Our Verdict: RATING UNKNOWN

Balsam, Peru (myroxylon Pereirae Klotzsch)

CAS8007-00-9

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

Balsam, Peru (myroxylon Pereirae Klotzsch) — food additive

Peru Balsam is a natural resinous extract from the Myroxylon Pereirae tree used as a flavoring agent in food products. It contributes vanilla, cinnamon, and spice-like notes to various food formulations.

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 Balsam, Peru?

Peru Balsam (myroxylon Pereirae Klotzsch) is a naturally derived resinous substance obtained from the trunk of the Myroxylon Pereirae tree, native to El Salvador and other Central American regions. The balsam is collected by making incisions in the bark and allowing the resinous exudate to accumulate, which is then scraped and refined. Also known as Peruvian balsam or Peru balm, it has been used for centuries in traditional medicine and more recently in food flavoring applications. The substance contains aromatic compounds including benzyl benzoate, cinnamein, and vanillin, which contribute to its characteristic warm, spicy-vanilla aromatic profile.

Common Uses

Peru Balsam functions primarily as a flavoring agent and flavoring adjuvant in food manufacturing. It is used in small quantities to enhance the flavor profiles of various food products, contributing warm spice, vanilla, and cinnamon-like notes. Applications include beverages, confections, baked goods, and other processed foods where such aromatic characteristics are desired. The additive is typically used at low concentrations due to its potent aromatic properties. Beyond food applications, Peru Balsam has historical use in pharmaceutical and cosmetic formulations, though food use remains relatively specialized.

Safety Assessment

Peru Balsam has not been granted GRAS (Generally Recognized as Safe) status by the FDA, indicating that it does not have widespread recognition of safety through long-standing common use in food. However, the FDA's Adverse Events database contains zero reported adverse events associated with this additive, and no product recalls have been initiated due to Peru Balsam contamination or safety concerns. This lack of reported incidents suggests minimal acute toxicity at typical food use levels.

Historically, Peru Balsam has been used in traditional medicine and some cosmetic applications, which provides limited evidence of use in human populations. The compound has been studied in dermatological contexts, as some individuals may develop contact sensitivity to Peru Balsam when exposed through cosmetic or topical applications. However, ingestion through food products presents a different exposure route and risk profile than dermal contact. The lack of widespread epidemiological data specific to food consumption prevents definitive safety conclusions at this time.

Regulatory Status

In the United States, Peru Balsam is not listed as GRAS for food use, which means it operates under the Food Additive Amendment and technically requires pre-market approval for food applications. However, its presence in the market suggests it may be used under specific regulatory allowances or in products that have not triggered FDA enforcement action. The regulatory status varies internationally; some countries permit limited use of natural flavoring substances with historical use patterns, while others may have different approval pathways for traditional plant-derived ingredients.

Manufacturers seeking to use Peru Balsam in food products should verify current FDA guidance and may need to establish their own safety documentation or obtain specific regulatory clearance depending on intended use levels and target food categories.

Key Studies

Limited peer-reviewed research specifically addresses Peru Balsam's safety as a food additive. Most scientific literature examines Peru Balsam in dermatological or cosmetic contexts rather than food applications. Studies on contact dermatitis have identified that some individuals may develop allergic sensitization to Peru Balsam components, though this typically occurs with repeated dermal exposure rather than occasional dietary exposure. The chemical composition has been well-characterized through phytochemical analyses, confirming the presence of aromatic compounds responsible for its flavor properties.

The absence of published adverse event data in the food science literature, combined with zero FDA-reported adverse events, suggests that food-level exposures have not generated safety signals worthy of investigation or regulatory action.

Frequently Asked Questions

What is Balsam, Peru (myroxylon Pereirae Klotzsch)?

Peru Balsam is a natural resinous extract from the Myroxylon Pereirae tree used as a flavoring agent in food products. It contributes vanilla, cinnamon, and spice-like notes to various food formulations.

Is Balsam, Peru (myroxylon Pereirae Klotzsch) safe?

Balsam, Peru (myroxylon Pereirae Klotzsch) 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 Balsam, Peru (myroxylon Pereirae Klotzsch) banned in any country?

Balsam, Peru (myroxylon Pereirae Klotzsch) 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.