Our Verdict: SAFE

Acetanisole

CAS100-06-1

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

Acetanisole — food additive

Acetanisole (4-methoxyacetophenone) is an organic compound used as a flavoring agent in food products. It imparts a subtle, pleasant aromatic note and is employed to enhance or modify flavor profiles in various food and beverage applications.

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 Acetanisole?

Acetanisole, also known as 4-methoxyacetophenone or para-methoxyacetophenone, is an organic aromatic compound with the CAS number 100-06-1. It is a white to off-white crystalline solid with a characteristic sweet, anise-like odor. The compound consists of a benzene ring with both a methoxy group (-OCH3) and an acetyl group (-COCH3) attached in the para position relative to each other. Acetanisole occurs naturally in trace amounts in certain plant sources and is synthetically manufactured for use in the flavor industry.

Common Uses

Acetanisole is primarily used as a flavoring agent and flavor adjuvant in the food and beverage industry. Its applications include:

- Alcoholic beverages, particularly anise-flavored spirits and liqueurs

- Baked goods and confectionery products

- Dairy products and ice cream

- Savory food applications where subtle aromatic enhancement is desired

- Fragrance and flavor compound formulations

The compound is valued for its ability to provide depth and complexity to flavor systems without dominating the sensory profile. It typically is used in very small concentrations, measured in parts per million (ppm), where it functions as an adjuvant to support or enhance other flavor components.

Safety Assessment

Acetanisole has been evaluated for safety in food applications. The available toxicological data indicates low acute toxicity when ingested. Laboratory studies in animal models have not revealed significant organ toxicity or genotoxic potential at tested dose levels. The compound's long history of use in flavor formulations, combined with the very small quantities used in food products, suggests a low risk profile for consumer exposure.

No adverse events have been reported to the FDA related to acetanisole consumption, and no food recalls have been issued due to its presence. The lack of reported incidents in decades of use provides additional reassurance regarding its practical safety in food applications.

Dermal and inhalation exposure during manufacturing or handling requires standard occupational safety precautions, but consumer exposure through food consumption occurs at negligible levels.

Regulatory Status

Acetanisole is not currently listed as a GRAS (Generally Recognized as Safe) substance by the U.S. Food and Drug Administration (FDA). However, this status does not indicate safety concerns; rather, it reflects that formal GRAS affirmation petitions have not been submitted or approved through the official FDA process. Many flavor compounds operate under this regulatory framework, authorized through flavor manufacturer proprietary determinations or through longstanding use in food.

The compound is used in food flavoring systems within the United States and other countries under existing flavor regulations. International regulatory bodies, including those in Europe, have not identified safety concerns with acetanisole at levels used in food applications.

Key Studies

While acetanisole has not been the subject of extensive published clinical research, available toxicological assessments demonstrate:

- Low acute oral toxicity in standard animal testing protocols

- No significant organ toxicity at tested exposure levels

- Absence of genotoxic potential in standard genetic toxicology assays

- Metabolism and clearance consistent with other simple aromatic compounds

The safety of acetanisole aligns with broader knowledge of structurally similar flavor compounds that have established safety records in food applications. Its use continues under established flavor industry standards and regulatory oversight.

Frequently Asked Questions

What is Acetanisole?

Acetanisole (4-methoxyacetophenone) is an organic compound used as a flavoring agent in food products. It imparts a subtle, pleasant aromatic note and is employed to enhance or modify flavor profiles in various food and beverage applications.

Is Acetanisole safe?

Acetanisole 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 Acetanisole banned in any country?

Acetanisole 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.