Yellow 6 Lake

Safety Information

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) has reviewed the safety of yellow 6 and yellow 6 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 6 is also permitted to be used as a color in food and drugs. According to U.S. regulations, all yellow 6 and yellow 6 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. 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 6

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.

You can learn more about the regulation and labeling of colors at
http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen…

Yellow 6 is listed as CI 15985 in the Cosmetics Directive of the European Union and is a coloring agent allowed for use in all cosmetics and personal care products. The insoluble barium, strontium and zirconium lakes, salts and pigments of yellow 6 are also permitted and must pass the test for insolubility (see Annex IV). When used in cosmetic products in the European Union, this ingredient must be called CI 15985.

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

 

Resources

Yellow 6 Lake

What Is It?

In cosmetics and personal care products, yellow 6 (FD&C Yellow No. 6) and yellow 6 lake are used in the formulation of a wide variety of product types, including makeup, bath products, nail care products and suntan products.

Why Is It Used?

Yellow 6 and yellow 6 lake impart color to cosmetics and personal care products.

Scientific Facts

Yellow 6 is a synthetic pigment sometimes referred to as a monoazo color. In addition to its use in cosmetics and personal care products, yellow 6, is commonly used in fermented foods which must be heat treated, such as marmalade and cheese sauce mix.

Yellow 6 is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid.