Iron Oxides
Safety Information
The U.S. Food and Drug Administration (FDA) lists iron oxides as a color additive exempt from certification. Iron oxides are safe for use in coloring products, including cosmetics and personal care products applied to the lips, and the area of the eye, provided they meet certain specifications. The FDA also includes iron oxides on its list of indirect food additives considered Generally Recognized As Safe (GRAS).
The Expert Panel for Cosmetic Ingredient Safety 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 Expert Panel 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.
FDA: Link to Code of Federal Regulations for iron oxides
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 Regulation 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.
