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European observatory for science-based and economic expert analysis of nanotechnologies, cognisant of barriers and risks, to engage with relevant stakeholders regarding benefits and opportunities

Final Report Summary - OBSERVATORYNANO (European observatory for science-based and economic expert analysis of nanotechnologies, cognisant of barriers and risks, to engage with relevant stakeholders regarding benefits and opportunities.)

Executive Summary:
Nanotechnology is a complex and rapidly changing field, often difficult to assess in terms of opportunities, challenges and risks. The FP7 ObservatoryNANO project was funded from April 2008 until March 2012 to address these issues by assessing all aspects of the value chain from basic research to market applications in terms of scientific, technological and socio-economic developments. Ethical, legal and societal aspects (ELSA); potential environment, health and safety (EHS) issues; and developments in regulations and standards were evaluated, and as far as possible integrated with the science and technology (ST) and economic analysis. The project objectives were:
• To support policy makers by providing validated information on the current and forecasted state of nanotechnology developments in ten key technology sectors.
• To engage with experts to discuss and review scientific and technical developments, and relate these to socio-economic impacts and wider issues.
• To consolidate this analysis in an online database of concise reports, which clearly identify developments, opportunities, challenges, and risks.
• To provide information and tools for the scientific and business communities to support the responsible development of nanotechnologies.
The project employed a combination of literature review, patents and peer-reviewed publication analysis, and extensive expert engagement. The project provided analysis of ten broad technology sectors (Aerospace, Automotive & Transport; Agrifood; Chemistry & Materials; Construction; Energy; Environment; Health, Medicine & Nanobio; Information & Communication; Security; Textiles), initially detailed reports were produced for each, but feedback from the target audience (policymakers) indicated a need for more succinct analysis in the form of annual factsheets (summarising key developments and taking account of wider aspects of the ST and economic developments), and briefings (summarising key developments in terms of the added value from nanotechnology, the impact on Europe, and considerations of ELSA, EHS, and regulatory aspects).
The consortium provided annual reports on the ethical and societal impact of nanotechnology developments, as well as interviewing opinion leaders on different aspects: individual and collective responsibility; nanobiomedical ethics; ICT; and communication between scientists, technology, and society. To support the responsible development of nanosciences and nanotechnologies (N&N) the consortium developed a toolkit to allow scientists to consider the larger societal and ethical implications of their research, and tools for business to support corporate social responsibility (CSR), including an updated NanoMeter (an online tool allowing businesses to assess their products and services in terms of EHS and societal aspects, and offering suggestions for improvement)
EHS aspects were largely integrated within the briefings and factsheets, however in addition stand-alone reports provided a detailed review of the implications in each sector and the landscape for EHS research in Europe. Furthermore an annual report described changes in hard and soft regulation, and standards, within Europe, internationally, and in selected third countries.
Finally, the long-term goal of this project was to provide a framework for the establishment of a permanent European Observatory on Nanotechnologies. To this end the structure and purpose of similar initiatives was reviewed, and an advisory board of international experts and policy makers established to assist in the elaboration of various models.
All project output is available through the website: www.observatory-nano.eu

Project Context and Objectives:
Context
The ObservatoryNANO project was funded to assist European decision-makers in governments, industry, and finance to objectively assess the implications of evolving nanoscience and nanotechnology (N&N) developments on their plans and programmes. Its aim was to collate and analyse data and interact with stakeholders including scientists, industry, business, NGOs, and policymakers to both validate the analysis and illuminate areas for which data is lacking and opinion based on specific experience is required.
N&N relate to the study and application of materials at the nanoscale (a nanometre is one billionth of a metre). At this size range many different material properties such as electrical, magnetic, strength, colour, chemical reactivity can be altered, conferring potential advantages such as lower (or alternative) material requirements, improved process efficiencies, and new applications. However, to address nanotechnology impacts one must first consider what is defined as nanotechnology. This poses some difficulties as precise definitions still remain the subject of much debate (as nanotechnology primarily takes advantage of the novel properties of materials at the nanoscale size range, which does not obey strict size ranges). Furthermore, manufactured nanomaterials need not be 100% nanoscale, they may contain a cheaper support (or matrix) material which is of a larger scale and into which the nanoscale material is added (to confer the new properties). A major milestone in the debate was the Royal Society and Royal Academy of Engineering report of 2004, in which nanoscience was defined as “the study of phenomena and manipulation of materials at atomic, molecular, and macromolecular scales, where properties differ significantly from those at a larger scale” and nanotechnologies as “the design, characterisation, production and application of structures, devices, and systems by controlling shape and size at the nanometre scale.” The EC has recently adopted a definition that also takes account of the proportion of nanoscale materials within a manufactured material:
‘A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 - 100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.’
Due to its strong interdisciplinary nature and rapid evolution, N&N has wide-spread and fragmented impacts. Thus, the creation of a reliable source of data and analysis, which is continuously monitored and updated, was seen as critical to provide comprehensive information to decision makers. Governments across the globe continue to invest huge amounts of public money in nanotechnology programmes and therefore look to assess the return on investment in terms of socio-economic impacts: the market potential of nanotechnology enabled products and processes (estimated at the start of the project to underpin a total market of up to one trillion US dollars by 2015, now slightly reduced, as a result of the global economic downturn); and the possibility of these products contributing significantly to alleviating global problems such as major diseases, energy, clean drinking water, and environmental pollution. However, it is also recognised that the socio-economic impacts of nanotechnologies are often exaggerated or placed in an over-optimistic time-frame. Furthermore, nanotechnologies, as with any new technology, have potential risks (socio-economic, to human health, and the environment), and it is important that these are identified early on and appropriate actions taken, to ensure that development occurs in a safe and responsible manner. Even more important are the ‘unknowns’ which remain even when nanotechnology-enabled products reach the market, and which will require more advanced forms of risk communication and corporate responsiveness to ensure market success.
Understanding the full implications of nanotechnology developments therefore needs to take account of the wider issues, such as unknowns regarding the health and safety aspects of nanomaterials, ethical and societal issues (such as the concerns of different groups regarding social inequalities that might arise from nanotechnology developments, and concerns over worker and consumer safety) and overarching all of these, developments in regulating this new suite of technologies and providing a means of referencing developments through international standards.
While efforts were underway in each of these areas, there was much fragmentation and few linkages, with the result that policymakers were often presented with disjointed analysis and recommendations, which were often difficult to reconcile.
The ObservatoryNANO intended to address these issues through:
• a consortium consisting of leading expert organisations in ST, economic, ELSA, EHS and regulatory and standards assessment (each of which had many years experience of nanotechnology and of working with other European and international organisations), thus providing both breadth and depth to the analysis;
• engagement with other experts in different organisations (industry, academia, NGOs, government) and countries through interviews, workshops, surveys, and peer-review of project output;
• engagement with the wider community through liaisons and information sharing with other public initiatives (such as the European Technology Platforms (ETPs) and other publicly-funded projects), international organisations (such as ISO, OECD, EPO), and government agencies in different Member States;
• dissemination of the project output to policymakers through government agencies, technology assessment bureaus, and more widely through partner networks and media websites;
• assessment of how a future European observatory on nanotechnology should operate and with what objectives.

