Our Verdict: RATING UNKNOWN

Tuberose, Oil (polianthes Tuberosa L.)

CAS8024-05-3

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

Tuberose, Oil (polianthes Tuberosa L.) — food additive

Tuberose oil is a natural flavoring agent derived from the tuberose flower (Polianthes tuberosa L.). It is used in food and beverage applications to impart floral and aromatic characteristics, though it is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA.

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 Tuberose Oil?

Tuberose oil (CAS Number: 8024-05-3) is an essential oil extracted from the flowers of Polianthes tuberosa L., a tropical flowering plant native to Mexico. The oil is obtained through steam distillation or solvent extraction of the tuberose flower petals. It is characterized by a rich, intensely floral and slightly fruity aroma with warm, creamy undertones. The oil contains numerous volatile compounds including indole, methyl anthranilate, and various terpenes that contribute to its distinctive sensory profile.

Common Uses

Tuberose oil is primarily used as a flavoring agent in the food and beverage industry, particularly in:

- Perfumery and fragrance applications

- Liqueurs and alcoholic beverages

- Confectionery products

- Baked goods and desserts

- Beverages including soft drinks and specialty drinks

- Cosmetic and personal care products

The oil is typically used in very small quantities, as its potent aroma requires minimal dosing to achieve desired flavor profiles. It is valued by food manufacturers and flavorists for adding complexity and sophistication to premium food products.

Safety Assessment

According to FDA records, there have been zero reported adverse events associated with tuberose oil and zero product recalls attributed to this ingredient. However, it is important to note that tuberose oil does not currently hold GRAS (Generally Recognized as Safe) status with the FDA, which means it has not undergone the formal review process for safety confirmation at specified levels of use.

The absence of GRAS designation does not necessarily indicate safety concerns. Rather, it suggests that formal toxicological and safety data submissions have not been evaluated through the FDA's GRAS notification process. Many natural flavoring ingredients operate under this status, particularly those from traditional or historical use.

As with most essential oils, tuberose oil should be used at appropriate levels in food applications. Essential oils are potent substances, and excessive consumption of concentrated forms could theoretically cause irritation. However, the levels used in flavored foods are typically minute and well below any concern threshold.

Regulatory Status

In the United States, tuberose oil may be used as a flavoring agent in food products, though without explicit GRAS status. The FDA permits natural flavoring agents, including essential oils, when used in accordance with good manufacturing practices and at levels that achieve the intended flavoring effect without creating safety concerns.

In the European Union, tuberose absolute and tuberose oil are recognized as flavoring substances. However, regulatory frameworks vary by region, and manufacturers must ensure compliance with local regulations when formulating products for specific markets.

The lack of GRAS status means that products containing tuberose oil may not require specific labeling declarations in some jurisdictions where it falls under "natural flavor" or "flavoring" categories, though labeling requirements vary by country and product type.

Key Studies

While tuberose oil has a long history of use in fragrance and traditional applications, published toxicological studies specifically focused on this ingredient are limited in the scientific literature. The safety profile is largely supported by:

- Historical use data and traditional applications

- The absence of adverse event reports in FDA databases

- General safety data on similar floral essential oils

- The minimal concentrations used in food applications

The EFSA (European Food Safety Authority) has evaluated various floral flavoring compounds, though comprehensive assessments of tuberose oil specifically may vary. Manufacturers using this ingredient typically rely on established safety data for similar essential oils and compounds.

Frequently Asked Questions

What is Tuberose, Oil (polianthes Tuberosa L.)?

Tuberose oil is a natural flavoring agent derived from the tuberose flower (Polianthes tuberosa L.). It is used in food and beverage applications to impart floral and aromatic characteristics, though it is not currently approved as a Generally Recognized as Safe (GRAS) substance by the FDA.

Is Tuberose, Oil (polianthes Tuberosa L.) safe?

Tuberose, Oil (polianthes Tuberosa 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 Tuberose, Oil (polianthes Tuberosa L.) banned in any country?

Tuberose, Oil (polianthes Tuberosa 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.