Our Verdict: RATING UNKNOWN

Dihydroxyacetophenone

CAS28631-86-9

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

Dihydroxyacetophenone — food additive

Dihydroxyacetophenone is an organic compound used as a flavoring agent in food products. It is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA, and its use in food is limited in most jurisdictions.

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 Dihydroxyacetophenone?

Dihydroxyacetophenone (CAS Number: 28631-86-6) is an organic compound belonging to the aromatic ketone family. It is a small molecule consisting of a benzene ring with an acetyl group and two hydroxyl groups attached. The compound has a molecular formula of C8H8O3 and exists as a crystalline solid at room temperature. In the flavoring industry, it is classified as a flavoring agent or flavoring adjuvant, meaning it is intended to contribute to the taste or aroma profile of food products.

Common Uses

Dihydroxyacetophenone is used primarily in the flavor industry as a flavoring compound. It may be employed in the formulation of artificial flavoring systems designed to replicate or enhance certain taste characteristics in food and beverage products. Like many aromatic compounds used in flavoring, it would typically be used at very low concentrations—measured in parts per million (ppm)—to achieve desired sensory effects. However, due to its non-GRAS status in the United States, its actual use in food products remains limited and subject to regulatory restrictions.

Safety Assessment

Dihydroxyacetophenone has not been formally evaluated and granted GRAS status by the FDA. This classification indicates that the compound has not undergone the comprehensive safety review and approval process required for widespread food use in the United States. However, the absence of GRAS status does not necessarily indicate the substance is unsafe; rather, it reflects a lack of formal FDA approval through either the GRAS notification process or food additive petition pathway.

According to FDA records, there have been zero adverse events reported in connection with this additive, and no food recalls have been associated with its use. This absence of reported safety incidents suggests that either the compound has minimal food industry use or has not been associated with documented consumer harm. The lack of adverse events and recalls provides some reassurance regarding acute safety concerns, though it does not constitute comprehensive toxicological approval.

The toxicological profile of dihydroxyacetophenone would depend on factors including its metabolism, bioavailability, and potential for accumulation in tissues. As with all flavor compounds, safety would be evaluated based on intended use levels, which are typically very low in food applications.

Regulatory Status

In the United States, dihydroxyacetophenone is not on the FDA's GRAS list and therefore cannot be legally added to food without either obtaining GRAS status through proper notification procedures or receiving approval as a food additive through a formal petition. This regulatory classification restricts its use in commercial food products sold in the U.S. market.

Regulatory approaches to this compound may vary internationally. Some countries may have different frameworks for evaluating flavor compounds, and acceptance may differ based on regional food safety standards and approval processes. Companies wishing to use this additive would need to comply with regulations specific to their target markets.

Key Studies

Published scientific literature specifically investigating the safety and toxicology of dihydroxyacetophenone appears limited in publicly available databases. Most flavor compounds undergo safety evaluation through industry-funded studies or through the GRAS notification process, which may or may not be publicly disclosed in detail. The absence of extensive published research may reflect either the limited market use of this particular compound or the proprietary nature of flavor industry safety evaluations.

For companies or regulatory bodies seeking to establish the safety profile of this compound, consultation with published toxicological databases, submission of new safety data through appropriate regulatory channels, or reference to industry safety assessments would be necessary. Any decisions regarding its use should be based on comprehensive risk assessment appropriate to the intended application level.

Frequently Asked Questions

What is Dihydroxyacetophenone?

Dihydroxyacetophenone is an organic compound used as a flavoring agent in food products. It is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA, and its use in food is limited in most jurisdictions.

Is Dihydroxyacetophenone safe?

Dihydroxyacetophenone 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 Dihydroxyacetophenone banned in any country?

Dihydroxyacetophenone 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.