What Is It?
In cosmetics and personal care products, Red 34 (D&C Red No. 34) and Red 34 Lake are used in the formulation of blushers, face powders and nail polish. Red 34 and Red 34 Lake are subject to certification by the Food and Drug Administration (FDA).
Why Is It Used?
Red 34 and Red 34 Lake color to cosmetics and personal care products.
Red 34 is in the class of monoazo colors. Color additives are classified as straight colors, lakes, and mixtures. A lake is an insoluble salt deposited on an inert substrate.
The FDA reviewed the safety of Red 34 and Red 34 Lake and determined that they may be safely used for coloring externally applied (not permitted for use in products intended for use on the lips or in the area of the eyes) cosmetics and personal care products, as well as externally applied drugs, when these ingredients conform to FDA specifications. According to U.S. regulations, all Red 34 and Red 34 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 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: http://www.cfsan.fda.gov/~dms/cos-col.html
Link to FDA Code of Federal Regulations for Red 34 and Lakes
Red 34 and Red 34 Lake are listed as CI 15880 in the Cosmetics Directive of the European Union (see Annex IV). CI 15880 is a coloring agent allowed in all cosmetic products. When used in cosmetic products in the European Union, this ingredient must be called CI 15880.
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 Red 34 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.
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/