Green 3 Lake

What Is It?

In cosmetics and personal care products, Green 3 (FD&C Green No. 3) and Green 3 Lake are used in the formulation of a wide variety of product types. Green 3 can also be added directly to food and drugs.

Why Is It Used?

Green 3 and its lake are used to color to cosmetics and personal care products.

Scientific Facts

Green 3 is a synthetic pigment sometimes referred to in general terms as a triphenylmethane 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 3 is a straight color. In addition to its use in cosmetics and personal care products, Green 3 is commonly used as a food dye and in the formulation of drugs.
Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Green 3 and Green 3 Lake and determined that these ingredients may be safely used for foods, drugs and for coloring cosmetics and personal care products when conforming to FDA specifications. The Food and Drug Administration (FDA) has reviewed the safety of Green 3 and Green 3 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. Green 3 is also permitted to be used as a color in food and drugs. According to U.S. regulations, all Green 3 and Green 3 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. 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 3

Green 3 is listed as CI 42053 in the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products according to the provisions of the Cosmetics Directive of the European Union (see Annex IV). When used in cosmetic products in the European Union, this ingredient must be called CI 42053.

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 3 is chemically known as the inner salt disodium salt of N-ethyl-N-[4-[[4-[ethyl [(3-sulfophenyl) methyl] amino] phenyl] (4-hydroxy-2-sulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide. It is a water-soluble color that produces an intense emerald green color even at very low concentrations. It is a very stable color that can be used in a wide variety of product types and formulations. Green 3 is the abbreviated regulatory name given by FDA to the certified color, FD&C Green No. 3.
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/