Bismuth Oxychloride

What Is It?

Bismuth Oxychloride is a synthetically prepared white or nearly white amorphous or finely crystalline powder. In cosmetics and personal care products, Bismuth Oxychloride is used in the formulation of many products, including make-up, nail products, cleansing products, fragrances and hair coloring products.

Why Is It Used?

Bismuth Oxychloride imparts a white color to cosmetics and personal care products.

Scientific Facts

Bismuth is a naturally occurring, brittle metal. Bismuth-containing compounds can be found in a number of applications: as a pigment (Bismuth Oxychloride) in cosmetics and personal care products, and in Over-The-Counter (OTC) medicines (bismuth subnitrate) such as some used to treat gastrointestinal problems. Because bismuth compounds come from the earth they may contain trace amounts of heavy metals. The levels of heavy metals in Bismuth Oxychloride 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 Bismuth Oxychloride as a color additive exempt from certification. Bismuth Oxychloride may be safely used in coloring cosmetics and personal care products, including products intended for use in the area of the eye. It is not allowed to be used in lip products. The Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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

FDA: Link to Code of Federal Regulations for Bismuth Oxychloride

Bismuth Oxychloride is listed as CI 77163 in Annex IV, Part I (colouring agent allowed for use in cosmetic products) of the Cosmetics Directive of the European Union and may be used without restriction in all cosmetics and personal care products. When used in cosmetic products in the European Union, this ingredient must be called CI 77163.

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

In cosmetics and personal care products, Bismuth Oxychloride functions as a colorantIngredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics.. To be used as a colorant, Bismuth Oxychloride must comply with FDA specifications. The material must be at least 98% Bismuth Oxychloride and contain not more than 0.5% volatile matter.

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/