Helleborus Niger Extract (Christmas Rose)

INCI: HELLEBORUS NIGER ROOT EXTRACT

CAS Number
84775-56-4 (root extract)
Function
Skin conditioning
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Not commonly used; no specific FDA cosmetic restriction, but subject to general safety requirements

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Helleborus species contain cardiotoxic steroidal saponins (helleborin, hellebrin/helleborein) and bufadienolides; protoanemonin causes blistering and contact dermatitis; the plant is classified as poisonous with extremely limited cosmetic safety data; rigorous safety assessment with quantified constituent analysis required before use; avoid around mucous membranes or broken skin.

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Concern Level: High

Regulatory Flags

plant-extract natural-origin

Frequently Asked Questions

Is Helleborus Niger Extract (Christmas Rose) safe in cosmetics?

Helleborus species contain cardiotoxic steroidal saponins (helleborin, hellebrin/helleborein) and bufadienolides; protoanemonin causes blistering and contact dermatitis; the plant is classified as poisonous with extremely limited cosmetic safety data; rigorous safety assessment with quantified constituent analysis required before use; avoid around mucous membranes or broken skin. The EU classifies Helleborus Niger Extract (Christmas Rose) as "prohibited". Safety rating: POOR.

Is Helleborus Niger Extract (Christmas Rose) allowed in the EU?

Helleborus Niger Extract (Christmas Rose) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Helleborus Niger Extract (Christmas Rose) do in cosmetics?

Helleborus Niger Extract (Christmas Rose) functions as: Skin conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 84775-56-4 (root extract).

What is the Margin of Safety for Helleborus Niger Extract (Christmas Rose)?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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