Our Verdict: RATING UNKNOWN

Dihydroxyacetone (dimer)

CAS62147-49-3

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 (dimer) — food additive

Dihydroxyacetone (dimer) is a flavoring agent derived from a simple three-carbon compound. It is used in food products to contribute to flavor profiles, though its use in foods remains limited and not formally approved by the FDA as a Generally Recognized as Safe (GRAS) substance.

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 (dimer)?

Dihydroxyacetone (dimer), identified by CAS Number 62147-49-3, is a dimeric form of dihydroxyacetone, a simple organic compound containing three carbon atoms and two hydroxyl groups. The dimer form represents two molecules of dihydroxyacetone bonded together. Dihydroxyacetone itself is a naturally occurring compound found in small quantities in foods like sugar cane and grapes, and is widely recognized as the active ingredient in sunless tanning products due to its ability to react with amino acids in skin cells.

Common Uses

Dihydroxyacetone (dimer) is classified as a flavoring agent or flavoring adjuvant in food applications. Flavoring adjuvants are substances that enhance or modify the sensory characteristics of foods without necessarily providing flavor themselves. In the food industry, this compound may be used in limited applications to contribute to overall flavor complexity or to act as a processing aid in flavor development. However, its use in commercial food products remains uncommon compared to other flavoring agents, likely due to its non-GRAS status in the United States.

Safety Assessment

The safety profile of dihydroxyacetone (dimer) is characterized by limited but notable features. According to FDA records, there have been zero adverse events reported associated with this additive and zero product recalls related to its use. This absence of reported safety incidents suggests that any exposure through food consumption has not resulted in documented health concerns. However, the lack of adverse events does not necessarily equate to comprehensive safety data, as limited food use may result in minimal consumer exposure.

Dihydroxyacetone itself has been studied more extensively than its dimer form, particularly in topical applications. The parent compound has generally demonstrated low toxicity in scientific literature. The dimer form may have different biochemical properties and metabolic pathways compared to the monomer, which underscores the importance of understanding its specific safety profile.

The absence of formal GRAS designation indicates that the FDA has not received a sufficient body of scientific evidence or expert consensus to recognize this substance as safe for its intended use in foods under current conditions of use.

Regulatory Status

Dihydroxyacetone (dimer) does not hold FDA GRAS status, meaning it has not been formally approved as Generally Recognized as Safe for use in foods. This regulatory status significantly impacts its availability and use in the U.S. food supply. Any company wishing to use this additive in foods would need to petition the FDA for approval or operate under specific exemptions.

The compound may have different regulatory classifications in other jurisdictions. The European Food Safety Authority (EFSA) may have separate assessments for similar substances, as regulatory frameworks vary between regions.

Key Studies

Scientific literature on dihydroxyacetone (dimer) specifically is limited, reflecting its minimal use in food applications. Most available research focuses on dihydroxyacetone monomer, particularly its use in cosmetic and pharmaceutical applications. Studies on the parent compound demonstrate rapid metabolism and minimal systemic absorption when applied topically, though oral or dietary studies are less prevalent in published literature.

The lack of extensive published research on this specific dimer form in food contexts represents a data gap. Future research examining the dimer's stability, metabolic fate, and safety in food matrices would be valuable for establishing a more comprehensive understanding of this additive.

Frequently Asked Questions

What is Dihydroxyacetone (dimer)?

Dihydroxyacetone (dimer) is a flavoring agent derived from a simple three-carbon compound. It is used in food products to contribute to flavor profiles, though its use in foods remains limited and not formally approved by the FDA as a Generally Recognized as Safe (GRAS) substance.

Is Dihydroxyacetone (dimer) safe?

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

Dihydroxyacetone (dimer) 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.