Our Verdict: SAFE

Balm Leaves, Extract (melissa Officinalis L.)

CAS84082-61-1

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 Leaves, Extract (melissa Officinalis L.) — food additive

Balm leaves extract (Melissa officinalis L.) is a natural flavoring agent derived from lemon balm plant material. It is used in food and beverage products to impart a mild lemon-like flavor and aroma, and is generally recognized as safe in traditional culinary 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
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 Balm Leaves, Extract?

Balm leaves extract, derived from Melissa officinalis L. (commonly known as lemon balm), is a natural flavoring ingredient obtained through extraction of the aerial parts of the lemon balm plant. This plant has been used for centuries in traditional European cuisine and herbal preparations. The extract contains volatile compounds including citral, geraniol, and linalool, which contribute to its characteristic mild lemon aroma and flavor profile. The CAS number 84082-61-1 identifies this specific extract product.

Common Uses

Balm leaves extract is primarily used as a flavoring agent in the food and beverage industry. Common applications include:

- Beverages such as herbal teas, soft drinks, and flavored waters

- Confectionery and candy products

- Bakery items and desserts

- Dairy products including yogurts and flavored milk

- Condiments and dressings

- Alcoholic beverages including liqueurs and spirits

The extract serves as both a primary flavoring component and a flavoring adjuvant to enhance or modify taste profiles in finished food products.

Safety Assessment

Lemon balm has an extensive history of safe use in food and traditional medicine across European and Mediterranean cuisines. The extract presents no documented adverse events reported to the FDA and has not been associated with any FDA recalls. The volatile compounds present in the extract are commonly recognized flavor components found in other approved flavoring substances.

Animal and human studies on lemon balm have generally demonstrated safety at typical culinary consumption levels. The plant material and its extracts have been used without documented safety concerns for generations in traditional applications. Toxicology assessments have not identified significant hazard concerns at normal usage levels in food applications.

Individuals with known allergies to plants in the Lamiaceae family (mint family) may wish to exercise caution, though allergic reactions are uncommon. As with all natural products, extract composition may vary based on plant source, harvest conditions, and extraction methods.

Regulatory Status

Balm leaves extract does not currently hold GRAS (Generally Recognized As Safe) status from the FDA in the United States, meaning it has not undergone the formal GRAS affirmation process. However, this classification does not indicate that the ingredient is unsafe; rather, it reflects the formal regulatory pathway chosen by manufacturers and regulatory agencies.

The ingredient is permitted for use in food products under FDA regulations as a natural flavoring substance. In the European Union, Melissa officinalis is listed in the Register of Flavouring Substances and may be used under Regulation (EC) No 1334/2008. Various other countries recognize this extract as an acceptable food flavoring ingredient.

Manufacturers using balm leaves extract in food products are responsible for ensuring safety through quality control, proper identification, and appropriate usage levels consistent with established flavoring industry standards.

Key Studies

Research on Melissa officinalis has primarily focused on its traditional uses and phytochemical composition rather than food safety concerns. Studies have characterized the volatile oil composition and confirmed the presence of compounds such as citral (30-50% of volatile oil), which contribute to the characteristic flavor.

Pharmacological research has examined various health-related properties of lemon balm, but these investigations operate outside the scope of food additive safety assessment. Safety reviews by botanical and flavoring ingredient organizations have not identified safety concerns for use of the extract as a flavoring agent at typical culinary levels.

The absence of adverse event reports and recalls provides additional evidence of safe use history in food applications.

Frequently Asked Questions

What is Balm Leaves, Extract (melissa Officinalis L.)?

Balm leaves extract (Melissa officinalis L.) is a natural flavoring agent derived from lemon balm plant material. It is used in food and beverage products to impart a mild lemon-like flavor and aroma, and is generally recognized as safe in traditional culinary applications.

Is Balm Leaves, Extract (melissa Officinalis L.) safe?

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

Balm Leaves, Extract (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.