Researching Nanotechnology and Selected Legal and Regulatory Issues

By Mohammad Ershadul Karim

Dr. Mohammad Ershadul Karim is a Senior Lecture at the Faculty of Law, University of Malaya, Kuala Lumpur, Malaysia, and a non-practicing lawyer enrolled with the Bangladesh Supreme Court.

Published May/June 2023

(Previously updated in May 2016)

See the Archive Version!

1. Introduction

The word ‘nano’ is derived from the Greek word ‘nanos’, meaning ‘dwarf’ or ‘very small man’. In the study of nanoscience and technology, this word is used to indicate a scale of measurement. Nanotechnology, according to the European Commission, is a branch of science and engineering that is devoted to designing, producing, and using structures, devices, and systems by manipulating atoms and molecules at the nanoscale, i.e., having one or more dimensions of the order of 100 nanometres (100 millionths of a millimeter) or less. In layman’s term, it is the study of nanoscale chemicals. To the scientists, everything we see, touch, can feel is made of chemicals; and if we can manipulate these chemicals at the atomic and molecule scale, we can theoretically control everything. Nanotechnology thus was hailed as the next wonder after the Internet because of its limitless potentials. At the beginning of this century, most of the developed countries started initiatives to exploit nanotechnologies treating these as ‘the wave of the future’. The policymakers and stakeholders involved in dealing with nanoparticles and nanomaterials have frequently endorsed nanotechnologies as important catalysts that promise to play a crucial role in harnessing the potentials of the so-called fourth industrial revolution.

The legal and regulatory discussion on nanotechnology mostly rotates around the study of chemical substances, the environment, occupational health and safety, product liability, and consumer protection etc. For someone without scientific and technological knowledge, including people with a legal background, a good starting point is the basics of nanoparticles, nanomaterials, nanoscience and nanotechnologies. Some introductory discussions on nanoscience and nanotechnology can be found on the website of the United States National Nanotechnology Initiative and the European Union.

2. Historical Development

The use of materials at the nanoscale is not something new or innovative; rather, people of ancient civilizations in Egypt, Rome, China, and India had techniques for using nanoscale materials in different products. However, the modern study of nanotechnology allows scientists to intentionally manipulate materials at the nanoscale (between 1-100 nanometer).

It is widely accepted that the modern history of nanotechnology started with the groundbreaking lecture of the Noble laureate Richard Feynman titled ‘There’s Plenty of Room at the Bottom’, delivered at a lecture in a meeting of the American Physical Society at the California Institute of Technology in 1959. Norio Taniguchi, a Professor of Tokyo Science University, coined the term ‘nanotechnology’ for the first time in 1974. The invention of extremely powerful microscopes has tremendous impacts on the advancement of nanoscience and technology.

Nanomaterials are ubiquitous in nature and scientists have already discovered the nanoscale formation of various things available in the nature such as milk, volcanic ashes, dust, fumes, etc. Even though there are debates about whether nanomaterials are a unique or simple fabrication of structures already designed in nature, scholars from various disciplines such as physics, chemistry, biology and material science have been working relentlessly in shaping the modern world of nanoscience and nanotechnologies. A complete history of involving the developments in these fields is difficult to share, but the National Nanotechnology Initiative of the United States has attempted to cover an authoritative history of nanotechnology development from the 4th century until the present. Researchers have also attempted to explore the history of nanoscience and nanotechnology and the historical development of nanoparticles in ancient materials.

Though nanomaterials are ubiquitous in nature and the people of the ancient civilizations used to know the technique to exploit different types of nanomaterials and used these in various products; apparently, the modern and more systematic move in this regard started with the enactment of the 21st Century Nanotechnology Research and Development Act, 2003 by the Congress of the United States of America. Following this, regulators from different parts of the world, mostly from developed countries though, initiated a similar move. Since then, the global community has been witnessing the development of various nanomaterials and nano-enabled products.

3. Selective Databases on Nanomaterials and Nano-Enabled Products

An understanding of nanomaterials and nano-enabled products may help us explore relevant legal and regulatory issues. The Woodrow Wilson International Center for Scholars through the Project on Emerging Nanotechnology developed a Consumer Products Inventory for the first time in 2005. Initially, there were some concerns and limitations of the inventory as the listing was voluntary and the list of the consumer nano-enabled products was listed as and when these were shared by the manufacturers. Subsequently, the organisers updated their methodology and currently one may get information of more than 1600 nano-enabled products in the inventory. Federal Environment Agency of Germany subsequently shared the Concept for a European Register of Products Containing Nanomaterials and Assessment of Impacts of a European Register of Products Containing Nanomaterials. At present, it is possible to find out various databases containing information on various aspects of nanotechnologies, nanomaterials, and nanoparticles. Some of these are shared below:

  • StatNano: This is the most comprehensive database that can be consulted to explore the development of various aspects of nanotechnologies and nanomaterials. Issues covered in the database include nanoproducts, policy documents, standards, companies, etc.
  • European Union Observatory for Nanomaterials maintains a nanotechnology knowledge base (NanoData) containing important information on the application of nanomaterials in various sectors such as agriculture, construction, consumer products, energy, environment, health, ICT, manufacturing, photonics, transport and others. One can find an overview of the application of nanomaterials in these sectors, market, R & D, patents, standards, regulations, products, etc.
  • The Nanodatabase, developed by the Danish Consumer Council and the Danish Ecological Council in cooperation with the Technical University of Denmark (DTU) Environment, contains information about more than 5330 nano-enabled consumer products. One distinctive feature of this database is Nano regulation where discussion on relevant European regulations such as EU Ecolabel, Novel Food, cosmetic product, biocidal products, medical devices and water are included. Similar databases or national registries can be identified in the context of France, Norway, Belgium and Sweden.
  • The Project on Emerging Nanotechnology: [This was the first of this kind and contains an inventory of consumer products containing nanoscale materials since 2005. Till date, 1,833 consumer products are listed in the database. Public Virtual Nanostructure Simulation (PubVINAS): This is a publicly available database containing the experimental data of 705 unique nanomaterials covering 11 material types.
  • Nanowerk Nanomaterial Database: Nanower LLC, a limited liability company maintains A to Z Directory of Nanotechnology Suppliers/Companies, alphabetical list, list of suppliers by country.
  • Center for Food Safety maintains an interactive database of consumer food products containing nanomaterials.
  • AZONANO also maintains a directory of companies dealing with the use of nanomaterials and directory of suppliers of various products.

Nanotechnologies and manufactured nanomaterials have the prospect of attaining almost all the goals listed in the United Nations Sustainable Development Goals. Nanomaterials are nanoscale chemicals. Considering the various stages in the cradle-to-grave lifecycle of nanomaterials—i.e., research and development, production and manufacturing, transportation, use by the consumers, and end use disposal of nano-enabled products and the stakeholders or parties involved in these various stages—one can anticipate various legal and regulatory issues in this regard. Looking at these from both public and private law angles can also help explore relevant legal and regulatory issues. The following section contains some important reference materials in this regard issued by authoritative international organisations.

