Our Verdict: SAFE

Amyris, Oil (amyris Balsamifera L.)

CAS8015-65-4

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

Amyris, Oil (amyris Balsamifera L.) โ€” food additive

Amyris oil is a volatile essential oil derived from the West Indian sandalwood tree (Amyris balsamifera L.), used as a flavoring agent in food products. It imparts warm, woody, and slightly balsamic notes to beverages, confections, and other food applications.

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 Amyris Oil?

Amyris oil, also known as West Indian sandalwood oil, is a volatile essential oil extracted from the wood of Amyris balsamifera L., a tropical tree native to the Caribbean and Central America. The oil is obtained through steam distillation of the wood and contains a complex mixture of volatile compounds, including sesquiterpenes and their derivatives. Its chemical composition gives it characteristic warm, woody, and slightly sweet balsamic aromatic properties that make it valuable in the flavor industry.

Common Uses

Amyris oil functions as a flavoring agent and flavoring adjuvant in food and beverage applications. It is commonly used in small quantities to enhance the flavor profiles of:

- Alcoholic beverages, particularly rum and other spirits

- Non-alcoholic beverages

- Confectionery and candy products

- Baked goods

- Fragranced food products

The oil's warm, woody character makes it particularly suitable for products seeking to add depth and sophistication to their flavor complexity. Typical usage levels are very low, measured in parts per million, as the oil is highly concentrated.

Safety Assessment

Amyris oil has been used in food flavoring for decades without documented adverse events reported to the FDA. The FDA database shows zero recorded adverse events and zero recalls associated with this additive. Essential oils, as a category, generally have a long history of safe use in food applications when used at appropriate levels.

The safety profile of amyris oil is supported by its volatilityโ€”the compounds that provide its flavor characteristics are typically not present in significant quantities in final food products, as many volatile components dissipate during food processing and storage. The oil's use is typically limited to small amounts in formulations, further reducing exposure.

As with most essential oils used in flavoring, individuals with known sensitivities to sesquiterpenes or aromatic compounds should be aware of products containing this ingredient, though adverse reactions are uncommon at food use levels.

Regulatory Status

Amyris oil has not been granted GRAS (Generally Recognized As Safe) status by the FDA, which means it has not undergone the formal FDA GRAS notification process. However, this designation does not indicate safety concerns; rather, it reflects that formal GRAS documentation may not have been submitted or completed for this particular ingredient.

The ingredient is permitted for use as a flavoring agent under FDA regulations (21 CFR 182.60), which allows certain essential oils and natural extractives to be used in food. Its continued use in commercial food applications without regulatory action or documented safety issues indicates regulatory acceptance of its safety at typical use levels.

The European Food Safety Authority (EFSA) does not maintain specific restrictions on amyris oil in food flavoring applications, consistent with its long history of safe use in food products across multiple regulatory jurisdictions.

Key Studies

While extensive published scientific literature specifically focused on amyris oil's safety in food applications is limited, the safety of essential oils as flavoring agents has been well-documented. The composition of amyris oil has been characterized through gas chromatography-mass spectrometry, identifying its primary components as sesquiterpenes, which are common constituents of food-grade essential oils.

The ingredient's safety is supported by decades of commercial use without documented adverse events, the low concentrations used in food products, and the volatile nature of its key flavor compounds. The lack of reported safety concerns from regulatory agencies, manufacturers, and consumers provides additional evidence of its acceptable safety profile when used as intended in food flavoring applications.

Research on essential oils generally demonstrates that when used at typical food flavoring levels, they present minimal toxicological risk to consumers.

Frequently Asked Questions

What is Amyris, Oil (amyris Balsamifera L.)?

Amyris oil is a volatile essential oil derived from the West Indian sandalwood tree (Amyris balsamifera L.), used as a flavoring agent in food products. It imparts warm, woody, and slightly balsamic notes to beverages, confections, and other food applications.

Is Amyris, Oil (amyris Balsamifera L.) safe?

Amyris, Oil (amyris Balsamifera 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 Amyris, Oil (amyris Balsamifera L.) banned in any country?

Amyris, Oil (amyris Balsamifera 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.