Our Verdict: SAFE

3-octyl Acetate

CAS4864-61-3

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

3-octyl Acetate — food additive

3-octyl Acetate (CAS 4864-61-3) is a synthetic flavoring compound used to impart fruity and floral notes in food products. This ester is employed in very small quantities as a flavoring agent or adjuvant in the food industry.

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 3-octyl Acetate?

3-octyl Acetate is a synthetic organic compound classified as an ester, formed from the combination of acetic acid and 3-octanol. It is identified by the CAS number 4864-61-3 and belongs to the category of flavoring substances. The compound exists as a clear liquid with a characteristic fruity aroma, making it suitable for use in the flavor industry. As a synthetic flavoring agent, it is created through chemical synthesis rather than extracted from natural sources.

Common Uses

3-octyl Acetate is used primarily in the food and beverage industry as a flavoring agent or flavoring adjuvant. Flavoring adjuvants are substances that enhance or modify the flavor profile of food products without necessarily providing the main flavor themselves. This compound is typically used in very small quantities—measured in parts per million (ppm)—in products such as beverages, confectionery, baked goods, and dairy products. The fruity and slightly floral character of 3-octyl Acetate makes it valuable in formulations where subtle fruit notes are desired, such as in tropical fruit beverages or candy applications.

Safety Assessment

Based on available data, 3-octyl Acetate has not been associated with significant safety concerns in food applications. The FDA has received zero adverse event reports related to this compound, and there have been no product recalls attributed to its use. While 3-octyl Acetate does not currently hold GRAS (Generally Recognized As Safe) status from the FDA, the absence of reported adverse events and recalls indicates that it has not demonstrated harmful effects in documented food use.

The compound is used at very low concentrations in food products, which is standard practice for synthetic flavoring agents. These minimal exposure levels are consistent with the principle that safety in food additives is largely dependent on the dose and frequency of exposure. The lack of adverse event reports suggests that at levels used in food, this flavoring agent has not caused documented health problems in consumers.

Regulatory Status

3-octyl Acetate's regulatory status varies by jurisdiction. In the United States, the compound does not hold GRAS status, which means it would require approval through the FDA's food additive petition process for use in food. However, the absence of GRAS status does not necessarily indicate that the substance is unsafe; rather, it reflects that the formal FDA review process may not have been completed or pursued.

The European Food Safety Authority (EFSA) maintains a Flavouring Group Evaluation (FGE) system for assessing flavoring substances used in the European Union. Regulatory acceptance of flavoring agents often depends on their chemical structure, intended use level, and available safety data. Manufacturers using or wishing to use 3-octyl Acetate must comply with the specific regulations of each country or region where products are marketed.

Key Studies

Scientific literature on 3-octyl Acetate specifically is limited, which is typical for synthetic flavoring agents used at very low concentrations. Safety assessments for flavoring substances in this class generally rely on structural analogy studies, in vitro testing, and the principle of threshold of toxicological concern (TTC). These approaches evaluate whether compounds have structural features associated with known toxins and estimate safe exposure levels based on chemical properties.

The limited documentation of adverse events and absence of recalls suggest that practical experience with 3-octyl Acetate in food applications has not raised safety red flags. Ongoing food safety monitoring systems continue to track any emerging concerns with flavoring agents.

Frequently Asked Questions

What is 3-octyl Acetate?

3-octyl Acetate (CAS 4864-61-3) is a synthetic flavoring compound used to impart fruity and floral notes in food products. This ester is employed in very small quantities as a flavoring agent or adjuvant in the food industry.

Is 3-octyl Acetate safe?

3-octyl 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 3-octyl Acetate banned in any country?

3-octyl 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.