Gallstone

INCI: GALLSTONE

CAS Number
Not standardized — animal-derived material
Function
Skin conditioning (traditional use, primarily TCM-origin ingredient)
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status prohibited
US Notes Prohibited due to BSE/TSE prion contamination risk and lack of FDA approval for cosmetic use

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Animal-derived material with significant BSE/TSE prion contamination risk; requires Certificate of Suitability or equivalent for EU use; potential for heavy metal contamination and batch-to-batch variability; not compliant with COSMOS/ECOCERT standards; prohibited in US.

⚠️
Concern Level: High

Frequently Asked Questions

Is Gallstone safe in cosmetics?

Animal-derived material with significant BSE/TSE prion contamination risk; requires Certificate of Suitability or equivalent for EU use; potential for heavy metal contamination and batch-to-batch variability; not compliant with COSMOS/ECOCERT standards; prohibited in US. The EU classifies Gallstone as "permitted". Safety rating: POOR.

Is Gallstone allowed in the EU?

Gallstone EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Gallstone do in cosmetics?

Gallstone functions as: Skin conditioning (traditional use, primarily TCM-origin ingredient). It is classified as a cosmetic ingredient in our database. CAS number: Not standardized — animal-derived material.

What is the Margin of Safety for Gallstone?

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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