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State of the Cosmetics Industry, Part II
By: Rachel L. Chapman
Posted: September 25, 2008, from the October 2008 issue of Skin Inc. magazine.
page 7 of 9
However, the top concern, according to Steinberg, is whether nanosized materials are actually used or present in finished formulations.
The United States Environmental Protection Agency (EPA) defines nanoscale as being from 1–100 nanometers (nm) in size, and it is generally recognized that particles smaller than 30 nm pass through the skin and into the bloodstream.
In June 2007, the Scientific Committee on Consumer Products (SCCP) of the European Union (EU) issued its Preliminary Opinion of Safety of Nanomaterials in Cosmetic Products, in which a nanoparticle was defined as having one or more dimensions at 100 nm or less. They also were divided into two groups: labile nanoparticles that disintegrate upon application to the skin, such as liposomes, microemulsions or nanoemulsions; and insoluble particles, such as fullerenes, zinc oxide and titanium dioxide. The SCCP concluded that for the labile group, conventional risk assessment methodologies may be adequate. However, for the insoluble group, the uptake must be considered due to their ability to penetrate the skin and enter the bloodstream because of their size. The group, therefore, is reviewing the complete safety of nanosized particles of inorganic sunscreens.
Reviewing the safety of materials based on particle size was dismissed by the FDA when the industry was dealing with microsized particles; however, if the industry is in fact using nanosized materials, the SCCP is correct in reviewing their safety.
However, Steinberg asks, are nanosized materials actually used or present in finished personal care formulations? He explained that microsize inorganic particles agglomerate readily as would nanosize materials. Once formulated, how stable would the small sizes actually be? Would they become much larger and thus have no safety issue?