Objectives of the ObservatoryNANO
The primary objective of the ObservatoryNANO project was to provide regularly updated data on scientific and technological (ST) developments (publications and patents), economic trends (such as markets, public-private funding and investment, IPOs), and to identify relevant activities of other organisations (such as strategies, roadmaps). However, the issue is that it can be extremely difficult to link ST developments with socio-economic impacts, as so many other factors need to be taken into account. Therefore the project was tasked with developing suitable methodologies to identify and validate ST and economic indicators in different technology sectors and allow government, funding agencies, investors, and industry to make strategic decisions regarding the potential of the sector, and obstacles to the full realisation of this potential; and the relative position of EU RTD with regards to the global market. This would allow the EU to focus its energies on the technologies of most relevance to EU society and to take appropriate actions to ensure that such technology development is capitalised by EU industry and not lost to another region. It would also give clear indications of whether the EU is competing effectively with other regions in growth areas, and if not, the reasons why this could be so and recommended actions.
This analysis required two types of data: quantitative (such as numbers of publications, patents, and IPOs, and funding levels) and qualitative (such as expert opinion of trends, opportunities, gaps). However, quantitative data is rarely complete (or accurate) and qualitative data can be highly subjective (dependent on the pool of experts sampled). A major objective of the project was therefore to develop suitable and robust methodologies to marry quantitative and qualitative analysis of ST and economic data to provide a clear understanding of the potential socio-economic opportunities, limits and risks posed by N&N, to ensure that key decision-makers are presented with enough facts, analysis and recommendations to make informed decisions on future development strategies.
Although the analysis of the ST and socio-economic impacts of nanotechnology developments was the main objective of the ObservatoryNANO, it was performed within a wider framework taking account of ethical and societal issues; potential environment, health and safety impacts; and new regulations, legislation, and standards. Much of this work was to be performed through active liaison with organisations or other projects focussed on these issues, however where appropriate the ObservatoryNANO planned to make recommendations for further work (identified through the ST and socio-economic analysis performed within the ObservatoryNANO project, but not already addressed by other, external activities).
ST and socio-economic analysis were provided for ten technology sectors: aerospace, automotive, and transport; agrifood; chemistry and materials; construction; energy; environment; health, medicine, and nanobio; ICT; security; and textiles. Overall the project aimed to:
• Identify new N&N developments in each of the ten sectors (encompassing all application areas); providing trend analysis (publications, patents, capacity) in different sectors, as well as broader RTD strategies (publicly and privately funded) and comparing the situation in the EU with other global regions.
• Determine the socio-economic impacts of these ST developments, through the analysis of public and private funding behind new developments, success rates (for example based on IPOs, or market shares) and the elaboration of methodologies to link this information qualitatively and quantitatively.
• Identify gaps that could prevent the effective capitalisation of EU nanotechnology RTD, including infrastructure, education and training needs, mobilisation of workforce, public-private funding.
• In the context of other ongoing (external) activities, analyse the ethical and societal issues of these developments and their implementation.
• In the context of other ongoing (external) activities, determine any potential risks from new developments in terms of to human health and environment.
• Communicate this information in an effective way to a variety of different stakeholders, policy and decision-makers.
The final goal of the ObservatoryNANO project was to establish the framework for a permanent European Observatory on Nanotechnologies that would provide ongoing, independent support to decision-makers. This would take account of the methodologies developed and validated during the project, the functions and activities of other similar initiatives, and input from a balanced Governing Board of high-level stakeholders formed during the project.

Project Results:
A key aspect of the ObservatoryNANO project was to integrate different types of analysis (ST, economic, ELSA, EHS, regulations and standards) in a coherent manner that would better inform policy and decision-makers. A fundamental requirement for this was the inclusion of qualified organisations within the project consortium that could provide the specific analysis, but additionally had the experience of working in multi-disciplinary projects that would allow understanding of broader issues and placing these in context. In addition, a number of support measures were developed alongside this analysis to support the research and business communities.

Figure 1. Overview of approach taken by ObservatoryNANO.

Nanotechnology developments were identified, observed, and assessed as a result of a variety of interventions:
• patent and publication analysis which revealed areas where significant new knowledge was being created;
• developments addressing grand societal challenges (such as sustainability, health, and green transport) that were the subject of major policy decisions in different global regions;
• recommendations from external experts who were engaged throughout the project life-time (through surveys, interviews, and workshops).
During the four year period the project evolved in terms of both its output and the methodologies it employed. The first year of the project essentially gathered large amounts of data (for each of the above analyses) in each of the ten technology sectors, and established strong links with the wider community through individual experts and liaisons with other organisations and projects.
Methodology
A primary aim of the project was to integrate different types of analysis from the different aspects: ST, economic, ELSA, EHS, regulations and standards. This required significant adaptation, sharing and mutual understanding of different perspectives throughout the project, and was effectively achieved by the third year. In the sections below a brief evolution of this is described along with the key methodologies employed to provide analysis of nanotechnology developments.
Initially the project had a rather simple annual activity cycle, with the first year devoted to collating information and performing analysis of all sectors from the different analytical perspectives. The rationale of the annual cycle was that different input would be incorporated at regular intervals through the interaction of project partners in common activities (see Figure 2 below):

Figure 2. Initial annual activity cycle of the ObservatoryNANO

Key input was the expert opinion, through interviews and workshops primarily, but also through surveys and review of project reports. In all over 1000 experts were engaged throughout the project for validation of ST and economic analysis, and several hundred more for the review of ELSA, EHS, and regulatory/standards aspects.
Input data was both qualitative and quantitative, and resulted in a number of indicators, that were used to measure the impact of N&N developments from the perspective of the different analyses, and through this provide recommendations.
Quantitative data came from:
• Public and private funding – providing an indicator of the input to nanotechnology developments. This information was presented in relevant sections of the project output described below, and in several stand-alone reports. Information was gathered at source; so from public funding agencies in different countries, venture capitalists and fund managers, and individual companies.
• Peer-reviewed publications – providing an indication of scientific output. Publications from the Web of Science (which contains millions of bibliographic records from over 10,000 peer reviewed, high impact journals covering a broad range of scientific disciplines) were ‘cleaned’ using a published methodology (making use of keyword sets) to contain only N&N publications. The resultant database initially contained over 500,000 entries from 1998 to 2007 and was updated annually. The project consortium used further keyword sets to search the database for publications related to the ten different technology sectors studied. Each set had an average of 80 keywords, based on existing database thesauri, such as from Inspec, Compendex and EMTREE. This also provided comparative analysis of developments in different countries and world regions over the period studied, and revealed which organisations were publishing the most and which had the highest impact (i.e. publications in more highly cited journals).
• Patents – providing an indication of early stage application and potential commercialisation (although not all patents lead to products). Data was derived from the European Patent Office (EPO) PATSTAT database (which contains patents from around the globe (including the US and Japanese Patent Offices). Updated bi-annually, the PATSTAT database was searched using keyword sets for each technology sectors to determine evolution of nanotechnology in each sector in different world regions over a ten year period.
Qualitative data came from:
• Non-peer reviewed literature – sources such as company reports, government agencies, other publicly funded projects. These provided an indicator of the development and exploitation of nanotechnology through reported facts and figures, opinions and strategies of various organisations.
• Expert engagement – confirming analysis derived from the quantitative data and from other qualitative sources, and in many cases enhancing the analysis by providing inside opinion on trends, which was validated by cross-referencing with other experts and other data sources. Expert engagement took the form of interviews, and workshops, and in some cases surveys and review of initial analysis.

