Our Verdict: RATING UNKNOWN

Alpha-irone

CAS79-69-6

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

Alpha-irone — food additive

Alpha-irone is a synthetic flavoring compound classified as a flavoring agent or adjuvant. It is used in small quantities in food products to provide or enhance flavor characteristics, though it is not approved as Generally Recognized as Safe (GRAS) by the FDA.

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 Alpha-irone?

Alpha-irone (CAS Number: 79-69-6) is a synthetic organic compound used as a flavoring agent in the food industry. It belongs to the class of chemical compounds designed to impart or modify flavor in food and beverage products. The compound is used in very small concentrations, typical of most synthetic flavoring agents, to achieve desired sensory characteristics without significantly altering the nutritional profile of foods.

Common Uses

Alpha-irone is employed as a flavoring agent or flavoring adjuvant in various food applications. Like other synthetic flavor compounds, it may be used in beverages, baked goods, dairy products, confections, and other processed foods where flavor enhancement or modification is desired. The specific flavor profile it contributes—whether fruity, floral, or other characteristics—determines its application in particular food categories. Typical usage levels for such flavoring compounds are measured in parts per million (ppm), reflecting the potency of synthetic flavor compounds.

Safety Assessment

Alpha-irone has generated zero adverse event reports in the FDA's database, indicating no documented safety incidents associated with its use in foods. Additionally, there have been no FDA recalls linked to this additive. These metrics suggest a favorable safety profile based on available post-market surveillance data.

However, it is important to note that alpha-irone has not been designated as Generally Recognized as Safe (GRAS) by the FDA. GRAS status requires either substantial scientific agreement regarding safety or a history of safe use in food before 1958. The absence of GRAS status does not necessarily indicate a safety concern; rather, it reflects differences in regulatory pathways and the level of toxicological documentation available for the compound. Foods containing this additive would require FDA approval through the food additive petition process for legal use in the United States.

The lack of adverse events combined with the absence of recalls suggests that any foods containing this additive have not raised safety red flags in post-market surveillance. However, comprehensive toxicological studies specific to alpha-irone would be necessary to fully characterize its safety profile across different population groups and consumption scenarios.

Regulatory Status

In the United States, alpha-irone is not GRAS-listed, meaning it must be approved as a food additive by the FDA before use. Its regulatory status may vary internationally; some countries may permit it under their own regulatory frameworks while others may restrict or prohibit it. Food manufacturers intending to use alpha-irone would need to ensure compliance with applicable regulations in their target markets.

The compound's regulatory pathway differs from additives with established GRAS status, which may be used more freely within specified parameters. This distinction is important for manufacturers and consumers to understand when evaluating the regulatory rigor applied to specific additives.

Key Studies

Public information regarding specific published toxicological studies on alpha-irone is limited in readily accessible databases. The absence of adverse events and recalls suggests either that safety data has been reviewed by regulatory authorities or that the compound has had minimal exposure in the food supply. Additional research or toxicological documentation may exist in proprietary regulatory files or scientific literature requiring specialized access.

When evaluating synthetic flavor compounds, the general principle is that they are used at extremely low concentrations—often below levels at which toxicological effects would be expected based on dose-response principles. The safety of flavoring agents is typically assessed based on their structure, metabolism, and the intended conditions of use.

Frequently Asked Questions

What is Alpha-irone?

Alpha-irone is a synthetic flavoring compound classified as a flavoring agent or adjuvant. It is used in small quantities in food products to provide or enhance flavor characteristics, though it is not approved as Generally Recognized as Safe (GRAS) by the FDA.

Is Alpha-irone safe?

Alpha-irone 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 Alpha-irone banned in any country?

Alpha-irone 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.