Our Verdict: SAFE

2-octanol

CAS123-96-6

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

2-octanol — food additive

2-octanol is a naturally occurring eight-carbon alcohol used as a flavoring agent in food and beverage products. It imparts fruity and floral notes and is employed in small quantities to enhance overall flavor profiles in various food applications.

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 2-octanol?

2-octanol (CAS Number 123-96-6) is a secondary alcohol with eight carbon atoms in its molecular structure. It occurs naturally in various fruits, plants, and fermented beverages, where it contributes to characteristic flavor and aroma profiles. The compound is a colorless to pale yellow liquid with a fruity, slightly floral odor. In food manufacturing, 2-octanol is synthesized chemically but mirrors the naturally occurring compound found in foods.

Common Uses

2-octanol functions as a flavoring agent and flavor adjuvant in the food and beverage industry. It is primarily used in small concentrations to:

- Enhance fruity and floral notes in beverages, including alcoholic drinks and non-alcoholic flavored waters

- Contribute to complex flavor profiles in confectionery products

- Improve aroma characteristics in baked goods and desserts

- Serve as a flavor component in processed foods requiring subtle fruity undertones

Typical usage levels are minimal, as the compound is potent and only small amounts are needed to achieve desired sensory effects. The actual concentration in finished food products is substantially lower than in the flavoring concentrate.

Safety Assessment

2-octanol has not been formally evaluated by the FDA as a Generally Recognized As Safe (GRAS) substance, meaning it has not undergone the specific GRAS notification process. However, the FDA's adverse event database contains zero reported adverse events associated with 2-octanol, and there are no product recalls linked to this ingredient.

The compound's safety profile is informed by its naturally occurring presence in foods and its chemical similarity to other approved food alcohols. Toxicological data on 2-octanol suggests a low order of toxicity when used at levels typical in food flavoring applications. Animal studies have not identified significant concerns at food-relevant exposure levels.

As with all flavoring agents, 2-octanol is used at very low concentrations in finished products—typically in the range of a few parts per million to tens of parts per million—which significantly reduces any theoretical risk.

Regulatory Status

In the United States, 2-octanol is not on the FDA's GRAS list, which means manufacturers using it operate under different regulatory frameworks. Some may use it under the flavor exemption provisions or as part of proprietary flavor blends where the specific components may not be individually disclosed to consumers.

In the European Union, 2-octanol is listed in the EFSA's flavoring database as an approved flavoring substance (FL No. 02.095). This approval reflects the European regulatory assessment that the substance is safe for use as a flavoring agent at the levels employed in food manufacturing.

The difference in regulatory status between the FDA and EFSA reflects different assessment and approval pathways rather than a safety concern. The FDA does not preclude use of 2-octanol in flavored foods; rather, it operates under different notification and approval mechanisms.

Key Studies

Scientific literature on 2-octanol is limited but supports its safety at food-use levels. Acute toxicity studies have shown low toxicity via oral, dermal, and inhalation routes. The compound does not demonstrate genotoxic potential in standard screening assays.

Its presence as a naturally occurring volatile compound in foods including beer, wine, and various fruits provides additional evidence that human exposure through traditional diet is established and occurs without documented adverse effects. The synthetic versions used in food flavoring are chemically identical to natural forms.

Frequently Asked Questions

What is 2-octanol?

2-octanol is a naturally occurring eight-carbon alcohol used as a flavoring agent in food and beverage products. It imparts fruity and floral notes and is employed in small quantities to enhance overall flavor profiles in various food applications.

Is 2-octanol safe?

2-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 2-octanol banned in any country?

2-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.