Our Verdict: RATING UNKNOWN

Tetrahydrolinalool

CAS78-69-3

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

Tetrahydrolinalool — food additive

Tetrahydrolinalool (CAS 78-69-3) is a synthetic flavoring compound derived from linalool, commonly used to impart floral and fresh notes in food and beverage products. It functions as a flavoring agent or adjuvant in various food applications.

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 Tetrahydrolinalool?

Tetrahydrolinalool is a synthetic aromatic compound with the CAS number 78-69-3. It is chemically derived from linalool, a naturally occurring terpene alcohol found in plants such as lavender, basil, and coriander. The compound is created through hydrogenation of linalool, which adds hydrogen atoms to its molecular structure, resulting in a more stable and shelf-stable flavoring ingredient. Tetrahydrolinalool is classified as a flavoring agent or adjuvant, meaning it is used to enhance, modify, or round out the flavor profile of food and beverage products.

Common Uses

Tetrahydrolinalool is primarily used in the food and beverage industry as a flavoring component. Its applications include:

- **Beverages**: Non-alcoholic drinks, soft drinks, and flavored waters where floral or fresh notes are desired

- **Confectionery**: Candies, chewing gums, and baked goods requiring subtle flavor enhancement

- **Dairy Products**: Yogurts, ice creams, and flavored milk products

- **Personal Care Integration**: While primarily a food additive, it is also used in cosmetic and fragrance applications

The compound is valued for its stability compared to natural linalool, which can be prone to oxidation and degradation during storage and processing. This stability makes it useful for manufacturers seeking consistent flavor profiles across production batches.

Safety Assessment

Tetrahydrolinalool has not been formally evaluated by the FDA under the Generally Recognized as Safe (GRAS) program, meaning it lacks official FDA GRAS status. However, the absence of approved GRAS status does not necessarily indicate safety concerns. Instead, it reflects that no formal GRAS petition has been submitted or approved through FDA channels.

Importantly, the FDA Adverse Events Reporting System (FAERS) contains zero documented adverse events associated with tetrahydrolinalool consumption. Additionally, there are no FDA-recorded recalls linked to this ingredient. These factors suggest that any safety issues with this compound are not evident from post-market surveillance data in the United States.

The compound's chemical similarity to linalool—a naturally occurring substance with a long history of use in foods and beverages—provides some basis for assuming a reasonable safety profile, though this is not a guarantee. Like all synthetic flavoring agents, tetrahydrolinalool undergoes toxicological evaluation by manufacturers and regulatory bodies before market introduction in regulated jurisdictions.

Regulatory Status

In the United States, tetrahydrolinalool exists in a regulatory category sometimes referred to as a "flavor ingredient of commerce" or is used under FDA's flavor ingredient regulations (21 CFR Part 182). While it does not hold explicit FDA GRAS certification, it may be used in foods under certain regulatory frameworks if manufacturers comply with applicable food additive regulations and safety standards.

The European Food Safety Authority (EFSA) and other international regulatory bodies may have separate evaluations and approval statuses for this ingredient. Manufacturers using tetrahydrolinalool must ensure compliance with regulations in each country or region where products are sold, as requirements vary globally.

Key Studies

Limited published scientific literature specifically addresses tetrahydrolinalool in isolation. Most research on related compounds focuses on linalool itself, the parent compound from which tetrahydrolinalool is derived. Linalool has been extensively studied and generally recognized as safe at typical consumption levels. Studies on linalool indicate low acute toxicity and minimal genotoxic or reproductive hazards at relevant exposure levels.

Manufacturers conducting safety assessments for tetrahydrolinalool typically rely on structure-activity relationships (SAR) comparing it to well-characterized compounds, toxicological testing protocols, and historical use data. The lack of reported adverse events in FDA databases provides additional reassurance regarding its safety profile in actual use conditions.

Further peer-reviewed research and formal safety assessments would provide additional clarity on this ingredient's toxicological profile and appropriate use levels.

Frequently Asked Questions

What is Tetrahydrolinalool?

Tetrahydrolinalool (CAS 78-69-3) is a synthetic flavoring compound derived from linalool, commonly used to impart floral and fresh notes in food and beverage products. It functions as a flavoring agent or adjuvant in various food applications.

Is Tetrahydrolinalool safe?

Tetrahydrolinalool 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 Tetrahydrolinalool banned in any country?

Tetrahydrolinalool 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.