Our Verdict: SAFE

Delta-dodecalactone

CAS713-95-1

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

Delta-dodecalactone — food additive

Delta-dodecalactone is a naturally occurring lactone compound used as a flavoring agent in food products. It imparts creamy, fruity, and coconut-like flavor notes and is commonly employed in dairy, beverage, and confectionery 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 Delta-dodecalactone?

Delta-dodecalactone (CAS Number 713-95-1) is a twelve-carbon lactone—a cyclic ester compound—that occurs naturally in various foods including fruits, dairy products, and fermented beverages. The molecule has a distinctive creamy, fruity aroma with coconut and peach undertones, making it valuable in flavor formulation. Lactones are a class of naturally occurring compounds found in foods like strawberries, pineapples, and aged cheeses, and delta-dodecalactone represents one member of this broader chemical family used in food manufacturing.

Common Uses

Delta-dodecalactone is primarily used as a flavoring agent in the food and beverage industry. Its applications include:

- Dairy products: yogurts, flavored milks, and ice creams

- Beverages: fruit juices, soft drinks, and flavored waters

- Confectionery: candies, chocolate products, and baked goods

- Processed foods: desserts, puddings, and flavoring compounds

The compound is typically used in very small concentrations, measured in parts per million (ppm), to achieve desired flavor profiles without creating unbalanced taste characteristics. Manufacturers value delta-dodecalactone for its ability to enhance creamy and fruity notes while maintaining product stability.

Safety Assessment

Delta-dodecalactone has generated no documented adverse events in FDA databases and has been associated with zero product recalls. The compound's safety profile is supported by its occurrence in nature and its low-level use in food applications.

The toxicological data available suggests delta-dodecalactone is well-tolerated at food-use levels. As a lactone with structural similarity to compounds present in natural foods, it does not present the same concerns as synthetic chemicals with novel structures. The compound does not appear on lists of banned or restricted food additives in major regulatory jurisdictions.

Like all food additives, delta-dodecalactone is metabolized in the body. Lactones of this type are generally broken down through standard hepatic metabolism pathways. No bioaccumulation or persistence concerns have been identified.

Regulatory Status

Delta-dodecalactone is not designated as Generally Recognized As Safe (GRAS) by the FDA through the formal GRAS notification process. However, its absence of GRAS status does not indicate safety concerns; rather, it reflects that formal GRAS petitions may not have been submitted or completed for this particular compound.

In the European Union, delta-dodecalactone is listed in the Flavouring Group Evaluation (FGE) framework under EFSA (European Food Safety Authority) guidelines. Its regulatory status varies by jurisdiction, with some countries permitting its use in flavoring applications while others may have specific restrictions or concentration limits.

Manufacturers using delta-dodecalactone must comply with local regulations regarding food additives and flavoring agents. In jurisdictions where it is permitted, it typically falls under general flavoring regulations that establish acceptable use levels based on established food industry practices.

Key Studies

Limited published peer-reviewed research specifically addresses delta-dodecalactone in isolation, as lactones as a chemical class have been extensively studied. The available literature indicates:

- Lactone compounds are metabolized through ester hydrolysis and oxidative pathways

- At food-use concentrations, exposure levels are substantially below those used in laboratory toxicology studies

- Natural occurrence in foods suggests a long history of safe consumption at background levels

- No evidence of genotoxicity or mutagenic potential has emerged from available chemical class data

The lack of adverse events and recalls in FDA records, combined with its structural similarity to naturally occurring food compounds, supports its continued use in food flavoring applications where permitted.

Frequently Asked Questions

What is Delta-dodecalactone?

Delta-dodecalactone is a naturally occurring lactone compound used as a flavoring agent in food products. It imparts creamy, fruity, and coconut-like flavor notes and is commonly employed in dairy, beverage, and confectionery applications.

Is Delta-dodecalactone safe?

Delta-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 Delta-dodecalactone banned in any country?

Delta-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.