Ext. Violet 2

What Is It?

Ext. (external) Violet 2 (Ext. D&C Violet No. 2) is a synthetic colorant used as a color additive in the formulation of a wide variety of product types. Ext. Violet 2 is subject to certification by the Food and Drug Administration (FDA).

Why Is It Used?

Ext. Violet 2, either alone or in combination with other ingredients, imparts color to to cosmetics and personal care products.

Scientific Facts

Ext. Violet 2 is a synthetic pigment sometimes referred to in general terms as an anthraquinone 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. Ext. Violet 2 is a straight color; the Ext. in its name designates that it is used for external applications only.
Safety Information

The FDA reviewed the safety of Ext. Violet 2 and determined that it may be safely used for coloring externally applied cosmetics and personal care products when it conforms to FDA specifications and is certified by FDA to meet the regulatory specifications. Ext. Violet 2 is not permitted for use in lip products or in products intended for use in the area of the eye. 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 Ext. Violet 2
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Ext. Violet 2 is listed as CI 60730 in the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products intended not to come into contact with the mucous membranes (see Annex IV). When used in cosmetic products in the European Union, this ingredient must be called CI 60730.

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

Ext. Violet 2 is chemically known as the monosodium salt of 2-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthracenyl) amino]-5-methyl-benzenesulfonic acid. Ext. Violet 2 is the abbreviated name given by FDA to the color, Ext. D&C Violet No. 2, that has been certified. Ext. Violet 2 is water-soluble and produces a deep purple-violet color even at very low concentrations. It is very stable and can be used in the formulation of a wide variety of products and formulation systems. Certifiable color additive, such as Ext. Violet 2, 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/