Iron Oxides

Safety Information

The 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.

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

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.

Resources

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Substances Generally Recognized As Safe (GRAS)
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EU Cosmetics Inventory
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Iron Oxides


Chemical image provided by National Cancer Institute
What Is It?

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.

Why Is It Used?

Iron oxides impart a color to cosmetics and personal care products. Depending on the specific iron oxides or mixtures of iron oxides used, the color will vary from orange, red, yellow to black.

Scientific Facts

Iron oxides are naturally occurring mineral deposits. These compounds are used as pigments in a variety of applications. Iron oxides used in cosmetic and personal care products are synthetic. Because some of the starting materials for synthetic iron oxide may come from the earth there may be trace amounts of heavy metals present. The levels of heavy metals in iron oxides are regulated by the FDA, and the small amounts that may eventually be in cosmetic or personal care products do not pose a risk to human health.

Iron oxides function as colorants in cosmetics and personal care products. Synthetic iron oxides are produced in various ways, including thermal decomposition of iron salts, such as ferrous sulfate, to produce reds; precipitation to produce yellows, reds, browns, and blacks; and reduction of organic compounds by iron to produce yellows and blacks.