ACTIVITIES AND INTENTIONS OF LEADING EUROPEAN AND GLOBAL COUNTRIES IN THE NANOSAFETY ISSUES. Jitka KUBATOVA

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1 ACTIVITIES AND INTENTIONS OF LEADING EUROPEAN AND GLOBAL COUNTRIES IN THE NANOSAFETY ISSUES Jitka KUBATOVA TECHNOLOGY CENTRE ASCR, Ve Struhach 27,160 00, Prague 6, Czech Republic, Abstract All countries systematically promoting nanosciences and nanotechnologies pay particular attention to potential risks associated with research, development and applications in this field. Specific national nanoregulations and risk management systems are introduced there. The most active countries in nanotechnology governance are in Europe Germany, Great Britain, France, The Netherlands and Swiss and also Austria, Norway and Finland. Beyond Europe the leading role in this respect play USA, Canada and Australia. The presentation will provide a brief overview of how the mentioned countries govern the development of nanotechnologies with the aim of avoiding potential risks associated with them and define adequate regulations and risk management structures with reference to both EHS (Environment, Health and Safety) issues and ELSA (Ethical, Legal and Social) aspects. Experiences of these countries may provide a model for the Czech Republic. Keywords: nanotechnology, nano safety, nano risk INTRODUCTION There is no doubt that commercial products containing nano particles represent innovation and help us in our normal life, whether they are products for household, sports, cosmetics, medicine or food goods. Similarly, use of nanotechnologies and nanomaterials in electronics, photonics, energy, etc. brings great benefits to people. However, it is known that nanoparticles due to their small size can penetrate cell walls and influence the life processes. Therefore, the question is whether and how nanoparticles can also be harmful to human health and negatively affect the environment. All over the world, therefore, extensive research is performed on nanoparticles which are used in commercial products. In March 2011 it was reported [1] that on the global scale more than 1300 consumer products contained nanoparticles are present and that this number have been constantly growing. The most exploited nanomaterials are: nano forms of silver, iron, gold, carbon, titanium dioxide, zinc oxide, silica and cerium oxide. The research is initiated and supported mainly by governmental institutions such as the European Commission or the NNI in the United States, international organizations such as OECD and national authorities. Despite the large amount of experimental data on nanoparticles that are already available not enough knowledge exists on how particular nanoparticles interact with living organisms and whether they can cause some health problems. Discussions on how to ensure nano safety are therefore common among both authorities and ordinary citizens. Citizens and their representatives are usually calling for labeling products containing nanoparticles and for specific regulations. It is therefore understandable that in professional circles and the general public the talk about how to prevent potential risks when dealing with nanoparticles or with products containing them. It is required labeling of products containing nanoparticles and also set standards for the use of nanoparticles and treatment. In EU the European Commission and the European Parliament have different opinions concerning hard regulation and voluntary measures. Some European countries have already introduced national regulations or are going to do it.

2 EUROPEAN COMMISSION NANOSAFETY RESEARCH 1.1. Projects support Within the EU Framework Programmes, completed FP6 and current FP7, the Commission encouraged and supported a considerable amount of research projects focused on study of properties of nanoparticles with regards on nanosafety. The list of such projects can be found on the web page of the Nanosafety Hub of the ETPIS European Technology Platform on Industrial Safety [2]. We highlight some of these projects: NANOSAFE2 - Safe production and use of nanomaterials: development of risk assessment and management for secure industrial production of nanoparticles (completed in 2009) ENRHES - Engineered Nanoparticles: Review of Health and Environmental Safety: comprehensive and critical scientific review of the health and environmental safety of fullerenes, carbon nanotubes (CNTs), metal and metal oxide nanomaterials (completed in 2009) NANEX - Development of Exposure Scenarios, for Manufactured Nanomaterials: catalogue of generic and specific (occupational, consumer and environmental release) exposure scenarios for manufactured nanomaterials (completed in 2010) ENPRA - Risk Assessment Of Engineered Nanoparticles: latest advances in toxicology ( ) NANOSUSTAIN - Development of sustainable solutions for nanotechnology-based products based on hazard characterization and LCA: investigation of products containing CNT, nano TiO2, nano ZnO and nanocellulose ( ) HINAMOX - Health Impact of Engineered Metal and Metal Oxide Nanoparticles: Response, Bioimaging and Distribution at Cellular and Body Level: investigation of TiO2 and ZnO as catalysts and UV protectors, CuO in anti-fouling paints, Al2O3 as a surface protector, CeO2 in polishing, indium-tin oxides forming antielectrostatic coatings and various rare earth oxides in electronics manufacturing ( ) NANORETOX - The Reactivity and Toxicity of Engineered Nanoparticles: Risks to the Environment and Human Health: investigation of TiO2, SiO2, ZnO, CuO, CdS, Ag, Au ( ) NANOIMPACTNET - The European Network on the Health and Environmental Impact of Nanomaterials: network of leading European research groups involved in the study of the environmental and health impact of nanomaterials with activities in nanosafety, nanorisk assessment, and nanotoxicology ( ) 1.2 International collaboration The European Commission recently initiated establishment of the NanoSafety Cluster, a cluster of projects promoting nanomaterial safety [3]. Aim of the cluster is to maximise the synergies between the existing FP6 and FP7 projects addressing all aspects of nanosafety including toxicology, ecotoxicology, exposure assessment, mechanisms of interaction, risk assessment and standardisation. The cluster is coordinated by Professor Kai Savolainen, Director of Nanosafety Research Centre, Finnish Institute of Occupational Health (FIOH) and has 7 working groups: Materials, Hazard, Exposure, Database, Risk, Modelling and Dissemination. The NanoSafety Cluster published in 2011 Compendium of Projects in the European NanoSafety Cluster, 2011 Edition (editors M. Riediker and G. Katalagarianakis, 218 pages) [4], an updated version of the 2010 edition. It contains detailed information on 24 EU projects including names and contacts of project partners. One of the aims of the NanoSafety Cluster is to promote EU-US nano EHS dialogue. On March 10-11, 2011 US and EU jointly held a workshop US EU bridging nanoehs research efforts at the George Washington University [5]. Presentations of top representatives of the European Commission, US National Nanotechnology Coordinations Office and governmental authorities, OECD, leading companies and institutions are available on the web site [6].

