Our Verdict: RATING UNKNOWN

Ambrette, Tincture (hibiscus Abelmoschus L.)

CAS977017-78-9

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, Tincture (hibiscus Abelmoschus L.) — food additive

Ambrette tincture is a flavoring agent derived from hibiscus Abelmoschus L., a plant native to tropical regions. It is used in the food industry to impart distinctive floral and musky flavor notes to various food products.

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, Tincture?

Ambrette tincture (CAS Number: 977017-78-9) is a liquid flavoring extract obtained from Abelmoschus moschatus, commonly known as ambrette or musk mallow. The plant belongs to the Malvaceae family and is cultivated primarily in tropical and subtropical climates. The tincture is produced through the extraction of flavor compounds from the plant material, typically using solvent extraction methods. Ambrette has been traditionally used in perfumery and, more recently, in food flavoring applications.

Common Uses

Ambrette tincture functions as a flavoring agent in the food industry, classified as a flavoring agent or adjuvant. It is used in small concentrations to provide unique floral, slightly musky, and warm flavor characteristics. The compound is employed in various food categories including beverages, confectionery, baked goods, and dairy products. Its distinctive aromatic profile makes it valuable for creating complex flavor compositions in premium or artisanal food products. The actual usage levels in commercial food products are typically minimal, reflecting the potent nature of the flavoring compound.

Safety Assessment

Ambrette tincture has not been classified as Generally Recognized As Safe (GRAS) by the FDA. However, the lack of GRAS status does not necessarily indicate safety concerns; rather, it reflects the limited petition or notification submissions for this particular ingredient. The FDA maintains zero reported adverse events associated with this additive, indicating no documented cases of consumer harm linked to its use. Additionally, there are zero FDA recalls involving ambrette tincture, suggesting that products containing this ingredient have not posed documented public health threats requiring regulatory intervention.

The absence of adverse event reports and recalls provides a form of post-market safety surveillance data. However, the limited regulatory attention to this ingredient means that comprehensive toxicological studies may not be extensively documented in the public domain. The traditional use of Abelmoschus moschatus in various cultural food preparations suggests historical acceptance, though historical use does not establish modern food safety standards.

Regulatory Status

Ambrette tincture's regulatory status varies internationally. While not GRAS-listed in the United States, it may be permitted in certain food categories under FDA regulations for natural flavoring substances. The European Food Safety Authority (EFSA) has not provided a specific safety assessment for ambrette tincture in their comprehensive database of food additives. Countries within the European Union may have varying regulations regarding its use in food products.

Manufacturers seeking to use ambrette tincture in food products should verify compliance with current regulations in their specific jurisdiction, as regulatory frameworks continue to evolve. The ingredient may require specific labeling declarations depending on local requirements.

Key Studies

Limited peer-reviewed scientific literature is publicly available specifically addressing the safety of ambrette tincture as a food additive. Research on Abelmoschus moschatus has primarily focused on traditional medicinal uses and phytochemical composition rather than food safety assessments. The phytochemical profile of ambrette includes various aromatic compounds, though detailed constituent analysis of commercial tincture preparations varies by manufacturer.

Further toxicological studies, including acute and subchronic toxicity assessments, would be beneficial for establishing comprehensive safety data. Any manufacturer or researcher seeking additional information should consult current scientific literature and regulatory guidance documents from the FDA and relevant international food safety authorities.

Frequently Asked Questions

What is Ambrette, Tincture (hibiscus Abelmoschus L.)?

Ambrette tincture is a flavoring agent derived from hibiscus Abelmoschus L., a plant native to tropical regions. It is used in the food industry to impart distinctive floral and musky flavor notes to various food products.

Is Ambrette, Tincture (hibiscus Abelmoschus L.) safe?

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

Ambrette, Tincture (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.