Our Verdict: RATING UNKNOWN

Indole

CAS120-72-9

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

Indole — food additive

Indole is an organic compound derived from coal tar or synthesized chemically, used as a flavoring agent in food products. It contributes a characteristic fecal or animalic note to certain fragrances and flavoring systems, though its use in food is limited and not officially approved by the FDA as a food additive.

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 Indole?

Indole (CAS Number 120-72-9) is a bicyclic aromatic compound consisting of a benzene ring fused to a pyrrole ring. It occurs naturally in small quantities in some foods, particularly in cruciferous vegetables like cabbage and Brussels sprouts, as well as in animal feces, where it contributes to characteristic odors. Indole can be extracted from coal tar or synthesized through various chemical processes. The compound has a distinctive, pungent odor described as fecal or animalic in nature.

Common Uses

In the fragrance and flavoring industry, indole is primarily used as a flavoring adjuvant rather than a standalone flavor. It is employed in very small concentrations to add depth and complexity to certain fragrance compositions and flavoring systems, particularly those intended to create animalic or fecal notes in perfumery. Its use in food flavoring is significantly limited compared to its application in the fragrance industry. When used in food, indole typically appears in very small quantities as part of complex flavoring formulations designed to mimic natural flavors or add subtle aromatic complexity to certain food products.

Safety Assessment

Indole has generated minimal safety concerns in the available scientific literature. The FDA has received zero adverse event reports associated with indole consumption, and there are no recalls linked to this substance. The compound's natural occurrence in foods, particularly in vegetables, suggests a history of human dietary exposure without documented widespread harm.

Toxicological studies on indole remain limited in the published literature. However, the compound's restricted use in food products and very low concentrations when employed suggest minimal exposure risk to consumers. The lack of adverse event reports and recalls indicates no documented safety incidents at current levels of food use. Most safety assessments of indole have focused on its role in the fragrance industry rather than food applications, where exposure levels are typically higher.

As with many flavor compounds, indole's safety profile is considered acceptable at the levels used in food products, though comprehensive modern toxicological studies are limited.

Regulatory Status

Indole is notably not designated as Generally Recognized as Safe (GRAS) by the FDA, distinguishing it from many other common flavoring agents. This status does not necessarily indicate safety concerns; rather, it reflects the limited formal FDA review process for this particular substance as a food additive. The compound is not banned in the United States or European Union, but its use in food remains restricted and controlled through existing flavor regulations.

In the European Union, indole may be used as a flavoring substance under certain conditions, though regulatory frameworks differ from the United States. The lack of GRAS status in the U.S. means that products containing indole as a direct food additive may require alternative regulatory pathways or may fall under the category of flavoring substances subject to existing regulations.

Key Studies

Direct studies on indole's safety in food applications are sparse in the peer-reviewed literature. Most available research focuses on indole's natural occurrence in foods and its role in plant biochemistry rather than its use as an intentional food additive. The compound's presence in cruciferous vegetables has been studied in the context of nutrition and plant secondary metabolites, but specific toxicological assessments related to its use as a flavoring agent remain limited.

The absence of adverse event reports and recalls suggests that current exposure levels through food products have not prompted safety investigations. Additional modern safety studies would strengthen the evidence base for this flavoring substance.

Frequently Asked Questions

What is Indole?

Indole is an organic compound derived from coal tar or synthesized chemically, used as a flavoring agent in food products. It contributes a characteristic fecal or animalic note to certain fragrances and flavoring systems, though its use in food is limited and not officially approved by the FDA as a food additive.

Is Indole safe?

Indole 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 Indole banned in any country?

Indole 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.