title: Dealing with nanosafety around the globe-Regulation vs. innovation.
abstract: 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.
authors.affiliation: Department of Pharmaceutical Technology and Nanosciences, Fraunhofer-Institute of Molecular Biology and Applied Ecology/Project group for Tanslational Medicine and Pharmacology, Max-von-Laue-Str. 9, D-60438 Frankfurt, Germany. Electronic address: matthias.wacker@ime.fraunhofer.de.
authors.forename: Matthias G
authors.initials: MG
authors.lastname: Wacker
authors.affiliation: Faculty of Physics, Sofia University, Sofia, Bulgaria.
authors.forename: Ana
authors.initials: A
authors.lastname: Proykova
authors.affiliation: Coordination of Therapeutic Equivalence, Agência Nacional de Vigilância Sanitária (ANVISA), Brasília, Brazil.
authors.forename: Gustavo Mendes Lima
authors.initials: GML
authors.lastname: Santos
mesh_terms: D001208:Asia; D001938:Brazil; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D005062:European Union; D014943:Global Health / Q000331:legislation & jurisprudence*; D006801:Humans; D049329:Nanostructures / Q000009:adverse effects*; D036103:Nanotechnology / Q000331:legislation & jurisprudence / Q000379:methods; D014481:United States
keywords: ANVISA; EFSA; EMA; Law; Nanomaterials; Nanoparticles; OECD; Regulations; Rules