Yellow 8

Safety Information

United States (U.S.)

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) reviewed the safety of yellow 8 and and approved its use for for coloring externally applied drugs and cosmetics when it conforms to FDA specifications. Yellow 8 may not be used in products intended for use in the area of the eye or in products intended for use on the lips.

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 8

Expert Panel for Cosmetic Ingredient Safety

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.

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

European Union (EU)

Yellow 8 is listed as CI 45350 in the Cosmetics Directive of the European Union and may be used as a coloring agent in all cosmetics and personal care products at a maximum concentration of 6% in the finished product. When used in products in the European Union, this ingredient must be called CI 45350.

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

Resources

Search the Code of Federal Regulations

Learn More

EU Cosmetics Inventory

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Yellow 8

What Is It?

Yellow 8 (D&C Yellow No. 8) is a colorant. In cosmetics and personal care products, yellow 8 is used in the formulation of bath products, bubble baths, cleansing products, depilatories, permanent waves, and shaving cream. Yellow 8 is subject to certification by the Food and Drug Administration (FDA).

Why Is It Used?

Yellow 8 imparts a color to cosmetics and personal care products.

Scientific Facts

Yellow 8, or Fluorescein Sodium, is a synthetic pigment sometimes referred to in general terms as a xanthene color. Color additives are classified as straight colors, lakes, and mixtures. Straight colors are color additives that have not been mixed or chemically reacted with any other substance. Yellow 8 is a straight color.

Certifiable color additives, such as yellow 8, 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. Yellow 8 is principally the disodium salt of fluorescein. In cosmetics and personal care products, yellow 8 functions as a colorant.