Black Oxide Of Iron(Ci 77499)

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 ≤5 ppm CoA). Nano-form requires additional SCCS assessment per SCCS/1618/20 before EU use.

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 — natural iron oxides excluded due to potential heavy metal contamination. No maximum concentration for cosmetic use.