Our Verdict: RATING UNKNOWN

4-phenyl-2-butanol

CAS2344-70-9

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

4-phenyl-2-butanol — food additive

4-phenyl-2-butanol (CAS 2344-70-9) is an organic compound used as a flavoring agent in food products. It is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA, though no adverse events or recalls have been associated with its use.

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 4-phenyl-2-butanol?

4-phenyl-2-butanol is an organic alcohol compound with the molecular formula C10H14O. It consists of a four-carbon chain with a hydroxyl group at the second carbon position and a phenyl group (benzene ring) attached to the fourth carbon. The compound exists as a colorless to pale yellow liquid with a characteristic sweet, floral aroma profile that makes it suitable for flavoring applications.

The chemical structure of 4-phenyl-2-butanol allows it to function as a flavoring agent by providing aromatic and taste-modifying properties to food and beverage formulations. Its sensory characteristics make it of interest to the fragrance and flavor industries.

Common Uses

4-phenyl-2-butanol is primarily used as a flavoring agent or flavoring adjuvant in food products. Due to its aromatic properties, it may be incorporated into various food and beverage applications where sweet, floral, or fruity flavor notes are desired. Common categories might include beverages, confectionery, baked goods, and dairy products, though its specific use in commercial products is limited.

The compound falls under the category of synthetic flavor compounds, which are increasingly common in the food industry as manufacturers seek to create complex flavor profiles and improve product consistency.

Safety Assessment

According to FDA records, there have been zero reported adverse events and zero recalls associated with 4-phenyl-2-butanol. This absence of safety incidents in the post-market surveillance system suggests no acute safety concerns have emerged from its use in food products.

However, the compound has not been designated as GRAS (Generally Recognized as Safe) by the FDA. GRAS status requires either a history of safe use before 1958 or successful completion of a rigorous safety review process. The lack of GRAS designation does not necessarily indicate safety concerns; rather, it reflects that the compound has not undergone the specific FDA review process required for this classification.

Limited toxicological data are publicly available for this compound. The safety profile of related compounds in the aliphatic alcohol family generally suggests low acute toxicity, though comprehensive long-term safety studies specific to 4-phenyl-2-butanol may be limited in public literature.

Regulatory Status

4-phenyl-2-butanol is not currently approved as a GRAS substance by the U.S. Food and Drug Administration. This means it cannot be used in food products intended for the U.S. market under the GRAS exemption without obtaining prior FDA approval or authorization.

Use of this compound in food applications would technically require FDA approval through the food additive petition process. In the European Union, this substance may be subject to different regulatory frameworks, and its use status should be verified with EFSA (European Food Safety Authority) regulations.

The absence of GRAS status suggests that either the compound is not widely used in food manufacturing, or manufacturers have not pursued the formal approval process with the FDA.

Key Studies

Publically available toxicological studies specifically focused on 4-phenyl-2-butanol are limited. Most safety assessments for such flavor compounds rely on structural analogues and established toxicity data for similar alcohol compounds.

The general toxicity profile of straight-chain aliphatic alcohols is well-established, with most showing low acute toxicity when used in appropriate quantities as flavoring agents. However, compound-specific studies would be necessary to establish definitive safety parameters for 4-phenyl-2-butanol.

Any manufacturer seeking to establish GRAS status or obtain FDA approval for this compound would need to submit comprehensive safety data, including absorption, distribution, metabolism, and excretion studies, as well as appropriate toxicology testing.

Frequently Asked Questions

What is 4-phenyl-2-butanol?

4-phenyl-2-butanol (CAS 2344-70-9) is an organic compound used as a flavoring agent in food products. It is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA, though no adverse events or recalls have been associated with its use.

Is 4-phenyl-2-butanol safe?

4-phenyl-2-butanol 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 4-phenyl-2-butanol banned in any country?

4-phenyl-2-butanol 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.