Our Verdict: SAFE

Isobutyl Butyrate

CAS539-90-2

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

Isobutyl Butyrate — food additive

Isobutyl butyrate is a synthetic ester compound used as a flavoring agent in food products. It imparts fruity, apple-like notes and is employed in beverages, confections, and processed foods to enhance taste 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 Isobutyl Butyrate?

Isobutyl butyrate (CAS Number 539-90-2) is a synthetic ester belonging to the class of organic compounds known as short-chain esters. It is produced through the chemical reaction between isobutanol and butyric acid. This colorless to pale yellow liquid has a characteristic fruity odor, commonly described as apple or pineapple-like, making it useful in the flavor industry. The compound is volatile and typically used in small concentrations where its aromatic properties can achieve the desired sensory effect.

Common Uses

Isobutyl butyrate functions primarily as a flavoring agent in the food and beverage industry. It appears in formulations for soft drinks, fruit juices, alcoholic beverages, dairy products, confectionery, baked goods, and other processed foods. The compound is particularly valued for creating or enhancing fruity flavor profiles that consumers associate with natural fruit tastes. Food manufacturers use it as part of complex flavor blends rather than as a standalone ingredient, allowing for precise taste customization in commercial food products. Its use is concentrated in the flavor industry, where it is typically applied by professional flavorists in very small amounts.

Safety Assessment

Isobutyl butyrate has not received formal FDA GRAS (Generally Recognized as Safe) status, indicating it has not undergone the specific FDA review process for GRAS designation. However, this designation is not equivalent to being unsafe; rather, it reflects that the compound may not have been formally submitted for GRAS review or approval. Notably, the FDA has recorded zero adverse events associated with isobutyl butyrate and zero product recalls involving this ingredient, suggesting a favorable safety history in commercial use.

The ester is a natural constituent found in some fruits, though commercial production uses synthetic synthesis. Short-chain esters like isobutyl butyrate are generally metabolized readily by the body through standard ester hydrolysis pathways. The lack of documented adverse effects in the FDA database, combined with decades of use in flavoring applications, provides practical evidence of safety at the levels used in food.

Regulatory Status

While isobutyl butyrate does not carry FDA GRAS status, this does not prevent its use in food products in the United States. Flavoring substances may be used in food under FDA regulations without explicit GRAS status, provided they meet safety standards and are used at appropriate levels. The compound is listed in various flavor chemical databases and is recognized as a legitimate flavoring ingredient by the flavor industry internationally.

In the European Union, isobutyl butyrate is recognized under the flavoring substance regulations and appears in relevant flavor chemical inventories. Its regulatory acceptance varies by jurisdiction, but major food-producing regions permit its use in flavoring applications at established levels.

Key Studies

Limited published peer-reviewed studies specifically address isobutyl butyrate in isolation, which is typical for synthetic flavoring compounds used in minute quantities. The compound's safety profile relies primarily on: (1) its classification as a short-chain ester with well-understood metabolic pathways, (2) the absence of adverse event reports in FDA systems despite widespread use, (3) its presence as a naturally-occurring minor component in fruits, and (4) the extensive safety history of similar ester-based flavorings.

Toxicological data for structurally similar short-chain esters support its safety profile, as these compounds are readily hydrolyzed and do not bioaccumulate. The flavor industry maintains proprietary safety databases on flavoring compounds, though detailed results are not always published in peer-reviewed literature due to their commercial sensitivity.

For current regulatory guidance, the FDA and relevant international bodies continue to monitor the safety of all food additives, including flavoring agents.

Frequently Asked Questions

What is Isobutyl Butyrate?

Isobutyl butyrate is a synthetic ester compound used as a flavoring agent in food products. It imparts fruity, apple-like notes and is employed in beverages, confections, and processed foods to enhance taste profiles.

Is Isobutyl Butyrate safe?

Isobutyl Butyrate 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 Isobutyl Butyrate banned in any country?

Isobutyl Butyrate 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.