Our Verdict: RATING UNKNOWN

4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one

CAS13215-88-8

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-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one — food additive

4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one (CAS 13215-88-8) is a synthetic organic compound used as a flavoring agent in food products. It is not approved as a Generally Recognized As Safe (GRAS) substance 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 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one?

4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one is a synthetic flavoring compound with the CAS number 13215-88-8. It belongs to the class of organic molecules known as unsaturated ketones and contains a cyclohexene ring structure with a butenyl side chain. This compound is produced through chemical synthesis rather than isolation from natural sources, though its structure may resemble compounds found in nature.

Common Uses

This additive functions as a flavoring agent or flavoring adjuvant in food products. Flavoring agents are used in small quantities to impart or enhance taste and aroma characteristics in processed foods, beverages, confections, and other food applications. The specific sensory profile this compound provides—likely fruity, floral, or woody notes given its chemical structure—determines its application in particular food categories. However, detailed information about specific food applications and concentration levels used is limited in publicly available databases.

Safety Assessment

The FDA has received zero adverse event reports associated with this additive, and no product recalls have been linked to its use. This lack of reported safety incidents suggests that if the compound is being used in food, it has not generated consumer health concerns that reached regulatory attention.

However, the absence of adverse reports does not constitute formal safety approval. The additive has not achieved GRAS (Generally Recognized As Safe) status with the FDA, which means it has not undergone the rigorous safety review process required for unrestricted use in foods. GRAS status typically requires either prior safe use history in food before 1958, or a formal petition with supporting toxicological and safety data submitted to the FDA.

Limited published scientific literature is available on the toxicological properties of this specific compound. Standard safety assessments for flavoring agents typically evaluate acute toxicity, subchronic toxicity, genotoxicity, and potential allergenicity. Without access to comprehensive safety data, the complete safety profile remains incompletely characterized.

Regulatory Status

In the United States, this compound does not have GRAS status. This means any food manufacturer wishing to use it would need to either demonstrate a history of safe use prior to 1958, or submit a Food Additive Petition to the FDA with supporting safety data. The lack of GRAS status limits its legal use in mainstream food products in the United States.

International regulatory status varies by country. The European Union's approach to flavoring substances involves evaluation through the EFSA (European Food Safety Authority), and inclusion on approved flavoring lists. This compound's status in EU regulations should be verified through the current FLAVIS database for comprehensive international information.

Key Studies

Publicly available peer-reviewed studies specifically evaluating 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one are limited. Safety data may exist in proprietary industry toxicology reports or FDA submissions that are not publicly disclosed. Any manufacturer seeking approval would need to generate or compile relevant safety studies including absorption, distribution, metabolism, and excretion (ADME) data, as well as standard toxicology testing protocols.

For consumers and manufacturers seeking detailed safety information, direct contact with regulatory agencies or review of specific food additive petitions (if filed) would provide the most current and comprehensive data.

Frequently Asked Questions

What is 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one?

4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one (CAS 13215-88-8) is a synthetic organic compound used as a flavoring agent in food products. It is not approved as a Generally Recognized As Safe (GRAS) substance by the FDA.

Is 4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one safe?

4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one 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-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one banned in any country?

4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one 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.