Our Verdict: SAFE

Gamma-dodecalactone

CAS2305-05-7

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Gamma-dodecalactone — food additive

Gamma-dodecalactone is a naturally-occurring organic compound used as a flavoring agent in food products. It provides fruity, creamy, and coconut-like flavor notes and is employed in small quantities to enhance the sensory profile of various processed foods and beverages.

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
ApprovedHealth 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 Gamma-Dodecalactone?

Gamma-dodecalactone (CAS Number: 2305-05-7) is a cyclic ester, or lactone, derived from a 12-carbon fatty acid chain. It occurs naturally in some fruits and dairy products, contributing to their characteristic flavor profiles. The compound is colorless to pale yellow and has a molecular structure that makes it volatile enough to contribute aroma and taste sensations in food applications.

Common Uses

Gamma-dodecalactone is primarily used in the flavor industry as a flavoring agent and flavor enhancer. It is commonly incorporated into processed foods, including:

- Dairy products (yogurts, cheese, ice cream)

- Baked goods and pastries

- Confectionery items

- Beverages (both alcoholic and non-alcoholic)

- Savory snacks

- Dessert sauces and toppings

The compound is valued for its ability to provide fruity, creamy, coconut, and peach-like notes at very low concentrations, typically measured in parts per million (ppm). Because it is used in minute quantities, its presence often goes unnoticed by consumers but contributes to overall flavor complexity.

Safety Assessment

Gamma-dodecalactone has not been formally affirmed as Generally Recognized As Safe (GRAS) by the FDA. However, it has a strong safety record in practical use. The FDA Adverse Event Reporting System (FAERS) contains zero reported adverse events associated with this additive, and there have been no product recalls linked to gamma-dodecalactone.

The compound's safety profile is supported by several factors:

- Its natural occurrence in foods suggests low toxicity at consumption levels

- It is used in extremely small quantities in food applications

- The lactone structure is common among naturally-occurring flavor compounds

- No acute or chronic toxicity studies have raised safety concerns in the scientific literature

As with all flavor compounds, gamma-dodecalactone undergoes metabolic breakdown in the body, with no evidence of bioaccumulation or systemic effects at food-use concentrations.

Regulatory Status

While not FDA GRAS-affirmed, gamma-dodecalactone is permitted for use as a flavoring agent in many countries under existing flavor regulations. In the European Union, it is listed in the Register of Flavouring Substances and can be used in food products subject to EU Regulation 1334/2008, which establishes rules for flavoring substances in foodstuffs.

The lack of GRAS affirmation does not indicate safety concerns; rather, it reflects that the compound operates under the broader category of approved flavoring substances that do not require individual GRAS status if they meet compositional and purity specifications.

Manufacturers using gamma-dodecalactone must ensure it meets food-grade purity standards and is used at levels that comply with Good Manufacturing Practice (GMP) principles, typically well below 10 ppm in finished food products.

Key Studies

Scientific evaluation of gamma-dodecalactone is limited, which is typical for minor flavor compounds used in trace amounts. Available data includes:

- Sensory and organoleptic studies confirming its flavor characteristics and threshold detection levels

- Metabolic studies demonstrating rapid breakdown and clearance from the body

- Natural occurrence studies in fruits and fermented products establishing a history of safe consumption

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated lactone-type compounds generally and found them to present minimal safety concerns when used as flavoring agents at typical food-use levels.

No long-term toxicity studies specific to gamma-dodecalactone have been published, but this is consistent with regulatory expectations for substances used in parts-per-million quantities and is not indicative of any hidden safety issue.

Frequently Asked Questions

What is Gamma-dodecalactone?

Gamma-dodecalactone is a naturally-occurring organic compound used as a flavoring agent in food products. It provides fruity, creamy, and coconut-like flavor notes and is employed in small quantities to enhance the sensory profile of various processed foods and beverages.

Is Gamma-dodecalactone safe?

Gamma-dodecalactone is currently rated "safe" 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 Gamma-dodecalactone banned in any country?

Gamma-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.