Our Verdict: RATING UNKNOWN

5-hydroxy-8-undecenoic Acid Delta-lactone

CAS68959-28-4

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

5-hydroxy-8-undecenoic Acid Delta-lactone โ€” food additive

5-hydroxy-8-undecenoic acid delta-lactone is a synthetic flavoring compound used to impart creamy, fruity, and buttery notes in food products. This lactone derivative functions as a flavoring agent 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 5-hydroxy-8-undecenoic Acid Delta-lactone?

5-hydroxy-8-undecenoic acid delta-lactone (CAS Number: 68959-28-4) is a synthetic organic compound classified as a lactone, which is a cyclic ester naturally occurring in many foods. This particular lactone is an 11-carbon chain compound featuring a hydroxyl group and an unsaturated double bond within its structure. Lactones are well-known flavor compounds that contribute creamy, fruity, coconut-like, and buttery sensory characteristics to food products. This compound is manufactured through chemical synthesis rather than extraction from natural sources.

Common Uses

As a flavoring agent or adjuvant, 5-hydroxy-8-undecenoic acid delta-lactone is used in the food industry to enhance flavor profiles in various processed foods. Typical applications include dairy products, beverages, confectionery items, and baked goods where creamy or fruity notes are desirable. The compound functions at very low concentrations, typically measured in parts per million (ppm), which is characteristic of most synthetic flavoring agents. Its specific aromatic properties make it useful for formulators seeking to achieve particular sensory attributes without using larger quantities of other ingredients.

Safety Assessment

This additive has no reported adverse events in the FDA database and has not been associated with any food recalls. The absence of documented safety concerns reflects the limited but available safety data on this substance. Like many synthetic flavoring compounds, this lactone would be expected to have low systemic toxicity given its intended use at minimal concentrations in food.

The compound's structural classโ€”lactonesโ€”has a generally recognized safety profile in food applications. Similar lactone compounds have been evaluated for safety without raising significant health concerns. However, it should be noted that this specific compound has not received FDA GRAS (Generally Recognized As Safe) status, meaning it has not undergone the formal GRAS notification process for food use in the United States.

Regulatory Status

This additive does not currently hold FDA GRAS status. In the United States, flavoring substances may be used under FDA regulations without GRAS status if they comply with applicable regulations and are used at levels that do not raise safety concerns. The FDA maintains authority over flavoring agents through its Color Additives and Flavoring Regulations (21 CFR Part 182 and related sections).

Regulatory approaches to this flavoring may differ internationally. The European Union's flavoring regulations (EU 1334/2008) establish different approval processes for flavoring substances. Manufacturers using this compound should verify compliance with regulations in all target markets, as flavoring approvals vary by country and region.

Key Studies

Limited published scientific literature is available specifically addressing 5-hydroxy-8-undecenoic acid delta-lactone. Safety assessments for synthetic lactone flavorings typically rely on structural similarity to known safe compounds, in vitro testing protocols, and established data on related lactone substances. The lack of reported adverse events and recalls suggests either safe use at approved levels or limited market distribution.

When evaluating synthetic flavoring compounds like this one, food safety professionals consider absorption, metabolism, and excretion patterns based on chemical structure. Lactones generally undergo hydrolysis in the gastrointestinal tract, which limits systemic exposure to intact molecules. Further safety research, if conducted, would follow standard protocols for food additive evaluation including acute and subchronic toxicity studies if required by regulatory authorities.

Frequently Asked Questions

What is 5-hydroxy-8-undecenoic Acid Delta-lactone?

5-hydroxy-8-undecenoic acid delta-lactone is a synthetic flavoring compound used to impart creamy, fruity, and buttery notes in food products. This lactone derivative functions as a flavoring agent in various processed foods and beverages.

Is 5-hydroxy-8-undecenoic Acid Delta-lactone safe?

5-hydroxy-8-undecenoic Acid Delta-lactone 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 5-hydroxy-8-undecenoic Acid Delta-lactone banned in any country?

5-hydroxy-8-undecenoic Acid Delta-lactone 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.