The global aim of this project is to provide investigative support for the elucidation of the toxicological impact of nanoparticles on human health and the environment. It is aimed at area 3.4.1.5. of the Nanotechnologies and Nanosciences, Knowledge Based Multifunctional Materials, New Production Processes and Devices work programme. Public organisations and nanotechnology companies across Europe are under pressure to improve the safety of nanoparticles. In this project, they will document potential methods of dispersal and contamination by nanoparticles and agglomerated nanocrystals (e.g. sorption, desorption, transport, aggregation, deposition, bio-uptake). The review will also address the following issues: physical and chemical properties of different types of nanoparticles and agglomerated nanocrystals; manufacturing and use; human health effects including side effects; animal toxicology; environmental impacts; mutagenicity/genotoxicity; metabolism/pharmacokinetics; standards for safe use; safe laboratory methods etc. Standards, legislation, ethical issues, policies and codes of practice, at international and European level, which have been put in place or are under development, will be assessed and reviewed. Their implications and effectiveness will be discussed. Ways in which existing legislation is applied to the macroscale counterparts of nanoparticles will also be examined. Guidelines and recommendations for the institution of future European standards, legislation, ethics, policies, and codes of practise, for the safe production and use of nanoparticles will be produced. All potential impacts revealed by this SSA will be documented in the final report and disseminated via the specialised web pages on the NANOFORUM web site. SCIENTIFIC AND TECHNOLOGICAL OBJECTIVES The primary aim of this specific support action is to provide investigative support for the elucidation of the toxicological impact of nanoparticles on human health and the environment. Near term nanotechnology, including nanoparticles, is here, and producing results, which can be seen as improvements to existing products (e.g. anti-graffiti coatings, catalysts, cosmetics, scratch-resistant lenses, stain-resistant fabrics, sunscreens, tennis balls) (Dreher, 2004). Nanoparticles occur naturally, in diesel soot, tyres and toner, and can be synthesized, from most elements, for their novel qualities (e.g. strength, reactivity, conductivity, imaging). Nanotubes, for example, are 100 times stronger than steel and about one-fifth lighter (ETC Group, 2002). They have many commercial applications and will impact on the environment and human health. Adequate toxicological information is lacking. Risk assessments for nanoparticles will need to encompass exposure assessments, toxicology, environmental and biological fate, transport, persistence, transformation, recyclability and sustainability. A major risk is that they cannot be detected, and hence cannot be removed, once they have been released into the environment (Krane, 2002). However, this should not be a problem for most nanoparticles, as they will be used in sealed units (e.g. polymers) or as nanofilms. There is also the unanswered question of where nanoparticle-based products are discarded presently (Feder, 2003)? Therefore, their impacts will be considered along the entire supply chain. The specific objectives of the NANOTOX specific support action are: To analyse information on the toxicological impact of nanoparticles, by reviewing information on (WP2: draft by Month 20, final report by Month 24): a) physical and chemical properties of different types of nanoparticles and agglomerated nanocrystals; b) manufacturing and use; c) human health effects including side effects; d) animal toxicology; e) environmental impacts; f) mutagenicity/genotoxicity; g) metabolism/pharmacokinetics; h) standards for safe use; i) safe laboratory methods etc. the potential methods of dispersal, and contamination by, nanoparticles and agglomerated nanocrystals (e.g. sorption, desorption, transport, aggregation, deposition, bio-uptake) To map current national and international research and development activities in the topic of the toxicological impact of nanoparticles on human health and the environment within the European Research Area (ERA) (WP2: by Month 18) To provide an on-line European database, linked to existing web sites and databases of specialist groups (WP2: by Month 18) To identify barriers to the development of safer methods for the production and use of nanoparticles (WP2: by Month 24) To make recommendations to major funding bodies for future research (WP2: by Month 24) To survey national, international and European standards, legislation, ethical issues, policies and codes of practice (WP3: draft by Month 20, final report by Month 24) To develop a set of guidelines and recommendations for best practice for the safe production and use of nanoparticles (WP3: draft by Month 20, final report by Month 24) To disseminate knowledge obtained in this field for use by other researchers. Dissemination will also be via the web pages on the NANOFORUM and NANOTOX / IMPART web sites (WP1: created at the start of the project), and a dissemination seminar (WP4: by Month 12) To promote collaboration between the European nanotechnology industry and nanotechnology researchers The focus of the project is to support the elucidation of the toxicological impact of nanoparticles on human health and the environment. There is great pressure on public organisations and nanotechnology companies across Europe to investigate the hazards and toxicological risks associated with the production and use of nanoparticles. Until recently this issue had been neglected, as nanoparticles were believed to behave like their macro-scale counterparts, in most cases. This project will investigate potential methods of dispersal and contamination by nanoparticles. This project will bring together research institutes, the nanotechnology industry, universities and specialists to review and assess the literature, standards, legislation, ethical issues, policies and codes of practice, and to raise awareness and the level of know-how throughout Europe. A comprehensive set of guidelines and recommendations will be developed for use by European legislators, regulators and policymakers. This project will increase knowledge of these problems in Europe, and ideas at academic level will be transferred to the nanotechnology sector. This will result in innovative approaches being discovered for the safe production and use of nanoparticles. The principal outputs (in order of delivery) of this specific support action will be: Web pages on the NANOFORUM and NANOTOX / IMPART web sites for dissemination of results from this and related projects A toxicology literature review on methods of dispersal, and causes of contamination by nanoparticles Expert group meetings, to stimulate discussion on 'hot topics', to encourage transfer of ideas, and formulation of recommendations Legislation workshop, seminar, and report to disseminate the status of current national and international standards, legislation, ethical issues, policies and codes of practice, to identify bottlenecks or loopholes, and to promote best practice Mapping of current research and development activities in Europe A dissemination workshop, and report, to measure the effectiveness of the dissemination process A set of guidelines and recommendations (in final report) of best practice for their safe production and use These outputs will lead to the following benefits: Better interaction between European researchers, less duplication of effort, safe commercialisation. For example, interaction with the IMPART project will improve the general level of knowledge of European researchers, and their awareness of ongoing research Increased knowledge of the potential of nanoparticles to impact on human health and the environment will eventually lead to a multitude of benefits to society from their safe use Increased awareness of the potential risks associated with nanoparticle production and use. By carefully targeting this information towards key stakeholders, this project will aid European policy-makers in creating suitable new policies Improved guidelines and recommendations to aid legislators, regulators and policymakers. If successful new legislation will be framed to protect society from the health and environmental risks associated with nanoparticles