Our Verdict: RATING UNKNOWN

Butyl Alcohol

CAS71-36-3

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

Butyl Alcohol — food additive

Butyl alcohol (CAS 71-36-3) is a four-carbon aliphatic alcohol used as a flavoring agent and solvent in food production. It provides fruity and fermented notes to beverages and food products, though its use is limited and not formally recognized as Generally Recognized As Safe (GRAS) 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 Butyl Alcohol?

Butyl alcohol, also known as 1-butanol or n-butanol, is a four-carbon straight-chain aliphatic alcohol with the chemical formula C₄H₁₀O. It exists as a colorless liquid with a characteristic alcoholic odor and is soluble in water and organic solvents. In food applications, butyl alcohol functions as both a flavoring agent and a solvent or vehicle, contributing fruity, fermented, and slightly sweet taste notes to food and beverage formulations.

Common Uses

Butyl alcohol is used in the food industry primarily as a flavor compound in beverages, particularly in beer and spirits where it contributes to the overall flavor profile. It may also appear in flavoring blends for confectionery, baked goods, and other processed foods. As a solvent, it facilitates the dissolution and distribution of other flavor compounds in food systems. The concentration levels used in food are typically very low, measured in parts per million (ppm), to achieve desired sensory effects without creating off-flavors or safety concerns.

Safety Assessment

Butyl alcohol has not been granted Generally Recognized As Safe (GRAS) status by the FDA, which means it does not qualify for the simplified regulatory pathway available to widely accepted food additives. However, according to FDA records, there have been zero reported adverse events associated with butyl alcohol in food use, and no food recalls have been linked to this additive. This absence of reported incidents suggests a favorable safety history in commercial food applications.

Toxicological studies on butyl alcohol have been conducted, primarily in occupational and industrial settings where exposure levels are substantially higher than in food. Animal studies have examined various endpoints including acute toxicity, repeated-dose effects, and reproductive toxicity. The compound shows relatively low acute toxicity with oral LD₅₀ values in rodents ranging from 790-2600 mg/kg depending on the species and study conditions. In occupational health contexts, butyl alcohol is recognized as an irritant at high concentrations, but food-use levels are orders of magnitude lower than occupational exposure limits.

The European Food Safety Authority (EFSA) has evaluated butyl alcohol in the context of flavor compounds, with some butyl alcohol esters and derivatives appearing on EU flavor approval lists. The presence on such lists indicates a level of safety assessment, though regulatory frameworks between regions differ in their specific requirements for individual components.

Regulatory Status

In the United States, butyl alcohol does not have GRAS status, meaning any food manufacturer using it must either petition the FDA for approval or operate under the pre-1958 grandfathering provisions if applicable. The lack of GRAS status does not inherently indicate a safety concern; rather, it reflects that the specific regulatory pathway for approval has not been formally completed or pursued for this particular additive. The additive may be used in some food categories under specific regulatory provisions or in very limited quantities.

International regulatory status varies. Some countries permit butyl alcohol in flavoring applications at restricted levels, while regulatory approaches differ based on each nation's food additive framework. The absence of FDA GRAS status may limit its use in certain U.S. food products compared to other approved solvents and flavorings.

Key Studies

Scientific literature on butyl alcohol relevant to food safety primarily derives from occupational health research and industrial toxicology studies. These investigations have characterized its absorption, metabolism, and elimination in mammals. Studies indicate that butyl alcohol is absorbed through oral, dermal, and inhalation routes and is metabolized to butyric acid and other metabolites before elimination. At the very low levels present in food products, systemic exposure would be negligible compared to occupational exposure scenarios that have been the focus of most research.

Flavor-specific research on butyl alcohol's sensory properties and contribution to food systems supports its continued exploration as a potential flavoring component, though additional formal safety documentation may be required for broader regulatory approval in certain jurisdictions.

Frequently Asked Questions

What is Butyl Alcohol?

Butyl alcohol (CAS 71-36-3) is a four-carbon aliphatic alcohol used as a flavoring agent and solvent in food production. It provides fruity and fermented notes to beverages and food products, though its use is limited and not formally recognized as Generally Recognized As Safe (GRAS) by the FDA.

Is Butyl Alcohol safe?

Butyl Alcohol 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 Butyl Alcohol banned in any country?

Butyl Alcohol 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.