Engagement with experts
As mentioned above the consortium pursued a number of means to engage with the expert community. This was a major part of the qualitative data collection and validation of analysis. The annual symposium was one such way to bring different experts (from different thematic areas and backgrounds) together; so natural scientists, environmental scientists, social scientists, industry, and business together to discuss specific nanotechnology developments that show promise but where obstacles (technical, economic, EHS, ethical/societal) may exist that would prevent or delay full exploitation. The workshops at the first annual symposium (Düsseldorf, March 2009) were designed to allow various stakeholders to discuss these aspects following an overview provided by the relevant project partner. While this worked well for several of the topics chosen, it did not for all- a result of the broad nature of nanotechnology and the difficulty in bringing quite disparate experts together at the same time. The emerging economic downturn also restricted the ability of many experts (in particular industry) to travel and to share information. In subsequent years it was decided to organise focused workshops aligned with specific topics and ideally with an existing event, rather than have all sectors and types of analysis represented ‘under the one roof’. Experts were additionally interviewed individually (by phone and in person, e.g. at events) to provide valuable insight.
An online survey was produced to cover all areas of analysis being performed by the ObservatoryNANO, and engage with a wider audience. The nature of the survey (ten technology sectors and multiple areas of analysis) required a complex decision tree structure (over 2200 questions were programmed) to direct respondents to only those questions that were relevant. Unfortunately this proved to be less successful than anticipated (a number of different dissemination routes were employed including direct contacts, however only 246 responses in various degrees of completion were received). In the second year a simpler questionnaire was designed, however a poor response was again received, and following this, such questionnaires did not form part of the data collection.


Data presentation and review processes
The consortium adopted a simplified version of NASA’s technology readiness level scheme to provide an assessment of the maturity of different technologies (see Figure 3 below):

Figure 3. Technology Readiness Level approach adopted by
the ObservatoryNANO and comparison with that of NASA

Alignment of a given technology with each TRL was initially made internally (the ST and/or economic lead partner on a piece of analysis), then validated by external review.
A graphic was used to summarise the TRL stage of different technologies relevant to the developments being analysed. An example illustrating this of the relative stage of development of different technologies for batteries for electric vehicles is given in Figure 4.

Figure 4. TRL for batteries for electric vehicles
The project consortium structured itself into working groups to address each of the ten industrial sectors according to the different types of analysis required, and ensure substantive review of any analysis prior to publication (see Table 1):


Table 1. Working group structure to assess implications of different aspects of nanotechnology developments.

Output
Initially the project focused on large reports that were updated on an annual basis (twice a year for the ST aspects). The initial concept was to review all ST developments in a particular technology sector, sub-divide these large reviews into defined topics, make each available as separate sections on the project website (tagged with keywords), allowing users to read, link and download the documents based on their individual needs. In such a way all aspects of nanotechnology development were contained within these reports, allowing interested individuals to easily access relevant material online and search for related information (e.g. from an ST entry point, to find relevant information on EHS aspects of the nanomaterial in question).
ST and economic analysis remained the major component of the ObservatoryNANO’s work throughout the four year period, however the means for presenting this analysis changed. Following a project review at month 9, more focused and shorter reports were produced, and after a workshop in month 21, with the EC and representatives from other relevant FP7 projects, it was agreed to re-focus efforts to produce more concise analysis (in the form of factsheets and briefings), targeted specifically to meet the needs of policymakers (Figure 5)..




Factsheets have 1-2 pages for each TS, and summarising the main developments and opportunities, and wider issues.

Briefings are 4 page documents, topical and responsive, including a more complete assessment of wider issues, specifically written for policy-makers.

General Reports are available for all types of analysis (ST, economic, ELSA, EHS, regulations and standards) and provide greater depth of analysis.

Figure 5. Project output.

The purpose and structures of different project outputs are described below.
Annual Reports – ST and Economic Aspects
Annual reports were published for all types of analysis in the first year of the project: ST, economic, ELSA, EHS, regulations and standards. New annual reports continued to be delivered for ELSA, and regulations and standards, however the ST, economic and EHS analysis became more integrated into briefings and factsheets in years 3 and 4.
In the first year of the project a total of 53 reports were published describing scientific and technical advances in the ten technology sectors:
• Aerospace, Automotive & Transport- Technologies to produce bulk nanostructured metals; Technologies to produce polymer nanocomposites; Technologies to produce and apply tribological nano-coatings
• Agrifood- Agricultural production; Food processing and functional food; Food packaging and distribution
• Chemistry & Materials- Carbon based nanomaterials; Nanocomposites; Nanostuctured metals and alloys; Nano-polymers; Nano-ceramics; Nano-fabrication technologies
• Construction- Cement based materials; Coatings; Living comfort and building safety; Sustainability and environment; Civil- and underground construction
• Energy- Photovoltaic; Thermoelectricity; Fossil fuel; Energy harvesting; Nuclear; Renewable energies; Fuel cells; Hydrogen production and storage; Batteries and supercapacitors
• Environment- Air purification; Wastewater purification; Drinking water treatment; Groundwater remediation; Soil remediation
• Health, Medicine & Nanobio- Cosmetics; Diagnostics; Novel bionanostructures; Implants, surgery and coatings; Therapeutics; Regenerative medicine
• ICT- Integrated circuits; Memory; Displays; Manufacturing; Photonics; Beyond CMOS
• Security- Chemical Weapons and Industrial Toxins Detection; Biological Threat Agent Detection; Radiological-Nuclear Weapon Detection; Explosives Detection; Narcotics Detection; Neutralising CBRNE effect; Decontamination; Forensics; Personnel Protection; Equipment and Infrastructure Protection; Condition Monitoring of civilian zones; Anti-counterfeiting; Authentication; Positioning and Localisation
• Textiles- Nanostructures; Fibre production; Finishing treatments; Textile products
Each report was structured as follows:
• Executive Summary – for each technology sector. Overview of relevant developments within the technology sector, and description of sub-sectors (described above) within each technology sector.
• For each sub-sector:
o Short description
o State of RTD (basic and applied research, and market applications – providing an assessment of TRLs for each development)
o Additional demand for research (challenges and drawbacks)
o Applications and perspectives
o Current situation within the EU (comparison with other countries and world regions)
o Key players and experts (scientists, institutions, companies)
o References and relevant literature

