Our Verdict: SAFE

Guaiene

CAS88-84-6

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

Guaiene — food additive

Guaiene is a naturally occurring sesquiterpene compound used as a flavoring agent in food products. It contributes woody, spicy, and herbal notes to various foods and beverages, and is derived from or chemically synthesized to replicate flavors found in natural sources.

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 Guaiene?

Guaiene (CAS Number: 88-84-6) is a sesquiterpene, a class of organic compounds found naturally in essential oils and plant materials. Chemically, it is a hydrocarbon with the molecular formula C15H24. Guaiene exists in different isomeric forms, with guaiene itself being used in the flavor industry. The compound exhibits characteristic woody, warm, and slightly spicy aromatic properties, making it valuable in creating complex flavor profiles in food and beverage applications.

Common Uses

Guaiene is primarily employed as a flavoring agent and flavor adjuvant in the food industry. Its applications include:

- Beverages: Used in alcoholic drinks, spirits, and non-alcoholic beverages to add depth and complexity to flavor profiles

- Confectionery: Added to candies, chewing gums, and other confectionery products

- Baked goods: Incorporated into breads, cookies, and other bakery items

- Dairy products: Used in flavored milk, yogurt, and cheese products

- Savory foods: Applied in seasonings, condiments, and processed meat products

- Fragrances in food: Used to enhance the aromatic characteristics of various food products

Guaiene typically appears in very small concentrations, as is standard for flavor compounds, where even trace amounts can significantly impact the sensory characteristics of food products.

Safety Assessment

Guaiene has not been formally evaluated and approved by the FDA as Generally Recognized as Safe (GRAS). However, this status does not indicate safety concerns; rather, it reflects that the compound has not undergone the specific GRAS notification process with the FDA.

According to available FDA data, there have been zero reported adverse events associated with guaiene consumption, and no product recalls have been initiated due to guaiene. The lack of adverse event reports suggests that the compound has not demonstrated toxicological concerns in real-world use at the concentrations employed in food products.

As a naturally derived or nature-identical sesquiterpene, guaiene belongs to a class of compounds with established use in food flavoring. Many similar sesquiterpenes are recognized as safe flavoring agents in various regulatory jurisdictions. The volatile nature of the compound and its typical use at low concentrations in food products further support its safety profile.

Any safety evaluation would consider typical exposure levels through food consumption, which remain well below theoretical levels that might raise concern for sesquiterpene compounds.

Regulatory Status

Guaiene does not hold FDA GRAS status, meaning it has not been formally notified to the FDA as a GRAS substance. However, absence of GRAS status does not prohibit its use in food products; manufacturers may use it under the FDA's food additive regulations or as a naturally derived flavoring component.

The regulatory approach to guaiene may vary by jurisdiction. In the European Union, flavor compounds are evaluated by the European Food Safety Authority (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings, and Processing Aids (CEF). Specific approval status for guaiene in the EU would require consultation of current flavor compound registries.

The compound's classification as a flavoring agent means it is governed by flavor-specific regulations rather than the general food additive pathway in most jurisdictions, allowing for streamlined oversight based on established flavor use patterns.

Key Studies

While guaiene has not been the subject of extensive independent published research specifically documenting its safety in food applications, it has been evaluated as part of broader sesquiterpene compound assessments. The compound's safety profile is supported by:

- Its presence in naturally occurring essential oils without documented toxicological concerns

- The absence of adverse event reports in FDA databases

- Its structural similarity to other approved flavor compounds

- Typical use at flavor concentrations (generally parts per million levels), which represent minimal dietary exposure

Further specific toxicological studies on guaiene may exist within proprietary flavor industry databases or regulatory submissions not publicly available. The flavor industry maintains extensive safety documentation that supports the continued use of established flavor compounds.

Frequently Asked Questions

What is Guaiene?

Guaiene is a naturally occurring sesquiterpene compound used as a flavoring agent in food products. It contributes woody, spicy, and herbal notes to various foods and beverages, and is derived from or chemically synthesized to replicate flavors found in natural sources.

Is Guaiene safe?

Guaiene 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 Guaiene banned in any country?

Guaiene 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.