Nanotechnologies pose unique regulatory challenges. The emergence of nanoscale materials is often referred to as the new industrial revolution, as it has the potential to yield novel applications and products across all sectors and aspects of life. At the same time, the ability for nanotechnologies to progress could be hindered by growing concerns regarding potential adverse impacts to health and the environment. To address these challenges effectively, our integrated nanotechnologies team, comprising lawyers, regulatory experts and scientists, provides our clients with integrated legal and technical support, enabling them to exploit the benefits of the nascent technology while ensuring the safe commercialization of nanotechnologies-based products.

Steptoe’s nanotechnologies practice is headed by Dr. Anna Gergely, who serves as the firm’s Director of EHS Regulatory and Principal Scientist. Dr. Gergely is based in Brussels. She is recognized as a leading expert in the science and regulation of nanotechnologies-based products and provides advice to clients in a wide range of industries. Our team includes legal and regulatory personnel in both the EU and US, and our nanotechnologies practice provides seamless advice under regimes across the span of our offices.

Practice areas

  • Chemical and Product Regulation: Our close relationships with US and EU institutions and public authorities help us to follow and shape the latest regulatory developments so that we can advise clients on compliance with both new and existing regulatory requirements for nanotechnologies-based products. We assist clients in obtaining pre-market approvals, advice on post-market regulatory tools, and classification and labeling issues. Our expertise is used by clients needing regulatory support at both the raw materials manufacturing level and the end-use production level.
  • Intellectual Property: Nanotechnologies present unique challenges in obtaining and enforcing patents for inventions. Members of Steptoe’s Patent group have deep technical experience in fields that are involved in nanoscience, including chemistry, physics, materials science, mechanical engineering, and biology. Our patent team provides support to develop, exploit and defend clients’ intellectual property as well as to ensure the effective interaction of companies’ IP and regulatory strategies.
  • Insurance and Reinsurance: Our nanotechnologies team benefits from deep expertise of Steptoe’s top-rated insurance, reinsurance, and surety practices. Our nanotechnologies team is available to advise clients on the resolution of risk assessment issues and the handling of litigation regarding nanotechnologies claims.
  • Trade: Our leading expertise in trade-related issues enables the nanotechnologies team to solve potential disputes arising from the lack of agreed definitions of nanomaterials.
  • Antitrust: Due to the disruptive nature of nanotechnologies, it is expected that the industrial landscape will fundamentally change, leading to challenging new competition law issues. Our existing expertise in this practice area can help our clients navigate through these changes.
  • Litigation: Supporting our product regulatory activities, we rely on our broad existing litigation experience to help our clients minimize litigation risks and resolve disputes successfully.

Through our participation in the work of different regulatory bodies to develop a suitable regulatory framework at both the EU and international levels, we actively contribute to the safe exploitation of nanotechnologies in many different applications. To this aim:

  • We assist companies in producing and using nanomaterials in nanotechnologies-enabled products by assessing regulatory requirements and advising on strategies for bringing products to market.
  • We support companies in developing regulatory arguments to comply with existing regulations and in developing further measures that are supportive of their products and market needs.
  • We participate on many levels, including international (OECD), European (EU Commission) and locally, in the ongoing debate on nanotechnologies governance, and we advise companies on appropriate project stewardship.
  • We develop concrete assessment models for companies to support their product stewardship against potential future litigation risks.
  • We work with industry groups and individual companies to develop a common position for responsible industry behavior and a regulatory environment that does not stifle innovative product development.