Regulatory developments and their impacts to the nano-industry: A case study for nano-additives in 3D printing

Nanotechnology has increasing applications in numerous markets, particularly in additive processing (3D printing) and manufacturing, which is important for consumer products, medical devices, construction, and general research and development across many other industries. Nanomaterials are desirable in many products due to their unique properties, but those same properties have made evaluating the risk and regulation of these materials challenging. For risk-based regulations, new applications and nanomaterials should be assessed for both human and environmental hazards and exposure to ensure protection. In general, many risk assessments to date have focused on the non-nano versions of chemicals. The lack of guidance on assessing the hazard and exposure of nanomaterials in 3D printing is apparent, and these areas of assessment are actively being evaluated. Industry in most cases will now need to provide specific additional information for assessing the risk of nanomaterials in 3D printing. This review paper focuses on the use of nanomaterials in 3D printing for industrial and manufacturing applications, summarizes the current literature on human health and safety related to 3D printing and inhalation exposure, and the regulations relating to 3D printing in the U.S., Canada, and Europe for this industry.