Our Verdict: RATING UNKNOWN

Amyris (amyris Balsamifera L.)

CAS977059-69-0

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

Amyris (amyris Balsamifera L.) — food additive

Amyris (Amyris balsamifera L.) is a natural flavoring agent derived from the wood of the amyris tree, native to the Caribbean and Central America. It is used in food and beverage products to impart woody, warm, and slightly balsamic flavor notes.

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 Amyris?

Amyris, scientifically known as Amyris balsamifera L., is a flavoring ingredient derived from the heartwood of the amyris tree, a tropical hardwood species native to the Caribbean region, particularly Jamaica, and parts of Central America. The tree produces aromatic wood that has been traditionally valued for its pleasant fragrance and flavor profile. In food applications, amyris extract or essential oil is used as a flavoring agent to provide woody, warm, and subtly balsamic taste characteristics.

The ingredient is typically processed into essential oils or concentrated extracts that capture the aromatic compounds responsible for its sensory properties. These compounds include sesquiterpenes and other volatile organic compounds that contribute to its distinctive flavor profile.

Common Uses

Amyris is employed as a flavoring agent in various food and beverage products, including:

- Alcoholic beverages, particularly spirits and liqueurs

- Non-alcoholic beverages

- Confectionery and candy products

- Baked goods

- Dairy products

- Savory food applications

The ingredient is valued in the flavor industry for its ability to add depth and complexity to formulations, particularly in products where warm, woody, or slightly oriental flavor notes are desired. It is typically used in very small quantities, as is standard practice with concentrated flavoring agents.

Safety Assessment

Amyris has not been formally evaluated by the FDA's Generally Recognized As Safe (GRAS) program, meaning it does not have official GRAS status in the United States. However, it has been used traditionally and in commercial food applications without documented adverse events reported to the FDA. As of available records, there are zero reported adverse events and zero recalls associated with amyris in the FDA database.

The absence of regulatory approval does not necessarily indicate a safety concern; rather, it reflects that formal GRAS notification or food additive petition processes have not been completed for this ingredient in the United States. Many natural flavoring ingredients operate in this regulatory space, having historical use or being subject to less formal regulatory pathways.

Safety considerations for amyris are generally similar to other natural essential oils and wood extracts. Individuals with sensitivities to tree products or fragrance compounds should exercise caution. As with all concentrated flavoring agents, amyris is used in extremely small quantities in food—typically parts per million—which further minimizes any potential exposure concern.

Regulatory Status

In the United States, amyris does not hold FDA GRAS status and is not listed as an approved food additive under FDA regulations. This means that any food product containing amyris would need to operate under either a prior sanctioned status, a food additive petition, or other regulatory authority.

The regulatory landscape for natural flavoring agents varies by country and region. The European Food Safety Authority (EFSA) and other international regulatory bodies may have different approval statuses for this ingredient. Manufacturers using amyris in food products should verify compliance with regulations in their target markets.

Importers and manufacturers should confirm that their use of amyris complies with applicable FDA regulations and state-level food laws. The ingredient's status as a natural botanical extract may provide different regulatory pathways than synthetic flavoring agents.

Key Studies

Limited peer-reviewed scientific literature is available specifically addressing the safety of amyris as a food additive. Most information derives from traditional use, fragrance industry applications, and general safety profiles of essential oils from similar botanical sources.

Research on structurally similar wood extracts and essential oils suggests that compounds found in amyris are generally recognized as safe at the concentrations used in food flavoring. However, comprehensive toxicology studies specifically designed to evaluate amyris in food applications appear limited in the published scientific literature.

Any manufacturers or researchers interested in establishing formal safety data or pursuing GRAS status would benefit from conducting appropriate toxicology studies and submitting formal petitions to regulatory authorities.

Frequently Asked Questions

What is Amyris (amyris Balsamifera L.)?

Amyris (Amyris balsamifera L.) is a natural flavoring agent derived from the wood of the amyris tree, native to the Caribbean and Central America. It is used in food and beverage products to impart woody, warm, and slightly balsamic flavor notes.

Is Amyris (amyris Balsamifera L.) safe?

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

Amyris (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.