Our Verdict: SAFE

Clary, Oil (salvia Sclarea L.)

CAS8016-63-5

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

Clary, Oil (salvia Sclarea L.) — food additive

Clary oil is an essential oil derived from the clary sage plant (Salvia sclarea L.) used as a flavoring agent in food products. It imparts herbal, slightly floral notes and is employed in beverages, confectionery, and other food applications to enhance flavor profiles.

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
ApprovedHealth 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 Clary Oil?

Clary oil (CAS Number 8016-63-5) is an essential oil extracted from the clary sage plant, scientifically known as Salvia sclarea L. The oil is obtained through steam distillation or solvent extraction of the plant's leaves and flowering tops. Clary oil contains various volatile organic compounds including linalyl acetate, linalool, and geranyl acetate, which contribute to its characteristic herbal and slightly fruity aroma. As a natural flavoring agent, it represents one of many botanically-derived additives used in the food industry.

Common Uses

Clary oil functions as a flavoring agent and flavoring adjuvant in food products. Its primary applications include:

- Alcoholic beverages, particularly vermouths and liqueurs

- Non-alcoholic drinks and soft beverages

- Confectionery and candy products

- Baked goods and grain-based foods

- Savory products where herbal notes are desired

- Dairy products and ice cream

The oil is typically used in very small quantities—often measured in parts per million—to achieve the desired flavor impact without overwhelming the end product. Food manufacturers value clary oil for its ability to provide depth and complexity to flavor formulations.

Safety Assessment

Clary oil has a favorable safety profile based on available evidence. The FDA has recorded zero adverse events associated with this additive in its adverse event reporting system. Additionally, no recalls related to clary oil have been documented in FDA records, suggesting a history of safe use in food applications.

The essential oil is generally recognized as safe when used as a flavoring ingredient at levels typical for food applications. Toxicological studies on clary oil and its primary constituents have not identified significant safety concerns at food use levels. The oil's long history of use in culinary and traditional applications provides additional support for its general safety.

It is important to note that while clary oil is considered safe as a food additive, essential oils in general should not be ingested in concentrated forms outside of food applications, and internal medicinal use should only occur under professional guidance.

Regulatory Status

Clary oil does not hold FDA GRAS (Generally Recognized As Safe) status, which means it has not undergone the formal GRAS notification process. However, this absence of GRAS status does not indicate safety concerns; rather, it reflects that manufacturers have not submitted a GRAS determination petition for this particular additive to the FDA.

The additive is permitted for use in food flavoring applications under FDA regulations as a food additive. In the European Union, clary oil is listed in the Community list of flavoring substances and is permitted for use in food products under EFSA guidance.

The lack of reported adverse events and recalls in FDA databases, combined with its acceptance in multiple regulatory jurisdictions, indicates regulatory confidence in its safety profile when used as intended.

Key Studies

While specific published toxicological studies on clary oil as a food additive are limited in public literature, the safety profile is supported by:

- General toxicological data on the plant and its major volatile constituents

- Long historical use in food, beverage, and fragrance applications

- Absence of adverse event reports in FDA systems

- Acceptance by EFSA and inclusion in European flavor databases

- Low concentrations required for flavoring effectiveness, resulting in minimal dietary exposure

The lack of reported safety concerns combined with decades of use in food products suggests that clary oil, when used at typical food flavoring levels, does not pose identified health risks to consumers.

Frequently Asked Questions

What is Clary, Oil (salvia Sclarea L.)?

Clary oil is an essential oil derived from the clary sage plant (Salvia sclarea L.) used as a flavoring agent in food products. It imparts herbal, slightly floral notes and is employed in beverages, confectionery, and other food applications to enhance flavor profiles.

Is Clary, Oil (salvia Sclarea L.) safe?

Clary, Oil (salvia Sclarea L.) 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 Clary, Oil (salvia Sclarea L.) banned in any country?

Clary, Oil (salvia Sclarea L.) 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.