Our Verdict: SAFE

Methyl 2-methylbutyrate

CAS868-57-5

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

Methyl 2-methylbutyrate — food additive

Methyl 2-methylbutyrate is a synthetic ester compound used as a flavoring agent in food products. It provides a fruity, apple-like aroma and taste and is employed in small quantities to enhance the sensory profile of beverages, confections, and 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 Methyl 2-methylbutyrate?

Methyl 2-methylbutyrate (CAS Number: 868-57-5) is a synthetic ester belonging to the class of organic compounds known as carboxylic acid esters. It is created through chemical synthesis by combining methanol with 2-methylbutyric acid. This colorless to pale yellow liquid possesses a characteristic fruity odor reminiscent of apples and pears, making it valuable in the flavor industry.

Common Uses

Methyl 2-methylbutyrate is utilized primarily as a flavoring agent or flavor adjuvant in the food industry. Its applications include:

- Beverage flavoring, particularly in fruit-flavored drinks and soft drinks

- Confectionery products, including candies and chewing gums

- Dairy products such as yogurts and flavored milks

- Baked goods and snack foods

- Processed fruit products

Typical usage levels are very small, typically in the range of parts per million (ppm), as synthetic flavor compounds require only minimal quantities to achieve desired sensory effects.

Safety Assessment

Methyl 2-methylbutyrate has not been formally designated as Generally Recognized as Safe (GRAS) by the FDA. However, the lack of GRAS status does not necessarily indicate a safety concern; rather, it reflects that the compound has not undergone the specific FDA petition and approval process for GRAS designation.

According to FDA records reviewed as of the latest available data, there are zero reported adverse events associated with methyl 2-methylbutyrate and zero product recalls linked to this ingredient. This absence of reported safety incidents provides reassurance regarding its use in food applications at typical exposure levels.

As a synthetic ester flavoring compound used in trace amounts, methyl 2-methylbutyrate is subject to the same safety considerations as other flavor chemicals. The very low concentrations at which it is used in food products substantially limit potential exposure to consumers.

Regulatory Status

In the United States, methyl 2-methylbutyrate may be used as a food additive under FDA regulations governing flavoring substances and adjuvants. While it lacks explicit GRAS status, its use is permitted under the Food Additives Amendment provisions, provided it complies with applicable regulations and good manufacturing practices.

The European Food Safety Authority (EFSA) and other international regulatory bodies maintain guidelines for flavoring compounds. Methyl 2-methylbutyrate's status and any usage restrictions vary by country and regulatory jurisdiction.

Manufacturers using this ingredient must comply with labeling requirements and declare it appropriately on product ingredient lists, typically as "artificial flavor" or specific flavoring compound identification when required.

Key Studies

Limited published scientific literature specifically examines methyl 2-methylbutyrate in isolation. The compound's safety profile is primarily assessed through:

- General toxicology data for structurally similar ester compounds

- Acute and chronic toxicity testing frameworks applied to flavor chemicals

- The principle of structural analogy with known safe flavoring esters

- Established safety thresholds for synthetic flavor compounds used at low concentrations

The flavor industry relies on historical safety data for ester compounds and their metabolic pathways. When ingested, ester compounds are typically hydrolyzed rapidly in the gastrointestinal tract and liver, breaking down into their constituent components (methanol and 2-methylbutyric acid) that are further metabolized through normal biochemical pathways.

No significant adverse health effects have been documented in scientific literature regarding methyl 2-methylbutyrate exposure at food-use concentrations.

Frequently Asked Questions

What is Methyl 2-methylbutyrate?

Methyl 2-methylbutyrate is a synthetic ester compound used as a flavoring agent in food products. It provides a fruity, apple-like aroma and taste and is employed in small quantities to enhance the sensory profile of beverages, confections, and processed foods.

Is Methyl 2-methylbutyrate safe?

Methyl 2-methylbutyrate 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 Methyl 2-methylbutyrate banned in any country?

Methyl 2-methylbutyrate 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.