Nanotechnologies are heralded as the basis for the 'next industrial revolution', with their commercial use growing exponentially. There are significant knowledge gaps in the understanding of their physico-chemical properties, making it difficult to assess their environmental and toxicological effects. To help foster this technology and fill the knowledge gap, the EU 7th Framework Programme ('FP7') established a budget of €3.5 billion for research on nanotechnologies. In this article, we examine the business challenges companies face and introduce NANOfutures, the EU's central initiative in this area.
NANOfutures: European project on nanotechnologies officially launched
In June 2010, the European Commission and the Spanish EU Presidency officially launched the NANOfutures project (as part of the FP7) to bring together industry, research institutions, and NGOs at all levels and coordinate their activity. The stated aim is to construct and communicate an integrated industrial and research roadmap for nanotechnologies. Eleven existing European Technology Platforms ('ETPs'), which are themselves networks co-ordinating regulator and stakeholder activity in particular technological fields, have joined the initiative. The sectors represented by the ETPs include nanomedicine, chemistry, construction, nanoelectronics, nanomanufacturing, transportation, textiles, and photonics.
NANOfutures is organised into 10 Working Groups, which aim to identify strategies and actions across all industry sectors — a horizontal approach — within their respective field:
- safety research
- industrial safety strategy
- technology transfer and institution financing
- industrialisation and manufacturing
- skills and education
- research and technology
Shaping nanotechnologies regulation
Steptoe's nanotechnology practice leader in Brussels, Dr. Anna Gergely, is chair of the NANOfutures Working Group on Regulation, appointed in recognition of her broad experience in regulatory issues and longstanding work on nanotechnologies. The Working Group will serve as a platform, co-ordinating the regulatory developments for nanotechnologies in the EU. Its role will be to identify the essential elements of a regulatory framework by taking into account all viable regulatory options (voluntary and/ or mandatory) as well as the different approaches of the industry sectors represented by the ETPs. The Working Group aims to build on industry's stewardship activities, building trust and confidence between industry and regulators and between industry and public.
Since nanotechnologies are enabling technologies, the Working Group on Regulation will adopt a two-tiered approach to address the wide range of affected industries. First, the Working Group will focus on horizontal issues which are of general interest to all sectors. It will compile and analyse past and present regulatory approaches and ongoing initiatives at the EU and national level. Second, the Working Group will focus on specific sectors, channelling and disseminating nanotechnologies-related information provided by the participating ETPs.
A priority will be to establish key regulation "nodes" (critical elements to be reviewed) including (i) a suitable regulatory definition of 'nanomaterial' which could be agreed internationally and (ii) identifying the basis for sector-specific needs.
The first report of the NANOfutures Working Group on Regulation will be published in the first quarter of 2011. In order to guarantee the delivery of a valuable and broadly agreed contribution, the Working Group on Regulation will solicit input from stakeholders.
Preparing for business challenges of emerging regulation
In addition to the NANOfutures initiative, numerous mandatory and voluntary schemes (at national and international level) are underway to provide an appropriate governance framework on nanotechnologies. One of the most recent examples is in France, where a mandatory reporting scheme was adopted as part of the 'Grenelle II' law, which has been presented as France's contribution to supporting the 'green economy'.
Companies have learned from experience the importance of ensuring that the regulatory environment enables them to innovate and bring products to market without undue restriction. Steptoe & Johnson LLP has an integrated team of lawyers and scientists, armed with the knowledge and experience to help companies evaluate compliance of their processes and products with today's regulation (both general and sector-specific) and anticipate the direction of future regulation. In addition to working constructively with the European Commission, we are involved in the work of the OECD and other bodies which are shaping the regulatory environment for nanotechnology-related activities.
Steptoe is providing support to clients with nanomaterials and nanotechnology-enabled products in order to:
- ensure compliance with horizontal (e.g. worker safety) and sector-specific requirements (e.g. REACH);
- protect intellectual property rights;
- manage liabilities and insurance related concerns; and
- effectively influence evolving regulation.
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