Our Verdict: SAFE

Gamma-hexalactone

CAS695-06-7

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-hexalactone — food additive

Gamma-hexalactone is a naturally occurring organic compound used as a flavoring agent in food products. It imparts fruity, coconut-like sensory characteristics and is employed in small quantities to enhance flavor profiles in 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
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 Gamma-hexalactone?

Gamma-hexalactone (CAS Number: 695-06-7) is an organic compound belonging to the lactone family of chemicals. Lactones are cyclic esters that occur naturally in many fruits, plants, and fermented foods. Gamma-hexalactone is a six-membered lactone ring with a saturated structure, and it naturally exists in certain fruits, particularly coconut and other tropical fruits. The compound is a colorless to pale yellow liquid with a characteristic fruity, creamy coconut aroma.

Common Uses

Gamma-hexalactone is primarily used in the food industry as a flavoring agent to enhance the sensory profile of food and beverage products. It is typically employed in very small concentrations—measured in parts per million (ppm)—in products such as beverages, baked goods, dairy products, confectionery items, and other processed foods where coconut or fruity notes are desirable. The compound may be used alone or as part of complex flavor blends designed to achieve specific taste and aroma profiles.

Safety Assessment

Gamma-hexalactone has been used in food flavoring applications with no reported adverse events documented by the FDA. The FDA's database contains zero adverse event reports and zero recalls associated with this additive, indicating a favorable safety history in commercial use. The compound's chemical structure as a naturally occurring lactone contributes to its general recognition as having low toxicological concern.

As with all flavoring agents, gamma-hexalactone is used at very low concentrations in food products, which further minimizes potential exposure. The cumulative exposure from food flavoring agents is typically far below levels that would raise safety concerns. The low molecular weight and volatility of gamma-hexalactone suggest it would be metabolized readily by the body if ingested.

Regulatory Status

Gamma-hexalactone has not been formally approved by the FDA as Generally Recognized as Safe (GRAS). However, the absence of GRAS status does not indicate concern; rather, it reflects that the additive may be regulated under other frameworks or that formal GRAS determination has not been pursued. The compound is permitted for use as a flavoring agent in certain food categories in many jurisdictions where it appears on positive lists of approved flavorings.

In the European Union, gamma-hexalactone is listed as a flavoring substance and is subject to the EU Flavouring Regulation (EC No 1334/2008). It appears in the FLAVIS database (Flavour Information System) maintained by EFSA, which catalogues approved flavoring substances used in Europe.

Key Studies

Specific published toxicological studies specifically focused on gamma-hexalactone are limited in the publicly available literature, which is not uncommon for minor flavoring compounds used at very low concentrations. The absence of published dedicated studies, however, should be distinguished from evidence of harm—no such evidence exists. The safety profile is supported by its natural occurrence in foods, its structural similarity to other approved lactone flavorings, its use at minimal concentrations, and the complete absence of adverse event reports or recalls.

The broader category of lactone flavorings has been extensively studied and reviewed by regulatory bodies including EFSA and FDA flavor panels. These reviews have generally supported the safety of lactone-based flavorings when used as intended in food applications.

Frequently Asked Questions

What is Gamma-hexalactone?

Gamma-hexalactone is a naturally occurring organic compound used as a flavoring agent in food products. It imparts fruity, coconut-like sensory characteristics and is employed in small quantities to enhance flavor profiles in various processed foods and beverages.

Is Gamma-hexalactone safe?

Gamma-hexalactone 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-hexalactone banned in any country?

Gamma-hexalactone 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.