Our Verdict: SAFE

Isobutyl Benzoate

CAS120-50-3

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

Isobutyl Benzoate — food additive

Isobutyl benzoate is an organic ester compound used as a flavoring agent in food products. It provides fruity and berry-like aromatic notes and is employed in beverages, confections, 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
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 Isobutyl Benzoate?

Isobutyl benzoate is an organic ester with the chemical formula C6H5COOC4H9 and CAS number 120-50-3. It is a synthetic flavoring compound created through the esterification of benzoic acid and isobutanol. This colorless to pale yellow liquid has a fruity aroma characteristic of berries and stone fruits, making it valuable in the flavor industry.

Common Uses

Isobutyl benzoate is primarily used as a flavoring agent and flavor adjuvant in food and beverage applications. It appears in formulations for:

- Soft drinks and carbonated beverages

- Flavored waters and juice drinks

- Confectionery products and candy

- Baked goods and desserts

- Dairy products including yogurt and flavored milk

- Savory snacks where fruity notes are desired

The compound typically appears in very small concentrations within complex flavor formulations, where it contributes to overall sensory profile rather than serving as a primary flavoring component.

Safety Assessment

Isobutyl benzoate has an established safety profile based on its chemical structure and use patterns. The compound is chemically related to benzoic acid, a widely used preservative that has been extensively studied. The ester form differs in metabolism and safety profile from its parent compound.

The FDA has not classified isobutyl benzoate as Generally Recognized as Safe (GRAS), meaning it does not have explicit GRAS affirmation. However, this status does not indicate safety concerns; rather, it reflects that formal GRAS petitions or notifications may not have been submitted to the FDA. Many flavor compounds function without GRAS status under FDA regulatory frameworks.

No adverse events related to isobutyl benzoate consumption have been reported to the FDA, and no product recalls specifically attributing safety issues to this ingredient have been documented. This absence of reported incidents over decades of use in flavor applications supports a history of safe use when applied at levels intended for flavoring purposes.

Toxicological data on isobutyl benzoate demonstrates low acute toxicity. The compound is readily metabolized through standard ester hydrolysis pathways in the body, breaking down into benzoic acid and isobutanol, both of which are handled through normal physiological processes. At the trace levels used in flavored foods, exposure is minimal and well below any identified safety thresholds.

Regulatory Status

In the United States, isobutyl benzoate may be used in foods as a flavoring substance under FDA regulations (21 CFR 182.60), which permits use of synthetic flavoring substances that are not specifically regulated elsewhere, provided they conform to the Food Chemicals Codex or meet established standards.

Within the European Union, flavor compounds including isobutyl benzoate are evaluated through the European Food Safety Authority (EFSA) using established risk assessment methodologies. The compound has been evaluated positively in flavor safety assessments and appears on lists of approved flavoring materials for use in food manufacturing.

International flavor industry organizations, including the Flavor and Extract Manufacturers Association (FEMA), have evaluated isobutyl benzoate as part of broader flavor safety assessments, with results supporting its continued safe use at typical flavoring levels.

Key Studies

While isobutyl benzoate has not been the subject of extensive independent research literature, its safety assessment relies on:

- Chemical structure-activity relationship analysis showing low toxicity potential

- Established metabolic pathways for ester hydrolysis and breakdown

- Comparative safety data from related benzoate esters and aromatic esters

- Decades of safe use history in flavor applications worldwide

- FEMA and EFSA flavor safety panel evaluations

The compound represents a standard example of low-risk synthetic flavor esters used across the food industry.

Frequently Asked Questions

What is Isobutyl Benzoate?

Isobutyl benzoate is an organic ester compound used as a flavoring agent in food products. It provides fruity and berry-like aromatic notes and is employed in beverages, confections, and other processed foods.

Is Isobutyl Benzoate safe?

Isobutyl Benzoate 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 Benzoate banned in any country?

Isobutyl Benzoate 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.