4.1. United Nations

Various specialized agencies of the United Nations Organisation (UN) have been working on and publishing important policy documents within their mandated areas to promote and exploitation of nanomaterials.

4.2. European Initiatives

Europe, as a region and continent, has realized the importance of nanotechnologies and has taken various initiatives aiming to exploit nanomaterials for the betterment of Europe. Nevertheless, since the findings of various scientific literature revealed that some of the nanomaterials widely used in consumer products may have an adverse effect on human health and environmental components, various European entities have already reviewed relevant sectoral laws. For example, European Commission, DG Research, Unit published a report on European activities in the field of ethical, legal and social aspects (ELSA) and governance of nanotechnology, 2008.

A list of other similar initiatives:

Various initiatives have been taken through various institutions by adopting different arrangements and allocating a considerable amount of budget, aiming at guiding the global community in shaping the legal and regulatory landscape of nanotechnologies and nanomaterials.

The European Commission considers nanotechnology as a key enabling technology and is convinced that this has great potential potentials though there are safety concerns. One of the main contributions in this regard is the recommendation on the definition of ‘nanomaterials’ based on the size of particles in 2011. An implementation guidance was also released. That recommended definition guided European regulators and others. The recommended definition was reviewed and revised in 2022 retaining the principal features of the old definition. According to the Commission’s updated recommendation on the definition of nanomaterial, 2022, ‘Nanomaterial’ means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50 % or more of these particles in the number-based size distribution fulfil at least one of the following conditions: (a) one or more external dimensions of the particle are in the size range 1 nm to 100 nm; (b) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm; (c) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.

The European Commission has funded the establishment of a European Union Observatory for Nanomaterials, which provides information about existing nanomaterials on the EU market. This initiative, hosted and maintained by the European Chemicals Agency, offers interesting reading about the safety, innovation, research and uses of nanomaterials.

The Joint Research Centre of the European Commission (JRC) provides independent, evidence-based knowledge and science, and advice to support European Union policy. JRC’s Nanomaterials Repository hosts a repository of representative industrial nanomaterials and provides a compilation of links to information sources relevant to nanomaterials. The JRC has already provided scientific and technical advice concerning nanomaterials to other Commission Services (e.g., DG Internal Market, Industry, Entrepreneurship and SMEs, DG Environment and DG Health and Food Safety) and regulatory agencies (European Chemical Agency, European Food Safety Authority and European Medicines Agency). JRC has also developed an open access Nanobiotechnology Laboratory with state-of-the-art facilities for interdisciplinary studies with a special emphasis on the characterisation of nanomaterials, nanomedicines, advanced materials, and micro(nano)plastics.

The European Commission also published a Code of Conduct for Responsible nanoscience and nanotechnology research in 2008. A project titled NanoCode involving multi-stakeholders was also taken to define and develop a framework aimed at supporting the successful integration and implementation of the Code of Conduct at the European level and beyond.

Other initiatives:

  • European Chemical Agency (ECHA), working closely in collaboration with Member State competent authorities, the European Commission, NGOs and industry associations as well as international organisations such as the Organisation for Economic Cooperation and Development (OECD), has been playing a decisive role in the governance and regulation of nanomaterials, and to help implement EU chemicals legislation for nanomaterials.
  • European Agency for Safety and Health at Work, which has the mandate to make the workplaces in the European Union safer, healthier and productive, has taken various initiatives concerning the management of nanomaterials in the work place.
  • The European Food Safety Authority, in response to requests for scientific advice from other institutions, undertakes various activities on different issues, including nanotechnologies.
  • Addressing the safety aspects of nanomaterials is crucial for the commercial success of nanotechnologies and for consumers to accept nano-enabled products. Realising this, the European Commission funded a research which published a document titled Nanosafety in Europe 2015-2025: Towards Safe and Sustainable Nanomaterials and Nanotechnology Innovations.
  • European NanoSafety Cluster initiative was taken through which projects addressing all aspects of nanosafety including toxicology, ecotoxicology, exposure assessment, mechanisms of interaction, risk assessment and standardization, etc. were compiled, and European NanoSafety Cluster Compendiums were released in 2012, 2013, 2014, and 2015.
  • Under the European Union’s Framework Programme for Research and Development (FP7), another project Nanopinion initiative has been taken to bring together 17 partners from 11 countries to monitor public opinion on what is hoped from innovation with nanotechnologies. The project is aimed at citizens with a special focus on hard-to-reach target groups, which are people who do not normally encounter and give their opinion on nanotechnologies at first hand.

4.3. Timeline: Nanotechnology Policy and Regulation

See a timeline of nanotechnology policy and regulation in Canada, Australia, the European Union, the United Kingdom, and the United States. This timeline contains important events since 1936 which help shape the development of nanotechnology policy and regulation in these countries.

4.4. Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative

The United States and Canada have established the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative to spur economic growth in each country; fuel job creation; lower costs for consumers, producers, and governments; and particularly help small and medium-sized businesses. The initiative also intends to eliminate unnecessary burdens on cross-border trade, reduce costs, foster cross-border investment, and promote certainty for businesses and the public by coordinating, simplifying and ensuring the compatibility of regulations, where feasible. Both countries are committed to working through the RCC to provide early notice of regulations with potential effects across their shared border, to strengthen the analytic basis of regulations, and to help make regulations more compatible.

5. International and Non-Governmental Organizations and Nanotechnology

Some international, both intergovernmental and non-governmental, organisations have been playing a crucial role in helping shape the legal and regulatory aspects of nanomaterials and nanotechnologies.

