What Is It?
In cosmetics and personal care products, Red 6 (D&C Red No. 6) and Red 7 (D&C Red No. 7), and the lakes of these ingredients, are colors used in the formulation of blushers, face powders, lipstick and other makeup products, as well as cleansing products, mouthwashes and breath fresheners, nail polish and enamels, and skin care products.
Why Is It Used?
Red 6 and Red 7 and lakes of these colors may be used alone or in combination with other colors to color cosmetics and personal care products.
Red 6 and Red 7 are referred to as monoazo colors. 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. A lake is a water-soluble color that has been converted to a water-insoluble salt by simple conversion to a salt. Red 6 is primarily produced as a color additive lake.
The Food and Drug Administration (FDA) reviewed the safety of Red 6, Red 6 Lake, Red 7 and Red 7 Lake and approved the use of these ingredients for coloring cosmetics and personal care product including products intended for use on the lips if these ingredients conform to FDA specifications. These colors are not permited for use in products intended for use on area around the eye. FDA also determined that these colors may also be used in coloring externally applied drugs. According to U.S. regulations, all Red 6, Red 6 Lake, Red 7 and Red 7 Lake 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 only be used if it is certified by the agency to meet the established 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.
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
and Red 7
Red 6 and Red 7 are listed as Color Index No. 15850 (CI 15850) in the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products. The lakes, salts and pigments are also permitted in Europe. When used in cosmetic products in the European Union, these ingredients must be called CI 15850.
Link to the EU Cosmetic Regulation:
You can learn more about the regulation and labeling of colors at:
More Scientific Information
Red 6 is chemically described as the disodium salt of 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-2-naphthalenecarboxylic acid. Red 7 is the calcium salt of Red 6. Red 6 has limited solubility in water and Red 7 is virtually insoluble in water. These colors are very stable and may be used in a wide variety of product types and formulations (depending on the solubility required). Red 6, Red 6 Lake, Red 7 and Red 7 Lake are the abbreviated names given by FDA for the certified color. Certifiable color additive such as Red 6 and 7 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. Lakes are often used to form the coating of drug tablets.
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/