Our Verdict: SAFE

Octyl Isobutyrate

CAS109-15-9

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

Octyl Isobutyrate โ€” food additive

Octyl isobutyrate (CAS 109-15-9) is a synthetic flavoring compound used to impart fruity and sweet notes to food and beverage products. This ester functions as a flavor adjuvant in various processed foods where it contributes to desired taste profiles.

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 Octyl Isobutyrate?

Octyl isobutyrate is a synthetic ester composed of an eight-carbon alcohol (octanol) and isobutyric acid. It is classified as a flavoring agent and flavor adjuvant under food additive regulations. The compound appears as a colorless to pale yellow liquid with characteristic fruity and slightly sweet organoleptic properties. Its chemical structure allows it to be volatile enough to contribute flavor notes while remaining stable in food matrices.

Common Uses

Octyl isobutyrate is used in the flavor industry primarily as a component in complex flavor formulations rather than as a standalone ingredient. Food manufacturers utilize this compound in:

- Beverages including soft drinks, juices, and flavored water products

- Confectionery items such as candies, chewing gums, and hard candies

- Dairy products including yogurts and flavored milk drinks

- Baked goods and snack foods

- Frozen desserts and ice cream products

Typical use levels are measured in parts per million (ppm), with concentrations generally remaining below 10 ppm in finished food products.

Safety Assessment

Octyl isobutyrate has generated no recorded adverse events in FDA databases and has been subject to zero recalls. The compound is not on the FDA's Generally Recognized As Safe (GRAS) list, meaning it has not undergone the specific GRAS notification process. However, the absence of GRAS status does not indicate a safety concern; rather, it reflects that manufacturers may use it under FDA food additive regulations through approved food additive petitions or as a flavor component in food flavoring complexes.

The toxicological profile of octyl isobutyrate is consistent with other similar ester flavoring compounds. Like related esters used in food flavoring, it undergoes hydrolysis in the digestive system to its component parts: octanol and isobutyric acid. Both metabolites are processed through normal metabolic pathways. The low concentrations used in food products contribute to a minimal dietary exposure level.

The European Food Safety Authority (EFSA) maintains databases of flavor compounds, and octyl isobutyrate appears in flavor ingredient inventories, indicating its acceptance in food use within European regulatory frameworks as well.

Regulatory Status

In the United States, octyl isobutyrate is regulated as a food additive flavoring agent. It may be used in accordance with FDA regulations under 21 CFR Part 182 (Substances Generally Recognized as Safe) or through approved food additive petitions. The compound is permitted for use in foods as a flavoring substance and adjuvant.

The ingredient is included in the International Organization for Standardization (ISO) list of flavoring substances permitted for use in food. This international recognition reflects its established use history in the flavor industry across multiple regulatory jurisdictions.

Manufacturers using octyl isobutyrate must comply with good manufacturing practices and declare it appropriately on product labels according to local regulations, typically under the broader category of "artificial flavoring" or as part of a proprietary flavor blend.

Key Studies

While octyl isobutyrate has not been subject to extensive independent research studies published in peer-reviewed literature, its safety assessment relies on the well-characterized toxicological profile of similar aliphatic ester flavoring compounds. The lack of published studies does not indicate a safety gap but rather reflects the established safety record and widespread industry use of structurally similar compounds.

The compound's metabolism follows predictable pathways based on ester biochemistry. Upon ingestion, esterase enzymes in saliva, gastric juices, and small intestine rapidly hydrolyze the ester bond, generating octanol and isobutyric acidโ€”compounds with known metabolic fates. This rapid degradation limits systemic exposure to the intact molecule.

Frequently Asked Questions

What is Octyl Isobutyrate?

Octyl isobutyrate (CAS 109-15-9) is a synthetic flavoring compound used to impart fruity and sweet notes to food and beverage products. This ester functions as a flavor adjuvant in various processed foods where it contributes to desired taste profiles.

Is Octyl Isobutyrate safe?

Octyl 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 Octyl Isobutyrate banned in any country?

Octyl 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.