Our Verdict: SAFE

2-phenylpropyl Isobutyrate

CAS65813-53-8

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

2-phenylpropyl Isobutyrate — food additive

2-phenylpropyl isobutyrate is a synthetic flavoring compound used to create fruity and floral taste profiles in food products. This ester functions as a flavoring agent to enhance or modify the sensory characteristics of 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 2-phenylpropyl Isobutyrate?

2-phenylpropyl isobutyrate is a synthetic organic compound classified as an ester, formed from the combination of isobutyric acid and 2-phenylpropanol. With CAS number 65813-53-8, this colorless to pale yellow liquid is widely used in the flavor industry. The compound belongs to the broader category of synthetic flavoring substances that mimic natural fruit and floral notes found in various botanical sources.

Common Uses

This flavoring agent is employed in a variety of food and beverage applications where fruity or slightly floral taste notes are desired. It appears in formulations for soft drinks, flavored waters, confectionery products, chewing gums, and other processed foods. Food manufacturers use 2-phenylpropyl isobutyrate in combination with other flavoring compounds to create complex flavor profiles that appeal to consumers. The compound typically appears in very small concentrations, measured in parts per million (ppm), which is standard practice for synthetic flavor chemicals.

Safety Assessment

The FDA has not designated 2-phenylpropyl isobutyrate as Generally Recognized As Safe (GRAS). However, this classification does not indicate the substance is unsafe; rather, it reflects that the compound has not completed the specific GRAS petition process with the FDA. The compound may still be used in foods under FDA regulations for synthetic flavoring substances, provided it meets applicable safety standards.

According to FDA records, there have been zero adverse events reported in association with this substance and zero recalls linked to its use. This absence of documented safety incidents supports its continued use in food products at approved concentrations. The safety profile is further informed by toxicological data and the established safety parameters for similar ester-based flavoring compounds.

Like all synthetic flavoring agents, 2-phenylpropyl isobutyrate is used at extremely low levels in food—typically in the range of parts per million—which significantly reduces potential exposure and any associated risk. The ester structure and chemical properties of this compound are well-understood within the flavor chemistry industry.

Regulatory Status

In the United States, 2-phenylpropyl isobutyrate is regulated as a synthetic flavoring substance under Title 21 of the Code of Federal Regulations (CFR). While not GRAS-listed, it may be used in foods under 21 CFR §182.60, which permits synthetic flavoring agents that meet safety criteria. Manufacturers using this compound must ensure compliance with FDA labeling requirements and usage limitations.

The European Food Safety Authority (EFSA) maintains standards for flavoring substances in the European Union. Similar ester-based flavoring compounds have been evaluated and approved for use in the EU under the Flavourings Regulation (EC No 1334/2008), though individual assessments vary by compound.

Key Studies

Toxicological data for 2-phenylpropyl isobutyrate and related phenylpropyl ester compounds indicate low acute toxicity. Studies on similar structural analogs have demonstrated no significant mutagenic or genotoxic potential at relevant exposure levels. The chemical structure and metabolic profile of ester-based flavoring compounds suggest rapid metabolism and excretion in standard animal studies.

Flavor industry databases, such as those maintained by the International Organization of the Flavor Industry (IOFI), catalog safety information on approved flavoring substances. The absence of adverse event reports over decades of use further supports the established safety margins for this compound when used at intended concentrations in food applications.

Frequently Asked Questions

What is 2-phenylpropyl Isobutyrate?

2-phenylpropyl isobutyrate is a synthetic flavoring compound used to create fruity and floral taste profiles in food products. This ester functions as a flavoring agent to enhance or modify the sensory characteristics of beverages, confections, and other processed foods.

Is 2-phenylpropyl Isobutyrate safe?

2-phenylpropyl 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 2-phenylpropyl Isobutyrate banned in any country?

2-phenylpropyl 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.