Our Verdict: SAFE

Isopropyl Acetate

CAS108-21-4

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

Isopropyl Acetate — food additive

Isopropyl acetate is a volatile organic compound used as a flavoring agent in food products. It imparts fruity, solvent-like notes and is employed in small quantities to enhance flavor profiles in processed foods and beverages.

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 Isopropyl Acetate?

Isopropyl acetate (CAS Number 108-21-4) is an ester compound composed of isopropanol and acetic acid. It is a clear, colorless liquid with a fruity, slightly solvent-like odor. The compound is volatile and readily evaporates at room temperature. Chemically, it belongs to the class of short-chain aliphatic esters commonly used in the flavor and fragrance industry.

Common Uses

Isopropyl acetate functions as a flavoring agent or flavoring adjuvant in food manufacturing. It is typically used in very small concentrations—often measured in parts per million—to contribute fruity, apple-like, or tropical notes to finished food products. Common applications include:

- Beverage flavoring (soft drinks, juices, flavored waters)

- Confectionery and candy flavoring

- Baked goods and dessert products

- Dairy products and yogurts

- Processed snack foods

Beyond food applications, isopropyl acetate is widely used as a solvent in industrial and cosmetic applications.

Safety Assessment

Isopropyl acetate has been evaluated for safety in food use. According to FDA records, there have been zero adverse events reported in connection with this additive and zero recalls linked to its use in food products. This lack of reported incidents suggests a favorable safety profile when used as intended in food applications.

Toxicological studies indicate that isopropyl acetate has low acute toxicity through oral ingestion. When inhaled at high concentrations in industrial settings, it may cause respiratory irritation, but the exposure levels in food products are far below thresholds of concern. The compound is readily metabolized by the body and does not bioaccumulate.

The European Food Safety Authority (EFSA) has evaluated similar esters used as flavorings and established acceptable daily intake levels based on extensive safety data. Isopropyl acetate falls within the category of flavorings that have been subject to these assessments.

Regulatory Status

Isopropyl acetate is not on the FDA's Generally Recognized As Safe (GRAS) list. However, this does not indicate a safety concern. Instead, it reflects the regulatory framework where certain flavorings are evaluated on a case-by-case basis or through industry petitions rather than through the GRAS affirmation process. Many legitimate food flavorings operate outside the GRAS designation through other regulatory pathways.

The compound is permitted for use in food flavoring in many countries, including within the European Union framework for flavor additives (Regulation (EC) No 1334/2008). Its use is regulated and limited to the minimum amounts necessary to achieve the desired flavoring effect.

Key Studies

While isopropyl acetate itself may not be the subject of extensive published literature in toxicology journals, its safety profile is informed by:

- General toxicological data on short-chain aliphatic esters

- Structure-activity relationship studies comparing similar esters

- Industrial hygiene and occupational exposure data

- Metabolic pathway studies confirming rapid breakdown and elimination

The lack of adverse event reports and recalls in FDA databases over decades of use provides strong real-world evidence of safety at food-use concentrations. The additive's volatility means that significant portions may be lost during food processing and preparation, further reducing actual human intake.

Regulatory agencies continue to monitor all food additives through post-market surveillance systems, ensuring that any emerging safety signals would be detected and addressed promptly.

Frequently Asked Questions

What is Isopropyl Acetate?

Isopropyl acetate is a volatile organic compound used as a flavoring agent in food products. It imparts fruity, solvent-like notes and is employed in small quantities to enhance flavor profiles in processed foods and beverages.

Is Isopropyl Acetate safe?

Isopropyl 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 Isopropyl Acetate banned in any country?

Isopropyl 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.