NANODEVICE and Opportunities for Standardization

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1 Novel Concepts, Methods, and Technologies for the Production of Portable, Easy-to-Use Devices for the Measurement and Analysis of Airborne Engineered Nanoparticles in Workplace Air NANODEVICE and Opportunities for Standardization Project ID: CP-IP A European Integrated Project supported throught the Seventh Framework Programme for Research and Technological Development 1

2 Background Nanotechnologies are predicted to have giant market potential. By 2020 it is expected that nearly every area of industry will be affected by nanotechnologies. The areas which are estimated to be affected most are chemistry (including materials), life sciences and electronics, followed by environment technologies, energy and transport and automotive. Growing production and use of ENM leads unavoidably to increased exposure of workers and consumers in terms of numbers exposed and levels of exposure. Furthermore, the environmental burden caused by ENM rapidly increases. This leads to a greater need than ever for reliable information on possible health and environmental effects of ENM and for the sharing of good practices and knowledge gained from recent research work. In this context, the NANODEVICE project has developed new and innovative concepts and methods for measuring and characterizing airborne ENP with novel portable and easy-to-use device(s) for workplaces. New technologies such as nanotechnology and related metrology techniques need standards to support safe and sustainable development and trade. Standardization is one of the most adequate solutions to quickly capitalize and disseminate knowledge in reference documents which result from a strong international consensus. Using standards for the implementation of knowledge in the industry will further ensure sustainable competitiveness and operations according to the state of the art. This 2nd brochure of the NANODEVICE series gives an introduction to standardization and provides guidance to develop standards based on the results of the NANODEVICE project. NANODEVICE Project summary Due to their unique properties, engineered nanoparticles (ENP) are now used for a myriad of novel applications with great economic and technological importance. However, some of these properties, especially their surface reactivity, have raised health concerns, which have prompted scientists, regulators, and industry to seek consensus protocols for the safe production and use of the different forms of ENP. There is currently a shortage of field-worthy, cost-effective ways - especially in real time - for reliable assessment of exposure levels to ENP in workplace air. In addition to the problems with the size distribution, a major uncertainty in the safety assessment of airborne ENP arises from the lack of knowledge of their physical and chemical properties, and the levels of exposure. A special challenge of ENP monitoring is to separate ubiquitous background nanoparticles from different sources from the ENP. Here the main project goal is to develop innovative concepts and reliable methods for characterizing ENP in workplace air with novel, portable and easy-to-use devices suitable for workplaces. Additional research objectives are: 1) identification of relevant physico-chemical properties and metrics of airborne ENP, establishment of reference materials 2) exploring the association between physico-chemical and toxicological properties of ENP 3) analyzing industrial processes as a source of ENP in workplace air 4) developing methods for calibration and testing of the novel devices in real and simulated exposure situations 5) dissemination of the research results to promote the safe use of ENP through guidance, standards and education, implementing of safety objectives in ENP production and handling, and promotion of safety related collaborations through an international nanosafety forum. 2

3 What is standardisation? For more information visit: : What is a standard? A standard is a technical document designed to be used as a rule, guideline or definition. It is a consensus-built, repeatable way of doing something Standards are created by bringing together all interested parties such as manufacturers, consumers and regulators of a particular material, product, process or service. All parties benefit from standardization through increased product safety and quality as well as lower transaction costs and prices. A European Standard (EN) automatically becomes a national standard in the 32 member countries. Standardization process Figure 1: Standardization process The usual standardization process is described in the figure 1, and in the CEN COMPASS, available at ftp://ftp.cen.eu/cen/aboutus/publications/compass.pdf. The document Getting started How to develop a European Standard is available at: ftp://ftp.cen.eu/cen/services/education/standardays/sd7/day1/ganesh.pdf: Benefits of European standards Standardization is an efficient tool for transposing the results of research to support the Single European Market and to strengthen European competitiveness in a global economy It fosters technical progress and innovation It helps to disseminate awareness and knowledge It helps to share good practices among all stakeholders, including: industry at large & small and medium-size enterprises public authorities and regulators as standards users academia and the research community consumers, etc It provides an opportunity for better regulation: Self regulation by the market and best practice benchmark A co-regulation approach in Europe since

