Our Verdict: SAFE

Isobutyl Acetate

CAS110-19-0

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

Isobutyl Acetate — food additive

Isobutyl acetate is a volatile organic compound used as a flavoring agent in food products. It occurs naturally in some fruits and is employed in the food industry to impart fruity, floral notes to various beverages 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
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 Acetate?

Isobutyl acetate (CAS Number: 110-19-0) is an ester compound composed of isobutanol and acetic acid. It is a colorless, volatile liquid with a characteristic fruity and slightly floral odor. The compound occurs naturally in small quantities in certain fruits and fermented products, though the majority used in food manufacturing is synthetically produced.

Common Uses

Isobutyl acetate functions as a flavoring agent and flavor adjuvant in the food industry. It is primarily used in beverages, including soft drinks, flavored waters, and alcoholic drinks, where it contributes fruity and slightly sweet aromatic notes. The compound is also used in confectionery, baked goods, and other processed foods where enhanced fruit flavors are desired. Due to its volatility, it is typically added in small concentrations to achieve the desired sensory impact without overwhelming other flavor components.

Safety Assessment

The toxicological profile of isobutyl acetate has been studied through various laboratory investigations. As a volatile organic compound, isobutyl acetate is absorbed through inhalation and oral routes. Studies have examined acute and chronic exposure effects, with particular attention to respiratory and neurological impacts. The compound demonstrates low acute toxicity in standard animal testing protocols.

The FDA has recorded zero adverse events associated with isobutyl acetate and no food recalls linked to this additive, indicating a favorable safety record in food applications. Environmental and occupational exposure studies have been conducted, primarily in industrial settings where the compound is manufactured or used at higher concentrations than in food products.

The European Food Safety Authority (EFSA) has reviewed flavoring compounds including esters of this category. When used in food at typical flavoring concentrations—measured in parts per million—isobutyl acetate is considered to present minimal dietary exposure concerns compared to occupational or environmental exposure scenarios.

Regulatory Status

Isobutyl acetate does not currently hold FDA GRAS (Generally Recognized As Safe) status, despite its long history of use and favorable safety data. This designation distinction does not necessarily indicate safety concerns; rather, it reflects that formal GRAS status may not have been formally established or petitioned through official FDA channels. The compound is used in food products under the FDA's flavor regulations as a flavoring substance.

In the European Union, isobutyl acetate is listed among approved flavoring substances. It has been subject to safety evaluations by the EFSA's Flavoring Evaluation Panel, which assessed its safety profile for the intended uses in food. The compound is also recognized in other regulatory frameworks globally, including those in Japan, Canada, and Australia.

Key Studies

Toxicological research on isobutyl acetate has included standard test protocols such as acute oral toxicity studies, irritation studies, and investigations into repeated-dose effects. These studies, conducted according to OECD guidelines, have informed regulatory assessments of the compound's safety profile.

Sensory and analytical chemistry research has characterized isobutyl acetate's flavor properties and its interactions with other flavor components. This work supports its continued use in food formulations where specific aromatic profiles are desired.

As with all food additives, ongoing monitoring and post-market surveillance by regulatory agencies ensures that safety data remains current. The absence of adverse event reports and recalls associated with isobutyl acetate in food applications supports its continued use within established regulatory frameworks.

Frequently Asked Questions

What is Isobutyl Acetate?

Isobutyl acetate is a volatile organic compound used as a flavoring agent in food products. It occurs naturally in some fruits and is employed in the food industry to impart fruity, floral notes to various beverages and processed foods.

Is Isobutyl Acetate safe?

Isobutyl Acetate 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 Acetate banned in any country?

Isobutyl Acetate 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.