Yellow 10 Lake
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) has reviewed the safety of yellow 10 and yellow 10 lake determined that these ingredients may be safely used for coloring cosmetics and personal care products including products intended to be used on the lips. These ingredients not permitted for use in products intended for use in the area of the eye. Yellow 10 is also permitted to be used as a color in drugs. According to U.S. regulations, all yellow 10 and yellow 10 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 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 yellow 10
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 the FDA. This deferral of review is according to the provisions of the Expert Panel procedures.
You can learn more about the regulation and labeling of colors at:
Yellow 10 is listed as CI 47005 in the Cosmetics Directive of the European Union and is a coloring agent allowed for use in all cosmetics and personal care products when purity requirements are fulfilled (see Annex IV). When used in cosmetic products in the European Union, this ingredient must be called CI 47005.
Link to the EU Cosmetic Regulation: