Our Verdict: SAFE

3,3,5-trimethylcyclohexyl Acetate

CAS67859-96-5

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

3,3,5-trimethylcyclohexyl Acetate โ€” food additive

3,3,5-trimethylcyclohexyl Acetate is a synthetic flavoring agent used to impart fruity and woody notes in food and beverage products. This cyclohexane derivative is not currently approved as Generally Recognized as Safe (GRAS) by the FDA but 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
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
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 3,3,5-trimethylcyclohexyl Acetate?

3,3,5-trimethylcyclohexyl Acetate (CAS Number: 67859-96-5) is a synthetic organic compound belonging to the class of cyclohexyl acetates. It consists of a cyclohexyl ring with three methyl substituents at the 3, 3, and 5 positions, combined with an acetate ester functional group. This structure is designed to provide specific aromatic properties characteristic of fruity and woody flavor profiles in food applications.

Common Uses

This flavoring agent is primarily used in the food and beverage industry to enhance or create fruity and woody flavor notes. It may be found in formulations for:

- Alcoholic beverages, particularly spirits and liqueurs

- Non-alcoholic flavored drinks

- Confectionery products

- Baked goods

- Dairy products

- Savory food flavoring systems

As a synthetic flavoring, 3,3,5-trimethylcyclohexyl Acetate allows manufacturers to achieve consistent flavor profiles and reduce dependence on natural flavor sources. Its use is typically at very low concentrations, measured in parts per million (ppm).

Safety Assessment

According to FDA records, there have been zero reported adverse events and zero product recalls associated with 3,3,5-trimethylcyclohexyl Acetate. This absence of reported incidents suggests a favorable safety profile in practical use.

However, it is important to note that this additive has not been designated as Generally Recognized as Safe (GRAS) by the FDA. GRAS status is not a requirement for all food additives; rather, it represents a specific regulatory designation based on the substance's history of safe use or extensive scientific evidence. The lack of GRAS status does not necessarily indicate safety concerns but rather reflects the specific regulatory pathway and approval status for this particular compound.

The chemical structure of 3,3,5-trimethylcyclohexyl Acetateโ€”a simple acetate ester with a cyclohexyl backboneโ€”is consistent with many approved flavoring compounds. Acetate esters are widely used in the flavor industry and are generally considered safe when used at appropriate concentrations.

Regulatory Status

In the United States, 3,3,5-trimethylcyclohexyl Acetate operates under FDA regulations for synthetic flavoring substances. While not GRAS-listed, it may be used in food if it complies with applicable FDA regulations and limitations.

The European Food Safety Authority (EFSA) maintains its own approval processes for flavoring substances. Food manufacturers should verify compliance with specific regional regulations before use, as approval status may differ between jurisdictions.

Manufacturers using this flavoring agent must ensure:

- Compliance with local and national food additive regulations

- Proper declaration on product labels where required

- Use at concentrations that do not exceed established safety limits

- Documentation of sourcing and purity standards

Key Studies

Limited published scientific literature specifically addresses 3,3,5-trimethylcyclohexyl Acetate in isolation. Safety data for this compound would primarily derive from:

- Manufacturer safety data sheets and toxicological assessments

- Industry testing following standard protocols for synthetic flavoring substances

- General safety literature on structurally similar cyclohexyl acetates and acetate esters

- Post-market surveillance data collected by regulatory agencies

The broader chemical class of cyclohexyl acetates has been studied for flavor applications, with safety profiles generally established through standard toxicology testing paradigms including acute toxicity, repeat-dose toxicity, and genotoxicity assessments.

As with all food additives, regulatory agencies continue to monitor scientific literature for any emerging safety concerns. The zero adverse event reports on file suggest this compound has maintained a satisfactory safety record in commercial food applications.

Frequently Asked Questions

What is 3,3,5-trimethylcyclohexyl Acetate?

3,3,5-trimethylcyclohexyl Acetate is a synthetic flavoring agent used to impart fruity and woody notes in food and beverage products. This cyclohexane derivative is not currently approved as Generally Recognized as Safe (GRAS) by the FDA but has not been associated with reported adverse events or product recalls.

Is 3,3,5-trimethylcyclohexyl Acetate safe?

3,3,5-trimethylcyclohexyl Acetate 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 3,3,5-trimethylcyclohexyl Acetate banned in any country?

3,3,5-trimethylcyclohexyl Acetate 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.