Violet 2

Safety Information

United States (U.S.)

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) permits violet 2 to be used for coloring externally applied cosmetics and personal care products, and externally applied drugs when violet 2 conforms to FDA specifications. Externally applied products do not include products intended for use on the lips, or products intended for use in the eye area. According to U.S. regulations, all violet 2 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.

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.

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 violet 2

European Union (EU)

Violet 2 is listed as CI 60725 in the Cosmetics Directive of the European Union (see Annex IV) and may be used in all cosmetics and personal care products. When used in cosmetic products in the European Union, this ingredient must be called CI 60725.

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…

Resources

Search the Code of Federal Regulations

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EU Cosmetics Inventory

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Violet 2

What Is It?

In cosmetics and personal care products, violet 2 (D&C Violet No. 2) is used in the formulation of a wide variety of product types. Violet 2 is subject to certification by the FDA.

Why Is It Used?

Violet 2 imparts a color to cosmetics and personal care products.

Scientific Facts

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. Violet 2 is a straight color.

Violet 2 is principally 1-hydroxy -4-[(4-methylphenyl) amino]-9,10-anthracenedione. Certifiable color additive such as 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. Certifiable color additives typically are available for use as either “dyes” or “lakes.” Dyes dissolve in water and are manufactured as powders, granules, liquids or other special purpose forms. Lakes are the water insoluble form of the dye. Lakes are typically more stable than dyes and are ideal for coloring products lacking sufficient moisture to dissolve dyes.