Excellent Cosmetic Ingredient NOAEL Data GHS Classified

CI 77004 (Kaolin)

INCI: CI 77004

CAS Number
1332-58-7
Function
Colorant. Natural white clay mineral composed principally of aluminium silicates (kaolinite: Al2O3·2SiO2·2H2O); also known as China Clay, Pigment White 19, and Kaolin Clay. When used as a colorant in cosmetics it is declared as CI 77004; when used as an active ingredient (e.g., in OTC skin protectant or cleansing products) it is declared as KAOLIN. Imparts white opacity and matte finish to cosmetic products. Also functions as absorbent, bulking, and anticaking agent. Listed in EU Annex IV (Restriction IV/119). CIR assessed naturally-sourced clays including kaolin as safe in cosmetics (2023 Final Safety Assessment).
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA delisted Kaolin as a standalone color additive for cosmetics on September 23, 1976 (formerly provisionally listed, delisted due to no commercial interest per FDA records at 21 CFR 186.1256). Not currently listed in 21 CFR Parts 73 or 74 as a formally approved cosmetic color additive. Kaolin is widely used in US cosmetics as a functional ingredient (absorbent, bulking agent) under its non-colorant INCI name, and is Generally Recognized as Safe (GRAS) as an indirect food additive under 21 CFR 186.1256. US formulators declaring it specifically as a colorant (CI 77004) should be aware of the delisted colorant status.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for CI 77004 (Kaolin). NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL ca.2500 mg/kg bw/day oral code:3544 oral REACH
NOAEL >5000 mg/kg bw/day oral rat oral REACH
NOAEL 10000 mg/kg bw/day oral code:3544 oral REACH
NOAEL 1760 other oral rat oral REACH
NOAEL 5270 other oral mouse oral REACH
NOAEL 8980 mg/kg bw/day oral rat oral REACH

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Hazard Statements
No hazard classification according to GHS criteria
Short-term Exposure Effects
May cause mechanical irritation.
Long-term Exposure Effects
Lungs may be affected by repeated or prolongated exposure to dust particles. This may result in fibrosis (kaolinosis).
Routes of Exposure
Exposure mainly occurs via inhalation.

Expert Verdict

CI 77004 (Kaolin / China Clay, CAS 1332-58-7) is a natural white clay mineral listed in EU Cosmetics Regulation Annex IV (Restriction IV/119) as a permitted colorant for all cosmetics. In the US, FDA delisted kaolin as a standalone color additive in 1976; it is not in 21 CFR Parts 73 or 74 for colorant use, but is GRAS as an indirect food additive and is broadly accepted as a functional cosmetic ingredient. CIR (2023) assessed naturally-sourced clays including kaolin and concluded they are safe as used in cosmetics. Excellent safety profile: inert mineral, no systemic exposure, no sensitization, no genotoxicity. One of the most widely used and safest cosmetic ingredients.

⚠️
Concern Level: None

Regulatory Flags

natural-colorant mineral-clay eu-annex-iv fda-delisted-1976 not-fda-standalone-colorant gras-indirect-food cir-safe-2023 kaolin white-pigment insoluble-mineral matte-effect epa_safer_alternative

Frequently Asked Questions

Is CI 77004 (Kaolin) safe in cosmetics?

CI 77004 (Kaolin / China Clay, CAS 1332-58-7) is a natural white clay mineral listed in EU Cosmetics Regulation Annex IV (Restriction IV/119) as a permitted colorant for all cosmetics. In the US, FDA delisted kaolin as a standalone color additive in 1976; it is not in 21 CFR Parts 73 or 74 for colorant use, but is GRAS as an indirect food additive and is broadly accepted as a functional cosmetic ingredient. CIR (2023) assessed naturally-sourced clays including kaolin and concluded they are safe as used in cosmetics. Excellent safety profile: inert mineral, no systemic exposure, no sensitization, no genotoxicity. One of the most widely used and safest cosmetic ingredients. The EU classifies CI 77004 (Kaolin) as "permitted". Safety rating: EXCELLENT. 6 toxicological study endpoint(s) are available in our database.

Is CI 77004 (Kaolin) allowed in the EU?

CI 77004 (Kaolin) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 77004 (Kaolin) do in cosmetics?

CI 77004 (Kaolin) functions as: Colorant. Natural white clay mineral composed principally of aluminium silicates (kaolinite: Al2O3·2SiO2·2H2O); also known as China Clay, Pigment White 19, and Kaolin Clay. When used as a colorant in cosmetics it is declared as CI 77004; when used as an active ingredient (e.g., in OTC skin protectant or cleansing products) it is declared as KAOLIN. Imparts white opacity and matte finish to cosmetic products. Also functions as absorbent, bulking, and anticaking agent. Listed in EU Annex IV (Restriction IV/119). CIR assessed naturally-sourced clays including kaolin as safe in cosmetics (2023 Final Safety Assessment).. It is classified as a cosmetic ingredient in our database. CAS number: 1332-58-7.

What is the Margin of Safety for CI 77004 (Kaolin)?

adequate 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.

What is the NOAEL for CI 77004 (Kaolin)?

The NOAEL (No Observed Adverse Effect Level) for CI 77004 (Kaolin) is ca.2500 mg/kg bw/day based on a oral study via oral route in code:3544. A total of 6 study endpoints are available. Source: REACH.

Compliance Tools

Check CI 77004 (Kaolin) compliance across multiple jurisdictions:

🔬
Ingredient Decoder
Paste a full ingredient list for instant analysis
 🌸
82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
Check compliance across 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

CI 73360
Good
CROCIN
Good
CI 77007 (Ultramarine Blue)
Excellent
CI 63010
Moderate
CI 24790
Moderate
Browse all 30,000+ ingredients →
📱

Is CI 77004 (Kaolin) in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for CI 77004 (Kaolin) in your formulation.

Ingredient Decoder MoS Calculator