Green 8

What Is It?

Green 8 (D&C Green No. 8) is a colorant. In cosmetics and personal care products, Green 8 is used in the formulation of bath products, cleansing products, hair conditioners, hair wave sets, moisturizers, shampoos, skin care products, and other hair care products. Green 8 is subject to certification by the Food and Drug Administration (FDA).

Why Is It Used?

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

Scientific Facts

Green 8 is a synthetic pigment sometimes referred to in general terms as a pyrene 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. Green 8 is a straight color.
Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Green 8 and determined that it may be safely used for coloring externally applied cosmetics and drugs in amounts not exceeding 0.01% by weight of the finished product. It is not permitted for use in products intended for use in the eye area or in products intended for use on the lips. Cosmetic Ingredient Review (CIR) 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 CIR 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

Link to FDA Code of Federal Regulations for Green 8

Green 8 is listed as CI 59040 in the Cosmetics Directive of the European Union and may be used as a coloring agent in cosmetics and personal care products (see Annex IV). It is not permitted in products intended for use in the eye area or on products intended for use on the lips. When used in products in the European Union, this color must be called CI 59040.

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

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

More Scientific Information

Certifiable color additives, such as Green 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. Green 8 is principally the trisodium salt of 8-hydroxy-1,3,6-pyrene-trisulfonic acid. In cosmetics and personal care products, Green 8 functions as a colorant.
Resources

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/