Nanoparticles and Their Regulation

Abstract

Since the year 2000, nanotechnology has been an emerging factor in science, economy, and also daily life. Although nano size was well known in the past in chemistry (e.g., kolloids, catalysts), due to the huge number of engineered synthetic nanomaterials and their wide range of technical applications, a new broad economic field has come up. Regulatory bodies developed strategies to include nanomaterials into the existing legislation of chemicals, biocides, and food additives. This process was facilitated by the fact that principally not the chemistry changed from micro- to nanoscale but mainly physico-chemical properties (specific surface, solubility, agglomeration status, etc.). Thus, toxicological effects were not expected to be principally different; however, the evaluation had to be expanded from target organ effects (e.g., lungs, skin) to potential systemic effects. Due to the tiny size and an increased dissolution of nanoparticles, the toxicokinetics became a predominant additional endpoint. This summary is based on the technical guidelines, decisions, and laws issued by the main regulatory bodies such as the Organisation for Economic Co-operation and Development (OECD), European Chemicals Agency (ECHA), European Food Safety Authority (EFSA), European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and U.S. Environmental Protection Agency (EPA). This chapter is presenting the regulatory status of nanomaterials being aware of the still ongoing process.