Green 5

What Is It?

In cosmetics and personal care products, Green 5 (D&C Green No. 5) is used as a color in the formulation of a wide variety of product types. Green 5 is subject to certification by the Food and Drug Administration.

Why Is It Used?

Green 5, either alone or in combination with other color ingredients, imparts a color to cosmetics and personal care products. It may also be used to color drugs and surgical sutures.

Scientific Facts

Green 5 is a synthetic pigment sometimes referred to in general terms as an anthraquinone color. Color additives are classified as straight colors, lakes, and mixtures. According to FDA, straight colors are color additives that have not been mixed or chemically reacted with any other substance. Green 5 is a straight color.
Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Green 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 it conforms to FDA specifications. FDA also allows the use of Green 5 in the formulation of drugs. The 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 5

Green 5 is listed as CI 61570 in the Cosmetics Directive of the European Union and may be used according to general provisions of the Cosmetics Regulation of the European Union. When used in cosmetic products in the European Union, this ingredient must be called CI 61570.

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

Green 5 is chemically identified as the disodium salt of 2,2′-[(9,10-dihydro-9,10-dioxo-1,4-anthracenediyl)diimino] bis-[5-methylbenzenesulfonic acid]. Green 5 is a water-soluble color that is very stable and can be used in the formulation of a wide variety of product types and formulations. Green 5 is the abbreviated name given by FDA to the certified color, D&C Green No. 5. Certifiable color additive such as Green 5 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.
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/