Iron Oxides used in cosmetic products is an inorganic compound consisting of any one or combinations of synthetically prepared iron oxides that includes hydrated forms of iron oxides. In cosmetics and personal care products, Iron Oxides are used in the formulation of a wide variety of product types, including makeup and skin care preparations.
The FDA also includes Iron Oxides on its list of indirect food additives considered Generally Recognized As Safe (GRAS).
The Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.
You can find out more about FDA regulation of colors at:
http://www.cfsan.fda.gov/~dms/cos-col.html
FDA: Link to Code of Federal Regulations for Iron Oxides
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
Iron Oxides are listed as CI 77489, CI 77491, CI 77492, and CI 77499 in Annex IV, Part I (colouring agent allowed for use in cosmetic products) of the Cosmetics Directive of the European Union and may be used without restriction when purity requirements are fulfilled. When used in cosmetic products in the European Union, this ingredient must listed on the label by its CI (Color Index) number.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-0.5 mg/kg body weight for Iron Oxides.
http://www.inchem.org/documents/jecfa/jeceval/jec_1137.htm
You can learn more about the regulation and labeling of colors at: http://www.personalcarecouncil.org/Content/NavigationMenu/Co...