Our Verdict: SAFE

Butyl Isobutyrate

CAS97-87-0

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 Isobutyrate — food additive

Butyl isobutyrate (CAS 97-87-0) is a synthetic ester compound used as a flavoring agent in food products. It provides fruity, apple-like and berry notes and is employed to enhance the sensory profile of beverages, confectionery, and other 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
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 Isobutyrate?

Butyl isobutyrate is a synthetic ester belonging to the class of organic compounds known as carboxylic acid esters. Its chemical structure consists of an isobutyric acid moiety esterified with butanol. The compound is a colorless to pale yellow liquid with a characteristic fruity odor. It is primarily used in the flavor industry as a flavoring agent or flavor adjuvant to impart fruity, apple, and berry-like sensory notes to food and beverage products.

Common Uses

Butyl isobutyrate is utilized in the food industry as a flavoring component in a variety of products, including:

- Beverages (soft drinks, juices, flavored water)

- Confectionery and candy

- Baked goods and bakery products

- Dairy products and ice cream

- Processed snacks

The compound is typically used in very small quantities, measured in parts per million (ppm), as flavoring agents are potent and require minimal amounts to achieve desired sensory effects. Its fruity profile makes it a common choice in formulations designed to mimic natural fruit flavors.

Safety Assessment

Butyl isobutyrate has a favorable safety profile based on available data. The FDA has recorded zero adverse events associated with this additive and no recalls linked to its use. The compound has been studied for potential toxicological effects, and published research indicates it does not present significant safety concerns at levels of use in food applications.

As with many synthetic flavoring agents, safety assessments focus on:

- Acute toxicity: Studies indicate low acute toxicity

- Subchronic and chronic toxicity: Limited evidence of concern at expected dietary exposure levels

- Genotoxicity: No significant genotoxic potential identified

- Reproductive/developmental toxicity: No evidence of developmental effects at relevant exposure levels

The absence of adverse event reports and recalls in FDA databases further supports the safety profile of this ingredient when used as intended in food products.

Regulatory Status

Butyl isobutyrate is not on the FDA's Generally Recognized as Safe (GRAS) list. However, this does not indicate the substance is unsafe; rather, it reflects that it may be regulated under other FDA provisions for food additives or may be used under specific regulatory frameworks for flavoring substances.

In the European Union, butyl isobutyrate is listed in the EU Register of flavoring substances and is permitted for use in food applications under EU Regulation 1334/2008, which governs flavorings used in foods. This indicates that regulatory bodies in multiple jurisdictions have evaluated the substance and determined it acceptable for use in food at specified levels.

The compound falls under the category of synthetic flavoring agents, which are subject to different regulatory pathways than artificial colors or certain other additives. Many synthetic flavoring compounds are approved through flavor industry self-regulatory mechanisms that are recognized by regulatory agencies.

Key Studies

While butyl isobutyrate is not extensively studied in the primary scientific literature compared to some other food additives, the available safety data comes from:

- Industry toxicology studies conducted as part of flavor ingredient safety assessments

- Regulatory submissions to governmental bodies (FDA, EFSA)

- General safety evaluations of similar ester-based flavoring compounds

The compound's chemical structure is well-characterized, and its metabolic fate in the body is understood to proceed via hydrolysis to isobutyric acid and butanol, both of which are normal metabolites handled efficiently by the body.

As a flavoring agent used in trace quantities in food, the actual dietary exposure to butyl isobutyrate remains extremely low, further contributing to its safe use profile.

Frequently Asked Questions

What is Butyl Isobutyrate?

Butyl isobutyrate (CAS 97-87-0) is a synthetic ester compound used as a flavoring agent in food products. It provides fruity, apple-like and berry notes and is employed to enhance the sensory profile of beverages, confectionery, and other processed foods.

Is Butyl Isobutyrate safe?

Butyl Isobutyrate 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 Isobutyrate banned in any country?

Butyl Isobutyrate 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.