Our Verdict: RATING UNKNOWN

2-tridecanone

CAS593-08-8

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

2-tridecanone — food additive

2-Tridecanone is a naturally occurring ketone compound used as a flavoring agent and flavor enhancer in food products. It is not approved as a food additive by the FDA and has no reported adverse events or recalls associated with its use.

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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 2-Tridecanone?

2-Tridecanone (CAS Number 593-08-8) is an organic compound belonging to the ketone family of chemicals. It is a thirteen-carbon straight-chain ketone with the chemical formula C₁₃H₂₆O. This compound occurs naturally in certain plants and foods, including some essential oils and plant-derived flavoring sources. The compound is volatile and contributes aromatic characteristics to products where it is used.

Common Uses

2-Tridecanone is utilized primarily as a flavoring agent and flavor enhancer in the food industry. Its applications are typically found in processed foods where complex flavor profiles are desired. The compound may be used in beverages, confectionery products, dairy items, and other food categories where fruity or woody aromatic notes are beneficial. Due to its GRAS (Generally Recognized as Safe) status not being established with the FDA, its use in the United States is limited and not formally permitted as a direct food additive in most applications.

Safety Assessment

There are zero reported adverse events associated with 2-tridecanone in the FDA database, and no food recalls have been linked to this substance. The absence of reported safety incidents suggests that exposure through food sources, where it may occur, has not generated consumer health complaints or regulatory concerns.

Limited toxicological data exists in published literature specifically addressing 2-tridecanone's safety profile in food applications. Like other volatile organic compounds used in flavoring, it would be expected to be present in food products at very low concentrations, typically measured in parts per million. The lack of systematic safety evaluation through the FDA's GRAS petition process means there is no formal regulatory determination of its safety status in the United States.

International regulatory bodies, including the European Food Safety Authority (EFSA), have not issued comprehensive assessments of 2-tridecanone as a food additive. Its use in European markets would be subject to the EU's flavoring regulations, though specific approval status varies by jurisdiction.

Regulatory Status

2-Tridecanone does not hold FDA GRAS (Generally Recognized as Safe) status, which means it cannot be legally added directly to food products in the United States without prior FDA approval or a successful GRAS petition. This distinguishes it from thousands of other flavoring substances that have been formally recognized as safe through either historical use documentation or formal safety review.

In the European Union, the regulatory framework for flavoring substances is distinct. Compounds may be permitted under EU Regulation 1334/2008 if they meet specific criteria and have been evaluated for safety. The regulatory status of 2-tridecanone in EU markets should be verified against current approved flavoring substance lists.

The lack of GRAS status does not necessarily indicate that 2-tridecanone is unsafe; rather, it reflects that a formal safety determination has not been completed or submitted to the FDA. Companies wishing to use this substance in food products in the United States would need to either submit a GRAS petition or obtain an FDA food additive petition approval.

Key Studies

Published scientific literature specifically evaluating 2-tridecanone's toxicology and safety in food applications is limited. Most information about this compound comes from its characterization as a naturally occurring volatile compound and its properties in chemical and flavor research contexts.

General toxicological principles for similar ketone compounds suggest that volatile organic compounds used in flavoring are typically metabolized and eliminated rapidly from the body, though individual safety data for 2-tridecanone would be needed to make definitive statements. Any regulatory approval or safety determination would require submission of appropriate toxicological studies to demonstrate safety at intended use levels.

Frequently Asked Questions

What is 2-tridecanone?

2-Tridecanone is a naturally occurring ketone compound used as a flavoring agent and flavor enhancer in food products. It is not approved as a food additive by the FDA and has no reported adverse events or recalls associated with its use.

Is 2-tridecanone safe?

2-tridecanone 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 2-tridecanone banned in any country?

2-tridecanone 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.