  • Organisation for Economic Cooperation and Development (OECD), the intergovernmental organisation of 38 industrialised countries, has been dedicated to promoting chemical safety, including nanosafety as nanomaterials are nano-scale chemicals. The OECD has been playing the most significant role in developing guidelines for the testing of nanomaterials. Concerning nanomaterials, the Organisation established two working parties i.e. Working Party on Manufactured Nanomaterials (WPMN) and Working Party on Nanotechnology (WPN). See a review of the achievements of the OECD Working Party on Manufactured Nanomaterials’ Testing and Assessment Program (from exploratory testing to test guidelines).
    • OECD has developed the principles of Good Laboratory Practice, which are harmonized, common tools used by the countries to test and assess the potential risks of chemicals. Another important contribution of the OECD in this regard is the development of Mutual Acceptance of Data.
  • Asia Nano Forum: An Organization of 15 economies [Australia, India, Malaysia, South Korea, Vietnam, Indonesia, New Zealand, Taiwan, China, Iran, Thailand, Hong Kong, Japan, Singapore and UAE] from Asia and the Pacific Region. This Organisation focuses to promote the responsible development of nanotechnology by fostering international network collaboration. The working groups of the organization consider standards, commercial aspects, nanosafety issues.
  • The International Risk Governance Council (IRGC) is an independent non-profit foundation that aims to improve the understanding and management of risks and opportunities by providing insight into systemic risks that have impacts on human health and safety, the environment, the economy and society at large. Earlier, IRGC conducted some research on Nanotechnology risk governance in general and with a special focus on the applications of nanotechnology in food and cosmetics.
  • International Center for Technology Assessment (ICTA), a non-profit, bi-partisan organization committed to providing the public with full assessments and analyses of technological impacts on society, is devoted to fully exploring the economic, ethical, social, environmental and political impacts that can result from the applications of technology or technological systems, including Nanotechnology. Earlier, ICTA filed a few lawsuits challenging the USA regulator’s failure to regulate nano-silver as a pesticide, the risk of nanotechnology, etc.
  • Friends of the Earth (FoE) International is the world’s largest and fastest growing federation of environmental organisations, with established groups in 77 countries and over 2 million individual members. This Organisation pushes policymakers in the U.S. and internationally to apply a precautionary approach to the regulation of nanotechnology by putting the health of people and the environment before corporate profits.
  • ETC Group works to address the socioeconomic and ecological issues surrounding new technologies, including nanotechnologies, that could have an impact on the world’s poorest and most vulnerable people.
  • Center for Food Safety works to empower people, support farmers, and protect the earth from the harmful impacts of industrial agriculture. Through groundbreaking legal, scientific, and grassroots action, the Center drives to protect and promote people’s right to safe food and the environment. CFS’s successful legal cases collectively represent a landmark body of case law on food and agricultural issues. maintains an interactive database of consumer food products containing nanomaterials. This Center maintains an interactive database of consumer food products containing nanomaterials and other relevant materials on food and nanotechnology.
  • Nanotechnology Industries Association, sector-independent, responsible voice for the industrial nanotechnologies supply chains.
  • The Innovation Society is an internationally active management- and technology consulting company and in 2012, the company released a Report on Social and Environmental Implications of Nanotechnology Development in the Asia Pacific Region.

6. Risk Assessment and Risk Management

The assessment and management of various types of risks are crucial for the sustainable and responsible development of nanotechnologies and their commercial success. Various organisations have developed some guidelines and produced some reports in this regard.

7. Nanotechnology and Standardization

Standards are crucial for the sustainable and responsible development of nanotechnologies and their commercial success. Various national and international stand development organisations have developed standards in this regard:

8. Nanotechnology, Occupational Health and Trade Union

Workers and employees dealing with nanomaterials in research or production processes may be exposed to nanoparticles in several ways. Although the potential health effects of such exposure are not fully understood for the time being, scientific studies indicate that at least some of these materials are biologically active, may readily penetrate intact human skin, and have produced toxicologic reactions in the lungs of exposed experimental animals. As a result, to the regulators of most of the developed countries, the protection of these groups of people from the adverse effects of nanomaterials is a priority and therefore, the regulators have taken various measures and issued guidance documents in this regard. For example, the U.S. National Institute for Occupational Safety and Health (NIOSH) established the Nanotechnology Research Center (NTRC) in 2004 to identify critical issues related to potential worker exposure to nanomaterials. Some relevant guidance documents are listed below:

9. Guidance Documents

Different authorities have issued different Guidance/Guidelines which are instrumental in the responsible and sustainable development of nanotechnology. Many of these Guidances are available in resources shared under different places of this Guide and some can be found on the website of GoodNanoGuide. Some other Guidance Documents/Guidelines are shared below.

9.1. Australia

9.2. Germany

German Federal Institute for Occupational Safety (BAuA)’s Safe handling of nanomaterials and other advanced materials in workplaces.

9.3. USA

The US FDA issued the following Guidances, which are non-binding recommendations, for the industry.

9.4. Others

10. National Chapters on Nanotechnology

  • The Nanotech Regulatory Document Archive [This is a free, searchable database of policy documents of different countries around the world. The resource is built and maintained by the Center for the Study of Law, Science, & Technology at the Sandra Day O’Connor College of Law at Arizona State University, USA, the Centre of Regulatory Studies in the Monash University Law School, Australia, and the Institute of Environmental and Energy Law at K.U. Leuven, Belgium].

11. Some Relevant Important Resources

11.1. General

11.2. Australia

11.3. Belgium

11.4. Canada

11.5. China

11.6. Denmark

  • Regulation of nanomaterials in Denmark.

11.7. India

11.8. New Zealand

11.9. Switzerland

  • Swiss precautionary matrix for synthetic nanomaterials This matrix is geared toward industry and trade, and is a method for assessing the nano-specific health and environmental risks of nanoproducts. It enables the structured assessment of the “nano-specific need for precautions” when handling synthetic nanomaterials, and is designed to help industry and trade comply with their due diligence and their duty to exercise self-control opposite employees, consumers and the environment.
  • Federal Office of Public Health, Nanotechnology, Legislation and Enforcement.

11.10. UK

11.11. USA

11.12. Others

11.13. Journals

12. Bibliography

12.1. Books

12.1.1. Encyclopedia, Dictionary and Handbook

  • Bezryadin, A., Bollinger, A., Hopkins, D., Murphey, M., Remeika, M., & Rogachev, A. (2003). Dekker Encyclopedia of Nanoscience and Nanotechnology. CRC Press.
  • Goddard III, W. A., Brenner, D., Lyshevski, S. E., & Iafrate, G. J. (Eds.). (2007). Handbook of nanoscience, engineering, and technology. CRC press.
  • D. Guston (Ed.). (2010). Encyclopedia of nanoscience and society. Thousand Oaks, CA: SAGE Publications, Inc.
  • Hari Singh Nalwa (2011), Encyclopedia of Nanoscience and Nanotechnology, American Scientific Publishers.
  • Bhushan, B. (2012). Encyclopedia of Nanotechnology. Springer.
  • Herrmann, P., & Schmitt, M. (2012). Dictionary of nanotechnology. Beuth Verlag.
  • Vogel, U., Savolainen, K., Wu, Q., van Tongeren, M., Brouwer, D., & Berges, M. (Eds.). (2013). Handbook of Nanosafety: Measurement, Exposure and Toxicology. Elsevier.