Each report was updated in the second year of the project, after which the focus moved towards factsheets and briefings (see below). However, these reports continued to be a baseline for the ST analysis from the project.
In addition to the ST analysis, the following reports on economic and market developments were published:
• Aerospace, Automotive & Transport- Structural parts/airframe; External panels/surfaces; Powertrain; Engine (ICE)/turbines
• Agrifood- Nanocomposite packaging; Coatings for packaging; Edible coatings; Biodegradable nanocomposites for packaging; Delivery systems for nutraceuticals
• Chemistry & Materials- Nanomagnetic materials; Carbon nanotubes; Nanodiamond; Intrinsic conducting polymers
• Construction- Cement based materials; Construction ceramics; Paints; Windows; Insulation systems/materials
• Energy- Photovoltaic; Fossil fuel
• Environment- Water treatment; Soil remediation
• Health, Medicine & Nanobio- Bone replacement materials; Dental nanomaterials; in vivo imaging; Drug delivery
• ICT- Memory; Displays; Materials
• Security- Detection
• Textiles- Water repellent/self-cleaning; Moisture absorption/wicking; Anti-static; Anti-bacteria; Filtration and UV protection

Each report was structured as follows:
• Executive summary
• Methodology
• General market description
o Brief market description
o Nanotechnology impact
o Drivers and barriers to innovation
o Relevant sector segmentation and applications
o Possible future products and time range
• Application profiles
o Short application description
o Functional requirements
o Boundary conditions
o Product examples
o Economic information and analysis
o Selected key companies profiles

Annual Reports – Ethics and Societal Aspects
This activity had the objective to monitor both the ethical and societal impact of N&N and the impact that societal developments and ethical reflection can have on N&N developments. In addition to contributing opinion directly to the ST and economic analysis, the partners responsible produced four annual reports on topics that are highly relevant to N&N development:
• individual and collective responsibility – provided a review of current nanoethics and social studies of science literature, the debate in Europe on responsible nanotechnology development (as well as various codes of conduct), and a review of ethical and societal issues identified in the ST and economic analysis of the ten technology sectors;
• nanobioethics – this explored issues surrounding human enhancement, synthetic biology, nanomedicine, agrifood, and animal testing;
• ICT and security – covering aspects such as privacy, security technologies and policies, and civil-military dual use of (nano)technology;
• communication between scientists, technology, and society – this discussed the need for improved communication and engagement between scientists, policymakers and wider society, which contributes to the goal of responsible research and innovation.
These reports were supported by a series of 16 interviews with opinion leaders (from industry, academia, government and NGOs).

Annual Reports – EHS
Activities in EHS analysis in the first year of the project included a report on seminal research taking place around the globe on nanotechnology EHS aspects, that acted as a baseline document for future reference. Liaisons were also established with relevant initiatives including other observatories investigating EHS aspects (SafeNano (UK), KIR (NL), OMNT (FR)), which were the subject of short reports summarising the rationale and objectives of each. This was followed in the second year by a thorough analysis of the ST and economic reports from the first year ObservatoryNANO work providing the following:
• Consideration of the potential for exposure arising throughout the lifecycle of each application (manufacture, use and recycling/final disposal).
• Outline of those nanoparticles/nanomaterials in use within each technology sector, according to application.
• Highlighting those applications where there was considered to be a high potential for release.
• Identification of the main (probable) routes for human and environmental exposure of each nanomaterial.
• Summary table of those identified nanomaterials which have potential EHS impact, according to application.
Following this in-depth review of each technology sector, ongoing EHS analysis was performed for each of annual factsheets and regular briefings (see below).
In the final year of the project an ‘EHS landscape’ report was published that mapped and provided a concise overview of key organisations (government, NGO, industry and academic) and their activities within the field of nano-EHS worldwide. Its purpose was to support communication of efforts, outlining those key initiatives, activities and projects within the field.

Annual Reports – Regulations and Standards
This work identified changes in both hard and soft regulation taking place within Member States, the EU as a whole and selected third countries (USA, Australia, Canada, Japan, China, India, Taiwan, South Korea, and Thailand). A primary activity was liaison with appropriate bodies to identify new regulations and standards which could have an impact on EU industry, and identifying any needs for new regulations, and standards.
Annual updates were published which reviewed developments in hard and soft regulation (such as the EC Code of Conduct, EPA-NSMP, DEFRA-VRS) and standards for nanotechnologies (including ISO TC 229, CEN TC 352, OECD). In addition to this, liaison with the various organisations established at the project start continued (several of the partners participate in national and international standards committees and contribute to the OECD WPN and WPMN).

Focus Reports
These combined the structure of the ST and economic components into a shorter report of around 30-35 pages ‘focused’ on a particular topic that were published in the second year of the project. Topics were chosen based on output from expert workshops during the first annual symposium 16 focus reports were published in year two of the project (Table 2):

Table 2. Focus reports published by ObservatoryNANO.
Factsheets
Factsheets were not an original project deliverable, but introduced after discussion with the EC in early 2010 when a need for such succinct information was highlighted. The purpose of the factsheets was to summarise key developments in terms of:
• Challenge – what was the nanotechnology development addressing (e.g. improved efficiency of solar cells).
• Nano-enabled solution – how nanotechnology is addressing the challenge (e.g. nanostructured materials to improve energy harvesting and energy transfer).
• TRL – how close to market the nano-enabled solution is.
• Barriers to commercialisation – including science and technology barriers (e.g. performance issues of the materials), manufacturing on an industrial scale, costs, lifespan.
• Measure of impact – if the nano-enabled solution was realised, what effect would this have on the economy, or on society?
• EU’s competitive position – how the EU compares with other world regions in terms of its academic research and industrial base.
• EHS, ELSA & other issues – what other issues need to be considered alongside the technology development?
Three sets of annual factsheets were produced in 2010, 2011, and 2012.

