Nanomaterial Toxicity and Regulatory Framework: Need of the Hour

Abstract

Nanoparticles (NPs) and Nano-Structured Materials (NSMs) represent a dynamic area of research and a fast-expanding techno-economic sector in diverse applications. Nano-materials exhibit multiple traits that make them suitable for diverse clinical applications. Their defining characteristics include super para-magnetism, high agglomeration and mechanical properties, along with a significant surface area-to-volume ratio. Monometallic nano-structured metal clusters act as precursors for heterogeneous catalysts. Nano Pharmaceuticals (NPs) are characterized as nano-materials that have at least one external dimension, or who’s internal or surface structure is within the nanoscale range (about 1 to 100nm). NPs have distinct physical and chemical properties that affect their toxicity, in contrast to those of larger counterparts. Research into nano-toxicity centers on the detrimental impacts of nano-materials, with the goal of determining their potential threat level to society and the environment. The FDA utilizes a product-focused and science-based regulatory policy that leverages this emerging technology to regulate products. Guidelines cover its physicochemical properties, biological properties and product applications.

Graphical Abstract

Figure 1:Graphical abstract for nanomaterial toxicity and regulatory framework.

Keywords: Nanoparticles; Toxicity; Regulations; FDA; EMEA; Nanomaterials