抄録
As of February 2013 there exist no globally comprehensive regulations on safety assessment of manufactured nanomaterials (MNs) while MN producers are required to investigate systematic methods individually. In light of that condition we have devised a scheme NanoDiversity Evaluation Scheme (NanoDiv) to run simulations for some representative MNs carbon nanotubes (CNTs), titanium oxide (TiO2), etc. This scheme considers manufacturing processes and possible effects caused by nanomaterials contained in finished products. This scheme reflects a concept of stepwise environmental risk assessment (ERA), already adopted for pharmaceuticals as a regulatory approach in the EU or US. Insoluble and high persistent nanomaterials (except metal materials) that might have an intrinsically active site cannot be systematically evaluated for environmental risk by conventional methods. In NanoDiv, exposure scenario will be firstly identified by clarifying exposure pathways and market penetration, and subsequent evaluation is determined based on the scenario. Those simulations showed that the scheme’s final stage could be reached in all cases; however, this scheme is conditional upon verification of human hazard screening and environmental risk assessment. Therefore, it is considered that technology enhancement on those concerns will allow the scheme to evolve into a more sophisticated design while the scheme would become a template for safety assessment of MNs