Briefings
Briefings were not an original project deliverable but evolved out of a need to provide policymakers with additional context surrounding key developments in nanotechnology. In total 33 briefings were published (see Table 3 below):
No. Technology sector Briefing title Publication date
1 Agrifood Biodegradable Food Packaging Jul 2010
2 Environment Photocatalysis for Water Treatment Aug 2010
3 Construction Nano-enabled Insulation Materials Aug 2010
4 ICT Universal Memory Oct 2010
6 Health, Medicine & Nanobio Next Generation Sequencing Oct 2010
6 Transport Nano-enhanced Automotive Plastic Glazing Oct 2010
7 Textiles Nano-enabled protective textiles Dec 2010
8 Security Nanotechnologies for anti-counterfeiting applications Dec 2010
9 ICT Nanotechnology for Flat Panel Displays Jan 2011
10 Chemistry and Materials Applications of Photocatalysis Feb 2011
11 Security Nanosensors for explosive detection Feb 2011
12 Energy Organic photovoltaics Mar 2011
13 Environment Nanostructured membranes for water treatment Mar 2011
14 Chemistry and Materials From microscope to nanoscope Apr 2011
15 Health, Medicine & Nanobio Bringing diagnosis closer to the patient Apr 2011
16 Environment Nanoenhanced membranes for improved water treatment Jun 2011
17 Energy Thermoelectricity for energy harvesting Jun 2011
18 Agrifood Improving delivery of essential vitamins and minerals Jul 2011
19 Security Nanotechnologies for secure communications Aug 2011
20 Statistical Patent Analysis Patents: an indicator of nanotechnology innovation Aug 2011
21 Construction Nanofillers – improving performance and reducing cost Sep 2011
22 Environment Nanosorbents for environmental applications Sep 2011
23 Transport Nanotechnology in automotive tyres Nov 2011
24 Textiles Nano-enabled automotive textiles Dec 2011
25 ICT Nanotechnology for Wireless Communications Dec 2011
26 Chemistry and Materials Addressing critical commodity scarcity Jan 2012
27 Publication Analysis Geographical Distribution of Nano S&T Publications Feb 2012
28 Agrifood Sensors in Food Production & Processing Mar 2012
29 Health, Medicine & Nanobio Pacemakers and ICDs Mar 2012
30 Chemistry and Materials Nanocomposite Materials Mar 2012
31 Energy Supercapacitors Mar 2012
32 Transport Nanotech in next-generation electric car batteries: beyond Li-ion Mar 2012
33 Textiles Nano-enabled Textiles in Construction and Engineering Mar 2012
Table 3. Briefings published by ObservatoryNANO.

Each 4-page briefing had the following structure:
• Introduction – why the topic is relevant and timely.
• Challenge to be addressed by nanotechnology – the added value that nanotechnology can bring.
• Background to the nanotechnology development.
• Impact – on wider society, on a particular industry. Including (where available): size of industry and projected growth, number of companies, number of employees, distribution across Europe, impact on manufacturing, infrastructure requirements.
• TRL – a graphic summarising the maturity of relevant nanotechnology developments (see below for an example).
• Societal impacts – on quality of life, and consumer choice.
• Challenges – ST, economic, societal and EHS challenges that would need to be overcome before the technology could be fully exploited by society.
• EU competitive position – comparing the EU with other world regions in terms of quantitative data (patents, publications, numbers of leading institutes and companies), and qualitative data (expert opinion, company survey).
• Summary.

Briefings thus combined all aspects of the ObservatoryNANO’s analysis in a concise format. To ensure integrity, inclusion of all aspects of the analysis and validation, each briefing followed a defined pathway from concept to publication:
1. Selection of topic (ST led) – based on expert feedback (from surveys or workshops, thus an area which several players have identified as a ‘hot topic’), societal grand challenges (new developments that address or contribute towards meeting society’s grand challenges such as sustainability, health), ‘hot spots’ in activity (measured by publication and/or patent spikes, investment in different companies, policy measures published by different governments).
2. Sharing of topic with other ObservatoryNANO partners who will perform different types of analysis.
3. Desk research – peer-reviewed publications, company and industry reports, strategy documents, databases (such as Eurostat, OECD). Assessment of the challenge and the impact of the nanotechnology development.
4. Identification of relevant organisations (industry and academia) and individual experts.
5. Engagement of experts – presentation of initial analysis and structured discussion, through interviews and/or workshops.
6. Inclusion of expert feedback (inside and outside consortium) into final draft of report.
7. Circulation to experts (inside and outside of consortium) for feedback on content.
8. Final editing for language and grammar.
9. Publication online and dissemination to other networks and organisations.

Other project output
In addition to the observation, analysis and reporting activities taking place within the project, support activities were undertaken specifically to assist science researchers and business to better address the wider aspects of N&N development.

Ethics toolkit
Ethical issues in nanotechnology are most often thought to concern only the general public. However, scientists and researchers are very much concerned by questions of responsibility and by the social impact of their research in general; such questions may dwell deep into their commitment to research in general. The Ethics Toolkit provides nanoscientists with a quite unique resource to help them clarify and strengthen their judgements and positions on ethical debates and questions raised by their own research. While it is not possible to provide a ‘one-size-fits-all’ answer to the ethical questions facing researchers, the toolkit hopefully helps, and perhaps guides, ethical thinking by offering concepts, notions, and methods for an application to practical cases.
The toolkit explores the concepts of nanotechnology from a philosophical perspective and presents a series of scenarios framed around ethical questions to illustrate issues that scientists may face, and by doing so allows them to broaden their assessment of the social and ethical implications of their research. It was made available to download from the ObservatoryNANO website in the second year of the project and refined over the course of the third year through practical demonstration at a series of workshops in different countries.

Corporate Social Responsibility Tools
The NanoMeter is a tool for the assessment of applications that are enabled by nanotechnologies. It covers aspects such as health, environment, ethics, and societal issues beyond standard product assessment. Its purpose is to identify opportunities and risks of single applications. Originally designed in the FP6 Nanologue project, this was further adapted in the ObservatoryNANO project to explore in greater depth different aspects of nanotechnology in different application areas.
Through a confidential online process, the user is asked a series of questions on their assessment of their product or process in terms of:
• exposure and hazard (to the environment and people);
• reduction or substitution of harmful substances;
• contribution to risk-related research;
• resource usage (energy, materials, end-of-life);
• added benefits (to users, to addressing relevant societal issues, accessibility to wider society);
• wider issues (such as ethical issues, regulation, precautionary principle, consumer information, responsiveness to stakeholders).

In each question the user is asked to rank how confident they are in the accuracy of the answer. The final analysis provides the user with a map of areas where there are knowledge gaps, where there could be improvements, and the basis for specific measures to assure performance and public acceptance and support market success. In such a way the NanoMeter contributes to Corporate Social Responsibility (CSR).
A report on CSR was published which complements the NanoMeter, and provides a means for companies applying nanotechnologies (in products or service) to broaden their view and enhance their practice regarding responsibilities.

Observing the Observers
A further aspect of the ObservatoryNANO project was to objectively assess the role and structure of other observatories, and compare and contrast with the evolving model in the project. The purpose of this was to support a framework for the elaboration of the function and structure of a future European observatory on nanotechnologies.
This work identified four basic questions that should frame the development of an observatory:
• Object of interest: interest in the technology vs interest in the sector.
• Judgement calls: abstinence from recommendations vs evaluative observation.
• Institutional standing and legitimacy: an observatory as a ‘support action’ vs an institution with conferred and earned political legitimacy.
• Research orientation: condensing expert extrapolations vs reflecting contemporary practice.

