Our Verdict: RATING UNKNOWN

Hydroxyacetone

CAS116-09-6

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

Hydroxyacetone — food additive

Hydroxyacetone is an organic compound used as a flavoring agent and adjuvant in food products. It occurs naturally in some foods and is primarily utilized to enhance or modify 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
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 Hydroxyacetone?

Hydroxyacetone (also known as acetol) is a simple organic compound with the chemical formula C3H6O2 and CAS number 116-09-6. It is a three-carbon ketone alcohol that exists as a colorless to pale yellow liquid. Hydroxyacetone occurs naturally in trace amounts in certain foods, including fermented products and some fruits. As a food additive, it functions as a flavoring agent or flavoring adjuvant, meaning it is used to enhance, modify, or support flavor characteristics in food products rather than serve as a primary flavor itself.

Common Uses

Hydroxyacetone is employed in the food industry primarily as a flavoring component in various processed foods and beverages. Its applications include use in seasonings, condiments, and other food products where flavor enhancement is desired. The compound's naturally occurring presence in some foods provides a basis for its use as an additive. Due to its chemical properties, it may be used in small concentrations to achieve desired sensory outcomes. The specific food categories and maximum use levels vary by regulatory jurisdiction and product type.

Safety Assessment

Hydroxyacetone has generated minimal adverse event reports in FDA databases, with zero recorded adverse events and zero recalls associated with its use as a food additive. This absence of reported incidents suggests a favorable safety profile in food applications at typical use levels. The compound's naturally occurring presence in certain foods also contributes to the general safety understanding. However, the lack of extensive published safety data in food-specific literature means that comprehensive risk assessments would benefit from additional research. General toxicology studies of hydroxyacetone have been conducted, though food-specific safety evaluations remain limited. Like all food additives, hydroxyacetone is used in carefully controlled concentrations to ensure consumer safety.

Regulatory Status

Hydroxyacetone is not currently listed as Generally Recognized As Safe (GRAS) by the FDA, which means it has not received this formal safety designation. However, its absence from the GRAS list does not indicate that it is unsafe; rather, it reflects that formal GRAS petition submissions and approvals have not been completed in the United States regulatory framework. The compound may be used in food products under specific FDA regulations or as part of approved food additive categories, depending on the intended use and product category. Regulatory status varies internationally, and manufacturers must comply with regulations in all markets where products are sold. The lack of GRAS status does not prevent its use but rather defines the regulatory pathway and documentation requirements for its application in foods.

Key Studies

While hydroxyacetone has been studied in various biochemical and industrial contexts, comprehensive peer-reviewed studies specifically addressing its safety as a food additive remain limited in publicly available literature. The compound's naturally occurring presence in foods has been documented in fermentation and food chemistry research. General toxicology research on hydroxyacetone has been published in scientific literature, though food-specific safety evaluations would strengthen the evidence base. The zero adverse events and recalls recorded by the FDA provide practical evidence of safe use at current application levels. Additional research focusing specifically on food applications, bioavailability, and long-term consumption patterns would contribute to more comprehensive safety understanding. Industry stakeholders and regulatory agencies continue to monitor safety data for all food additives, including hydroxyacetone.

Frequently Asked Questions

What is Hydroxyacetone?

Hydroxyacetone is an organic compound used as a flavoring agent and adjuvant in food products. It occurs naturally in some foods and is primarily utilized to enhance or modify flavor profiles in various food applications.

Is Hydroxyacetone safe?

Hydroxyacetone 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 Hydroxyacetone banned in any country?

Hydroxyacetone 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.