Our Verdict: RATING UNKNOWN

Alpha-isomethylionone

CAS127-51-5

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-isomethylionone — food additive

Alpha-isomethylionone (CAS 127-51-5) is a synthetic flavoring compound used to impart woody and floral notes in food and beverage products. It is not approved as a Generally Recognized As Safe (GRAS) substance by the FDA, though it has not been associated with reported adverse events or product recalls.

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-isomethylionone?

Alpha-isomethylionone is a synthetic organic compound belonging to the class of ionones, which are aromatic ketones commonly used in the flavor and fragrance industries. With the CAS number 127-51-5, this compound is characterized by a woody, floral aroma profile and is primarily employed as a flavoring agent or flavoring adjuvant in food manufacturing.

Common Uses

Alpha-isomethylionone is utilized in the formulation of complex flavor compounds intended for use in beverages, confectionery, baked goods, and other processed food products. Its woody and slightly floral character makes it particularly valuable in creating sophisticated flavor profiles that enhance product appeal. The compound functions as a minor component within larger flavoring systems, contributing depth and complexity to the overall sensory experience.

Safety Assessment

As of the available data, alpha-isomethylionone has generated zero reported adverse events to the FDA and has not been associated with any product recalls. However, it is important to note that the lack of reported incidents does not constitute formal approval or GRAS status. The compound's safety profile is not extensively documented in publicly available peer-reviewed literature, which is typical for many synthetic flavor compounds used at very low concentrations in food.

The absence of GRAS status means the compound has not undergone the formal FDA evaluation process required for some food additives. For manufacturers wishing to use this substance, compliance with FDA flavor regulations and ingredient approval requirements is necessary. In the European Union, ionone compounds are subject to evaluation by the European Food Safety Authority (EFSA) for use in flavorings.

Regulatory Status

Alpha-isomethylionone is not listed as a GRAS substance by the FDA, meaning it does not have blanket approval for use in food products in the United States. However, it may be used in food in certain jurisdictions under specific regulatory frameworks governing flavor additives. In the EU, flavor compounds are regulated under Regulation (EC) No 1334/2008, which establishes the Union List of flavoring substances permitted for use in food.

Manufacturers seeking to use alpha-isomethylionone must ensure compliance with applicable regulations in their target markets. This may involve providing documentation of the compound's purity, specifications, and intended use levels. The regulatory status of this compound may vary by country and region.

Key Studies

Limited independent peer-reviewed research specifically addressing alpha-isomethylionone safety is publicly available. Most safety data for ionone-class compounds comes from manufacturer submissions to regulatory authorities and proprietary toxicological assessments. General ionone compound research indicates these substances are used at extremely low concentrations—typically in the parts per million range—which significantly reduces potential exposure concerns.

Studies on related ionone compounds suggest they are rapidly metabolized and eliminated from the body. The flavor industry generally relies on historical use data and structural similarity assessments when evaluating safety of novel flavoring compounds. Manufacturers typically conduct or commission acute toxicity studies, genotoxicity assessments, and other standard safety evaluations before commercializing new flavor compounds, though these studies are often proprietary and not published in open literature.

Frequently Asked Questions

What is Alpha-isomethylionone?

Alpha-isomethylionone (CAS 127-51-5) is a synthetic flavoring compound used to impart woody and floral notes in food and beverage products. It is not approved as a Generally Recognized As Safe (GRAS) substance by the FDA, though it has not been associated with reported adverse events or product recalls.

Is Alpha-isomethylionone safe?

Alpha-isomethylionone 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-isomethylionone banned in any country?

Alpha-isomethylionone 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.