Orange 10

What Is It?

Orange 10 (D&C Orange No. 10) and Orange 10 Lake are colorants. In cosmetics and personal care products, Orange 10 may be used in the formulation of externally applied products. Orange 10 and Orange 10 Lake are subject to certification by the Food and Drug Administration (FDA).

Why Is It Used?

Orange 10 and Orange 10 Lake impart a color to cosmetics and personal care products.

Scientific Facts

Orange 10 is a synthetic pigment that contains iodine. It is sometimes referred to in general terms as a fluoran color. Color additives are classified as straight colors, lakes, and mixtures. Mixtures are color additives formed by mixing one color additive with one or more other color additives or non-colored diluents, without a chemical reaction. Orange 10 is a mixture. Lakes, such as Orange 10 Lake, are pigments which consist generally of an insoluble metallic salt of a certified color additive deposited on an inert substrate.
Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Orange 10 and Orange 10 Lake and determined that they may be safely used for coloring externally applied drugs and cosmetics when it conforms to FDA specifications. These ingredients are not permitted for use in products intended for use in the eye area, or in products intended for use on the lips. Cosmetic Ingredient Review (CIR) has deferred evaluation of these ingredients 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

Link to FDA Code of Federal Regulations for Orange 10 and Lakes

Because of concerns about the iodine content of these colors, Orange 10 and Orange 10 Lake are not permited for use as coloring agents in the European Union (see Annex IV). These colors were previously permitted for use in the European Union under the name CI 45425.

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

You can learn more about the regulation and labeling of colors at: 
http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen…

More Scientific Information

Certifiable color additives such as Orange 10 and Orange 10 Lake are used widely because their coloring ability is more intense than most colors derived from natural products; thus, they are often added in smaller quantities. In addition, certifiable color additives are more stable, provide better color uniformity and blend together easily to provide a wide range of hues. Certifiable color additives generally do not impart undesirable odors or flavors while color derived from foods such as beets and cranberries can produce such unintended effects. Certifiable color additives typically are available for use as either “dyes” or “lakes.” Dyes dissolve in water and are manufactured as powders, granules, liquids or other special purpose forms. Lakes are the water insoluble form of the dye. Lakes are typically more stable than dyes and are ideal for coloring products lacking sufficient moisture to dissolve dyes. Orange 10 is a mixture consisting principally of 4′,5′-diiodofluorescein, 2′,4′,5′-triiodofluorescein, and 2′,4′,5′,7′-tetraiodofluorescein. In cosmetics and personal care products, Orange 10 and Orange 10 Lake function as colorants.
Resources

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/