Our Verdict: RATING UNKNOWN

Omega-6-hexadecenlactone

CAS7779-50-2

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

Omega-6-hexadecenlactone — food additive

Omega-6-hexadecenlactone (CAS 7779-50-2) is a synthetic flavoring agent used to impart fruity, creamy, and lactone-based taste profiles in processed foods. It belongs to the lactone class of flavor compounds and is utilized in small quantities to enhance the sensory characteristics of beverages, dairy products, and confectionery items.

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 Omega-6-hexadecenlactone?

Omega-6-hexadecenlactone is a synthetic organic compound belonging to the lactone family of flavor chemicals. Lactones are cyclic esters derived from hydroxy acids and are naturally occurring in many foods. This particular compound features a 16-carbon chain structure with a lactone ring and an unsaturated (double) bond, which contributes to its characteristic flavor profile. The compound is manufactured through chemical synthesis rather than extracted from natural sources, though similar compounds exist in nature.

Common Uses

Omega-6-hexadecenlactone is primarily used as a flavoring agent in the food and beverage industry. Its applications include:

- Dairy products (yogurts, cream-based desserts, flavored milks)

- Confectionery and chocolate products

- Beverages (soft drinks, flavored waters)

- Baked goods and snack foods

- Processed desserts and puddings

The compound is typically used in very small concentrations, measured in parts per million (ppm), as flavoring agents require minimal quantities to achieve desired sensory effects. Food manufacturers select this ingredient for its ability to provide fruity, creamy, and buttery notes that enhance product appeal.

Safety Assessment

Omega-6-hexadecenlactone has no recorded adverse events reported to the FDA and has not been associated with any food recalls. The compound has not undergone formal FDA GRAS (Generally Recognized as Safe) determination, meaning it has not been officially classified as safe through the standardized review process. However, the absence of reported adverse events and recalls suggests it has not raised significant safety concerns in its current use patterns.

Lactone-based flavor compounds are generally recognized as having low toxicity profiles. The lack of adverse events over its period of commercial use indicates an apparent safety margin in typical food applications. As with all synthetic flavorings, safety depends on proper formulation and adherence to established use levels. The compound is used in minute quantities that would be expected to pose minimal risk to consumers.

Regulatory Status

Omega-6-hexadecenlactone is not explicitly listed on the FDA's GRAS list, which means it has not received the agency's official safety determination through the GRAS notification process. However, this does not indicate the additive is unsafe; rather, it reflects that manufacturers may not have pursued formal GRAS status. The compound may be used under FDA regulations governing food additives if it complies with relevant safety and labeling requirements.

In the European Union, lactone-based flavor compounds are evaluated by the European Food Safety Authority (EFSA). Regulatory approaches between the FDA and EFSA may differ, and inclusion status varies by jurisdiction. Food manufacturers must ensure compliance with regulations in their specific markets.

Key Studies

Limited published scientific literature specifically addresses omega-6-hexadecenlactone in isolation. Research on structurally related lactone compounds indicates that this class of chemicals is metabolized efficiently by the body and does not accumulate in tissues. Toxicological studies on similar compounds have consistently shown low acute and chronic toxicity at relevant exposure levels.

The absence of adverse event reports and recalls provides real-world evidence suggesting acceptable safety margins in current food applications. Continued monitoring through FDA adverse event reporting systems and market surveillance remains standard practice for all food additives.

Consumers concerned about synthetic flavoring agents can identify products using this ingredient through food label examination, as all additives must be declared in ingredient lists according to FDA regulations.

Frequently Asked Questions

What is Omega-6-hexadecenlactone?

Omega-6-hexadecenlactone (CAS 7779-50-2) is a synthetic flavoring agent used to impart fruity, creamy, and lactone-based taste profiles in processed foods. It belongs to the lactone class of flavor compounds and is utilized in small quantities to enhance the sensory characteristics of beverages, dairy products, and confectionery items.

Is Omega-6-hexadecenlactone safe?

Omega-6-hexadecenlactone 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 Omega-6-hexadecenlactone banned in any country?

Omega-6-hexadecenlactone 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.