Gentiana Lutea Root Extract

INCI: GENTIANA LUTEA ROOT EXTRACT

CAS Number
72968-42-4
Function
Skin Conditioning
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No specific FDA restrictions under MoCRA; listed in FDA UNII system as S72O3284MS; no CIR monograph published

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Permitted in EU under general safety provisions with no Annex restrictions; however, EFSA FEEDAP Panel (2021, 2023) identified unresolved genotoxicity concerns for constituent gentiopicroside and xanthones (gentisin, isogentisin) due to potential DNA adduct formation, with no dermal absorption or sensitization data available to establish adequate margin of safety for cosmetic use.

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Concern Level: Moderate

Regulatory Flags

unresolved-genotoxicity efsa-flag gentiopicroside-dna-adduct xanthone-genotoxicity no-sccs-opinion no-cir-review no-dermal-absorption-data no-sensitization-data data-gap fda_food_additive

Frequently Asked Questions

Is Gentiana Lutea Root Extract safe in cosmetics?

Permitted in EU under general safety provisions with no Annex restrictions; however, EFSA FEEDAP Panel (2021, 2023) identified unresolved genotoxicity concerns for constituent gentiopicroside and xanthones (gentisin, isogentisin) due to potential DNA adduct formation, with no dermal absorption or sensitization data available to establish adequate margin of safety for cosmetic use. The EU classifies Gentiana Lutea Root Extract as "permitted". Safety rating: MODERATE.

Is Gentiana Lutea Root Extract allowed in the EU?

Gentiana Lutea Root Extract EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Gentiana Lutea Root Extract do in cosmetics?

Gentiana Lutea Root Extract functions as: Skin Conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 72968-42-4.

What is the Margin of Safety for Gentiana Lutea Root Extract?

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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