Our Verdict: RATING UNKNOWN

Octyl Octanoate

CAS2306-88-9

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

Octyl Octanoate — food additive

Octyl Octanoate (CAS 2306-88-9) is a synthetic ester compound used as a flavoring agent in food products. It is not currently approved as GRAS (Generally Recognized As Safe) by the FDA but has no reported adverse events or recalls associated with its use.

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 Octyl Octanoate?

Octyl Octanoate is a synthetic ester formed from the combination of octanol and octanoic acid (caprylic acid). It appears as a colorless to pale yellow liquid with a fruity, waxy odor. The compound has the molecular formula C16H32O2 and is identified by CAS Number 2306-88-9. As a synthetic flavoring compound, it belongs to the broader category of ester-based flavor molecules used to create fruity and fatty notes in food products.

Common Uses

Octyl Octanoate functions as a flavoring agent or flavor adjuvant in the food industry. It is used to impart fruity and slightly waxy flavor characteristics to various food products, including beverages, confectionery, baked goods, and dairy products. The ester's fruity profile makes it valuable in formulations where manufacturers seek to enhance or modify the sensory experience of their products. Like other synthetic esters, it typically appears in products in very small concentrations—often in parts per million.

Safety Assessment

According to FDA records, there are zero reported adverse events associated with Octyl Octanoate and zero FDA recalls involving this ingredient. This absence of adverse event reports and recalls suggests that the compound has not been associated with consumer health complaints or safety incidents in the American food supply.

However, it is important to note that Octyl Octanoate has not received GRAS (Generally Recognized As Safe) designation from the FDA. This distinction means the compound has not undergone the formal FDA review process for safety affirmation, though GRAS status is not a prerequisite for all food ingredients, particularly in some jurisdictions or under certain regulatory frameworks.

The compound's ester structure is chemically similar to other approved flavor esters that have extensive safety histories. Esters in general are considered to have low toxicity profiles, and many are approved for use in food across multiple regulatory jurisdictions. The lack of reported adverse events combined with the chemical similarity to established safe esters suggests a likely favorable safety profile, though comprehensive toxicological data would be needed for definitive risk assessment.

Regulatory Status

In the United States, Octyl Octanoate does not hold FDA GRAS status. This means it may be used in foods only where permitted by FDA regulation or where a food additive petition has been approved, depending on the specific product category and regulatory pathway. The absence of GRAS status does not necessarily indicate safety concerns—rather, it reflects that the formal recognition process has not been completed or pursued.

Regulatory status may differ internationally. The European Food Safety Authority (EFSA) and other regulatory bodies may have different classifications or approval statuses for this ingredient. Manufacturers using Octyl Octanoate must comply with the specific regulations of each market where their products are sold.

Key Studies

Limited published scientific literature specifically addresses Octyl Octanoate in isolation. However, the compound's ester structure places it within a well-studied class of compounds. Numerous toxicological and safety studies have been conducted on similar octanoate esters and related flavor compounds. The absence of adverse event reports in FDA databases over decades of potential food ingredient use provides empirical support for its apparent safety profile in practical applications.

Further peer-reviewed research on this specific compound's toxicology, metabolism, and safety parameters would provide additional data for regulatory and scientific assessment. As with many flavor compounds, the margin of safety is established partly through the use of very low concentrations in food products—typically far below levels that might produce toxicological effects in animal studies.

Frequently Asked Questions

What is Octyl Octanoate?

Octyl Octanoate (CAS 2306-88-9) is a synthetic ester compound used as a flavoring agent in food products. It is not currently approved as GRAS (Generally Recognized As Safe) by the FDA but has no reported adverse events or recalls associated with its use.

Is Octyl Octanoate safe?

Octyl Octanoate 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 Octyl Octanoate banned in any country?

Octyl Octanoate 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.