Our Verdict: RATING UNKNOWN

Heptyl Isobutyrate

CAS2349-13-5

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Heptyl Isobutyrate — food additive

Heptyl isobutyrate is a synthetic flavoring compound used to impart fruity, berry-like notes in food and beverage products. It is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA, though it has not been associated with adverse events or recalls in the U.S. food supply.

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 Heptyl Isobutyrate?

Heptyl isobutyrate (CAS Number: 2349-13-5) is a synthetic ester commonly used as a flavoring agent in the food industry. It is produced through the chemical synthesis of heptyl alcohol and isobutyric acid. The compound is part of a broader category of synthetic esters utilized in flavor formulation, designed to replicate fruity, berry-like, and slightly tropical flavor notes found in natural sources.

Common Uses

Heptyl isobutyrate is primarily employed as a flavoring adjuvant in processed foods and beverages. Its fruity characteristics make it valuable in applications such as:

- Fruit-flavored beverages and soft drinks

- Confectionery and candy products

- Dairy products including yogurts and flavored milk

- Baked goods and desserts

- Chewing gums and mints

The compound typically appears in formulations at very low concentrations, as is standard with synthetic flavoring compounds, where small amounts contribute significantly to overall flavor profiles.

Safety Assessment

Heptyl isobutyrate has not been associated with any reported adverse events or product recalls in FDA databases. This absence of documented safety concerns reflects its limited but established use in food applications over many years without incident reports.

As a synthetic ester, heptyl isobutyrate shares structural characteristics with other flavoring esters that have undergone safety evaluation. The safety profile of similar compounds suggests this additive is likely metabolized readily in the body through standard ester hydrolysis pathways.

No published scientific literature currently documents significant toxicological concerns associated with heptyl isobutyrate at levels used in food flavoring. However, comprehensive toxicity studies specific to this compound are limited in the publicly available scientific literature.

Regulatory Status

Heptyl isobutyrate is not listed as a GRAS (Generally Recognized as Safe) substance by the FDA. This designation does not indicate the additive is unsafe; rather, it means the compound has not undergone the formal GRAS affirmation process or petition review that would allow unrestricted use in the United States.

Despite the lack of GRAS status, heptyl isobutyrate may be used in foods under specific regulatory provisions or in jurisdictions where it has been approved for flavoring use. Food manufacturers considering its use should verify compliance with current FDA regulations and consult with regulatory affairs specialists regarding permissibility in specific product categories.

Regulatory status varies internationally. Some jurisdictions may have approval processes for synthetic flavoring compounds that differ from FDA procedures, and manufacturers should confirm compliance in each market.

Key Studies

Published peer-reviewed research specifically examining heptyl isobutyrate toxicity or safety is limited. The compound appears in flavor chemistry literature primarily in the context of flavor formulation rather than safety assessment.

Safety evaluation of structurally similar esters has been conducted by organizations including the Flavor and Extract Manufacturers Association (FEMA) and the European Food Safety Authority (EFSA). These organizations have evaluated many synthetic ester flavorings and established that, at typical use levels, they do not present known safety concerns.

The absence of adverse events in FDA databases, combined with the lack of documented safety concerns in scientific literature and the chemical similarity to other approved flavor compounds, suggests heptyl isobutyrate poses minimal risk at intended-use concentrations. However, definitive safety conclusions would benefit from additional formal toxicological evaluation.

Frequently Asked Questions

What is Heptyl Isobutyrate?

Heptyl isobutyrate is a synthetic flavoring compound used to impart fruity, berry-like notes in food and beverage products. It is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA, though it has not been associated with adverse events or recalls in the U.S. food supply.

Is Heptyl Isobutyrate safe?

Heptyl Isobutyrate is currently rated "unknown" 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 Heptyl Isobutyrate banned in any country?

Heptyl 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.