Our Verdict: RATING UNKNOWN

Isoquinoline

CAS119-65-3

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

Isoquinoline — food additive

Isoquinoline is a naturally occurring alkaloid compound used as a flavoring agent in food products. It belongs to a class of nitrogen-containing aromatic compounds and is employed to create or enhance specific flavor profiles in various 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 Isoquinoline?

Isoquinoline (CAS Number 119-65-3) is a heterocyclic aromatic compound containing a benzene ring fused to a pyridine ring with a nitrogen atom. It is a naturally occurring alkaloid found in small quantities in various plants and is also produced synthetically for use in food flavoring applications. The compound has a characteristic chemical structure that contributes to its flavor-active properties.

Common Uses

Isoquinoline is used in the food industry as a flavoring agent and flavor adjuvant. It is employed in trace amounts to contribute to or modify flavor profiles in food and beverage products. Like other synthetic flavoring compounds, isoquinoline would typically be used in very small concentrations—often measured in parts per million—to achieve desired sensory characteristics. Its applications may include use in processed foods, beverages, and other food products where flavor enhancement is desired.

Safety Assessment

Isoquinoline has not received FDA GRAS (Generally Recognized as Safe) status, which means it has not been formally affirmed as safe for general food use under FDA regulations. However, the lack of GRAS status does not necessarily indicate that the compound is unsafe; rather, it indicates that formal safety approval through the GRAS process has not been obtained or pursued.

According to FDA records, there are zero reported adverse events associated with isoquinoline and zero product recalls attributed to this additive. This suggests that if the compound is being used in foods, it has not generated safety concerns substantial enough to trigger adverse event reports or enforcement actions through FDA surveillance systems.

The absence of adverse event reports and recalls provides some reassurance regarding real-world safety experience, though this does not constitute formal safety approval. The toxicological profile of isoquinoline would need to be evaluated through standard safety testing protocols including acute toxicity, chronic toxicity, genotoxicity, and other endpoints to establish formal safety determinations.

Regulatory Status

Isoquinoline's regulatory status varies internationally. In the United States, without GRAS status, its use in food would require either GRAS affirmation or approval through the food additive petition process before it could be used as an intentional food additive in interstate commerce. The FDA maintains strict regulations governing which substances can be added to food, and approval pathways exist for new additives seeking market authorization.

In the European Union, flavoring substances are regulated under specific legislation, and the approval status of isoquinoline would depend on whether it appears on the Union's approved flavoring substances list. International regulatory frameworks for flavoring substances often differ, and what is permitted in one country may not be approved in another.

Key Studies

Limited published safety data appears to be available specifically for isoquinoline's use as a food flavoring agent. The compound has been studied in various scientific contexts due to its occurrence in nature and its chemical properties, but comprehensive food safety studies specific to flavoring applications may be limited in the publicly available literature.

When food additives lack GRAS status but show no adverse event reports, this can indicate either that the compound is not widely used in foods, that it has a good safety record if used, or that formal safety evaluations have simply not been completed or published. Further evaluation of isoquinoline's safety would require access to toxicological data and risk assessment studies if such compounds were to be formally approved for broader food use.

Researchers and regulatory agencies continue to evaluate flavoring substances based on current scientific understanding and available safety data. Anyone considering the use of isoquinoline in food applications should consult with regulatory authorities in their jurisdiction regarding current approval status and requirements.

Frequently Asked Questions

What is Isoquinoline?

Isoquinoline is a naturally occurring alkaloid compound used as a flavoring agent in food products. It belongs to a class of nitrogen-containing aromatic compounds and is employed to create or enhance specific flavor profiles in various food applications.

Is Isoquinoline safe?

Isoquinoline 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 Isoquinoline banned in any country?

Isoquinoline 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.