Our Verdict: RATING UNKNOWN

Ambrette Seed, Oil (hibiscus Abelmoschus L.)

CAS8015-62-1

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

Ambrette Seed, Oil (hibiscus Abelmoschus L.) — food additive

Ambrette seed oil is a natural flavoring agent derived from the hibiscus Abelmoschus plant, used to impart musky, warm aromatic notes in food and beverage products. It is not currently approved as GRAS (Generally Recognized As Safe) by the FDA, though it has not been associated with reported adverse events or 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
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 Ambrette Seed, Oil?

Ambrette seed oil (CAS Number 8015-62-1) is a volatile essential oil extracted from the seeds of Abelmoschus moschatus, commonly known as ambrette or musk mallow, a member of the hibiscus family. The oil is characterized by a warm, musky aroma with slightly sweet and woody undertones. The primary fragrant compounds in ambrette seed oil include ambrettolide (a macrocyclic musk) and various other volatile organic compounds. This natural product has been traditionally used in perfumery and more recently in food flavoring applications.

Common Uses

Ambrette seed oil functions as a flavoring agent and flavoring adjuvant in the food industry. It is primarily used in beverages, confectionery, baked goods, and other food products where warm, musky, or slightly animalic flavor notes are desired. The oil is often employed in small quantities—typically less than 1% by weight in final food products—due to its potent aromatic profile. It serves both as a direct flavoring component and as an ingredient in complex flavor blends intended to enhance or modify the overall sensory characteristics of food and drink products.

Safety Assessment

Ambrette seed oil presents a mixed safety profile that warrants consideration. The FDA database records zero adverse events and zero recalls associated with this additive, suggesting no documented acute toxicological incidents in the U.S. food supply. However, the absence of reported adverse events does not necessarily indicate extensive safety testing has been completed.

One notable concern involves ambrettolide, the primary macrocyclic musk constituent in ambrette seed oil. Macrocyclic musks have been studied for potential bioaccumulation and endocrine-disrupting properties. Some macrocyclic musks can persist in the environment and bioaccumulate in animal tissues over time. While ambrettolide itself has shown lower bioaccumulation potential compared to certain polycyclic musk compounds, the long-term safety profile of chronic dietary exposure remains incompletely characterized.

Additionally, ambrette seed oil is not listed as GRAS by the FDA, meaning it has not undergone the formal FDA GRAS determination process or has not been submitted for such review. This regulatory status suggests either that manufacturers have not sought GRAS approval or that a determination has not been made based on available scientific evidence.

Regulatory Status

Ambrette seed oil is not FDA GRAS-approved, which means it cannot be freely used in food without prior FDA authorization or a completed GRAS notification. In the European Union, ambrette seed oil may be listed in flavor regulations depending on the specific composition and source material; EU regulations on natural flavoring substances are detailed in Commission Regulation (EC) No. 1334/2008. Its regulatory status varies internationally—some countries may permit its use within defined limits, while others may restrict or prohibit it.

Manufacturers wishing to use ambrette seed oil in food products intended for FDA-regulated markets must either have specific FDA approval or submit a GRAS notice for regulatory evaluation. The lack of GRAS status suggests limited commercial use in mainstream U.S. food products, though it may appear in specialty or imported food items.

Key Studies

Limited peer-reviewed research specifically addresses ambrette seed oil safety in food applications. Available toxicological studies on ambrettolide and related macrocyclic musks have focused primarily on environmental persistence and bioaccumulation potential rather than acute food safety. Dermal and respiratory exposure studies in occupational settings exist, but dietary toxicology data specific to ambrette seed oil are sparse.

The European Food Safety Authority (EFSA) has evaluated certain natural flavor compounds, but ambrette seed oil has not been a primary focus of recent safety assessments. Additional research on long-term dietary exposure, potential endocrine effects, and bioaccumulation in humans would strengthen the safety database for this ingredient.

Frequently Asked Questions

What is Ambrette Seed, Oil (hibiscus Abelmoschus L.)?

Ambrette seed oil is a natural flavoring agent derived from the hibiscus Abelmoschus plant, used to impart musky, warm aromatic notes in food and beverage products. It is not currently approved as GRAS (Generally Recognized As Safe) by the FDA, though it has not been associated with reported adverse events or recalls.

Is Ambrette Seed, Oil (hibiscus Abelmoschus L.) safe?

Ambrette Seed, Oil (hibiscus Abelmoschus L.) 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 Ambrette Seed, Oil (hibiscus Abelmoschus L.) banned in any country?

Ambrette Seed, Oil (hibiscus Abelmoschus 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.