12.1.2. General

  • Drexler, K. E., & Minsky, M. (1990). Engines of creation. London: Fourth Estate.
  • Miller, J. C., Serrato, R., Represas-Cardenas, J. M., & Kundahl, G. (2004). The handbook of nanotechnology: Business, policy, and intellectual property law. John Wiley & Sons.
  • Shelley, T. (2006). Nanotechnology: new promises, new dangers. Zed Books.
  • Mader, K., Brune, H., Ernst, H., Grunwald, A., Grünwald, W., Hofmann, H., … & Wyrwa, D. (2006). Nanotechnology: assessment and perspectives (Vol. 27). Springer.
  • Hodge, G. A., Bowman, D., & Ludlow, K. (Eds.). (2007). New global frontiers in regulation: The age of nanotechnology. Edward Elgar Publishing.
  • Roco, M. C., & Bainbridge, W. S. (Eds.). (2007). Nanotechnology: Societal Implications: I: Maximising Benefits for Humanity; II: Individual Perspectives (Vol. 2). Springer.
  • Guillermo Foladori, Noela Invernizzi (2007), Nanotechnology in Latin America.
  • Boucher, P. M. (2008). Nanotechnology: legal aspects. CRC Press.
  • Allhoff, F., Lin, P., & Moore, D. (2009). What is nanotechnology and why does it matter: from science to ethics. John Wiley & Sons.
  • Arnaldi, S., Lorenzet, A., & Russo, F. (Eds.). (2009). Technoscience in Progress: Managing the Uncertainty of Nanotechnology. IOS Press.
  • Liu, L. (2009). Emerging Nanotechnology Power: Nanotechnology R&D and Business Trends in the Asia Pacific Rim: World Scientific.
  • Binns, C. (2010). Introduction to nanoscience and nanotechnology (Vol. 14). Wiley.
  • Bowman, D. M., & Maynard, A. D. (2010). International handbook on regulating nanotechnologies. Edward Elgar Limited.
  • Sutton, V. (2011). Nanotechnology Law and Policy. Carolina Academic Press.
  • Murashov, V., & Howard, J. (2011). Nanotechnology standards. Springer.
  • Brazell, L. (2012). Nanotechnology Law. Best Practices, Kluwer Law International.
  • Dana, D. (Ed.). (2012). The Nanotechnology Challenge: Creating Legal Institutions for Uncertain Risks. Cambridge University Press.
  • Grunwald, A. (2012). Responsible Nanobiotechnology: Philosophy and Ethics. CRC Press.
  • Hunt, G., & Mehta, M. (Eds.). (2013). Nanotechnology:” Risk, Ethics and Law”. Routledge.
  • Throne-Holst, H., Soto, E., Strandbakken, P., & Scholl, G. (2013). Consumers and Nanotechnology: Deliberative Processes and Methodologies. CRC Press.
  • Asmatulu R. (2013). Nanotechnology Safety, Elsevier.
  • Throne-Holst, H., Soto, E., Strandbakken, P., & Scholl, G. (2013). Consumers and Nanotechnology: Deliberative Processes and Methodologies. CRC Press.
  • Gordijn, B., & Cutter, A. M. (Eds.). (2014). In Pursuit of Nanoethics. Springer Netherlands.
  • Simone Arnaldi, Arianna Ferrari, Paolo Magaudda, Francesca Marin (eds.) (2014), Responsibility in Nanotechnology Development, Springer.
  • Dalton-Brown, S. (2015). Nanotechnology and Ethical Governance in the European Union and China, Springer.
  • Escoffier, Luca; Ganau, Mario; Wong, Julielynn (2016), Commercializing nanomedicine: industrial applications, patents, and ethics, Pan Stafford Publishing.
  • Dale A. Stirling (2018), The Nanotechnology Revolution: A Global Bibliographic Perspective. Jenny Stanford Publishing.

12.1.3. Regulations

  • Matsuura, J. H. (2006). Nanotechnology regulation and policy worldwide: Artech House London.

12.1.4. Environmental and Health Aspects

  • Maynard, A. D., & Pui, D. Y. (Eds.). (2007). Nanotechnology and occupational health. Springer.
  • Kaiser, M. (Ed.). (2009). Governing future technologies: nanotechnology and the rise of an assessment regime (Vol. 27). Springer.
  • Lead, J. R., & Smith, E. L. (Eds.). (2009). Environmental and human health impacts of nanotechnology. Hoboken (NJ): Wiley.
  • Sellers, K., Mackay, C., Bergeson, L. L., Clough, S. R., Hoyt, M., Chen, J., Henry, K., & Hamblen, J. (2010). Nanotechnology and the Environment. CRC Press.
  • Ramachandran, G. (2011). Assessing nanoparticle risks to human health. William Andrew.
  • Fadeel, B., Pietroiusti, A., & Shvedova, A. A. (Eds.). (2012). Adverse Effects of Engineered Nanomaterials: Exposure, Toxicology, and Impact on Human Health. Academic Press.
  • Shatkin, J. A. (2012). Nanotechnology: health and environmental risks. CRC Press.
  • Malsch, I., & Emond, C. (Eds.). (2013). Nanotechnology and Human Health. CRC Press.
  • Matthew Hull, Diana Bowman (2018), Nanotechnology Environmental Health and Safety. Risks, Regulation, and Management, 3rd Edition, Elsevier.
  • Ilise L. Feitshans (2018), Global health impacts of nanotechnology law: A tool for stakeholder engagement. Jenny Stanford Publishing.

12.1.5. Societal Aspects

  • Allhoff, F. (Ed.). (2007). Nanoethics: the ethical and social implications of nanotechnology. John Wiley & Sons.
  • Fritz Allhoff & Patrick Lin (Ed.). (2008) Nanotechnology & Society: Current and Emerging Ethical Issues. Springer
  • Fisher, E., Selin, C., & Wetmore, J. M. (Eds.). (2008). The Yearbook of Nanotechnology in Society, Volume I: Presenting Futures (Vol. 1). Springer Science+ Business Media BV.
  • Cozzens, S. E., & Wetmore, J. M. (Eds.). (2010). Nanotechnology and the challenges of equity, equality and development (Vol. 2). Springer.
  • Maclurcan, D., & Radywyl, N. (Eds.). (2011). Nanotechnology and global sustainability. CRC Press.
  • Maclurcan, D. (2012). Nanotechnology and Global Equality. CRC Press.
  • Khan, A. S. (Ed.). (2012). Nanotechnology: Ethical and Social Implications. CRC Press.
  • Harthorn, B. H., & Mohr, J. W. (2013). The social life of nanotechnology (Vol. 18). Routledge.

