Our Verdict: RATING UNKNOWN

Phenethyl Anthranilate

CAS133-18-6

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

Phenethyl Anthranilate — food additive

Phenethyl anthranilate is an organic compound used as a flavoring agent in food products. It is not approved as a GRAS substance by the FDA and has limited commercial use in food 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 Phenethyl Anthranilate?

Phenethyl anthranilate (CAS Number 133-18-6) is an organic chemical compound belonging to the class of aromatic esters. It is composed of a phenethyl group attached to an anthranilic acid moiety. The compound exists as a colorless to pale yellow liquid with a characteristic fruity aroma, which makes it of potential interest for flavor development in the food industry.

Common Uses

Phenethyl anthranilate is primarily investigated for use as a flavoring agent or flavoring adjuvant in food and beverage products. Its fruity odor profile suggests potential applications in confectionery, beverages, and other flavored food products. However, due to its non-GRAS status in the United States, its actual commercial use in foods intended for the U.S. market is limited. In other jurisdictions, regulatory approvals and applications may differ.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with phenethyl anthranilate, and no recalls have been issued for products containing this ingredient. This absence of reported incidents suggests that, where it has been used, it has not been linked to consumer safety concerns.

The toxicological profile of phenethyl anthranilate has not been extensively documented in published scientific literature available to regulatory agencies. Like many flavor compounds, safety assessment would typically involve evaluation of acute and subchronic toxicity data, potential mutagenicity, and other relevant endpoints. The compound's structural similarity to other known flavor compounds provides some basis for assessment, but specific detailed studies on this particular molecule appear limited in the public domain.

Regulatory Status

Phenethyl anthranilate is not listed as a GRAS (Generally Recognized as Safe) substance by the FDA. This means it has not received the classification allowing it to be used without premarket approval in foods intended for the U.S. market. To be used in food products in the United States, phenethyl anthranilate would require either GRAS affirmation through the FDA or approval as a food additive through the food additive petition process.

Regulatory status may differ in other countries. The European Food Safety Authority (EFSA) maintains separate evaluations for flavoring substances used in the EU and associated regions. Manufacturers seeking to use this compound would need to verify compliance with regulations in their specific target markets.

The lack of FDA GRAS status does not necessarily indicate safety concerns; rather, it reflects that formal regulatory approval pathways have not been completed in the United States for this particular substance as a food ingredient.

Key Studies

Published scientific literature specifically addressing phenethyl anthranilate's safety profile appears limited. Most information available comes from chemical databases and regulatory submissions rather than peer-reviewed toxicological studies in the scientific literature. Comprehensive safety data, including standard toxicity testing parameters, would typically be required to support regulatory approval or GRAS status.

For manufacturers or researchers interested in pursuing regulatory approval for this substance, conducting or compiling appropriate toxicological studies would be necessary. This would likely include assessments of acute oral toxicity, short-term repeat-dose toxicity, potential genetic toxicity, and potentially reproductive or developmental effects, depending on intended use levels and exposure.

Frequently Asked Questions

What is Phenethyl Anthranilate?

Phenethyl anthranilate is an organic compound used as a flavoring agent in food products. It is not approved as a GRAS substance by the FDA and has limited commercial use in food applications.

Is Phenethyl Anthranilate safe?

Phenethyl Anthranilate 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 Phenethyl Anthranilate banned in any country?

Phenethyl Anthranilate 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.