Due to the rapid and diverse growth of engineered nanomaterials (NMs), it is difficult for regulators and risk assessors to understand the potential for exposure to nanomaterials and whether methods used for assessing risk of conventional chemicals can be used for nanomaterials. The U.S. Food and Drug Administration (FDA) has finalized guidelines on the evaluation and use of NMs in FDA-regulated products. These guidelines focus on assessing safety, effectiveness and quality of products containing NMs. Many NMs are also regarded as “chemical substances” under the Toxic Substances Control Act (TSCA). Whereas, NMs that are used as pesticides are subject to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulations.

Physicochemical characterisation (Cosmetics)

  • As a minimum, characterisation of NMs intended for use in a cosmetic product should be determined at three stages
  • As manufactured (pristine state) to identify the basic NM
  • The final cosmetic formulation to identify how consumers are exposed
  • As used for toxicological investigations
  • Concentration of NM in the spray mist released from the container

Analytical Chemistry

  • Chemical identity
  • Chemical composition & concentration
  • Production process particles
  • Particle size and size distribution including presence of agglomeration or aggregation state
  • Morphology /Shape structure
  • Crystallographic structure
  • Surface characteristics, surface area, density and pour density
  • Solubility, viscosity & dispersibility
  • Catalytic activity & redox potential
  • pH, stability, UV absorption
  • Dispersion stability in octanol and water
  • Rate of dissolution in water and relevant aqueous environments e.g., bodily fluids


Toxicology studies

Toxicokinetic assessment

The ames test for mutagenicity

Environmental fate and behavior endpoints