U.S. Food and Drug Administration (FDA)
The FDA has reviewed the safety of yellow 5 and determined that it may be safely used 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 these ingredients conforms to FDA specifications. Yellow 5 is also permitted as to be used as a color in food and drugs. According to U.S. regulations, all yellow 5 and yellow 5 lake that are 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.
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. The 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
FDA based their decision to approve Yellow 5 for use in food, drugs and cosmetics on extensive toxicology and chemistry information. In addition, FDA set specifications on the amount that can be used in certain products and, as a synthetic color additive, requires that each manufactured lot of color be submitted to the agency for analysis and certification.
FDA: Link to Code of Federal Regulations for Yellow 5
Yellow 5 is sometimes converted to an insoluble pigment for use in those 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 may be labeled as “Yellow 5 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:
You can learn more about the regulation and labeling of colors at:
Expert Panel for Cosmetic Ingredient Safety
The Expert Panel for Cosmetic Ingredient Safety 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 Expert Panel procedures.
Yellow 5 is listed as CI 19140 in Annex IV, Part I (colouring agent allowed for use in cosmetic products) of the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products provided it conforms to the specifications listed in the food regulations. The insoluble barium, strontium and zirconium lakes, salts and pigments of Yellow 5 are also permitted and must pass the test for insolubility. When used in cosmetic products in the European Union, yellow 5 and yellow 5 lake must be called CI 19140.
Link to the EU Cosmetic Regulation: