Blue 1 Lake
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 Expert Panel for Cosmetic Ingredient Safety 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 Expert Panel 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 as 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.
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 ingredients must be called CI 42090.