Our Verdict: RATING UNKNOWN

Acetolein

CAS28060-90-4

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

Acetolein โ€” food additive

Acetolein (CAS 28060-90-4) is a chemical compound that may be used in food manufacturing, though its specific function remains undocumented in available scientific literature. It has not been approved by the FDA as a Generally Recognized As Safe (GRAS) substance and has generated no reported adverse events or recalls.

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 Acetolein?

Acetolein, identified by CAS number 28060-90-4, is a chemical compound with limited documentation regarding its application in food systems. The compound has not been extensively characterized in food safety databases or peer-reviewed literature, making it difficult to establish its chemical properties, manufacturing process, or mechanisms of action in food products. Unlike many food additives with well-defined purposes, acetolein's functional role in food manufacturing remains unclear and unstudied in publicly available scientific records.

Common Uses

The specific applications of acetolein in food manufacturing have not been clearly documented in FDA databases, industry literature, or scientific publications. Unlike approved food additives such as gums, colorants, or preservatives, acetolein does not appear in standard lists of permitted food ingredients with established functions. This lack of documentation suggests either extremely limited use, discontinued applications, or use under restricted or non-food contexts. Without clear evidence of intentional use in commercially produced foods, the prevalence and scope of acetolein in the food supply cannot be accurately determined.

Safety Assessment

The FDA has not classified acetolein as GRAS (Generally Recognized As Safe), meaning the substance has not undergone the formal approval process required for food additives in the United States. As of the available data, there are zero reported adverse events associated with acetolein in FDA databases and no product recalls attributable to this substance. However, the absence of adverse event reports does not constitute proof of safetyโ€”it may reflect minimal use, non-food applications, or limited monitoring. Comprehensive toxicological studies, including acute toxicity, chronic exposure data, genotoxicity, and carcinogenicity assessments, would be necessary to establish a complete safety profile.

The European Food Safety Authority (EFSA) has not issued publicly available authorizations or safety assessments for acetolein as a food additive. This suggests the compound either does not fall under EFSA's purview for food use or has not been formally evaluated for European market approval.

Regulatory Status

Acetolein is not approved for food use in the United States under FDA regulations. It does not appear on the FDA's GRAS list, the Food Additive Status List, or Color Additives Status List. This regulatory classification means that intentional addition of acetolein to food intended for human consumption would require premarket approval through the FDA's food additive petition process, which has not been submitted or approved.

The regulatory status in other jurisdictions remains unclear from available public records. No evidence suggests acetolein is approved as a food additive in Canada, Australia, Japan, or other major regulatory regions. Any use would likely require separate approval processes in individual countries or regions.

Key Studies

Publicly available peer-reviewed research specifically addressing acetolein's safety, efficacy, or use in food systems appears limited or absent. The compound may be referenced in chemical databases and synthetic chemistry literature, but food-specific toxicology or functionality studies have not been identified in standard scientific databases such as PubMed or Google Scholar. Without published data on absorption, metabolism, distribution, and excretion (ADME) in humans or animals, a comprehensive risk assessment cannot be completed. Any manufacturer considering acetolein for food application would need to commission proprietary safety studies to support regulatory approval.

Frequently Asked Questions

What is Acetolein?

Acetolein (CAS 28060-90-4) is a chemical compound that may be used in food manufacturing, though its specific function remains undocumented in available scientific literature. It has not been approved by the FDA as a Generally Recognized As Safe (GRAS) substance and has generated no reported adverse events or recalls.

Is Acetolein safe?

Acetolein 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 Acetolein banned in any country?

Acetolein 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.