Red 17

What Is It?

Red 17 (D&C Red No. 17) is described as reddish brown crystals and is used as a coloring agent. In cosmetics and personal care products, Red 17 is used in the formulation of bath products, cleansing products, colognes and fragrances, hair conditioners, hair wave sets, makeup, nail products, skin care products and suntan products. Red 17 is subject to certification by the Food and Drug Administration.

Why Is It Used?

Red 17 imparts a color to cosmetics and personal care products.

Scientific Facts

Red 17, or Sudan III, is a synthetic pigment sometimes referred to in general terms as a diazo 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. Red 17 is a straight color.
Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Red 17 and determined that it may be safely used for coloring externally applied drugs and cosmetics when it conforms to FDA specifications. Red 17 may not be used in products intended for use in the area of the eye 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 Red 17

Red 17 is listed as CI 26100 in the Cosmetics Directive of the European Union and may be used as a coloring agent allowed in cosmetics and personal care products except in products intended for use in the eye area and those intended for use on the lips. Purity requirements must be followed (see Annex IV). When used in products in the European Union, this ingredient must be called CI 26100.

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 Red 17. 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. Red 17 is principally 1-[[4-(phenylazo)phenyl]azo]-2-naphthalenol. In cosmetics and personal care products, Red 17 functions as a colorant.
Resources

The International Agency for Research on Cancer (IARC) monograph on Some Aromatic Azo Compounds, including Sudan III (Red 17) http://monographs.iarc.fr/ENG/Monographs/vol8/volume8.pdf

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/