Our Verdict: SAFE

Alpha-ionone

CAS127-41-3

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

Alpha-ionone — food additive

Alpha-ionone (CAS 127-41-3) is a synthetic flavoring compound used to impart fruity, floral, and woody notes in food and beverage products. It functions as a flavoring agent or adjuvant in the food industry to enhance taste and aroma profiles.

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
ApprovedHealth 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-ionone?

Alpha-ionone is a synthetic organic compound classified as a flavoring agent. It is a cyclic ketone with the molecular formula C13H20O. The compound is known for its characteristic fruity, floral, and woody sensory properties, making it valuable in the flavor industry for creating complex taste and aroma profiles in food products.

Common Uses

Alpha-ionone is primarily used in the flavor and fragrance industry. In food applications, it appears in beverages, dairy products, confectionery, and baked goods where fruity and floral notes are desired. The compound is typically used in very small concentrations, as is standard practice with synthetic flavoring agents. Its sensory profile makes it particularly useful in fruit-flavored beverages, yogurts, desserts, and other products requiring enhanced fruity or woody notes.

Safety Assessment

Alpha-ionone has not been formally approved by the FDA as a Generally Recognized As Safe (GRAS) substance. However, the compound has an established safety record in flavor applications within the European Union and other regulatory jurisdictions. No adverse events have been reported to the FDA regarding alpha-ionone, and no product recalls associated with this ingredient have been documented in FDA records.

The safety profile of alpha-ionone is supported by its long history of use in flavor applications and its classification within established flavor chemical databases. Like all synthetic flavoring agents, it is used at very low levels in food products, which further mitigates potential risk. The compound is subject to the same stringent manufacturing standards and purity requirements as other approved flavoring ingredients.

Regulatory Status

While not on the FDA's GRAS list, alpha-ionone is permitted for use in flavoring applications in several regulatory jurisdictions. In the European Union, it is listed among acceptable flavoring substances and is regulated under the EU Flavourings Regulation (EC) No 1334/2008. This approval indicates that it has undergone safety evaluation and been deemed acceptable for use in food at specified concentrations.

The absence of FDA GRAS status does not indicate a safety concern; rather, it reflects differences in how various regulatory agencies classify and approve flavoring agents. Flavoring compounds may be approved through different pathways, and many synthetic flavors operate under FDA's Food Additive regulations or through other established safety frameworks.

Key Studies

Alpha-ionone's safety profile is documented in flavor industry databases and regulatory submissions to the European Food Safety Authority (EFSA). The compound has been included in safety evaluations of flavor chemical complexes and has not raised safety concerns in published assessments. Its use levels in food are controlled and based on established practices in the flavor industry, typically measured in parts per million.

The lack of reported adverse events or recalls associated with alpha-ionone, combined with its acceptance in major regulatory markets, suggests an acceptable safety margin when used according to established flavoring practices. As with all food additives, proper manufacturing quality control and adherence to permitted use levels are essential for safe application.

Frequently Asked Questions

What is Alpha-ionone?

Alpha-ionone (CAS 127-41-3) is a synthetic flavoring compound used to impart fruity, floral, and woody notes in food and beverage products. It functions as a flavoring agent or adjuvant in the food industry to enhance taste and aroma profiles.

Is Alpha-ionone safe?

Alpha-ionone 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 Alpha-ionone banned in any country?

Alpha-ionone 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.