Our Verdict: SAFE

3-octanol

CAS589-98-0

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-octanol — food additive

3-octanol is a naturally occurring organic compound used as a flavoring agent in food products. It imparts fruity and woody notes and is employed in small quantities to enhance the sensory profile of beverages, baked goods, 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 3-octanol?

3-octanol (CAS Number: 589-98-0) is an eight-carbon primary alcohol with the chemical formula C₈H₁₈O. It exists as a colorless to pale yellow liquid with a fruity, slightly woody aroma. The compound occurs naturally in various fruits and plant materials, contributing to their characteristic flavor profiles. In food manufacturing, 3-octanol is synthesized chemically and used as a flavoring agent to replicate or enhance natural fruit and botanical notes in food and beverage products.

Common Uses

3-octanol is utilized primarily in the flavor and fragrance industry as a component of complex flavor formulations. Its applications in food include:

- Flavoring agent in alcoholic beverages, particularly spirits and liqueurs

- Component in fruit-flavored beverages and juice products

- Additive in baked goods and confectionery items

- Flavoring in dairy products and ice cream

- Enhancement of savory and umami profiles in processed foods

The compound is typically used at very low concentrations, measured in parts per million (ppm), reflecting its potent sensory impact. Food manufacturers employ 3-octanol as part of multi-component flavor systems designed to achieve specific taste and aroma objectives.

Safety Assessment

3-octanol has not been formally evaluated by the FDA for GRAS (Generally Recognized as Safe) status. However, the compound presents a favorable safety profile based on available scientific evidence. No adverse events have been reported to the FDA regarding 3-octanol consumption, and no product recalls have been associated with this additive.

The chemical structure of 3-octanol—a simple primary alcohol—suggests low systemic toxicity. As with most flavoring agents used in food, exposure occurs at minimal levels, substantially below any threshold of toxicological concern. The compound is readily metabolized by the body through standard oxidation pathways for alcohols.

The European Commission's Scientific Committee on Food (now EFSA) and international flavor safety organizations have evaluated structurally similar aliphatic alcohols and found them safe at typical use levels in food. 3-octanol's use in cosmetics and fragrances, where dermal and inhalation exposure may occur, provides additional safety data supporting its low hazard profile.

Regulatory Status

3-octanol is not approved by the FDA as a GRAS substance, meaning it has not undergone formal FDA review for GRAS designation. However, it may be used in food under FDA regulations governing flavoring substances and adjuvants (21 CFR 182.60), which permits use of substances that are generally recognized as safe by qualified experts.

The additive is permitted for use in food products in several countries, including those within the European Union, subject to regulation under flavoring substance guidelines. It is listed in the Flavor and Extract Manufacturers' Association (FEMA) GRAS list, which represents an independent expert evaluation of flavoring safety.

In the United States, manufacturers using 3-octanol must comply with FDA labeling requirements and ingredient disclosure rules. The compound must be declared on product labels when present in finished foods.

Key Studies

Direct toxicological studies specifically on 3-octanol are limited in the published scientific literature. However, safety assessments of structurally similar aliphatic alcohols (C₆-C₁₀ primary alcohols) have been conducted and published in peer-reviewed journals. These studies, referenced by flavor safety organizations, indicate:

- Low acute toxicity in animal studies

- Rapid metabolism and elimination from the body

- Absence of genotoxic or mutagenic potential

- No evidence of reproductive or developmental toxicity at relevant exposure levels

The compound's extensive use history in the flavor industry without reported adverse effects provides additional evidence of safety. The zero FDA adverse event reports and zero recalls further support the benign safety profile of 3-octanol when used as intended in food flavoring applications.

As with all food additives, appropriate use levels—typically in the range of 1-10 ppm in finished products—ensure consumer safety while achieving desired sensory outcomes.

Frequently Asked Questions

What is 3-octanol?

3-octanol is a naturally occurring organic compound used as a flavoring agent in food products. It imparts fruity and woody notes and is employed in small quantities to enhance the sensory profile of beverages, baked goods, and other processed foods.

Is 3-octanol safe?

3-octanol 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-octanol banned in any country?

3-octanol 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.