Dealing with nanosafety around the globe-Regulation vs. innovation

Int J Pharm. 2016 Jul 25;509(1-2):95-106. doi: 10.1016/j.ijpharm.2016.05.015. Epub 2016 May 13.


In recent years, nanotechnology has become increasingly important for global industries. Today, many nanomaterials are used as ingredients in cosmetics, food products, medical devices and pharmaceuticals. In some cases they exert unexpected risks and potentially pose a threat to human health and the environment. Regulatory authorities all over the world carefully observe recent developments in this area, striving to find a balance between consumer safety and the interests of the industry. In the following, the current legislation in the United States of America, the European Union, Asia and Brazil will be presented. Further, the requirements defined by these different authorities and methodology to investigate relevant characteristics of nanomaterials will be discussed.

Keywords: ANVISA; EFSA; EMA; Law; Nanomaterials; Nanoparticles; OECD; Regulations; Rules.

Publication types

  • Review

MeSH terms

  • Asia
  • Brazil
  • Consumer Product Safety / legislation & jurisprudence
  • European Union
  • Global Health / legislation & jurisprudence*
  • Humans
  • Nanostructures / adverse effects*
  • Nanotechnology / legislation & jurisprudence
  • Nanotechnology / methods
  • United States