Our Verdict: RATING UNKNOWN

Birch Tar, Oil (betula Pendula Roth And Related Betula Spp.)

CAS8001-88-5

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

Birch Tar, Oil (betula Pendula Roth And Related Betula Spp.) — food additive

Birch tar oil is a flavoring agent derived from the bark of birch trees (Betula pendula and related species). It is used sparingly in food production to impart smoky, woody flavoring characteristics, though it is not approved as a Generally Recognized as Safe (GRAS) ingredient 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
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 Birch Tar, Oil?

Birch tar oil (CAS Number 8001-88-5) is a complex mixture of organic compounds extracted from the bark of birch trees, primarily Betula pendula Roth and related Betula species. The oil is obtained through dry distillation or destructive distillation of birch bark, producing a dark, viscous liquid with a characteristic smoky, resinous aroma. The composition includes phenolic compounds, aromatic hydrocarbons, and other volatile organic compounds that contribute to its sensory properties.

Common Uses

Birch tar oil is employed as a flavoring agent in food production, primarily to add smoky and woody notes to products. Its use is limited and specialized, appearing in some European food formulations, particularly in traditional or artisanal products. The additive functions as a flavoring adjuvant, meaning it enhances or modifies the taste profile of foods rather than serving as a primary ingredient. Applications may include smoked meat products, certain beverages, or specialty food preparations, though such uses remain relatively niche in the global food industry.

Safety Assessment

Birch tar oil has not been formally evaluated or approved by the FDA as a Generally Recognized as Safe (GRAS) ingredient for food use in the United States. However, the FDA database contains zero reported adverse events and zero recalls associated with this additive. The absence of reported adverse events does not necessarily indicate comprehensive safety data, but rather reflects limited documented complaints or identified safety incidents in the FDA's voluntary reporting system.

In the European Union, birch tar oil has received attention from the European Food Safety Authority (EFSA) as part of evaluations of flavoring substances. The EFSA has assessed certain birch tar preparations under its flavoring evaluation program. Traditional use of birch tar in Nordic and Eastern European cuisines suggests long-standing human exposure in specific populations, though formal toxicological studies specific to food-grade birch tar oil are limited in the public scientific literature.

The primary safety considerations for birch tar oil relate to its composition, which includes compounds such as catechol and other phenolic substances that may have biological activity. Exposure through food is typically minimal due to the small quantities used as a flavoring agent, which generally falls below levels of concern for regulatory agencies when properly applied.

Regulatory Status

Birch tar oil is not GRAS-approved in the United States, meaning manufacturers cannot legally use it in food under the GRAS exemption. Any use in U.S. food products would technically require either FDA pre-approval as a food additive or authorization under a different regulatory pathway, making its use in American foods extremely limited or non-existent in mainstream commercial products.

In the European Union, birch tar oil may be permitted as a natural flavoring substance under Regulation (EC) No 1334/2008, subject to specific conditions and purity criteria. Its approval status varies by member state, and it may be listed in EU flavoring substance databases with established specifications.

Key Studies

Formal peer-reviewed toxicological studies specifically examining food-grade birch tar oil are sparse in publicly available scientific literature. Most safety information derives from: (1) historical use data in traditional Nordic and Eastern European food practices, (2) general toxicology data on birch tar compounds from industrial and pharmaceutical applications, and (3) EFSA flavoring evaluations of related substances.

The absence of extensive modern safety studies reflects both the narrow scope of use and regulatory positioning of this additive. Regulatory agencies typically conduct risk assessment based on intended use levels, chemical composition, and any available toxicity data for component compounds.

Frequently Asked Questions

What is Birch Tar, Oil (betula Pendula Roth And Related Betula Spp.)?

Birch tar oil is a flavoring agent derived from the bark of birch trees (Betula pendula and related species). It is used sparingly in food production to impart smoky, woody flavoring characteristics, though it is not approved as a Generally Recognized as Safe (GRAS) ingredient by the FDA.

Is Birch Tar, Oil (betula Pendula Roth And Related Betula Spp.) safe?

Birch Tar, Oil (betula Pendula Roth And Related Betula Spp.) 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 Birch Tar, Oil (betula Pendula Roth And Related Betula Spp.) banned in any country?

Birch Tar, Oil (betula Pendula Roth And Related Betula Spp.) 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.