12.2. Articles

12.2.1. General

  • Fiedler, F. A., & Reynolds, G. H. (1993). Legal problems of nanotechnology: an overview. S. cal. interdisc. LJ, 3, 593.
  • Moore, F. N. (2002). Implications of nanotechnology applications: using genetics as a lesson. Health Law Rev, 10(3), 9-15.
  • Nicolau, D. (2004). Challenges and opportunities for nanotechnology policies: an Australian perspective. Nanotech. L. & Bus., 1, 446.
  • Castro, F. (2004). Legal and Regulatory concerns facing Nanotechnology. J. Intell. Prop., 4, 140.
  • Pinson, R. D. (2004). Is nanotechnology prohibited by the biological and chemical weapons conventions. Berkeley J. Int’l L., 22, 279.
  • Thayer, J. D. (2005). The SPS Agreement: Can It Regulate Trade in Nanotechnology?. Duke L. & Tech. Rev., 2005, 15-26.
  • Van Calster, G. (2006). Regulating nanotechnology in the European Union. Nanotech. L. & Bus., 3, 359.
  • Van Calster, G. (2006). Regulating nanotechnology in the European Union. European Environmental Law Review, 238.
  • Ludlow, K. (2007). The Readiness of Australian Food Regulation for the Use of Nanotechnology in Food and Food Packaging, 26 U. Tas. L. Rev. 177.
  • Munir, A. B., & Yasin, S. H. M. (2007). Nanotechnology in healthcare: are existing laws adequate?. European journal of health law, 14(3), 261-272.
  • Michelson, E. S. (2008). Globalization at the nano frontier: The future of nanotechnology policy in the United States, China, and India. Technology in Society, 30(3), 405-410.
  • Hansen, S. F., Maynard, A., Baun, A., & Tickner, J. A. (2008). Late lessons from early warnings for nanotechnology. Nature nanotechnology, 3(8), 444-447.
  • Paradise, J., Wolf, S. M., Ramachandran, G., & Kokkoli, E. (2008). Developing oversight frameworks for nanobiotechnology. Minn. JL Sci. & Tech., 9, 399.
  • Rakhlin, M. (2008). Regulating nanotechnology: a private-public insurance solution. Duke L. & Tech. Rev., 1.
  • Throne-Holst, H., & Strandbakken, P. (2009). “Nobody Told Me I was a Nano-Consumer:” How Nanotechnologies Might Challenge the Notion of Consumer Rights. Journal of consumer policy, 32(4), 393-402.
  • Fairbrother, A., & Fairbrother, J. R. (2009). Are environmental regulations keeping up with innovation? A case study of the nanotechnology industry. Ecotoxicology and environmental safety, 72(5), 1327-1330.
  • D’Silva, J., & Bowman, D. M. (2010). To Label or Not to Label-It’s More than a Nano-Sized Question. Eur. J. Risk Reg., 420.
  • Faunce, T. A., & Nasu, H. (2010). Nanotechnology and the International Law of Weaponry: Towards International Regulation of Nano-Weapons. Journal of Law, Information and Science, 20, 21-54.
  • Helwegen, W. (2010). The research exemption from a nanotechnology perspective, European Intellectual Property Review, 32:341-351
  • Malloy, T. F. (2011). Nanotechnology regulation: a study in claims making. ACS nano, 5(1), 5-12.
  • Marchant, G., & White, A. (2011). An international nanoscience advisory board to improve and harmonize nanotechnology oversight. Journal of Nanoparticle Research, 13(4), 1489-1498. doi: 10.1007/s11051-011-0226-1
  • Jennifer Nash (2012), The Massachusetts Toxics Use Reduction Act: A Model for Nanomaterials Regulation?, Harvard Kennedy School.
  • Nasu, H. (2012). Nanotechnology and challenges to international humanitarian law: a preliminary legal assessment. International Review of the Red Cross, 94(886), 653-672.
  • Pertoldi-Bianchi, S. (2012). The Extended Producer Responsibility in Waste Regulations In a Multilevel Global Approach: Nanotechnology as a Case Study. European Energy and Environmental Law Review, 21(5), 198-219.
  • Fleege, L., & Lawrenz, F. (2012). An Empirical Examination of the Current State of Publically Available Nanotechnology Guidance Materials. The Journal of Law, Medicine & Ethics, 40(4), 751-762.
  • Dana, D. A. (2012). The Case for an Information-Forcing Regulatory Definition of Nanomaterials, Pace Envtl. L. Rev., 30, i.
  • Kai, K. (2012). Nanotechnology and Medical Robotics; Legal and Ethical Responsibility. Waseda Bulletin of Comparative Law, 30, 1-6.
  • Bleeker, E.A., de Jong, W.H., Geertsma, R.E., Groenewold, M., Heugens, E.H., Koers-Jacquemijns, M., van de Meent, D., Popma, J.R., Rietveld, A.G., Wijnhoven, S.W. and Cassee, F.R., (2013). Considerations on the EU definition of a nanomaterial: science to support policy making. Regulatory toxicology and pharmacology, 65(1), 119-125.
  • Karim, M. E., Munir, A. B., Reza, A. W., Muhammad-Sukki, F., Yasin, S. H. M., Abu-Bakar, S. H., & Rahim, R. A. (2015). Too enthusiastic to care for safety: Present status and recent developments of nanosafety in ASEAN countries. Technological Forecasting and Social Change, 92, 168-181.
  • Amenta, V., Aschberger, K., Arena, M., Bouwmeester, H., Moniz, F.B., Brandhoff, P., Gottardo, S., Marvin, H.J., Mech, A., Pesudo, L.Q. and Rauscher, H., (2015). Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries. Regulatory Toxicology and Pharmacology, 73(1), 463-476.
  • Boverhof, D. R., Bramante, C. M., Butala, J. H., Clancy, S. F., Lafranconi, M., West, J., & Gordon, S. C. (2015). Comparative assessment of nanomaterial definitions and safety evaluation considerations. Regulatory Toxicology and Pharmacology, 73(1), 137-150.
  • Karim, M., & Munir, A. B. (2015). Nanotechnology in Asia: A Preliminary Assessment of the Existing Legal Framework. Abu Bakar, Nanotechnology in Asia: A Preliminary Assessment of the Existing Legal Framework (April 4, 2015).

