Chapter 18 - Regulations for using nanotechnology in food and medical products

Abstract

This chapter deals with the use of the nanoscale in the production of food and packaging as well as medical equipment and materials. On the nanoscale, materials behave differently from their macroscale counterparts. In the case of food and packaging, this is especially important because nanoscale materials may have undesirable effects on human health. The use of the nanoscale in medical products, such as medicines and hospital equipment, may also affect human health. In addition, nanoscale materials may have unknown environmental effects. In the United States and the European Union, legal standards produced mainly by regulatory agencies are already in place. The Organisation for Economic Co-operation and Development (OECD) has also produced several directive and regulatory documents. Such regulatory texts may serve as an inspiration to assist other countries where specific nanoregulation does not yet exist, such as Brazil. Therefore, based on bibliographic research, this chapter builds a framework model relating established legal standards with NanoAction principles and the principles and rules already in force in Brazil. This third corpus—of Brazilian rules and principles—does not explicitly mention nanotechnologies, nanomaterials, or nanoparticles. However, its content can be associated with specific NanoAction principles as well as the legal standards instituted by the United States, European Union, and the OECD. Thus, a normative model emerges that can serve to regulate the entire life cycle of nanomaterials, even without legislative prognosis currently in force. In its totality, this chapter opens a space in which research structures a “regulatory environment” with plural sources and the participation of various social actors involved with the world on a nanoscale.