3 The European Commission has recently launched a new infrastructure project, QNANO A pan-european infrastructure for quality in nanomaterials safety testing [7]. This four year project began in February 2011 and comprises 27 top European analytical & experimental facilities in nanotechnology, medicine and natural sciences. It aims to create an integrated hub to support Europe s nanosafety research community. Besides other tasks QNano is dedicated to provide members of the European nanosafety community access to nanomaterials processing, characterisation and exposure assessment facilities. Access to these 15 major European research sites is via a single application and evaluation process. 1.3 Repository An European repository of reference nanomaterials was recently created in the JRC Institute for Health and Consumer Protection [8]. So far it contains 25 different types of reference materials (CNTs, nanoparticles of silver, gold, titanium dioxide, zinc oxide, cerium oxide, silica and bentonide) for use in standardisation. EU NANOSAFETY REGULATIONS AND STANDARDS 2.1 Current hard and soft regulations in EU The main EU regulation with an impact on nanosafety, European Community Regulation on Chemicals and their safe use REACH [9], was published on 18 December 2006 and entered into force on 1 June It addresses chemical substances in whatever size, shape or physical state, though no special provisions referring nanomaterials are given there. The European Commission considers this document as a sufficient regulation for nanomaterials. REACH is based on the principal that manufacturers, importers and downstream users have to ensure that they manufacture, place on market or use substances that do not adversely affect human health or environment. Regulatory aspects of nanomaterials under REACH are in detail discussed in the Commission Staff Working Document [10] published in June A more specific regulation, EU Regulation on Cosmetic Goods [11] issued in November 2009 contains a special article (No 16) on nanomaterials. European Commission published in 2008 a Recommendation CoC - Code of Conduct for responsible nanosciences and nanotechnologies Research [12]. This complementary measure to existing hard regulation recommends the stakeholders in the member states how to undertake nanosciences and nanotechnologies research in a safe, ethical and effective way, supporting sustainable economic, social and environmental development. CoC is based on seven general principles: Meaning, Sustainability, Precausion, Inclusiveness, Excellence, Innovation and Accountability. Explanation of these principles is given in the document. The European Parliament at its meeting in April 2009 asked for tighter controls on nanotechnologies [13], particularly in the case of chemicals and materials, cosmetics, foods, occupational health and worker safety, environmental safety and waste. Therefore, the European Commission will review all relevant legislation by the end of 2011 with a view to propose regulatory changes where necessary and to develop more nanospecific instruments for the implementation of regulation. 2.2 Current ISO TC 229 standards An overview of ISO standards concerning measurement and characterisation of nanoparticles and in the field of health, safety and environment is presented in the report DEVELOPMENTS IN NANOTECHNOLOGIES REGULATION & STANDARDS 2011 [14] elabotated within the FP7 project ObservatoryNANO: ISO/TS 10808: Characterization of nanoparticles in inhalation exposure chambers for inhalation

