Ext. Yellow 7
What Is It?
Ext. Yellow 7 (Ext. D&C Yellow No. 7) and Ext. Yellow 7 Lake are colorants. Ext. in the ingredient name is an abbreviation for “external.” In cosmetics and personal care products, Ext. Yellow 7 is used in the formulation of soaps and detergents, hair bleaches, hair conditioners, moisturizers, shampoos and skin care products. Ext. Yellow 7 and Ext. Yellow 7 Lake are subject to certification by the Food and Drug Administration (FDA).
Why Is It Used?
Ext. Yellow 7 and Ext. Yellow 7 Lake impart color to cosmetics and personal care products.
Ext. Yellow 7 is a synthetic pigment sometimes referred to in general terms as a nitro color. Color additives are classified as straight colors, lakes, and mixtures. Straight colors are color additives that have not been mixed or chemically reacted with any other substance. Ext. Yellow 7 is a straight color. Lakes, such as Ext. Yellow 7 Lake, are pigments which consist generally of an insoluble metallic salt of a certified color additive deposited on an inert substrate.
The FDA reviewed the safety of Ext. Yellow 7 and Ext. Yellow 7 Lake and determined that they may be safely used for coloring externally applied drugs and cosmetics, when conforming to FDA specifications. Ext. Yellow 7 and Ext. Yellow 7 Lake may not be used to color products intended for use in the eye area, or in products intended for use on the lips. According to U.S. regulations, all Ext. Yellow 7 and Yellow 7 Lake that is manufactured for use in products is subject to certification by the FDA. This certification process ensures that the strict chemical and identity specifications set by FDA are met. The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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:
Link to FDA Code of Federal Regulations for Ext. Yellow 7 and Lakes
Ext. Yellow 7 and Ext. Yellow 7 Lake are listed as CI 10316 in the Cosmetics Directive of the European Union and may be used as coloring agents in all cosmetics and personal care products except those intended to be applied to the area around the eye. When used in cosmetics and personal care products in the European Union, these colorants must be called CI 10316.
Link to the EU Cosmetic Regulation:
You can learn more about the regulation and labeling of colors at:
More Scientific Information
Certifiable color additive such as Ext. Yellow 7 and Ext. Yellow 7 Lare 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. Ext. Yellow 7 is principally the disodium salt of 8-hydroxy-5,7-di-nitro-2-naphthalenesulfonic acid. In cosmetics and personal care products, Ext. Yellow 7 and its lake function as colorants.
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/