State of Nanotechnology – what have we learned from four years of the ObservatoryNANO?
Nanotechnology has a broad scope and thus it is difficult to condense the output from the ObservatoryNANO in a short space. In all over 140 reports were published, comprising several thousand pages of analysis and recommendations. In the following sections highlights from the research are described, but for a fuller analysis, the reader is directed to the ObservatoryNANO website where all reports are freely available for download.
The Wider Nanotechnology Landscape
Nanotechnology continues to be an area of high investment for governments around the globe (in total around €50b since 2000), although this has levelled out since the economic downturn. See Table 4):

Table 4. Public funding of N&N by selected countries (from ObservatoryNANO publication ‘Public Funding of Nanotechnology’ published March 2012)

Our initial analysis of quantitative indicators suggested that Europe was good at generating results (based on peer-reviewed publications), but poor at exploiting them (based on patents, Table 5):

Table 5. N&N publications vs patents (1998-2007).

However, this knowledge production capability is being eroded. Looking at trends in publications we observe that China and other countries (in particular other South East Asian countries such as South Korea) are increasing their output far more than the EU and therefore taking a bigger share of the overall output (see Figure 6):

Figure 6. N&N publications as a percentage of total global output, 1998-2008

Despite this decrease in output, European Member States continue to produce higher quality output than countries other than the US (measured by citation index, see Figure 7):

Figure 7. Numbers of publications and citation ratios.

The productivity of EU researchers is also high compared with other global regions (see Figure 8):

Figure 8. Publication records per 1000 researchers (full-time equivalents).

The EU performs relatively well in all ten industrial sectors studied according to scientific output (Figure 9), but with regards to patenting only manages to perform well in aerospace, automotive and transport, and in construction (Figure 10).

Figure 9. Share of N&N publications 1998-2008, per industrial sector.


Figure 10. Share of N&N patent applications 1998-2008, per industrial sector.

European Nanotechnology Landscape
Underpinning any recommendations for how governments should support nanotechnology is an understanding of what is already present and how this fits together. To this end the ObservatoryNANO undertook a comprehensive review of the European nanotechnology landscape. It took as its starting point databases which can unequivocally assign organisations to nanotechnology, namely the project publication database and the patent database PATSTAT. This was further supplemented with a search of companies which partnered in nanotechnology projects within the EU’s framework programme.
The hotspots of N&N research activity in Europe (measured at the NUTS 3 geographic level) are Ile de France, Madrid, London, Berlin, and Grenoble (each area with more than 1000 N&N publications in 2010). However, there is also a high level of N&N spread across other EU regions (Figure 11 below indicates the levels of N&N publication activity over the period 1998-2007):

Figure 11. European Basic Nano S&T Clusters, 1998-2007

While this spreads knowledge and capability across the EU, the concern could be that critical mass required to compete on a global stage is being lost. In contrast the publication activity in Japan is much more centralised (Figure 12):

Figure 12. Tokaido Corridor visualisation using 2010 Nano S&T research output.

Around 11,000 patent applications were made between 2000 and 2010 from approximately 1700 European organisations (approximately 1300 of these were companies). This equates to approximately 1 patent application per ~€10 billion of GDP or 500,000 inhabitants. The number of new patent applications appears to have plateaued in Europe and the US, while it continues to grow in China (see Figure 13).


Figure 13. N&N patent applications from 1998- 2010.

While 70% or more patent applications in Europe come from companies, two of the largest institutions patenting are the CEA and CNRS (see Figure 14):

Figure 14. Total number of N&N patent application by EU organisation.

The ObservatoryNANO built upon this analysis to identify a total of 1540 unique European companies which manufacture or develop nanotechnology-enabled products or services; so excluding research institutes, consultancies, etc. This was achieved through the extraction, correlation, and cleaning of publication data, patent data, and participation in NMP thematic projects – see Figure 15 below.

Figure 15. Numbers of nanotechnology companies identified in different EU Member States.

These companies were contacted and invited to participate in a short survey to obtain further general information about each company and specific information regarding their use of nanotechnology, positioning in the value chain, and views on government support. 100 companies responded, and while nanotechnology was only a small part of their business for the majority; 61% indicated that revenue from their nanotechnology business had grown. Key outcomes regarding government support and barriers to commercialisation are described in Tables 6 and 7 below.


Table 6. Extract from European Nanotechnology Landscape report showing respondent companies’ level of satisfaction with government support (EU, National and Local).

Table 7. Extract from European Nanotechnology Landscape report showing respondent companies’ perception of the level of impact that different barriers (technological, economic, policy, society, and EHS) have on commercial success.

An online and interactive map was produced that lists each of the 1540 companies identified (Figure 16). This is available at http://batchgeo.com/map/5ff2e051d47a9e9198fe9b095f33d2da

Figure 16. Online map of N&N companies.
Innovation policies were identified that support the exploitation of N&N, and are summarised in Figure 17. An evaluation of two Member States (Spain and Finland) was performed and it became clear that innovation policies are strong for the initial stages, but weaker for market entry support and public procurement.
Figure 17. Nanotechnology innovation policies (from the ‘European Nanotechnology Landscape’ report).

Responsible innovation requires the embedding of policies to support the wider aspects of nanotechnology development. In the ObservatoryNANO project partners reviewed ELSA and EHS aspects to determine what instruments were in place and actions being taken both in Europe and in other global regions.
A mindmap of EHS actions was one of these outputs (published within the ‘Nanotechnology EHS Landscape Document’) to visualise how different actions come together to support nanotechnology safety:

Figure 18. The Nanotechnology EHS Landscape Map
The document identified key organisations which are considered to be contributing substantially to moving forward the issues relating to nanotechnology EHS at each position of the mindmap (divided into seven main areas of activities: research, knowledge transfer and reviews, public engagement, professional bodies, guidance, standardisation and regulation). This looks at Europe as a whole, and key activities within different Member States and selected third countries, as well as international organisations such as the OECD, WHO and FAO, and various company initiatives.
In Figure 19 below an illustration is provided of initiatives in the research node. Further detail is provided within the report.

Figure 19. Mindmap of the research node - international organisations, industry and FP research.

Developments in regulation and standards are also critical to supporting responsible innovation. The project partners have observed a change in the way different governments are addressing the issues of good governance of nanotechnology over the four years of the project, with several now implementing mandatory reporting schemes. This is summarised in Table 8 below (taken from the annual report on regulations and standards):


Bringing it Together in a Coherent Picture
This analysis was consolidated within the European Nanotechnology Landscape report, by making use of Societal Grand Challenges and illustrating these in the form of value chain analysis.
There are several grand challenges facing society at present, including sustainable energy and transport, health, environment, and food. In the final year of the ObservatoryNANO, the contribution of nanotechnology to addressing these issues was studied. Taking the example of the need for a new energy economy, specific issues were identified, how nanotechnology might be able to address these, and the specific developments required (see Figure 20).

Figure 20. Example of a societal grand challenge (‘New Energy Economy’) and nanotechnology developments which could help address key issues.

These were further expounded through value chain analysis. Below we use the example of the ‘Green Car’ to illustrate (some) nanotechnology impacts at each stage of the value chain:

Figure 21. Some key stages in the Green Car Value Chain.