12.2.2. Nanotechnology Regulations

  • David Forrest. (1989). Regulating Nanotechnology Development, Foresight Institute.
  • Lin-Easton, P. C. (2001). It’s Time for Environmentalists to Think Small-Real Small: A Call for the Involvement of Environmental Lawyers in Developing Precautionary Policies for Molecular Nanotechnology. Geo. Int’l Envtl. L. Rev., 14, 107.
  • Reynolds, G. H. (2003). Nanotechnology and regulatory policy: three futures. Harvard Journal of Law and Technology, 17, 179.
  • Haim, R., Petschow, U., Steinfeldt, M., & von Gleich, A. (2004). Nanotechnology and Regulation within the Framework of the Precautionary Principle. Schriftenreihe des IÖW, 173(04).
  • Segal, S. H. (2004). Environmental Regulation of Nanotechnology: Avoiding Big Mistakes for Small Machines. Nanotech. L. & Bus., 1, 290.
  • Marchant, G. E., & Sylvester, D. J. (2006). Transnational models for regulation of nanotechnology. The Journal of Law, Medicine & Ethics, 34(4), 714-725.
  • Abbott, K. W., Marchant, J. D., Gary, E., & Sylvester, D. J. (2006). A framework convention for nanotechnology?. Environmental law reporter, 36.
  • Wilson, R. F. (2006). Nanotechnology: the challenge of regulating known unknowns. The Journal of Law, Medicine & Ethics, 34(4), 704-713.
  • Bowman, D. M., & Hodge, G. A. (2006). Nanotechnology: Mapping the wild regulatory frontier. Futures, 38(9), 1060-1073.
  • Helland, A., Kastenholz, H., Thidell, A., Arnfalk, P., & Deppert, K. (2006). Nanoparticulate materials and regulatory policy in Europe: an analysis of stakeholder perspectives. Journal of Nanoparticle Research, 8(5), 709-719.
  • Abbott, K. W., Marchant, J. D., Gary, E., & Sylvester, D. J. (2006). A framework convention for nanotechnology?. Environmental law reporter, 36.
  • Romig Jr, A. D., Baker, A. B., Johannes, J., Zipperian, T., Eijkel, K., Kirchhoff, B., … & Walsh, S. (2007). An introduction to nanotechnology policy: Opportunities and constraints for emerging and established economies. Technological Forecasting and Social Change, 74(9), 1634-1642.
  • Lin, A. C. (2007). Size matters: regulating nanotechnology. Harv. Envtl. L. Rev., 31, 349.
  • Dawson, S. (2007). Proposal for an International Framework Convention to Assess the Environmental Risk of Commercially Available Nanomaterials, A. U. Balt. J. Envtl. L., 15, 129.
  • Bowman, D. M., & Hodge, G. (2007). A small matter of regulation: An international review of nanotechnology regulation. Columbia Sci Technol Law Rev, 8(1).
  • Wardak, A., Gorman, M. E., Swami, N., & Rejeski, D. (2007). Environmental Regulation of Nanotechnology and the TSCA. Technology and Society Magazine, IEEE, 26(2), 48-56.
  • Faunce, T. A. (2007). Nanotherapeutics: new challenges for safety and cost-effectiveness regulation in Australia. Medical Journal of Australia, 186(4), 189.
  • De Ville, K. A. (2008). Law, regulation and the medical use of nanotechnology. In Emerging Conceptual, Ethical and Policy Issues in Bionanotechnology (pp. 181-200). Springer Netherlands.
  • Bowman, D. M., & Hodge, G. A. (2008). ‘Governing’ nanotechnology without government?. Science and Public Policy, 35(7), 475-487.
  • Besley, J. C., Kramer, V. L., & Priest, S. H. (2008). Expert opinion on nanotechnology: risks, benefits, and regulation. Journal of Nanoparticle Research, 10(4), 549-558.
  • Guerra, G. (2008). European regulatory issues in nanomedicine. NanoEthics, 2(1), 87-97.
  • Powell, M. C., Griffin, M. P., & Tai, S. (2008). Bottom-up risk regulation? How nanotechnology risk knowledge gaps challenge federal and state environmental agencies. Environmental management, 42(3), 426-443.
  • D’Silva, J., & Van Calster, G. (2009). Taking temperature—A review of European Union regulation in nanomedicine. European journal of health law, 16(3), 249-269.
  • Ludlow, K., Bowman, D. M., & Kirk, D. D. (2009). Hitting the mark or falling short with nanotechnology regulation?. Trends in biotechnology, 27(11), 615-620.
  • Ponce, A. (2009). The EU Approach to Regulating Nanotechnology. ETUI Working Paper 2010.05.
  • Corley, E. A., Scheufele, D. A., & Hu, Q. (2009). Of risks and regulations: how leading US nanoscientists form policy stances about nanotechnology. Journal of Nanoparticle Research, 11(7), 1573-1585.
  • Marchant, G. E., Sylvester, D. J., & Abbott, K. W. (2009). What does the history of technology regulation teach us about nano oversight?. The Journal of Law, Medicine & Ethics, 37(4), 724-731.
  • Stokes, E. (2009). Regulating nanotechnologies: sizing up the options. Legal Studies, 29(2), 281-304.
  • Lee, M. (2010). Risk and beyond: EU regulation of nanotechnology. Eur Law Rev, 35(6), 799-821.
  • Perez, O. (2010). Precautionary Governance and the Limits of Scientific Knowledge: A Democratic Framework for Regulating Nanotechnology. UCLA J. Envtl. L. & Pol’y, 28, 29.
  • Marchant, G. E. (2010). New Soft Law Approach to Nanotechnology Oversight: A Voluntary Product Certification Scheme, A. UCLA J. Envtl. L. & Pol’y, 28, 123.
  • Tyshenko, M. G., Farhat, N., Lewis, R., & Shilnikova, N. (2010). Applying a precautionary risk management strategy for regulation of nanotechnology. International Journal of Nanotechnology, 7(2), 243-264.
  • Abbott, K. W., Merchant, G. E., & Corley, E. A. (2011). Soft Law Oversight Mechanisms for Nanotechnology. Jurimetrics, 52, 279.
  • George, A. (2011). International handbook on regulating nanotechnologies. Prometheus, 29(3), 319-324.
  • Huang, C., Notten, A., & Rasters, N. (2011). Nanoscience and technology publications and patents: a review of social science studies and search strategies. The Journal of Technology Transfer, 36(2), 145-172.
  • Micallef-Borg, C., & Van Calster, G. (2011). Non-Contractual Liability as an Instrument for Regulating Nano and New Technologies–A Thorough Review Using National and European Union Tort Law. Available at SSRN 1934730.
  • Malloy, T. (2012). Soft Law and nanotechnology: A functional perspective. Jurimetrics, 52(3), 12-02.
  • Paradise, J. (2012). Reassessing Safety for Nanotechnology Combination Products: What Do Biosimilars Add to Regulatory Challenges for the FDA?. St. Louis University Law Journal, 56(2).
  • Stokes, E. (2012). Nanotechnology and the products of inherited regulation. Journal of law and society, 39(1), 93-112.
  • Kaddour, N. (2012). No Laws in Nanoland: How to Reverse the Trend: The French Example. Pace Envtl. L. Rev., 30, i.
  • Rucinski, T. L. (2012). Searching for the Nano-needle in a Green Haystack: Researching the Environmental, Health, and Safety Ramifications of Nanotechnology. Pace Envtl. L. Rev., 30, i.
  • Karlaganis, G., & Liechti, R. (2013). The Regulatory Framework for Nanomaterials at a Global Level: SAICM and WTO Insights. Review of European, Comparative & International Environmental Law, 22(2), 163-173.
  • Brosset, E. (2013). The Law of the European Union on Nanotechnologies: Comments on a Paradox. Review of European, Comparative & International Environmental Law, 22(2), 155-162.
  • Malsch, I. (2013). Governing nanotechnology in a multi-stakeholder world. Nanoethics, 7(2), 161-172.
  • Del Castillo, A. M. P. (2013). The European and Member States’ Approaches to Regulating Nanomaterials: Two Levels of Governance. NanoEthics, 7(3), 189-199.
  • Elizabeth Vogelezang-Stoute, ‘Regulating Nanomaterials. Bottlenecks and Perspectives in EU Legislation on Chemicals and Products’ (2012) 21 European Energy and Environmental Law Review, Issue 1, pp. 41–50
  • Reese, M. (2013). Nanotechnology: Using Co-regulation to Bring Regulation of Modern Technologies into the 21st Century. Health Matrix, 23, 537-607.
  • Marchant, G. E. (2014). ‘Soft Law’mechanisms for nanotechnology: liability and insurance drivers. Journal of Risk Research, 17(6), 709-719.
  • Pritom Chowdhury, Madhurjya Gogoi, Sangeeta Borchetia, and Tanoy Bandyopadhyay. “Nanotechnology applications and intellectual property rights in agriculture.” Environmental Chemistry Letters 15 (2017): 413-419.
  • Sheila Devasahayam, “Nanotechnology and nanomedicine in market: a global perspective on regulatory issues.” In Characterization and Biology of Nanomaterials for Drug Delivery, pp. 477-522. Elsevier, 2019.
  • Soltani, Ali Mohammad, and Hassan Pouypouy. “Standardization and regulations of nanotechnology and recent government policies across the world on nanomaterials.” In Advances in phytonanotechnology, pp. 419-446. Academic Press, 2019.
  • Ilise L. Feitshans and Philippe Sabatier. “Global health impacts of nanotechnology law: Advances in safernano regulation.” Materials Today: Proceedings 67 (2022): 985-994.

