Orange 11

What Is It?

Orange 11 (D&C Orange No. 11) is a coloring agent. In cosmetics and personal care products, Orange 11 may be used in the formulation of externally applied products. Orange 11 is subject to certification by the Food and Drug Administration (FDA).

Why Is It Used?

Orange 11 imparts a color to cosmetics and personal care products.

Scientific Facts

Orange 11 is a synthetic pigment that contains iodine. It is sometimes referred to in general terms as a xanthene 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 11 is a mixture.
Safety Information

The Food and Drug Administration (FDA) reviewed the safety of Orange 11 and determined that it may be safely used for coloring externally applied drugs and cosmetics when it conforms to FDA specifications. Orange 11 is not permitted for use in products intended for use in the area of the eye or in products intended for use on the lips. 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

Link to FDA Code of Federal Regulations for Orange 11

Because of concerns about the iodine content of this color, Orange 11 is not permited for use as a coloring agent in the European Union (see Annex IV). This color was 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 11, 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. Orange 11 is a mixture consisting principally of the disodium salts of 4′,5′-diiodofluorescein, 2′,4′,5′-triiodofluorescein and 2′,4′,5′,7′-tetraiodofluorescein. In cosmetics and personal care products, Orange 11 functions as a colorant.
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/