In addition to the ST impacts we also consider wider issues (ELSA, EHS, and regulatory) at each stage of the value chain (see Figures 22 to 24 below):


Figure 22. Some EHS issues associated with different stages of the Green Car value chain.


Figure 23. Some ethical issues associated with different stages of the Green Car value chain.


Figure 24. Some regulatory issues associated with different stages of the Green Car value chain.

This multi-layered approach, assessing new product development and challenges or obstacles (which can be technical, economic, societal, safety, or regulatory in nature) to that development, provides a rapid means for policy and decision makers to view and understand critical components.

Conclusions
Nanotechnology is a key component of public investment to help address societal grand challenges, and boost innovation. It operates within a complex sphere of policy (technology, economic, regulatory, safety, and societal), with different countries adopting different approaches, making it difficult to make direct comparisons.
Data is needed to evaluate impacts and make these comparisons, and needs to take account of the fact that nanotechnology operates alongside other technologies and in a varied policy environment. It is necessary to understand the contribution it makes, but also the influence other factors have in achieving a particular outcome (e.g. the green car, which is the culmination of many different technologies, the policies and regulations that have driven its development, and the public ‘valuation’ of its necessity). As part of this evaluation, value chain assessment becomes highly important to determine the full economic value and impact being derived from nanotechnology investment, and to help address the problem of defining the involvement of nanotechnology in a final product where economic value is most often assessed. Finally, many of the tools developed within the ObservatoryNANO (in particular the publication and patent analysis) could be further developed to identify and quantify the interaction of different organisations in the development of nanotechnologies.

Potential Impact:
Potential Impact of the ObservatoryNANO
The ObservatoryNANO was funded primarily to support policymakers, although other stakeholders found utility in the analyses performed. As such it is most relevant to consider the impact that the project had on this group and the means by which the project engaged with policymakers. Policymakers are essentially looking to identify all the key considerations required when making decisions on actions regarding nanotechnology and later to measure the effectiveness of these policy decisions (in terms of impact).
The difficulty with nanotechnology is that it is an enabling technology (one of several Key Enabling Technologies, KETs), i.e. it supports the realisation of very many products and services across many different disciplines, industry and business sectors. Some of the challenges in the assessment of nanotechnologies are listed below:
• Only a few of the applications have reached a mature technology readiness level. As with other KETs, there is a consistent gap to overcome in order to translate RTD concepts and results into innovation (application and products on the market);
• They operate in a multivariate environment; so many other technologies and activities can have an influence on their impact;
• Much of the data required to make a full assessment is unavailable (e.g. because companies do not perceive themselves as using nanotechnology, or do not publicise this fact);
• Their impressive capabilities are also the source of divergence and uncertainties about the possible risks for environment, health and safety (EHS) and the ethical, legal and societal aspects (ELSA) of their use;
• Scientific knowledge and experience on EHS (and ELSA) is still limited, challenging the application of existing procedures (or the development of new ones) for the evaluation, monitoring, handling of specific nanomaterials and nanotechnologies applications;
• The proprietary nature of information on novel materials and the lack of harmonised standards or guidance (somewhat typical of immature technologies).
The ObservatoryNANO has gone some way to integrating these aspects into a coherent whole. The model of a core group of experienced individuals in organisations each with specific expertise in the analysis of different aspects of (nano)technology assessment, supplemented with the input of external experts (for more specific thematic areas) has worked well and, from feedback from the EC, provided the type of analysis required by policymakers.
Governments are focused on identifying the impacts of their policies on key economic measures such as job creation, improved economic growth, sustainability, and improving the health of citizens. Such socio-economic objectives are rarely (if ever) addressed solely through investment in one or more technologies, but are subject to a number of different fiscal and legislative policies, and allied measures including communication and education. Investment in nanotechnology then becomes one of many options open to governments when considering specific socio-economic objectives. Taking this into account the first and largest challenge in assessing the impact of nanotechnology, and governments’ investments in nanotechnology, is the lack of a broad framework which links applications and impacts of nanotechnology to economic data, or in other words, which allows governments to disentangle the impact of nanotechnology from a whole host of other factors.
The second major challenge is a lack of understanding of the stages and roles of nanotechnology in present and future industries by those responsible for collecting and analysing economic data. This is largely due to the fact that nanotechnology can have a direct or indirect impact in the development or manufacture of a particular process or product. The question is how to measure the worth of nanotechnology to the final product? Would it be possible to produce this without nanotechnology? What components are critical, and what incremental benefit do other nanotechnology enabled components provide? What if a component is produced through a nanotechnology enabled process, but contains no nanoscale features itself? The issue here is how to place a value on this improvement.
The economic impacts of government support for any technology can be both direct and indirect. Direct impacts from the products and processes that are created can include increased market share, growth of companies, new products, and wealth creation. The indirect impacts are more difficult to generalise as they depend on the nature of the technology development.
To determine this impact requires significant data for all aspects that will affect and be affected by nanotechnology. These can be divided into three types of data: those that measure input (e.g. public and private investment, infrastructure, numbers of graduates), those that measure output (e.g. publications, patents, product sales), and those that measure impact (e.g. job creation, numbers of companies, market growth). The ObservatoryNANO contributed to this in the following ways (Table 9):

How did the Project Engage with Policymakers and other Key Stakeholders?
Policymakers have limited time to process new information. The ObservatoryNANO project thus tailored its initial output to a more focused and condensed form (factsheets, briefings and data rich analysis) – essentially validated end-points in mixed qualitative/quantitative data processing. It also engaged directly with policymakers through specific meetings and workshops. Details of these can be found in Section A2, and a few key ones are highlighted below:
• EC - regular meetings (including the inter-services group on nanotechnology) to inform about latest analysis from the project.
• UK government - one-day workshop for UK government policymakers (March 2009), regular presentation to the UK’s nanotechnology stakeholder forum, and engagement with policymakers in several government departments (BIS, Defra, TSB), regular posting of new information to the Parliamentary Office for Science and Technology (POST), participation in a UK parliamentary dinner organised by BASF.
• French government – information to Francoise Roure (chair of the ObservatoryNANO Governing Board) and Head of the Technology and Society Section, French Ministry of Economy, Finance and Industry, regular postings to French government agencies;
• German government – regular postings to BMBF.
• Dutch government – regular postings to Dutch policymakers through the monthly ‘Signals’ bulletin.
• OECD – information sharing via Francoise Roure (chair of the OECD’s working party on nanotechnology, WPN), presentation to WPN in Helsinki (October 2008).
In addition to these contacts, relevant EU parliamentary committees and technology assessment bureaus in different Member States were identified and sent the quarterly newsletters (summarising project output).
Other relevant actors included important EU initiatives such as NANOfutures and the NanoSafety cluster, to which the ObservatoryNANO regularly supplied analysis, and attended meetings and workshops.

