in human diets throughout history at low levels.

Research on short-chain fatty acids and organic acids more broadly supports the safety of these compounds at food use levels. The pungent odor and flavor characteristics of 2-methylbutyric acid itself serve as natural limiting factors for its use, as excessive quantities would be organoleptically unacceptable in food products.

Frequently Asked Questions

What is 2-methylbutyric Acid?

2-methylbutyric acid is an organic carboxylic acid used as a flavoring agent in food products. It occurs naturally in some foods and provides a fruity, cheese-like aroma in small quantities.

Is 2-methylbutyric Acid safe?

2-methylbutyric 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 2-methylbutyric Acid banned in any country?

2-methylbutyric 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.