4 Standardisation context related to research and nanotechnologies A new European Standardization Policy proposal: more standards and faster delivery The new European Standardization Policy proposal 1 communicated on June 1st, 2011 insists on the importance to increase the number of standards and to speed-up the development of standards in a fast changing global landscape. This is particularly true for nanotechnologies that impact a lot of industrial sectors and where safety and social acceptance are important elements. In the new European Standardization Policy proposal, standards in the field of nanotechnologies are considered very important because they can facilitate the introduction of new products by bridging the gap between research and marketable products, and also because they contribute to the public acceptance of the innovations. Expressed need for standardization The standardization appears to be a key valorization and output of collaborative research, especially of the research performed on emerging technologies at European level. Standardization enables to share knowledge and good practices in an effective way, in particular giving the access of the information to SMEs and contributing to effective, clear and transparent governance. CEN has launched the STAIR initiative (An Integrated Approach for Standardization, Innovation and Research) that is encouraged to be applied to research projects dealing with emerging technologies such as ENM. According to the STAIR approach, standardization does not come as an afterthought but is built into a project proposal right at the start. This introduces significant benefit potential for the project itself and for any actions after the project s life-time. Figure 2: STAIR Think about the standardization potential at every step of the proposal development 1 European Commission COM(2011) 311 final: A strategic vision for European standards: Moving forward to enhance and accelerate the sustainable growth of the European economy by 2020, 4

5 Standardization for nanotechnologies The European Committee for Standardization, CEN, has started standardization work on (i) classification, terminology and nomenclature (ii) metrology, measurement and characterization (including procedures for calibration), (iii) health, safety and environmental issues; and (iv) nanotechnology products and processes. As various aspects of standardization work may be relevant for the implementation of regulation, the Commission has, in accordance with Directive 98/34/EC addressed a formal standardization mandate to the European standards bodies CEN & CENELEC Mandate M/409 for the elaboration of a programme of standards to take into account the specific properties of nanotechnology and nanomaterials (see report dated May 2008). More recently, CEN & CENELEC have accepted a mandate M/461 requesting to develop the standardization deliverables listed in Annexes I and II of the mandate, and in particular: Annex I - Characterisation of and exposure from nanomaterials Elaboration of normative documents, Technical Specifications or European Standards on: i) Methodologies for characterisation of nanomaterials in the manufactured form and prior toxicity and ecotoxicity testing; ii) Sampling and measurement of workplace, consumer and environmental exposure to nanomaterials; iii) Methods to simulate exposure to nanomaterials Annex II - Health, Safety, and Environment Elaboration of a series of guidances: Guidance on safe handling of manufactured nanoparticles and other nanoscale entities; Guidance on containment, trapping and destruction of nanoparticles and other nanoscale entities; Guidance on a common data-format for an integrated analysis for risk assessment; Guidance on integrated testing strategies (ITS) and integrated risk assessment; Guidance on dosimetry and exposure determination in occupational settings relevant to manufactured nanomaterials; Guidance on detection and identification of nanoparticles and other nanoscale entities; Protocols for the characterization of manufactured nanoparticles from aerosols and from environmental sources, including sampling, sample stabilization, agglomeration, aggregation, etc. Guidance on nano-material characterization prior to, or in association with toxicity testing; Guidance on sample preparation for toxicity testing, toxicokinetic and ecotoxicokinetic (air, water, soil) studies on nanoparticles and other nanoscale entities; Validated test methods for in vivo toxicology and toxicokinetics of nanoparticles and other nanoscale entities; Protocols for in vitro toxicology evaluation of nanoparticles and other nanoscale entities; Protocols for evaluating the effects of short and long term dermal, nasal, oral and pulmonary exposure to, elimination of, and fate determination for nanoparticles and other nanoscale entities; Fast track protocols for predicting the toxicity and ecotoxicity for classification of nanoparticles and other nanoscale entities, particularly for identifying and tracking the most dangerous ones in the framework of the REACH directive; Protocols for determining the explosivity and flammability of nano-powders (for transport, handling and storage); Protocols for risk assessment of potentially hazardous nanoparticles and other nanoscale entities; Protocols for risk management that specifically refers to potential nanotechnology hazards; Protocols for whole life cycle assessment of nanoscale materials, devices and products. 5