4 ISO/TS 10867: Characterization of single-wall carbon nanotubes using near infrared photoluminescence spectroscopy ISO/TS 11251: Characterization of volatile components in single-wall carbon nanotube samples using evolved gas analysis/gas chromatograph-mass spectrometry ISO 10801: Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method ISO 29701: Endotoxin test on nanomaterial samples for in vitro systems -- Limulus amebocyte lysate (LAL) test ISO/TR 12885: Health and safety practices in occupational settings relevant to nanotechnologies ISO/TR 13121: Nanomaterial risk evaluation. NANOSAFETY NATIONAL AND INTERNATIONAL ACTIVITIES In September 2010 a high-level workshop Towards a regulatory framework for the traceability of nanomaterials took place in Brussels [15]. Conclusions of the action highlighted all tasks to be solved in order protect the workers, consumers health and the environment, and at the same time guarantee the development of a secure and sound economy based notably on innovation and societally acceptable industrial applications. The full text of of the Conclusions and individual presentations are given in [15]. 8 th Meeting of the OECD Working Party on Manufuctured Nanomaterials held in Paris March 2011 discussed recent achievements in individual countries in the field of human health and environmental safety of manufuctured nanomaterials. The OECD document CURRENT DEVELOPMENTS/ACTIVITIES ON THE SAFETY OF MANUFACTURED NANOMATERIALS [16] contains a large range of information on situation in 9 countries in Europe, 8 countries beyond Europe and 4 international organisations. Open questions will be discussed at conferences. We highlight at least two of them which will be held in 2012, namely SENN2012 [17] and nanosafe 12 [18]. The goal of SENN2012 International Congress on Safety of Engineered Nanoparticles and Nanotechnologies (Helsinki, October 2012), organized by NANODEVICE project partners and the Finnish Institute of Occupational Health is to summarize and share the latest knowledge on the safety of engineered nanomaterials and nano-related technologies. Its another aim is to enable commercial opportunities for the safe use of these materials and technologies. The second conference, nanosafe 12 International Conference on Safe production and use of nanomaterials (Grenoble, November 2012) will be the third conference of of this series organized by MINATEC France. Research of EHS issues and regulatory aspects are considered a priority in all countries which have developed their national nanotechnology strategy/plans. Among them, the most active in Europe are France, Germany, Switzerland, the Netherlands and UK. We present here short profiles of them: FRANCE: The Nano-INNOV plan was launched in mid 2009 by the French Research Ministry. The nano research is concentrated within CNRS (Centre National de la Recherche Scientifique) and CEA (Atomic Energy and Alternative Energies Commission). CNRS developed a Network of competence centres C Nano which organize specific programmes on ELSA. CEA coordinates the large EU project NANOSAFE. GERMANY: Action Plan Nanotechnology 2015 launched by the German Ministry for Education and Research BMBF outlines the strategy for further resposible development, innovation and public dialogue for the period Regulations and standards are emphasized as priorities. SWITZERLAND: Swiss Action Plan on Synthetic Nanomaterials has been in force since During this period several publications were issued, namely Safety data sheet (SDS): Guidelines for synthetic nanomaterials (last modification in December 2010), Nanoparticles at workplaces (2009), Report on nano waste management (2010) and Fire and explosion properties of synthetic nanomaterials (2010).

5 THE NETHERLANDS: In 2010 the Dutch government approved the continued investment in the successful nano- and microtechnology programmes MicroNed, BioMade and NanoNed. NanoNext NL is a newly established national colleborative programme joining more than one hundred companies, universities, institutes and university medical centres. It was launched on 9 June Risk analysis and technology assessment is one of 10 programme priorities. UK: In March 2010 the UK government published the UK Nanotechnologies Strategy Small Technologies, Great Opportunities [19]. It is a plan for realization of the vision presented in the introduction: The UK s economy and consumers will benefit from development of nanotechnologies through Government s support of innovation and promotion of use of these emerging and enabling technologies in safe, responsible and sustainable way reflecting the needs of the public, industry and academia. LITERATURE [1.] PEN The Project on Emerging Nanotechnologies [2.] ETPIS NANOSAFETY HUB [3.] NanoSafety Cluster [4.] Compendium of Projects in the European NanoSafety Cluster [5.] Joint workshop March 10-11, Agenda [6.] Joint workshop March 10-11, Presentations [7.] QNANO [8.] Repository of nanomaterials [9.] REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 concerning the Registration, Evaluation, Authorusation and Restriction of Chemicals (REACH) [10.] COMMISSION STAFF WORKING DOCUMENT (Accompanying document to the COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE - REGULATORY ASPECTS OF NANOMATERIALS): Summary of legislation in relation to health, safety and environment aspects of nanomaterials, regulatory research needs and related measures [11.] REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products [12.] COMMISSION RECOMMENDATION ON CODE OF CONDUCT FOR RESPOSIBLE NANOSCIENCES AND NANOTECHNOLOGIES RESEARCH [13.] European Parliament resolution of 24 April 2009 on regulatory aspects of nanomaterials (2008/2208(INI) [14.] MANTOVANI, E. et al. Developments in Nanotechnologies Regulations and Standards, Report of the ObservatoryNano, July 2011 [15.] Workshop Towards a regulatory framework for the traceability of nanomaterials [16.] CURRENT DEVELOPMENT/ACTIVITIES OF THE SAFETY OF MANUFUCTUTED NANOMATERIALS, No. 29 Series of the Safety of Manufuctured Nanomaterials (2011) [17.] SENN International Congress on Safety of Engineered Nanoparticles and Nanotechnologies [18.] nanosafe 12 International Conference on Safe production and use of nanomaterials [19.] UK Nanotechnologies Strategy Small Technologies, Great Opportunities