What Is It?
Blue 1, also called FD&C Blue No. 1, is a synthetic color that is subject to certification by the Food and Drug Administration (FDA). Blue 1 Lake is a water insoluble form of Blue 1 that is made from the certified color. In cosmetics and personal care products, Blue 1 is used in the formulation of a wide variety of product types, eye makeup, makeup, personal cleansers and skin care products. Blue 1 Lake is used in lipstick. Blue 1 and Blue 1 Lake are allowed to be used in food.
Why Is It Used?
Blue 1 and Blue 1 Lake impart a blue color to cosmetics and personal care products.
Blue 1 is a synthetic water-soluble pigment. Blue 1 Lake is a water-insoluble salt of Blue 1. In addition to its use in cosmetics and personal care products, Blue 1 is commonly used as a food coloring and may be found in ice cream and sweets. A listing of approved colorants (except hair colors) that may be used in the U.S. may be found in FDA color additive regulations.
The FDA reviewed the safety of Blue 1 and Blue 1 Lake and determined that they may be safely used in food, and for coloring cosmetics and personal care products, including products intended for use on the lips and in products intended for use in the area of the eye, when conforming to FDA specifications. According to U.S. regulations, all Blue 1 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 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 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
Links to Code of Federal Regulations for Blue 1 and Blue 1 Lake
Blue 1 is sometimes converted to an insoluble pigment for use in situations where migration of the color to surrounding ingredients needs to be controlled. The same type of consideration applies for foods such a confectionaries where migration from the decorative frosting to the cake might spoil the intended effect. These insoluble pigments are referred to as “lakes” and the ingredient declaration on the product read “Blue 1 Lake”. FDA has also considered the safety of these lakes and has issued regulations that address their use in products.
Link to FDA Code of Federal Regulations for color additive lakes:
Blue 1 and Blue 1 Lake are listed as CI 42090 in the Cosmetics Directive of the European Union (Annex IV, Part I) and may be used in all cosmetics and personal care products without limitation. When used in cosmetic products in the European Union, these ingredient must be called CI 42090.
Link to the EU Cosmetic Regulation:
You can learn more about the regulation and labeling of colors at:
More Scientific Information
Blue 1 and Blue 1 Lake are triphenylmethane colors. Certifiable color additive such as Blue 1 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, solutions 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/