Ultramarines

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What Is It?

Ultramarines are synthetic pigments (blue, green, pink, red, and violet) of sodium aluminum sulfosilicate. In cosmetics and personal care products, Ultramarines are used in the formulation of a wide variety of product types.

Why is it used in cosmetics and personal care products?

Ultramarines impart color to cosmetics and personal care products.

Scientific Facts:

Ultramarines are synthetic blue, green, pink, red and violet pigments. Natural Ultramarine occurs as a component of the deep-blue stone, lapis lazuli. They are made from mineral sources such as clay and sodium carbonate. Because compounds come from the earth they may contain trace amounts of heavy metals. The levels of heavy metals in Ultramarines are regulated by the FDA, and the small amounts that may eventually be in cosmetic or personal care products do not pose a risk to human health.

Safety Information:

The Food and Drug Administration (FDA) lists Ultramarines as color additives exempt from certification. Ultramarines may be safely used for coloring cosmetics and personal care products, including products intended for use in the area of the eye, when they conform to FDA specifications. Ultramarines are not allowed to be used in lipstick. The FDA also includes Ultramarines on its list of indirect food additives as a colorant for polymers in contact with food. 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.

More safety Information:

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

FDA: Link to Code of Federal Regulations for Ultramarines

Ultramarines are listed as CI 77007 in the Cosmetics Dirctive of the European Union (Annex IV, Part I) and may be used in cosmetics and personal care products without limitation. When used in cosmetic products in the European Union, this ingredient must be called CI 77007.

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:

Ultramarines are complex sodium aluminum sulfosilicates. They are made by heating a mixture of kaolin, sulfur, sodium carbonate, silicious maater, sodium sulfate and carbonaceous matter at temperatures above 700 degrees C. The proportions of the elements (sodium, aluminum, silica, oxygen, sulfur) in the pigments vary with each color. In cosmetics and personal care products, Ultramarines function as colorants.

Resources:

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

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/