D&C Black No. 3, or "bone black," has been approved by the US Food and Drug Administration (FDA) for formulation into eye shadow, eyeliner, mascara and face powder. The pigment, made from carbonized cow bones, is a black pigment with low oil absorption that provides a matte color. The pigment was approved in the June 18 Federal Register and is now allowed in cosmetics provided there are no noteworthy objections from stakeholders.
Currently, black iron oxides are the only available options for black pigment colorization in the cosmetic industry, according to the FDA. The inclusion of D&C Black No. 3 is a result of a petition filed by Ebonex Corp., a manufacturer of "bone black," in 2003.
The pigment is made from cattle bones that are heated to temperatures in excess of 700°C, followed by the char being washed. The FDA noted that while the pigment may contain low levels of potentially carcinogenic polycyclic aromatic hydrocarbon (PAH), studies have concluded that it is safe. The agency is limiting the PAHs in the pigment to 5 milligrams per kilogram. The FDA also recognized that safety concerns may arise surrounding bovine spongiform encephalopathy. To address this concern, the FDA noted that the cattle materials used to create the pigment do not carry a high risk of transmitting the agent.The agency is restricting arsenic and lead to no more than 3 mg/kg (3 ppm) and 10 mg/kg (10 ppm). The FDA is also setting the following specifications:
Carbon 7%
Calcium 75-84%
Hydroxyapatite <7%
Moisture and Silica <5%
The regulation will go into effect next week. Stakeholders have until July 18 to object, specifying which part of the legislation they object to. More information can be obtained by visiting www.regulations.gov or www.fda.gov.
