Regulatory Focus™ > News Articles > FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products

FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products

Posted 20 April 2012 | By

The US Food and Drug Administration (FDA) has issued new draft guidance pertaining to the inclusion of nanomaterials in cosmetic products.

The draft guidance, Safety of Nanomaterials in Cosmetic Products, was released 20 April and discusses the FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products.

"Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers - particles so small that they can not be seen with a regular microscope," explained FDA in a statement.

"FDA is investing in an FDA-wide nanotechnology regulatory science program to further enhance FDA's scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products," added FDA.

The guidance provides a general framework for assessing the safety of nanomaterials, which FDA notes can be quite complicated. "At the nanoscale, properties of materials might change resulting in changes to the product's performance, quality, safety, and/or effectiveness," wrote FDA in the guidance. Further, "the use of nanomaterials may alter the bioavailability of the cosmetic formulation," which may require further safety testing on the finished product.

Existing safety assessment methods, including hazard identification, dose-response assessment, exposure assessment and risk characterization is generally adequate to understand the risks associated with a cosmetic product's nanomaterials, but modified testing may be needed to address the nanomaterial's unique chemical and physical traits, said FDA.

All nanomaterials must be fully described to FDA in terms of their physio-schemical properties, be tested for any impurities, undergo toxicological testing, have an understood routes of exposure and have defined uptake and absorption rates.


Read more:

FDA - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products


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