Our Verdict: RATING UNKNOWN

Dihydroxyacetone (monomer)

CAS96-26-4

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

Dihydroxyacetone (monomer) — food additive

Dihydroxyacetone (DHA) monomer is a small organic compound used as a flavoring agent or flavoring adjuvant in food products. It is a naturally occurring substance that can be derived from various sources and is primarily utilized to enhance or modify flavor profiles in food and beverage formulations.

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 Dihydroxyacetone?

Dihydroxyacetone (DHA), with CAS number 96-26-4, is a three-carbon organic compound with the chemical formula C3H6O3. The monomer form refers to the single molecule unit, as opposed to polymeric forms. DHA is a naturally occurring compound found in small amounts in various organisms and fermentation processes. It exists as a white to off-white crystalline solid at room temperature and is soluble in water and polar solvents.

Common Uses

In the food industry, dihydroxyacetone is classified as a flavoring agent or flavoring adjuvant. Its primary application involves enhancing, modifying, or improving the sensory characteristics of food and beverage products. DHA can contribute subtle sweet or caramel-like notes to formulations. It is used in relatively small quantities in finished food products, typically as part of complex flavoring systems rather than as a standalone ingredient. Applications may include beverages, confectionery, baked goods, and other processed foods where flavor enhancement is desired.

Safety Assessment

Dihydroxyacetone has not been designated as Generally Recognized as Safe (GRAS) by the FDA under 21 CFR 182 or other relevant sections. However, the absence of GRAS status does not inherently indicate a safety concern; rather, it means the compound has not undergone the formal GRAS notification process or been formally affirmed as GRAS by FDA.

According to FDA data, there have been zero reported adverse events associated with dihydroxyacetone monomer and zero product recalls attributed to this substance. This lack of adverse event reports suggests that at current levels of use and exposure, no significant safety issues have been identified in the food supply.

DHA is distinct from similar compounds used in other applications (such as cosmetic self-tanning formulations), where different safety assessments may apply. Food-grade use of DHA monomer represents a different exposure scenario and regulatory category than cosmetic applications.

Regulatory Status

In the United States, dihydroxyacetone monomer is not on the FDA's GRAS list, meaning companies using it as a food ingredient would need to comply with Food Additive Petition (FAP) requirements or operate under the category of "prior sanctioned" ingredients if applicable. Manufacturers must ensure compliance with 21 CFR Part 170 (Food Additives) when incorporating this substance into food products.

Regulatory status may vary internationally. Some regions may have different approval pathways or may not permit this ingredient in food applications. Companies marketing products containing DHA should verify compliance with local regulations in target markets.

Key Studies

Limited published research specifically addresses DHA monomer's safety as a food additive. The compound's chemical structure and behavior in food systems suggest it would be metabolized similarly to other simple carbohydrate compounds. DHA has been studied in various contexts including fermentation biochemistry and cosmetic applications, but dedicated food safety toxicology studies evaluating it as a food flavoring agent appear limited in the published literature.

The absence of adverse event reports in FDA databases over decades of potential food use, combined with the compound's relatively simple chemical structure and small molecular weight, suggests acceptable safety margins at intended use levels. However, formal toxicological assessment data would strengthen the evidence base. Any manufacturer considering use of this ingredient should conduct or review relevant safety studies and maintain documentation supporting safe use levels.

Frequently Asked Questions

What is Dihydroxyacetone (monomer)?

Dihydroxyacetone (DHA) monomer is a small organic compound used as a flavoring agent or flavoring adjuvant in food products. It is a naturally occurring substance that can be derived from various sources and is primarily utilized to enhance or modify flavor profiles in food and beverage formulations.

Is Dihydroxyacetone (monomer) safe?

Dihydroxyacetone (monomer) 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 Dihydroxyacetone (monomer) banned in any country?

Dihydroxyacetone (monomer) 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.