Our Verdict: RATING UNKNOWN

Epsilon-dodecalactone

CAS16429-21-3

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

Epsilon-dodecalactone — food additive

Epsilon-dodecalactone is a naturally occurring organic compound belonging to the lactone family, used as a flavoring agent in processed foods. It provides fruity, creamy, and coconut-like sensory notes and is employed to enhance or create desired flavor profiles in various food products.

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 Epsilon-dodecalactone?

Epsilon-dodecalactone (CAS Number: 16429-21-3) is a twelve-carbon cyclic ester compound classified as a lactone. Lactones are organic molecules formed from the condensation of a hydroxy acid and are commonly found in nature, contributing to the flavor profiles of fruits, dairy products, and other foods. Epsilon-dodecalactone is known for imparting fruity, creamy, peach-like, and coconut characteristics to food formulations, making it valuable in the flavor chemistry industry.

Common Uses

Epsilon-dodecalactone is utilized primarily in the food industry as a flavoring agent and flavor enhancer. It is employed in the formulation of:

- Dairy products, including yogurts, cheeses, and flavored milk beverages

- Processed fruits and fruit-flavored products

- Confectionery and baked goods

- Beverages, particularly those with tropical or stone fruit profiles

- Dessert flavorings and ice cream bases

- Savory applications where creamy notes are desired

The compound is typically used in very small quantities, measured in parts per million (ppm), as it is a potent flavoring agent with significant organoleptic impact at minimal concentrations.

Safety Assessment

Epsilon-dodecalactone has not been designated as Generally Recognized as Safe (GRAS) by the FDA, indicating that it has not undergone the formal GRAS notification process. However, this classification does not imply safety concerns. The lack of GRAS status may reflect the compound's limited use profile or the absence of a formal submission rather than identified hazards.

According to available FDA data, there are zero documented adverse events associated with epsilon-dodecalactone consumption, and no product recalls have been issued related to this ingredient. This absence of reported harm provides a degree of reassurance regarding its safety profile in current food applications.

As a lactone compound, epsilon-dodecalactone is structurally similar to naturally occurring flavor compounds found in foods. The safety of lactone-based flavoring agents has been extensively studied, and many related compounds are widely recognized as safe for food use. The chemical structure, known metabolic pathways, and limited exposure levels contribute to the overall safety consideration of this additive.

Regulatory Status

The regulatory status of epsilon-dodecalactone varies by jurisdiction. In the United States, it is not on the FDA's GRAS list, which means its use may be subject to additional regulatory scrutiny and may require specific approval for particular food categories. Manufacturers using this ingredient must ensure compliance with FDA regulations regarding food additives.

In the European Union, epsilon-dodecalactone may be evaluated under the European Food Safety Authority (EFSA) framework for flavorings. The EU maintains a list of approved flavoring substances, and regulatory status should be verified against current EU regulations.

The absence of an established acceptable daily intake (ADI) reflects the limited toxicological data available through formal regulatory channels, though this does not necessarily indicate safety concerns given the minimal quantities used in food applications.

Key Studies

Lactone compounds, including epsilon-dodecalactone, have been subject to flavor chemistry research examining their sensory properties and chemical stability in food systems. While comprehensive toxicological studies specifically focused on epsilon-dodecalactone are limited in publicly available literature, the chemical class has been studied for metabolic fate and potential interactions.

Research on structurally related lactones suggests these compounds are metabolized through standard hepatic pathways and do not bioaccumulate. The high potency of these flavoring agents means exposure levels remain very low, further reducing theoretical risk. Industry-sponsored safety assessments and flavor chemistry databases provide additional information on this compound's characterization.

Frequently Asked Questions

What is Epsilon-dodecalactone?

Epsilon-dodecalactone is a naturally occurring organic compound belonging to the lactone family, used as a flavoring agent in processed foods. It provides fruity, creamy, and coconut-like sensory notes and is employed to enhance or create desired flavor profiles in various food products.

Is Epsilon-dodecalactone safe?

Epsilon-dodecalactone 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 Epsilon-dodecalactone banned in any country?

Epsilon-dodecalactone 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.