Good Cosmetic Ingredient GHS Classified

CI 77002 (Alumina)

INCI: CI 77002

CAS Number
21645-51-2
Function
Colorant. Aluminium hydroxide sulphate white mineral pigment; also known as Alumina, Aluminium Hydroxide, Pigment White 24, and Hydrated Aluminium Oxide. Used as a white opacifying colorant in cosmetic products and as a substrate for aluminium lake color additives. Also functions as an abrasive, absorbent, anticaking, and bulking agent in cosmetics. Listed in EU Annex IV as a permitted white colorant. CIR Expert Panel found Alumina and Aluminum Hydroxide safe as used in cosmetics (2016 assessment, non-respirable grade).
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status restricted
US Notes FDA delisted Aluminum Hydroxide (CAS 21645-51-2) as a standalone color additive on April 4, 1975 (formerly provisionally listed for cosmetics, delisted due to no commercial interest per FDA records). Not currently listed in 21 CFR Parts 73 or 74 as an approved standalone cosmetic colorant. Alumina is separately approved as a substrate in FDA-certified aluminum lake color additives (e.g., FD&C Blue No. 1 Aluminum Lake) under 21 CFR 82.51 and related sections, but this approval applies to the lake composite, not to alumina as a standalone color additive. CIR (2016, IJCS) concluded alumina safe as formulated to be non-respirable.

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.

GHS Hazard Classification

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

Routes of Exposure
The substance can be absorbed into the body by inhalation.

Expert Verdict

CI 77002 (Alumina/Aluminium Hydroxide, CAS 21645-51-2) is permitted in EU Cosmetics Regulation Annex IV as a white colorant. In the US, FDA delisted aluminium hydroxide as a standalone color additive in 1975 and it is not listed in 21 CFR Parts 73 or 74 for standalone colorant use, though it remains widely used as a functional ingredient and substrate in certified lake colors. CIR (2016) and SCCS assessments confirm good safety when formulated to be non-respirable.

⚠️
Concern Level: Low

Regulatory Flags

inorganic-colorant mineral-pigment eu-annex-iv fda-delisted-1975 not-fda-standalone-colorant lake-substrate cir-safe aluminium white-pigment non-respirable fda_food_additive

Frequently Asked Questions

Is CI 77002 (Alumina) safe in cosmetics?

CI 77002 (Alumina/Aluminium Hydroxide, CAS 21645-51-2) is permitted in EU Cosmetics Regulation Annex IV as a white colorant. In the US, FDA delisted aluminium hydroxide as a standalone color additive in 1975 and it is not listed in 21 CFR Parts 73 or 74 for standalone colorant use, though it remains widely used as a functional ingredient and substrate in certified lake colors. CIR (2016) and SCCS assessments confirm good safety when formulated to be non-respirable. The EU classifies CI 77002 (Alumina) as "permitted". Safety rating: GOOD.

Is CI 77002 (Alumina) allowed in the EU?

CI 77002 (Alumina) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 77002 (Alumina) do in cosmetics?

CI 77002 (Alumina) functions as: Colorant. Aluminium hydroxide sulphate white mineral pigment; also known as Alumina, Aluminium Hydroxide, Pigment White 24, and Hydrated Aluminium Oxide. Used as a white opacifying colorant in cosmetic products and as a substrate for aluminium lake color additives. Also functions as an abrasive, absorbent, anticaking, and bulking agent in cosmetics. Listed in EU Annex IV as a permitted white colorant. CIR Expert Panel found Alumina and Aluminum Hydroxide safe as used in cosmetics (2016 assessment, non-respirable grade).. It is classified as a cosmetic ingredient in our database. CAS number: 21645-51-2.

What is the Margin of Safety for CI 77002 (Alumina)?

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.

Compliance Tools

Check CI 77002 (Alumina) compliance across multiple jurisdictions:

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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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