Our Verdict: RATING UNKNOWN

Perilla Leaf Oil

CAS977186-33-6

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

Perilla Leaf Oil — food additive

Perilla Leaf Oil is a natural flavoring agent derived from perilla leaves, used to impart distinctive aromatic and taste characteristics to food products. It functions as a flavoring adjuvant in the food industry, though it has not received FDA GRAS (Generally Recognized as Safe) status.

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 Perilla Leaf Oil?

Perilla Leaf Oil (CAS Number: 977186-33-6) is an essential oil extracted from the leaves of Perilla frutescens, an herbaceous plant native to East and Southeast Asia. The oil is obtained through various extraction methods, including steam distillation or solvent extraction, and contains volatile aromatic compounds characteristic of the perilla plant. These compounds contribute distinctive sensory properties to food formulations.

Common Uses

Perilla Leaf Oil is primarily used as a flavoring agent and flavoring adjuvant in the food industry. It is employed in beverages, confectionery, savory products, and other food applications where its characteristic aromatic profile is desired. The oil's flavor compounds provide sensory complexity and are valued in specialty food formulations seeking natural or botanical flavor profiles. In traditional food systems, particularly in Asian cuisines, perilla leaves have long been used as both a culinary ingredient and flavoring component.

Safety Assessment

No adverse events related to Perilla Leaf Oil have been reported to the FDA, and no food recalls involving this additive have been documented in FDA databases. The absence of reported safety incidents suggests minimal acute toxicity concerns at typical food use levels. However, the lack of FDA GRAS status indicates that the ingredient has not undergone the formal safety review process required for that designation in the United States.

Like other plant-derived essential oils, Perilla Leaf Oil contains naturally occurring compounds that warrant consideration. Some perilla oil constituents, particularly if concentrated, may pose considerations for certain sensitive populations. The safety profile would be influenced by the specific extraction method, purity level, and concentration used in food applications. Dermal exposure or ingestion of undiluted essential oils can differ significantly from exposure through flavored food products containing minute quantities.

Regulatory Status

Perilla Leaf Oil does not hold FDA GRAS status, meaning it has not been formally recognized as safe for its intended use by the FDA's established review processes. However, this does not indicate the substance is unsafe—rather, it reflects that a formal safety petition or GRAS notice has not been submitted or approved. The ingredient may be used in food under FDA regulations for color additives and substances generally recognized as safe, or under specific authorization for particular uses.

Regulatory treatment varies internationally. In the European Union, botanical extracts and essential oils are subject to EFSA (European Food Safety Authority) evaluation for food additive status. The regulatory classification of perilla products may differ between jurisdictions based on their respective safety assessment frameworks.

Key Studies

Scientific literature on Perilla frutescens demonstrates its use in traditional medicine systems and food applications across Asia. Research has identified various volatile compounds in perilla leaf oil, including perillaldehyde, limonene, and other terpenes. However, formal toxicology studies specifically designed to support food additive safety petitions do not appear to have been published in peer-reviewed literature or submitted to regulatory agencies.

The absence of reported adverse events and recalls suggests that any historical food use has not generated safety signals. However, comprehensive safety data from controlled studies—such as acute toxicity testing, subchronic studies, and allergenicity assessments—would typically be expected to support GRAS status or regulatory approval in major markets.

Prospective manufacturers or importers considering use of Perilla Leaf Oil should conduct appropriate safety assessments aligned with their target market's regulatory requirements and consider whether submission of a formal GRAS notice or food additive petition would be advantageous for regulatory compliance.

Frequently Asked Questions

What is Perilla Leaf Oil?

Perilla Leaf Oil is a natural flavoring agent derived from perilla leaves, used to impart distinctive aromatic and taste characteristics to food products. It functions as a flavoring adjuvant in the food industry, though it has not received FDA GRAS (Generally Recognized as Safe) status.

Is Perilla Leaf Oil safe?

Perilla Leaf Oil 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 Perilla Leaf Oil banned in any country?

Perilla Leaf Oil 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.