6 The mandate M/461 explicitly mentions there is a key role for standardization as regard measurement and testing tools for the characterization, behavior of nanomaterials and exposure, complementing the work being carried out in the framework of the OECD and in the context of the implementation of REACH and CLP. The CEN/TC 352 Nanotechnologies has been asked to take care of the mandate M/461 and to involve Technical Committees in CEN and ISO in the work to be executed. Before developing a CEN Workshop Agreement (CWA) or a Technical Report (TR) or a Technical Specification (TS), it will be necessary to contact all these TC to inform about this initiative and the intentions. List of TC concerned by the mandate M/461 CEN/TC 137 CEN/TC 138 CEN/TC 162 CEN/TC 195 CEN/TC 230 CEN/TC 352 ISO/TC 24/SC4 ISO/TC 142 ISO/TC 194 ISO/TC 201 ISO/TC 202 ISO/TC 229 IEC/TC113 Assessment of workplace exposure to chemical &biological agents Non-destructive testing Protective clothing including hand and arm protection and lifejackets Air filters for general air cleaning Water analysis Nanotechnologies Particle characterization Cleaning equipment for air and other gases Biological evaluation of medical devices Surface chemical analysis Microbeam analysis Nanotechnologies Nanotechnology standardisation for electrical and electronic products and systems Commission Nanotechnologies homepage What is a nanomaterial? European Commission common definition Joint Research Centre of the European Commission reports on the definition of the term nanomaterial. The document entitled Considerations on a definition of nanomaterial for regulatory purposes can be downloaded at the following webaddress: Standards and Standardisation - A practical guide for researchers Pre and co normative research for standardisation STAIR Approach ApproacMandate M/461 ftp://ftp.cencenelec.eu/cenelec/europeanmandates/m_461.pdf 6

7 Opportunities for standardisation from NANODEVICE results In the NANODEVICE project, several opportunities in line with the mandate M461 for standardization have been identified. In order to launch a standardization work item proposal, there is a need to gather a critical mass of expertise with results ready to be standardized. Complementary to NANODEVICE, many European initiatives like ETPIS, NanoFutures, NanoSafety Cluster, NanoImpactNet and several European research projects referenced in the Nansafety Cluster (MARINA, QNANO, NANOVALID ) have similar objectives to improve the management of risks and to share of best practices by developing documentary standards related to: Occupational health and safety issues in relation with ENM, Measurement protocols for ENM. Therefore, a survey has been launched to gather interest in standardization activities from other project consortia and to join the effort with NANODEVICE consortium. The access to the survey is available at: References Relevant websites Michael Riediker and Georgios Katalagarianakis, Compendium of Projects in the European NanoSafety Cluster, 2012 Edition (available at: NANODEVICE project: European Technology Platform on Industrial Safety: NanoFutures: Nanosafetycluster: NanoSTAIR project: Establishing a process and a platform to support standardization for nanotechnologies implementing the STAIR approach: EXPRESS Report 7

8 SENN International Congress on Safety of Engineered Nanoparticles and Nanotechnologies October 2012, Marina Congress Centre, Helsinki, Finland Join us in the next step of the nanosafety discussion! Consortium 29 partners from 10 EU member states including associated partners Partners Sweden Norway United- Kingdom Denmark Finland Universities, Research institutes, Industry partners Coordinator: FIOH Germany Project lasts until March 2013 Project consists of 6 Subprojects 21 Workpackages The Netherlands France Hungary Poland 8 Contact details: Professor Kai Savolainen, Finnish Institute of Occupational Health, Topeliuksenkatu 41 a A, Helsinki, Finland. kai.savolainen@ttl.fi. Internet pages: