Regulation of engineered nanomaterials: current challenges, insights and future directions.

Substantial production and wide applications of engineered nanomaterials (ENMs) have raised concerns over their potential influences on the environment and humans. However, regulations of products containing ENMs are scarce, even in countries with the greatest volume of ENMs produced, such as the United States and China. After a comprehensive review of life cycles of ENMs, five major challenges to regulators posed by ENMs are proposed in this review: (a) ENMs exhibit variable physicochemical characteristics, which makes them difficult for regulators to establish regulatory definition; (b) Due to diverse sources and transport pathways for ENMs, it is difficult to monitor or predict their fates in the environment; (c) There is a lack of reliable techniques for quantifying exposures to ENMs; (d) Because of diverse intrinsic properties of ENMs and dynamic environmental conditions, it is difficult to predict bioavailability of ENMs on wildlife and the environment; and (e) There are knowledge gaps in toxicity and toxic mechanisms of ENMs from which to predict their hazards. These challenges are all related to issues in conventional assessments of risks that regulators rely on. To address the fast-growing nanotechnology market with limited resources, four ENMs (nanoparticles of Ag, TiO2 , ZnO and Fe2 O3 ) have been prioritized for research. Compulsory reporting schemes (registration and labelling) for commercial products containing ENMs should be adopted. Moreover, to accommodate their potential risks in time, an integrative use of quantitative structure-activity relationship and adverse outcome pathway (QSAR-AOP), together with qualitative alternatives to conventional risk assessment are proposed as tools for decision making of regulators.