Our Verdict: SAFE

Acetophenone

CAS98-86-2

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Acetophenone — food additive

Acetophenone is an organic compound used as a flavoring agent and solvent in food products. It imparts a subtle almond or fruity note and functions as a vehicle for other flavor compounds in food manufacturing.

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 Acetophenone?

Acetophenone (CAS Number 98-86-2) is an organic aromatic ketone compound with the chemical formula C8H8O. It consists of a benzene ring bonded to an acetyl group (CH3CO-). The compound appears as a colorless to pale yellow liquid with a characteristic almond-like or fruity odor. Acetophenone is a naturally occurring volatile compound found in trace amounts in various plant sources, including essential oils and fruits.

Common Uses

In the food industry, acetophenone functions primarily as a flavoring agent and flavor adjuvant. It is used in very small quantities to enhance or modify the sensory profile of food products, particularly in confectionery, beverages, and processed foods. The compound also serves as a solvent or vehicle, helping to dissolve and distribute other flavor compounds more effectively throughout food formulations. Its almond or fruity notes make it particularly useful in products designed to mimic natural fruit or nut flavors. The actual concentrations used in food are typically in the parts per million (ppm) range.

Safety Assessment

Acetophenone has been evaluated for safety in food applications. According to FDA records, there have been zero adverse events reported in association with acetophenone use as a food additive. Additionally, no FDA recalls have been issued for products containing this compound. The absence of reported adverse events and regulatory actions suggests a favorable safety profile under conditions of intended use.

The compound's safety profile is partly supported by its presence in nature and established use in fragrance and flavor industries. However, acetophenone is not on the FDA's Generally Recognized as Safe (GRAS) list, meaning it has not undergone the formal GRAS affirmation process. This does not necessarily indicate a safety concern; rather, it reflects that the additive may be used under FDA Color Additives or other regulatory pathways, or that formal GRAS documentation has not been submitted.

Toxicological studies on acetophenone in laboratory animals have generally shown low acute toxicity. The compound is metabolized in the body and does not appear to bioaccumulate. Dermal and ocular irritation studies indicate mild irritation potential at high concentrations, but such exposures are not representative of food use scenarios where concentrations are minimal.

Regulatory Status

In the United States, acetophenone may be used as a flavoring substance under FDA regulations for food additives. While not GRAS-listed, it can be legally used in food products under the Food Additive Amendment framework, subject to specific limitations and purity standards.

The European Food Safety Authority (EFSA) has evaluated acetophenone within the context of flavoring substances. It appears on various regulatory lists of permitted flavoring agents in European Union countries, though regulatory status may vary by jurisdiction and specific food application.

International flavor and fragrance regulatory bodies, including the International Organization of the Flavor Industry (IOFI) and flavor industry associations, recognize acetophenone as an acceptable flavoring ingredient when used at appropriate levels.

Key Studies

Limited published scientific literature specifically addresses acetophenone as a food additive in isolation. Most safety data derives from industrial toxicology reports and flavor industry safety assessments rather than peer-reviewed academic studies. Acute toxicity studies indicate LD50 values in the moderate range for oral administration in rodents, consistent with the low hazard classification assigned to the compound.

The lack of reported adverse events in FDA databases over decades of use suggests that acetophenone, when used as intended in food flavoring applications, poses minimal risk to consumers. The compound's metabolism and clearance from the body appear to be rapid and complete, with no evidence of systemic accumulation or chronic toxicity at food-relevant exposure levels.

Frequently Asked Questions

What is Acetophenone?

Acetophenone is an organic compound used as a flavoring agent and solvent in food products. It imparts a subtle almond or fruity note and functions as a vehicle for other flavor compounds in food manufacturing.

Is Acetophenone safe?

Acetophenone is currently rated "safe" 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 Acetophenone banned in any country?

Acetophenone 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.