Our Verdict: RATING UNKNOWN

Isobutyl N-methylanthranilate

CAS65505-24-0

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

Isobutyl N-methylanthranilate โ€” food additive

Isobutyl N-methylanthranilate is a synthetic flavoring compound used to impart fruity and grape-like taste notes in food and beverage products. It is not currently approved by the FDA as a Generally Recognized as Safe (GRAS) substance but has no recorded 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 Isobutyl N-methylanthranilate?

Isobutyl N-methylanthranilate (CAS Number: 65505-24-0) is a synthetic organic compound belonging to the class of anthranilate esters. It is a colorless to pale yellow liquid with a characteristic fruity aroma, particularly reminiscent of grape flavor. The compound consists of an isobutyl ester of N-methylanthranilic acid and is designed to function as a flavoring agent in the food industry.

Common Uses

This additive is employed primarily as a flavoring agent in processed foods and beverages, particularly in products where grape or fruit-forward flavor profiles are desired. It may be used in beverages, confectionery, dairy products, and other food applications. The compound is typically used at very low concentrations to achieve the desired sensory effect. Like many synthetic flavoring compounds, it works by stimulating taste receptors and olfactory systems to create specific flavor impressions.

Safety Assessment

Isobutyl N-methylanthranilate has not been formally evaluated by the FDA as a GRAS (Generally Recognized as Safe) substance. This classification means that while the compound may be used in foods, it does not have blanket FDA approval based on established safety consensus. However, the absence of reported adverse events associated with this additive suggests it has not caused documented health problems in consumer populations.

As with all synthetic flavoring compounds, safety assessment typically involves evaluating acute and chronic toxicity, potential mutagenic or carcinogenic effects, and metabolic fate in the human body. The compound's chemical structure and properties would inform its classification and acceptable use levels. When used as a flavoring agent, the actual exposure levels in food are typically very low, which is an important consideration in safety evaluation.

The lack of FDA recalls related to this additive indicates that no contamination or safety issues have been identified in products containing it at consumer level. The zero recorded adverse events in FDA databases suggests that either the compound is not widely used, or it has demonstrated safety in existing applications.

Regulatory Status

Isobutyl N-methylanthranilate's regulatory status varies by jurisdiction. In the United States, its non-GRAS designation means it operates in a regulatory gray areaโ€”it may be used under certain conditions, but manufacturers cannot claim established safety consensus. Some manufacturers may use it under FDA regulations for food additives, potentially under a food additive petition or other regulatory framework.

In the European Union, synthetic flavoring compounds must be evaluated by the European Food Safety Authority (EFSA) for approval. Specific approval status under EU regulations would need to be verified against the EFSA's flavor evaluation program.

Regulatory approval and use levels vary internationally, and manufacturers must ensure compliance with local food safety regulations in each market where products are sold.

Key Studies

Limited publicly available scientific literature specifically addresses isobutyl N-methylanthranilate's safety profile. Most safety data on synthetic anthranilate esters comes from broader evaluations of the anthranilate ester class. The compound's chemical similarity to other approved anthranilate flavoring agents suggests it likely undergoes similar metabolic pathways. General toxicology data for related compounds indicates that anthranilate esters are typically metabolized and excreted relatively quickly.

The absence of significant scientific literature on this specific compound may reflect either limited commercial use or an acceptable safety profile that has not prompted extensive independent research. Manufacturers using this additive would typically maintain proprietary toxicology and safety data supporting their use in food applications.

Frequently Asked Questions

What is Isobutyl N-methylanthranilate?

Isobutyl N-methylanthranilate is a synthetic flavoring compound used to impart fruity and grape-like taste notes in food and beverage products. It is not currently approved by the FDA as a Generally Recognized as Safe (GRAS) substance but has no recorded adverse events or recalls.

Is Isobutyl N-methylanthranilate safe?

Isobutyl N-methylanthranilate 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 Isobutyl N-methylanthranilate banned in any country?

Isobutyl N-methylanthranilate 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.