Our Verdict: AVOID

2-butanol

CAS78-92-2

Significant regulatory concerns

This additive is banned, restricted, or under active review in one or more major jurisdictions. The data below explains what we know.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

2-butanol — food additive

2-butanol is a four-carbon alcohol used as a flavoring agent and flavor enhancer in food products. It is not approved as a food additive by the FDA and is not classified as GRAS (Generally Recognized As Safe) for food use in the United States.

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 2-butanol?

2-butanol, also known as secondary butanol or sec-butanol, is a four-carbon alcohol with the chemical formula C₄H₁₀O. It exists as a colorless liquid with a characteristic sharp, alcoholic odor. The compound has a CAS number of 78-92-2 and is one of four isomeric forms of butanol. In industrial applications, 2-butanol is primarily used as a solvent and chemical intermediate, though it has been explored as a potential flavoring compound in the food industry due to its sensory properties.

Common Uses

In food applications, 2-butanol is proposed as a flavoring agent and flavor enhancer, intended to contribute fruity, alcoholic, or solvent-like notes to food and beverage formulations. However, its actual use in food products sold in the United States is extremely limited due to its regulatory status. The compound is more commonly encountered in industrial, pharmaceutical, and cosmetic applications where it serves as a solvent or processing aid. When 2-butanol does appear in food products outside the United States, it is typically in trace amounts as a naturally occurring component or processing residue rather than as an intentionally added ingredient.

Safety Assessment

The toxicological profile of 2-butanol has been studied in laboratory settings, though comprehensive human safety data specific to food consumption is limited. Animal studies have examined its acute and chronic effects, with findings suggesting moderate toxicity at high exposure levels. The primary concern with 2-butanol relates to its potential effects on the nervous system and respiratory system with significant exposure. As a volatile organic compound, inhalation exposure is a primary route of concern in occupational settings rather than dietary consumption.

According to FDA records, there are zero adverse events reported in association with 2-butanol in food products, and no product recalls have been issued related to this substance. This limited event history reflects both the minimal authorized use of this additive in food and the lack of widespread exposure through dietary sources in the United States.

Regulatory Status

2-butanol is not approved by the FDA as a food additive and does not have GRAS (Generally Recognized As Safe) status for food use in the United States. This means it cannot be intentionally added to food products marketed in the U.S. without prior FDA approval through a food additive petition process. The absence of FDA approval distinguishes it from thousands of flavoring agents that have undergone safety evaluation and received authorization.

Regulatory approaches vary internationally. Some regional food safety authorities may have different classifications or usage permissions for 2-butanol, though comprehensive global regulatory data for this substance as a food ingredient is not widely documented in public databases. Manufacturers seeking to use novel flavoring agents must comply with applicable regulations in their target markets.

Key Studies

Scientific literature on 2-butanol includes occupational health studies examining inhalation exposure in industrial workers, which provide insights into its toxicological properties at elevated doses. However, specific peer-reviewed studies evaluating 2-butanol's safety as a food additive at typical consumption levels are limited in the published scientific record. Most available safety data derive from general toxicology research rather than food-specific risk assessments.

The lack of extensive food-specific safety data, combined with the absence of FDA GRAS determination, reflects the limited development of this compound as an approved food ingredient. Any future authorization would require submission of a comprehensive safety dossier to regulatory authorities.

Frequently Asked Questions

What is 2-butanol?

2-butanol is a four-carbon alcohol used as a flavoring agent and flavor enhancer in food products. It is not approved as a food additive by the FDA and is not classified as GRAS (Generally Recognized As Safe) for food use in the United States.

Is 2-butanol safe?

2-butanol is currently rated "avoid" 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-butanol banned in any country?

2-butanol 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.