Our Verdict: SAFE

Balm, Oil (melissa Officinalis L.)

CAS8014-71-9

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

Balm, Oil (melissa Officinalis L.) — food additive

Balm oil (melissa officinalis L.) is a natural flavoring extract derived from lemon balm plant leaves, used primarily as a flavor enhancer and flavoring agent in food and beverage products. It imparts a mild lemon-like taste and aroma to various 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
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
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 Balm, Oil (melissa officinalis L.)?

Balm oil, scientifically known as melissa officinalis L., is a volatile oil extracted from the leaves of the common lemon balm plant (Melissa officinalis). The oil is obtained through steam distillation or solvent extraction of fresh or dried plant material. The CAS number 8014-71-9 uniquely identifies this substance in chemical databases. The oil contains numerous volatile compounds including citral, geraniol, linalool, and other terpenes that contribute to its characteristic lemon-like flavor profile and aromatic properties.

Common Uses

Balm oil is used in the food and beverage industry as a flavoring agent and flavor enhancer. It appears in applications including beverages (soft drinks, herbal teas, flavored waters), dairy products, confectionery, baked goods, and culinary preparations. The natural lemon-like flavor makes it particularly suitable for products seeking citrus notes without using citrus fruit concentrates. In pharmaceutical and nutraceutical formulations, it may also serve as a flavoring agent for dietary supplements and herbal preparations.

Safety Assessment

Balm oil derived from melissa officinalis has a long history of culinary and traditional use in European cuisine and herbal medicine. The plant itself is widely recognized as safe for consumption in food applications across multiple regulatory jurisdictions. According to available FDA records, there are zero reported adverse events associated with balm oil and zero documented product recalls, suggesting a favorable safety profile in commercial food use.

The volatile compounds found in lemon balm oil, including citral and geraniol, are commonly found in other approved flavoring substances and essential oils used in food applications. These compounds have been individually assessed in various safety studies. The low levels at which balm oil is typically used as a flavoring (generally below 1-2 ppm in finished products) further support a safe usage profile.

Inhalation or ingestion at extremely high doses may cause mild gastrointestinal irritation in sensitive individuals, consistent with other essential oil-based flavorings, but such occurrences are not documented in normal food consumption patterns. Pregnant and nursing women should consult healthcare providers before consuming products with concentrated herbal extracts, as is standard with all herbal ingredients.

Regulatory Status

Balm oil does not currently hold FDA GRAS (Generally Recognized as Safe) status, meaning it has not undergone the formal GRAS petition process. However, this designation does not indicate safety concerns; rather, it reflects that manufacturers have not submitted formal GRAS applications for this particular ingredient. The substance is permitted for use in food flavoring under FDA regulations as a natural flavoring substance (21 CFR 182.60 permits essential oils and oleoresins from plants not specifically excluded).

In the European Union, melissa officinalis is listed on the EFSA's approved flavoring plant list, and balm oil is recognized as a valid flavoring ingredient in EU food applications under Regulation (EC) No 1334/2008. This broader regulatory acceptance across major markets reflects the ingredient's established safety history.

Key Studies

While balm oil itself has limited published clinical studies specific to food flavoring applications, extensive research exists on melissa officinalis plant extracts and their constituent compounds. Studies on individual components like citral and geraniol demonstrate safety at food-relevant concentrations. The long traditional use of lemon balm in European herbal medicine and culinary applications spanning centuries provides substantial empirical safety data. The absence of adverse event reports in FDA databases over decades of potential use further supports the safety profile of this ingredient at typical food flavoring concentrations.

Frequently Asked Questions

What is Balm, Oil (melissa Officinalis L.)?

Balm oil (melissa officinalis L.) is a natural flavoring extract derived from lemon balm plant leaves, used primarily as a flavor enhancer and flavoring agent in food and beverage products. It imparts a mild lemon-like taste and aroma to various food applications.

Is Balm, Oil (melissa Officinalis L.) safe?

Balm, Oil (melissa Officinalis 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 Balm, Oil (melissa Officinalis L.) banned in any country?

Balm, Oil (melissa Officinalis 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.