Excellent Colorant

CI 77499 (Black Iron Oxide)

INCI: CI 77499

CAS Number
1317-61-9
Function
Colorant
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permanently listed under 21 CFR 73.2250 (cosmetics), 73.200 (food), 73.1200 (drugs), 73.3125 (medical devices). Exempt from batch certification. Permitted in eye area cosmetics and contact lens products (GMP). Only synthetically prepared iron oxides are permitted โ€” natural iron oxides excluded due to potential heavy metal contamination. No maximum concentration for cosmetic use.

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.

Expert Verdict

CI 77499 (Fe3O4) is a permitted colorant under EU Annex IV Entry 137 with no concentration limit for non-nano form and must meet E 172 food-grade purity. FDA permanently listed and exempt from certification under 21 CFR 73.2250 for all cosmetics including eye area (synthetic manufacture required). Excellent safety profile with negligible systemic exposure; primary concern is heavy metal impurities in natural-source materials (use synthetic-grade with Pb โ‰ค5 ppm CoA). Nano-form requires additional SCCS assessment per SCCS/1618/20 before EU use.

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Concern Level: None

Regulatory Flags

synthetic-only heavy-metal-impurity-risk nano-form-requires-assessment eye-area-permitted no-concentration-limit

Frequently Asked Questions

Is CI 77499 (Black Iron Oxide) safe in cosmetics?

CI 77499 (Fe3O4) is a permitted colorant under EU Annex IV Entry 137 with no concentration limit for non-nano form and must meet E 172 food-grade purity. FDA permanently listed and exempt from certification under 21 CFR 73.2250 for all cosmetics including eye area (synthetic manufacture required). Excellent safety profile with negligible systemic exposure; primary concern is heavy metal impurities in natural-source materials (use synthetic-grade with Pb โ‰ค5 ppm CoA). Nano-form requires additional SCCS assessment per SCCS/1618/20 before EU use. The EU classifies CI 77499 (Black Iron Oxide) as "permitted". Safety rating: EXCELLENT.

Is CI 77499 (Black Iron Oxide) allowed in the EU?

CI 77499 (Black Iron Oxide) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 77499 (Black Iron Oxide) do in cosmetics?

CI 77499 (Black Iron Oxide) functions as: Colorant. It is classified as a Colorant in our database. CAS number: 1317-61-9.

What is the Margin of Safety for CI 77499 (Black Iron Oxide)?

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.

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