Our Verdict: SAFE

Elder Tree Leaves (sambucus Nigra L.)

CAS977038-74-6

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

Elder Tree Leaves (sambucus Nigra L.) โ€” food additive

Elder tree leaves (Sambucus nigra L.) are a botanical flavoring agent derived from the European elderberry plant. Used primarily as a natural flavoring adjuvant in food and beverage products, this ingredient has a long history of culinary use in traditional European cuisines.

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 Elder Tree Leaves?

Elder tree leaves (Sambucus nigra L.) are derived from the black elderberry plant, a deciduous shrub native to Europe, western Asia, and North Africa. The leaves have been utilized for centuries in traditional culinary preparations across European cultures. In modern food manufacturing, elder tree leaves are processed and standardized as a flavoring agent or adjuvantโ€”a substance that modifies or enhances the sensory properties of food without being the primary flavoring component.

The botanical material contains various naturally occurring compounds including phenolic acids, flavonoids, and volatile organic compounds that contribute to its sensory profile. The leaves possess a distinctive herbaceous, slightly bitter character that can complement or modify flavor in beverages and prepared foods.

Common Uses

Elder tree leaves are typically incorporated into food products as a flavoring adjuvant rather than a primary flavoring ingredient. Common applications include:

- Herbal and botanical beverages

- Flavored spirits and liqueurs

- Herbal tea blends and infusions

- Prepared foods requiring subtle herbaceous notes

- Natural flavoring formulations

The ingredient is used in relatively small quantities within formulated products, functioning to add complexity and depth to existing flavor profiles rather than providing dominant taste characteristics.

Safety Assessment

Elder tree leaves have not been formally evaluated and approved by the FDA under the Generally Recognized As Safe (GRAS) designation. However, this classification reflects the absence of a formal petition and review process rather than evidence of safety concerns.

Historically, elderberry leaves have been consumed in traditional European food preparations for generations without documented widespread adverse health effects from culinary use. The European Food Safety Authority (EFSA) and various national food safety authorities in Europe have permitted elder tree leaves in food applications under specific regulatory frameworks.

According to FDA records, there are zero reported adverse events associated with elder tree leaves and zero product recalls attributable to this ingredient. This absence of reported incidents supports its general safety profile in food applications at typical use levels.

It should be noted that while elder leaves have culinary applications, other parts of the elderberry plant (particularly unripe berries and bark) contain cyanogenic glycosides and should not be consumed raw. Only properly processed and prepared culinary applications of the leaves should be considered safe for food use.

Regulatory Status

The regulatory landscape for elder tree leaves varies internationally:

- **United States**: Not GRAS-designated; permitted in food under FDA's general authority for food additives, though not explicitly listed in 21 CFR Part 182 (GRAS substances).

- **European Union**: Permitted as a natural flavoring substance under Regulation (EC) No 1334/2008, with specific provisions for botanical ingredients.

- **Other jurisdictions**: Various countries permit elderberry leaves in food applications under their respective natural flavoring or traditional food ingredient provisions.

Manufacturers using this ingredient in the U.S. market may rely on the general recognition of safety through long historical use and traditional food preparation practices, or may petition for formal GRAS status.

Key Studies

Limited peer-reviewed research specifically addresses the safety of elder tree leaves as a food additive at typical use concentrations. Most published research focuses on:

- Chemical composition analysis of elderberry plant materials

- Antioxidant and phytochemical profiles of various plant parts

- Traditional and ethnobotanical uses in European cuisines

- Comparative studies with other herbal flavoring substances

The absence of reported adverse events, combined with centuries of culinary use in European food traditions, represents the primary evidence basis for its safety as a food flavoring agent. However, additional modern toxicological assessment may provide further safety documentation.

Frequently Asked Questions

What is Elder Tree Leaves (sambucus Nigra L.)?

Elder tree leaves (Sambucus nigra L.) are a botanical flavoring agent derived from the European elderberry plant. Used primarily as a natural flavoring adjuvant in food and beverage products, this ingredient has a long history of culinary use in traditional European cuisines.

Is Elder Tree Leaves (sambucus Nigra L.) safe?

Elder Tree Leaves (sambucus Nigra 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 Elder Tree Leaves (sambucus Nigra L.) banned in any country?

Elder Tree Leaves (sambucus Nigra 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.