A Future European Observatory on Nanotechnology?
A key potential impact of the project is whether this leads to the creation of a future European observatory on nanotechnology. When considering how such an observatory might contribute to understanding issues and supporting policy solutions, we need to consider a number of aspects:
• Data issues – an observatory is only as good as the data it uses to make its observations. There is a real need to consolidate efforts across Europe to provide validated data from different Member States, in different industrial sectors, and from different perspectives. The ObservatoryNANO has started along this route, but having greater political support behind collection of data would make this process much more effective. The databases started within the ObservatoryNANO could be usefully expanded and interrogated in greater depth, providing valuable insight into nanotechnology developments.
• Purpose of the observatory – is it to continue to be broad in approach (as the ObservatoryNANO was) or more focussed on certain elements (e.g. economic impact, safety issues, societal concerns)? The strength of the current format is that all aspects of the analysis are integrated (although this has improved over the project’s term, there is still opportunity to further improve). The disadvantages are that it can take longer and be more expensive to provide analysis, and that there are several other initiatives tasked with similar elements (e.g. the NanoSafety Cluster, and NANOfutures).
• Correlation with other KETs – nanotechnology is one of a suite of tools available to organisations to develop and exploit new ideas as marketable products and services, technologically innovative companies may be using several to achieve their objectives. Many of the individuals engaged with through the ObservatoryNANO project (and other activities the partners were involved with) may only use nanotechnology in a small part of their activities, when there is a compelling reason to do so. They may also not recognise (or choose not to publicise) that they are using nanotechnologies. All of which makes identifying the added value of nanotechnology difficult.
• Who is it for? The ObservatoryNANO project served policymakers who needed a better understanding of the interaction of various elements to allow informed policy interventions with the purpose of achieving socio-economic objectives. Such analysis is anchored in what previous policy decisions have been made thus giving a need for a nanotechnology-focussed approach that can be quite broad in the aspects it analyses. In contrast for industry (and for economic impact assessments), this may be too narrow (as described above) – nanotechnology helps deliver products, but it is not a market in itself.
• Structure – should this be permanent or a support action (to deliver specific output to a target group)? The choice also affects the legitimacy that others will perceive of an observatory (transparent and accountable, versus delivering a service whose workings may not be visible to the public).
• Output – observations or analysis with recommendations? Only in English or all other EU languages? Accessible to everyone or restricted?

To conclude, we can provide some reflection on what we have observed of the environment in which the ObservatoryNANO has operated over the last four years. Huge amounts of public and private investment have gone into nanotechnology. This must continue to be assessed to ensure maximum return on investment, and that ongoing support is focused to where the greatest socio-economic impacts can be realised. This must be evidence based. The ObservatoryNANO offers a Multi-disciplinary structure to support this, and importantly three quantitative tools: the patent, publication, and company databases. The combination of all three allows existing clusters to be identified and measured in terms of levels of collaboration and the value of that output. Adding a further layer of value chain analysis onto this, allows gaps and under-used resources to be identified. These need to be the targets for future investment to ensure that Europe has the critical mass to compete on the global stage. By providing a new focus on value-chains, other contributory factors can be assessed (e.g. other KETs, regulatory and fiscal policies).
Economic imperatives do not operate in a vacuum however, and one of the key lessons from the ObservatoryNANO analysis has been the promotion of Responsible Research and Innovation (RRI), using multi-stakeholder approaches and addressing EHS, ELSA and regulatory issues throughout the entire lifecycle of products.
Over the past 4 years there has been increased momentum on the debate on nanotechnology governance. Relevant activities have been undertaken to deepen and clarify EHS and ELSA issues, develop best practices, guidelines, standards, foster international cooperation. Improved implementation tools and specific requirements for nanotechnologies have been introduced in some regulatory regimes, and others are planned in the near future. Particular attention has been given to “upstream” regulation (nanomaterials) and regulation of products coming into direct contact with humans or animals.
In addition, the attitude of stakeholders (research, industry, policy makers) has, generally speaking, changed, with an increased awareness about knowns as well as unknowns related to the safety of nanomaterials and nano-related products.
Regulation can profoundly influence the path of the development of nanotechnology-related products and processes. Recommendations for future actions includes: facilitating multi-stakeholder approaches, setting a responsive and adaptive regulatory framework, with an appropriate balance between hard and soft regulation, continue the effort to foster international coordination and harmonisation. These are considered pivotal to pursue RRI as a driver for promoting competition and growth.
List of Websites:
All information on the ObservatoryNANO can be accessed at www.observatory-nano.eu (see below for a screenshot of the homepage).

Information is divided into the type of output (e.g. factsheet, briefing, report, support tool (Nanoethics toolkit, NanoMeter, CSR briefing), industrial sector (Aerospace, Automotive & Transport; Agrifood; Chemistry & Materials; Construction; Energy; Environment; Health, Medicine & Nanobio; Information & Communication; Security; Textiles) and type of analysis (ST, economic, ELSA, EHS, regulatory and standards, communication).

Project consortium:
Institute of Nanotechnology (IoN), UK, www.nano.org.uk Mark Morrison, mark.morrison@nano.org.uk
VDI Technologiezentrum GmbH (VDI-TZ), DE, www.vditz.de Michael Gleiche, gleiche@vdi.de
Commissariat à l'énergie atomique (CEA), FR, www.cea.fr Alexei Grinbaum, alexei.grinbaum@cea.fr
Institute of Occupational Medicine (IOM), UK, www.iom-world.org Rob Aitken, rob.aitken@iom-world.org
Malsch TechnoValuation (MTV), NL, www.malsch.demon.nl Ineke Malsch, postbus@malsch.demon.nl
triple innova, DE, www.triple-innova.de Brigitte Biermann, brigitte.biermann@triple-innova.de
Spinverse, FI, www.spinverse.com Tom Crawley, tom.crawley@spinverse.com
Bax & Willems Consulting Venturing (B&W), ES, www.bwcv.es Laszlo Bax, l.bax@bwcv.es
Dutch National Institute for Public Health and the Environment (RIVM), NL, www.rivm.nl Robert Geertsma, robert.geertsma@rivm.nl
Technical University of Darmstadt (TUD), DE, www.philosophie.tu-darmstadt.de Stefan Gammel, stefan.gammel@phil.tu-darmstadt.de
AIRI/Nanotec IT (AIRI), IT, www.nanotec.it Elvio Mantovani, mantovani@airi.it
Nano and Micro Technology Consulting (NMTC), DE, www.nmtc.de Matthias Werner, Werner@nmtc.de
Swiss Federal Laboratories for Materials Testing and Research (EMPA), CH, www.empa.ch Bernd Nowack, Bernd.Nowack@empa.ch
Centre for Bioethics and Nanoethics, Aarhus (AU), DK, www.teo.au.dk Anne-Mette Frueland, aman@km.dk
MERIT, Universiteit Maastricht (MERIT), NL, www.merit.unu.edu/ Ad Notten, Ad.Notten@MERIT.unimaas.nl
Technology Centre AS (TCASCR), CZ, www.tc.cz Gabriela Salejova, salejova@tc.cz
final1-218528-1118978-observatorynano-final-report-figures-and-tables.pdf