Good Active Ingredient Sensitization Data

Curcuma Longa Root Extract

INCI: CURCUMA LONGA ROOT EXTRACT

CAS Number
458-37-7
Function
Antioxidant, skin conditioning, anti-inflammatory
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No FDA pre-market approval required for cosmetic use. Curcumin (CI 75300) is an FDA-approved color additive for food (21 CFR 73.600). Not approved as OTC drug active. No CIR final safety assessment for cosmetic use. MoCRA safety substantiation required. No GRAS listing relevant to topical 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
low

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Curcuma Longa Root Extract based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
botanical
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: IVDK; literature review

Expert Verdict

Curcuma longa extract (curcumin, demethoxycurcumin, bisdemethoxycurcumin) is permitted in EU cosmetics under Regulation (EC) No 1223/2009 without specific Annex restrictions. Not listed in Annex II or Annex III. No dedicated SCCS opinion. CIR has not issued a final safety assessment for curcumin as a cosmetic ingredient. In the US, no FDA pre-market approval is required for cosmetic use; curcumin (CI 75300) is an approved color additive for food use. Bioavailability is the central limitation due to poor aqueous solubility and rapid metabolism. In vitro antioxidant potency confirmed. Heavy metal and mycotoxin contamination risk from raw Ayurvedic supply chains requires supplier COA and DNA barcoding authentication.

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Concern Level: Low

Regulatory Flags

eu-unrestricted no-sccs-opinion no-cir-assessment ci-75300-color-additive-us poor-bioavailability nano-delivery-investigated heavy-metal-contamination-risk ayurvedic-supply-chain clinical-trials-ongoing antioxidant anti-inflammatory skin-brightening

Frequently Asked Questions

Is Curcuma Longa Root Extract safe in cosmetics?

Curcuma longa extract (curcumin, demethoxycurcumin, bisdemethoxycurcumin) is permitted in EU cosmetics under Regulation (EC) No 1223/2009 without specific Annex restrictions. Not listed in Annex II or Annex III. No dedicated SCCS opinion. CIR has not issued a final safety assessment for curcumin as a cosmetic ingredient. In the US, no FDA pre-market approval is required for cosmetic use; curcumin (CI 75300) is an approved color additive for food use. Bioavailability is the central limitation due to poor aqueous solubility and rapid metabolism. In vitro antioxidant potency confirmed. Heavy metal and mycotoxin contamination risk from raw Ayurvedic supply chains requires supplier COA and DNA barcoding authentication. The EU classifies Curcuma Longa Root Extract as "permitted". Safety rating: GOOD.

Is Curcuma Longa Root Extract allowed in the EU?

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

What does Curcuma Longa Root Extract do in cosmetics?

Curcuma Longa Root Extract functions as: Antioxidant, skin conditioning, anti-inflammatory. It is classified as a Active Ingredient in our database. CAS number: 458-37-7.

What is the Margin of Safety for Curcuma Longa 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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