Our Verdict: SAFE

2-methylbutyl Isovalerate

CAS2445-77-4

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

2-methylbutyl Isovalerate โ€” food additive

2-methylbutyl isovalerate is a synthetic ester compound used as a flavoring agent in food products. It contributes fruity, apple-like, and fermented notes to beverages, confections, and processed foods. The additive has no reported adverse events or recalls in FDA databases.

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-methylbutyl Isovalerate?

2-methylbutyl isovalerate is a synthetic ester (CAS Number 2445-77-4) commonly employed as a flavoring agent in the food industry. Esters are organic compounds formed from the reaction of alcohols and carboxylic acids, and this particular compound combines 2-methylbutanol with isovaleric acid. It exists as a colorless to pale yellow liquid with a characteristic fruity aroma reminiscent of apples, pears, and fermented fruits.

Common Uses

This flavoring agent is primarily used in:

- Carbonated and non-carbonated beverages

- Confectionery and candy products

- Baked goods and desserts

- Dairy products including yogurts and flavored milk

- Processed snack foods

- Alcoholic beverages, particularly craft beers and spirits

The compound is valued for its ability to impart subtle fruity notes that enhance the sensory profile of products. Typical usage levels are in the range of parts per million (ppm), reflecting the potency of synthetic flavor compounds.

Safety Assessment

According to FDA records, 2-methylbutyl isovalerate has generated zero adverse event reports and zero product recalls. This lack of reported safety incidents suggests a generally benign safety profile in typical food applications at approved concentrations.

As a synthetic ester-based flavoring compound, it undergoes metabolism similar to other food-grade esters. The body processes such compounds through standard enzymatic pathways involving ester hydrolysis and subsequent metabolism of the resulting alcohols and acids.

Like most synthetic flavor compounds, toxicological data on this additive is limited in the public domain. However, structurally similar esters have been extensively evaluated and generally recognized as safe at food use levels. The absence of adverse events in real-world use, combined with its application in minute quantities, supports its apparent safety profile.

Regulatory Status

2-methylbutyl isovalerate is **not** listed as GRAS (Generally Recognized As Safe) by the FDA, meaning it has not undergone the formal GRAS notification process. However, this classification does not indicate the additive is unsafe; rather, it reflects that formal GRAS status documentation may not have been submitted to the FDA.

The compound is permitted for use in food flavoring in many jurisdictions and is commonly listed in commercial flavor formulations. It falls under flavor regulations in countries including the United States, European Union, Canada, and others, where it is used in accordance with good manufacturing practices (GMP).

Regulatory bodies establish maximum use levels for flavoring agents based on their intended function and typical consumption patterns. For synthetic esters like this compound, permitted levels are typically very lowโ€”often less than 10 ppm in finished products.

Key Studies

Published peer-reviewed research specifically focused on 2-methylbutyl isovalerate is limited in the scientific literature. Safety evaluation of this compound is primarily based on:

1. **Structural similarity analysis** - Comparison with other approved esters and their established safety profiles

2. **Metabolic pathway data** - Understanding how the body processes this ester and its breakdown products

3. **Historical use data** - Long-term safety record from decades of industrial use in food flavoring

4. **FEMA GRAS assessment** - The Flavor Extract Manufacturers Association (FEMA) maintains panels that evaluate flavor ingredient safety, and related compounds have been reviewed

The combination of zero adverse event reports, zero recalls, structural similarity to safe compounds, and appropriate use levels provides reasonable assurance of safety for this ingredient.

Frequently Asked Questions

What is 2-methylbutyl Isovalerate?

2-methylbutyl isovalerate is a synthetic ester compound used as a flavoring agent in food products. It contributes fruity, apple-like, and fermented notes to beverages, confections, and processed foods. The additive has no reported adverse events or recalls in FDA databases.

Is 2-methylbutyl Isovalerate safe?

2-methylbutyl Isovalerate 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 2-methylbutyl Isovalerate banned in any country?

2-methylbutyl Isovalerate 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.