Our Verdict: RATING UNKNOWN

5-hexenol

CAS821-41-0

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

5-hexenol — food additive

5-hexenol is a naturally occurring organic compound used as a flavoring agent in food products. It contributes fruity and floral notes to beverages, confections, and processed foods, though it is not currently approved as a GRAS substance by the FDA.

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 5-hexenol?

5-hexenol (CAS Number 821-41-0) is an unsaturated aliphatic alcohol with the chemical formula C6H12O. It is a clear, colorless liquid with a characteristic fruity aroma. The compound occurs naturally in small quantities in various fruits and plant materials, contributing to their natural flavor profiles. As a synthetic flavoring agent, 5-hexenol is manufactured for use in the food industry to replicate or enhance fruity and floral taste characteristics.

Common Uses

5-hexenol is primarily used as a flavoring agent in the food and beverage industry. Its applications include:

- Soft drinks and carbonated beverages

- Fruit-flavored products and juices

- Confectionery and candy

- Baked goods and desserts

- Dairy products including yogurt and flavored milk

- Alcoholic beverages

The compound is valued by food manufacturers for its ability to provide fruity and slightly floral notes that enhance product appeal. Due to its volatile nature, it is typically used in small concentrations to achieve desired flavor profiles without overwhelming other taste components.

Safety Assessment

According to FDA records, there are currently zero reported adverse events associated with 5-hexenol consumption, and no food recalls have been linked to this substance. These metrics indicate no documented safety incidents in the U.S. food supply related to this additive.

As an unsaturated alcohol, 5-hexenol belongs to a class of compounds that have been studied for safety in food applications. The lack of adverse event reports suggests that at typical use levels in food products, the substance has not demonstrated harmful effects in the consumer population. However, the absence of reported adverse events does not constitute formal safety approval by regulatory agencies.

Toxicological data on 5-hexenol is limited compared to more widely used food additives. Like many flavor compounds, its safety profile is based on the principle of "threshold of toxicological concern," which assumes that flavoring substances used at very low concentrations pose minimal risk. The typical use levels in food are substantially below concentrations that have demonstrated effects in animal studies.

Regulatory Status

5-hexenol is not currently listed as a GRAS (Generally Recognized as Safe) substance by the FDA. This means it has not received formal FDA affirmation as safe for use in food. Despite this classification, the compound may be used in food under certain regulatory frameworks, including the FDA's indirect food additive regulations or through other compliance pathways, though its use is not as broadly permissible as GRAS-affirmed substances.

In the European Union, 5-hexenol falls under the flavor regulation framework (EC No 1334/2008) and is included in the Union list of flavoring substances. It is permitted for use in food products within specified maximum use levels determined by European food safety authorities.

The regulatory distinction between FDA GRAS approval and use under other frameworks means that manufacturers using 5-hexenol in the United States must ensure compliance with applicable regulations for their specific product category.

Key Studies

Systematic scientific literature on 5-hexenol's safety is limited compared to high-volume food additives. Available data comes primarily from:

- General toxicology studies on aliphatic alcohols as a chemical class

- Flavor industry safety assessments based on structure-activity relationship models

- Traditional use data from naturally occurring sources

- EFSA evaluations of flavor compounds under EC 1334/2008

The absence of published adverse event data and regulatory recalls provides empirical evidence of safety at current use levels, though definitive human clinical studies specifically on 5-hexenol are not readily available in public literature. Safety assessments for similar flavor compounds suggest that 5-hexenol, when used at typical food-grade concentrations, would not be expected to pose health concerns for the general population.

Frequently Asked Questions

What is 5-hexenol?

5-hexenol is a naturally occurring organic compound used as a flavoring agent in food products. It contributes fruity and floral notes to beverages, confections, and processed foods, though it is not currently approved as a GRAS substance by the FDA.

Is 5-hexenol safe?

5-hexenol 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 5-hexenol banned in any country?

5-hexenol 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.