12.2.3. Patent and Nanotechnology

  • Marinova, D., & McAleer, M. (2002). Nanotechnology strength indicators: international rankings based on US patents. Nanotechnology, 14(1), R1.
  • Hullmann, A., & Meyer, M. (2003). Publications and patents in nanotechnology. Scientometrics, 58(3), 507-527.
  • Bawa, R. (2004). Nanotechnology Patenting in the US. Nanotech. L. & Bus., 1, 31.
  • Sabety, T. (2004). Nanotechnology innovation and the patent thicket: Which IP policies promote growth. Alb. LJ Sci. & Tech., 15, 477.
  • Lemley, M. A. (2005). Patenting nanotechnology. Stanford Law Review, 601-630.
  • Zekos, G. I. (2006). Nanotechnology and biotechnology patents. International Journal of Law and Information Technology, 14(3), 310-369.
  • Zekos, G. I. (2006). Patenting abstract ideas in nanotechnology. The Journal of World Intellectual Property, 9(1), 113-136.
  • Bowman, D. M. (2007). Patently obvious: Intellectual property rights and nanotechnology. Technology in Society, 29(3), 307-315.
  • Kallinger, C., Veffkind, V., Michalitsch, R., & Verbandt, Y. (2008). Patenting nanotechnology: a European patent office perspective. Nanotech. L. & Bus., 5, 95.
  • Barpujari, I. (2010). The patent regime and nanotechnology: issues and challenges. Journal of Intellectual Property Rights, 15(3), 206-213.
  • Schellekens, M. (2010). Patenting nanotechnology in Europe: making a good start? An analysis of issues in law and regulation. The Journal of World Intellectual Property, 13(1), 47-76.
  • Huang, C., Notten, A., & Rasters, N. (2011). Nanoscience and technology publications and patents: a review of social science studies and search strategies. The Journal of Technology Transfer, 36(2), 145-172.

12.2.4. Environmental and Health Implications of Nanotechnology

  • Colvin, V. L. (2003). The potential environmental impact of engineered nanomaterials. Nature biotechnology, 21(10), 1166-1170.
  • Hoet, P. H., Nemmar, A., & Nemery, B. (2004). Health impact of nanomaterials?. Nature Biotechnology, 22(1), 19-19.
  • Warheit, D. B., Sayes, C. M., Reed, K. L., & Swain, K. A. (2008). Health effects related to nanoparticle exposures: environmental, health and safety considerations for assessing hazards and risks. Pharmacology & therapeutics, 120(1), 35-42.
  • Grassian, V. H. (Ed.). (2008). Nanoscience and nanotechnology: environmental and health impacts. John Wiley & Sons.
  • Köhler, A. R., & Som, C. (2008). Environmental and health implications of nanotechnology—Have innovators learned the lessons from past experiences?. Human and ecological risk assessment, 14(3), 512-531.
  • Xia, T., Li, N., & Nel, A. E. (2009). Potential health impact of nanoparticles. Annual review of public health, 30, 137-150.
  • Elder, A., Lynch, I., Grieger, K., Chan-Remillard, S., Gatti, A., Gnewuch, H., E. Kenawy & Shvedova, A. (2009). Human health risks of engineered nanomaterials. In Nanomaterials: Risks and benefits (pp. 3-29). Springer Netherlands.
  • Savolainen, K., Pylkkänen, L., Norppa, H., Falck, G., Lindberg, H., Tuomi, T., … & Seipenbusch, M. (2010). Nanotechnologies, engineered nanomaterials and occupational health and safety–A review. Safety science, 48(8), 957-963.
  • Theodore, L., & Stander, L. (2012). Regulatory Concerns and Health/Hazard Risks Associated with Nanotechnology. Pace Envtl. L. Rev., 30, i.
  • Neena Mitter and Karen Hussey. “Moving policy and regulation forward for nanotechnology applications in agriculture.” Nature Nanotechnology 14, no. 6 (2019): 508-510.

12.2.5. Societal Implications of Nanotechnology

  • Roco, M. C. (2003). Broader societal issues of nanotechnology. Journal of Nanoparticle Research, 5(3-4), 181-189.
  • Macnaghten, P., Kearnes, M. B., & Wynne, B. (2005). Nanotechnology, governance, and public deliberation: what role for the social sciences?. Science communication, 27(2), 268-291.
  • Bennett, I., & Sarewitz, D. (2006). Too little, too late? Research policies on the societal implications of nanotechnology in the United States. Science as Culture, 15(4), 309-325.
  • Currall, S. C. (2009). Nanotechnology and society: New insights into public perceptions. Nature Nanotechnology, 4(2), 79.
  • Kahan, D. M. (2009). Nanotechnology and society: The evolution of risk perceptions. Nature nanotechnology, 4(11), 705-706.
  • Roco, M. C., Harthorn, B., Guston, D., & Shapira, P. (2011). Innovative and responsible governance of nanotechnology for societal development. In Nanotechnology Research Directions for Societal Needs in 2020 (pp. 561-617). Springer Netherlands.
  • Roco, M. C., Mirkin, C. A., & Hersam, M. C. (2011). Nanotechnology research directions for societal needs in 2020: summary of international study. Journal of Nanoparticle Research, 13(3), 897-919.
  • Gupta, N., Fischer, A. R., George, S., & Frewer, L. J. (2013). Expert views on societal responses to different applications of nanotechnology: a comparative analysis of experts in countries with different economic and regulatory environments. Journal of nanoparticle research, 15(8), 1-15.

