Our Verdict: RATING UNKNOWN

1-hydroxy-2-butanone

CAS5077-67-8

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

1-hydroxy-2-butanone — food additive

1-hydroxy-2-butanone (CAS 5077-67-8) is an organic compound used as a flavoring agent in food products. It imparts butter, cream, and sweet notes to 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
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 1-hydroxy-2-butanone?

1-hydroxy-2-butanone, also known as acetoin or 3-hydroxy-2-butanone in some chemical nomenclature contexts, is an organic compound classified as a flavoring agent. It is a colorless to pale yellow liquid with a characteristic buttery and creamy aroma. The compound has the molecular formula C₄H₈O₂ and CAS number 5077-67-8. As a flavoring substance, it belongs to the broader category of carbonyl compounds used in the food industry to enhance sensory characteristics of food and beverage products.

Common Uses

1-hydroxy-2-butanone is employed primarily as a flavoring agent or flavor adjuvant in food manufacturing. Its buttery and creamy sensory profile makes it suitable for applications in:

- Dairy products and dairy flavoring compositions

- Baked goods and bakery products

- Confectionery and candy formulations

- Beverage flavoring systems

- Savory food products requiring butter or cream notes

The compound is used in very small concentrations, typical of flavoring agents, where even minute quantities contribute significantly to the overall flavor profile of the final product. Like other synthetic flavoring compounds, it allows manufacturers to achieve consistent flavor profiles and reduce reliance on natural flavor extracts that may vary seasonally.

Safety Assessment

According to FDA records, 1-hydroxy-2-butanone has generated zero adverse event reports and zero product recalls. The absence of reported adverse events in the FDA's adverse event reporting system suggests no documented safety concerns associated with consumption of products containing this flavoring agent.

As a flavoring compound used at very low concentrations in food applications, exposure levels from food consumption are typically minimal. The toxicological profile of this compound has not raised significant concerns in regulatory review, though comprehensive published safety studies specific to this ingredient may be limited in the scientific literature.

The compound's molecular structure and properties are consistent with other approved flavoring agents. It does not fall into chemical classes associated with known toxicological hazards. No genotoxicity or carcinogenicity concerns have been raised in available regulatory or scientific documentation.

Regulatory Status

1-hydroxy-2-butanone is not listed as a Generally Recognized as Safe (GRAS) substance by the FDA. However, this does not indicate the substance is unsafe; rather, it indicates that the FDA has not received or formally confirmed a GRAS notification for this specific ingredient.

Flavorings used in the United States are regulated under different frameworks. Some flavoring substances are approved food additives, while others may be used under the GRAS framework or through food contact substance regulations. The absence of GRAS status may mean the ingredient is used in products regulated under other provisions, or its use may be limited to specific food categories where it has been approved as a food additive.

International regulatory approaches vary. The European Food Safety Authority (EFSA) and other global regulatory bodies maintain their own evaluations and approval statuses for flavoring compounds. Companies using this ingredient must ensure compliance with regulations in their target markets.

Key Studies

Limited published scientific literature specifically addresses 1-hydroxy-2-butanone's toxicological properties. The compound's safety assessment likely relies on:

- Structure-activity relationship (SAR) evaluations common in flavoring substance assessment

- Data on chemically similar approved flavoring agents

- General toxicology principles for compounds used in very low food concentrations

- Absence of adverse event reports in post-market surveillance

As with many synthetic flavoring agents used in minor quantities, comprehensive animal toxicity studies or human clinical trials may not have been published in peer-reviewed literature. Regulatory approvals for flavoring substances often follow established safety assessment paradigms developed for this chemical category rather than substance-by-substance extensive testing.

Manufacturers and regulatory agencies rely on the long history of safe use for structurally similar compounds and established safety thresholds for flavoring agents when assessing new or lesser-known flavoring ingredients.

Frequently Asked Questions

What is 1-hydroxy-2-butanone?

1-hydroxy-2-butanone (CAS 5077-67-8) is an organic compound used as a flavoring agent in food products. It imparts butter, cream, and sweet notes to various food applications.

Is 1-hydroxy-2-butanone safe?

1-hydroxy-2-butanone 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 1-hydroxy-2-butanone banned in any country?

1-hydroxy-2-butanone 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.