Our Verdict: SAFE

Butyl Isovalerate

CAS109-19-3

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

Butyl Isovalerate — food additive

Butyl isovalerate (CAS 109-19-3) is an ester compound used as a flavoring agent in food products. It provides fruity, apple-like aromatic notes and is employed in beverages, confections, and other 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
ApprovedHealth 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 Butyl Isovalerate?

Butyl isovalerate is an organic ester compound with the molecular formula C9H18O2. It is a volatile liquid that occurs naturally in trace amounts in some fruits and fermented products. The compound is synthesized commercially through esterification reactions between butanol and isovaleric acid. As a flavoring agent, it contributes fruity, apple-like, and slightly herbaceous sensory notes to food and beverage formulations.

Common Uses

Butyl isovalerate is primarily used in the food industry as a flavoring compound. Its applications include:

- Fruit-flavored beverages and soft drinks

- Confectionery and candy formulations

- Baked goods and bakery products

- Dairy-based beverages and yogurts

- Processed snack foods

- Flavor blends and compounds for food manufacturers

The compound is used in very small concentrations—typically measured in parts per million—to achieve desired aromatic profiles without contributing nutritional value.

Safety Assessment

Butyl isovalerate has not been formally evaluated by the U.S. FDA for GRAS (Generally Recognized As Safe) status. However, this classification does not indicate a safety concern; rather, it reflects that the additive may not have undergone formal GRAS notification procedures or may not be widely used in FDA-regulated products in the United States.

To date, the FDA has recorded zero adverse events associated with butyl isovalerate and zero product recalls linked to this ingredient. This absence of reported safety incidents suggests a favorable safety profile in food applications where it has been used.

The compound is structurally related to other approved food flavoring esters and shares chemical characteristics with ingredients that have been used safely in foods for many years. Ester compounds in general are considered low-toxicity flavoring ingredients when used at typical food application levels.

Regulatory Status

Regulatory approval for butyl isovalerate varies by jurisdiction:

**United States:** While not bearing FDA GRAS status, butyl isovalerate may be used in food flavoring formulations under FDA regulations for food additives, provided it meets specifications and use levels that maintain safety.

**European Union:** The European Food Safety Authority (EFSA) has evaluated various ester-based flavorings. Many similar compounds are included in the EU's approved flavor substance lists, though specific EFSA determination for butyl isovalerate should be confirmed through current regulatory databases.

**International:** The Flavor and Extract Manufacturers' Association (FEMA) maintains the GRAS list for flavoring substances, which includes numerous ester compounds with long histories of safe use in foods.

Manufacturers using butyl isovalerate must comply with food additive regulations in their respective markets and declare it appropriately in product ingredient statements.

Key Studies

Limited published peer-reviewed research specifically addresses butyl isovalerate alone. However, the scientific understanding of this ingredient is informed by:

- General toxicology studies on ester-based flavorings, which consistently demonstrate low acute and chronic toxicity at food use levels

- Structure-activity relationship (SAR) analysis, which classifies similar esters as low-risk flavoring compounds

- Historical use data in food applications across multiple countries without documented safety incidents

- Absorption and metabolism studies on similar short-chain ester compounds, showing rapid hydrolysis and elimination from the body

The lack of specific clinical studies on butyl isovalerate reflects its status as a minor flavoring ingredient used in trace amounts, consistent with regulatory expectations for such compounds.

Additional research or regulatory submissions would be warranted if use levels or applications were significantly expanded beyond current practice.

Frequently Asked Questions

What is Butyl Isovalerate?

Butyl isovalerate (CAS 109-19-3) is an ester compound used as a flavoring agent in food products. It provides fruity, apple-like aromatic notes and is employed in beverages, confections, and other processed foods to enhance flavor profiles.

Is Butyl Isovalerate safe?

Butyl 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 Butyl Isovalerate banned in any country?

Butyl 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.