12.2.6. Risk, Exposure Assessment, and Management

  • Dreher, K. L. (2004). Health and environmental impact of nanotechnology: toxicological assessment of manufactured nanoparticles. Toxicological Sciences, 77(1), 3-5.
  • Thomas, K., & Sayre, P. (2005). Research strategies for safety evaluation of nanomaterials, Part I: evaluating the human health implications of exposure to nanoscale materials. Toxicological Sciences, 87(2), 316-321.
  • Holsapple, M. P., Farland, W. H., Landry, T. D., Monteiro-Riviere, N. A., Carter, J. M., Walker, N. J., & Thomas, K. V. (2005). Research strategies for safety evaluation of nanomaterials, part II: toxicological and safety evaluation of nanomaterials, current challenges and data needs. Toxicological Sciences, 88(1), 12-17.
  • Balshaw, D. M., Philbert, M., & Suk, W. A. (2005). Research strategies for safety evaluation of nanomaterials, Part III: nanoscale technologies for assessing risk and improving public health. Toxicological Sciences, 88(2), 298-306.
  • Renn, O., & Roco, M. (2006). Nanotechnology risk governance. The International Risk Governance Council, Geneva.
  • Tsuji, J. S., Maynard, A. D., Howard, P. C., James, J. T., Lam, C. W., Warheit, D. B., & Santamaria, A. B. (2006). Research strategies for safety evaluation of nanomaterials, part IV: risk assessment of nanoparticles. Toxicological sciences, 89(1), 42-50.
  • Wiesner, M. R., Lowry, G. V., Alvarez, P., Dionysiou, D., & Biswas, P. (2006). Assessing the risks of manufactured nanomaterials. Environmental science & technology, 40(14), 4336-4345.
  • Marchant, G. E., Sylvester, D. J., & Abbott, K. W. (2008). Risk management principles for nanotechnology. Nanoethics, 2(1), 43-60.
  • O’Brien, N., & Cummins, E. (2008). Recent developments in nanotechnology and risk assessment strategies for addressing public and environmental health concerns. Human and Ecological Risk Assessment, 14(3), 568-592.
  • Wardak, A., Gorman, M. E., Swami, N., & Deshpande, S. (2008). Identification of Risks in the Life Cycle of Nanotechnology‐Based Products. Journal of Industrial Ecology, 12(3), 435-448.
    Satterfield, T., Kandlikar, M., Beaudrie, C. E., Conti, J., & Harthorn, B. H. (2009). Anticipating the perceived risk of nanotechnologies. Nature Nanotechnology, 4(11), 752-758.
  • Tyshenko, M. G., & Krewski, D. (2008). A risk management framework for the regulation of nanomaterials. International Journal of Nanotechnology, 5(1), 143-160.
  • Linkov, I., Satterstrom, F. K., Monica Jr, J. C., & Foss, S. (2009). Nano risk governance: current developments and future perspectives. Nanotech. L. & Bus., 6, 203.
  • Grieger, K. D., Hansen, S. F., & Baun, A. (2009). The known unknowns of nanomaterials: Describing and characterizing uncertainty within environmental, health and safety risks. Nanotoxicology, 3(3), 222-233.
  • Morimoto, Y., Kobayashi, N., Shinohara, N., Myojo, T., Tanaka, I., & Nakanishi, J. (2010). Hazard assessments of manufactured nanomaterials. J Occup Health, 52(6), 325-334.
  • van Broekhuizen, P., & Reijnders, L. (2011). Building blocks for a precautionary approach to the use of nanomaterials: positions taken by trade unions and environmental NGOs in the European nanotechnologies debate. Risk Analysis, 31(10), 1646-1657.
  • Fadel, T. R., Steevens, J. A., Thomas, T. A., & Linkov, I. (2015). The challenges of nanotechnology risk management. Nano Today, 10(1), 6-10.

12.2.7. Nanotechnology and Occupational Health

  • Munir, A. B., Yasin, M., & Hajar, S. (2008). Nanotechnology: regulatory challenges to occupational safety and health. Policy and Practice in Health and Safety, 6(1), 97-113.
  • Murashov, V., Schulte, P., Geraci, C., & Howard, J. (2011). Regulatory approaches to worker protection in nanotechnology industry in the USA and European Union. Industrial health, 49(3), 280-296.
  • Savolainen, K., Pylkkänen, L., Norppa, H., Falck, G., Lindberg, H., Tuomi, T., … & Seipenbusch, M. (2010). Nanotechnologies, engineered nanomaterials and occupational health and safety–A review. Safety science, 48(8), 957-963.
  • Schulte, P., Geraci, C., Zumwalde, R., Hoover, M., & Kuempel, E. (2008). Occupational risk management of engineered nanoparticles. Journal of occupational and environmental hygiene, 5(4), 239-249.
  • Schulte, P. A., Geraci, C. L., Murashov, V., Kuempel, E. D., Zumwalde, R. D., Castranova, V., … & Martinez, K. F. (2014). Occupational safety and health criteria for responsible development of nanotechnology. Journal of Nanoparticle Research, 16(1), 1-17.
  • Murashov, V., & Howard, J. (2015). Risks to Health Care Workers from Nano-Enabled Medical Products. Journal of occupational and environmental hygiene, 12(6), D75-D85.
  • Mirabile, M., Boccuni, F., Gagliardi, D., Rondinone, B. M., & Iavicoli, S. (2014). Workplace exposure to engineered nanomaterials: The Italian path for the definition of occupational health and safety policies. Health policy, 117(1), 128-134.

12.2.8. Nano Food Regulation

  • Chau, C. F., Wu, S. H., & Yen, G. C. (2007). The development of regulations for food nanotechnology. Trends in Food Science & Technology, 18(5), 269-280.
  • Cushen, M., Kerry, J., Morris, M., Cruz-Romero, M., & Cummins, E. (2012). Nanotechnologies in the food industry–Recent developments, risks and regulation. Trends in food science & technology, 24(1), 30-46.
  • Salvi, L. (2015). EU’s Soft Reaction to Nanotechnology Regulation in the Food Sector, The. Eur. Food & Feed L. Rev., 186.Ehnert, T. (2015). The Legitimacy of New Risk Governance—A Critical View in Light of the EU’s Approach to Nanotechnologies in Food. European Law Journal, 21(1), 44-67.
  • Smolkova, B., El Yamani, N., Collins, A. R., Gutleb, A. C., & Dusinska, M. (2015). Nanoparticles in food. Epigenetic changes induced by nanomaterials and possible impact on health. Food and Chemical Toxicology, 77, 64-73.
  • Vinod Kumar Yata, Bhupesh Chandra Tiwari, and Irfan Ahmad. “Nanoscience in food and agriculture: research, industries and patents.” Environmental Chemistry Letters 16 (2018): 79-84.
  • Faraat Ali, “Nano-Food Safety and Regulatory Perspectives.” In Nanoemulsions in Food Technology, pp. 279-300. CRC Press, 2021.
  • Muhammad Nizam Awang, and Sharifudin Md Shaarani. “Regulatory Responses to the Use of Nanoscale Substances in Food in ASEAN.” In Food Safety and Technology Governance, pp. 162-182. Routledge, 2023.