Our Verdict: RATING UNKNOWN

Beta-ionone

CAS14901-07-6

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

Beta-ionone — food additive

Beta-ionone is a synthetic flavoring compound used to impart fruity, woody, and floral notes to food and beverages. It is not currently approved as a food additive by the FDA but may be used in some food applications in certain jurisdictions.

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 Beta-ionone?

Beta-ionone (CAS Number 14901-07-6) is a synthetic organic compound belonging to the ionone family of flavoring chemicals. It is characterized by a fruity, woody, and slightly floral aroma profile. The compound is structurally related to naturally occurring ionones found in various plant sources, including essential oils and plant extracts. Beta-ionone is produced through chemical synthesis rather than derived directly from natural sources, though it may be marketed as a "natural identical" flavoring in some regions due to its similarity to compounds found in nature.

Common Uses

Beta-ionone is utilized primarily as a flavoring agent and flavor adjuvant in the food and beverage industry. Its fruity and woody characteristics make it suitable for:

- Beverage formulations, including soft drinks and flavored waters

- Dairy products such as yogurts and flavored milk beverages

- Confectionery and candy applications

- Baked goods and desserts

- Flavor blends and fragrance compounds

The compound is also used in cosmetic and fragrance applications outside of food manufacturing. The typical use levels in food products are generally very low, measured in parts per million (ppm), reflecting the potent nature of flavoring compounds.

Safety Assessment

Beta-ionone has not been subjected to extensive formal safety evaluations by major regulatory agencies. The FDA has recorded zero adverse events and zero recalls associated with this additive, suggesting no documented safety incidents in commercial food use to date. However, the lack of comprehensive toxicological studies means that its complete safety profile has not been extensively established through formal regulatory review processes.

As a synthetic flavoring compound used at very low concentrations, the exposure levels from food consumption are expected to be minimal. The ionone family of compounds has generally been considered to have low toxicity profiles, though individual members may have different safety characteristics. Any toxicological assessment would typically evaluate acute toxicity, chronic toxicity potential, genotoxicity, and reproductive/developmental effects.

Regulatory Status

Beta-ionone is not listed on the FDA's Generally Recognized as Safe (GRAS) list for use as a food additive in the United States. This means it does not have formal FDA approval for food use in the U.S. market. In the European Union, beta-ionone may be permitted under certain flavor regulations, though specific approvals vary by member state and product category.

Manufacturers seeking to use beta-ionone in food products would need to ensure compliance with applicable regulations in their target markets. In jurisdictions where it is permitted, its use is typically limited to specific food categories with defined maximum usage levels.

Key Studies

Limited published literature exists specifically evaluating the safety of beta-ionone in food applications. Research on the ionone family generally suggests low acute toxicity, though comprehensive chronic toxicity and safety data for beta-ionone specifically remain limited in publicly available scientific literature. Any evaluation of this compound's safety would require consultation of proprietary industry safety data and regulatory submissions where available.

The absence of reported adverse events and recalls in FDA databases suggests no identified public health concerns associated with its use at approved levels in jurisdictions where it is permitted. However, ongoing safety monitoring and additional toxicological research would strengthen the evidence base for this flavoring agent.

Frequently Asked Questions

What is Beta-ionone?

Beta-ionone is a synthetic flavoring compound used to impart fruity, woody, and floral notes to food and beverages. It is not currently approved as a food additive by the FDA but may be used in some food applications in certain jurisdictions.

Is Beta-ionone safe?

Beta-ionone 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 Beta-ionone banned in any country?

Beta-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.