here - nanoSTAIR - EU-VRi
Transcription
here - nanoSTAIR - EU-VRi
The role of standardization in promoting exploitation of innovations Olivier Salvi, EU-VRi (inputs from Andrea Gulacsi, CEN) NANODEVICE Annual Forum April 25th 2012, NRCWE, Copenhagen Outline 1. What is standardization? 2. Standardization of innovations & the STAIR approach 3. Standardization context related to nanotechnologies 4. Opportunities of the nanoSTAIR project 1. WHAT IS STANDARDIZATION? EU Bodies The European Committee for Standardization The European Committee for Electrotechnical Standardization The European Telecommunications Standards Institute = the European Standards Organisations (“ESOs”) + 32 full members (EU+EFTA+Croatia) + International standards bodies (ISO, IEC, ITU-T) CEN / CENELEC Members NSB Various levels International Europe ISO IEC ITU CEN CENELEC WTO WTO ETSI Membership Nation al NSBs for CEN & CENELEC Companies for ETSI Industry, other stakeholders, standards‘ users... EC EFTA National authorities What does CEN do? ¾ CEN develops European harmonised documents • • • European Standards Technical Specifications Workshop Agreements ¾ CEN provides a platform for stakeholders in a specific area to come together and reach consensus at European level ¾ CEN provides a tool to facilitate the transfer of innovative ideas to the market ¾ CEN helps build consensus for the European Single Market Where do standards fit in: Law Mandatory Voluntary Regulations Standards Public CEN / CENELEC Workshop Agreements Professional good practice, corporate specs, etc. Private Type of documents from formal standards bodies (ISO or CEN) ¼Normative documents (requirements) ¼Technical Specifications ¼Full Standards (European Standards: EN or International Standards: ISO) ¼Informative documents (no requirement) ¼Technical Reports ¼“Guidelines” ¼Workshop Agreements (CWA or IWA) © 2009 CEN – all rights reserved 24/05/2012 2. STANDARDIZATION OF INNOVATIONS – STAIR Political Perspective European standardization conference "Innovation and market access through standards“ (Berlin, 27 March 2007) Günter Verheugen, Vice-President of the EC ¼ "We must prepare Europe for the rapid political, economic and cultural challenges that affect and threaten us." ¼ “I can justifiably claim that, as far as European industry is concerned, European standardization is a trump card in global markets.” © 2009 CEN – all rights reserved 24/05/2012 Political Perspective (2) ¼At the World Economic Forum in Davos 2007 the German Chancellor Angela Merkel emphasized the importance of technical standards ¼Standardization has been recognized by the governments as a tool for promoting innovation ¼Research and innovation are to be more closely interlinked with standardization Goal: Creating optimum conditions for future innovations and promoting their marketability. © 2009 CEN – all rights reserved 24/05/2012 Promoting innovation ¼EXPRESS recommendations ¼ To increase the cooperation between standardization bodies and for a/consortia (strategic goal 9 recommendation) ¼ Implementing an integrated approach on standardization, innovation and research ¼STAIR – Promoting Innovation ¼ Creation of CEN/CENELEC BT working group on Standardization, Innovation and Research (STAIR) ¼ Implementing an integrated approach on standardization, innovation and research ¼ Promoting the use of the integrated approach in contacts with all stakeholders at the national level ¼ Promoting the use of the integrated approach as an efficient tool for European innovation policy ¼ Ensuring a better place for standardization issues in Framework Programmes and in their individual calls Benefits of European Standards ¼ 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 ¼ It fosters technical progress and innovation ¼ It helps to disseminate awareness and knowledge ¼ It helps to share good practices among all stakeholders, including: ¼ industry at large & small and medium-size enterprises ¼ public authorities and regulators as standards users ¼ academia and the research community ¼ consumers, etc ¼ It provides an opportunity for better regulation: ¼ ‘Self regulation’ by the market and best practice benchmark ¼ A co-regulation approach in Europe since 1985 14 © 2009 CEN – all rights reserved 24/05/2012 STAIR : a step by step process: Think about the ‘standardization potential’ at every step of the proposal development © CEN-CENELEC 2012 - 15 Why should FP7 project proposers consider standardization? From the STAIR approach ¼ Use recognized methodologies, processes, terminology: don’t reinvent the wheel ! ¼ Enhance interoperability , comparability , compatibility with existing products, services, methodologies... ¼ Enable easier and faster market take-up of research results ¼ Ensure research results adapt to market conditions, e.g health and safety requirements ¼ Facilitate easier access to public procurement markets ¼ Increase impact of proposal ¼ Long-term dissemination and exploitation of research results Match needs with solutions: • Define which kind of standardization activity you want to develop! – RDI project running? • Link with on-going standardization activities through Project Liaison – RDI project proposal? • Develop new standardization activities – a European Standard or a pre-Standard (Workshop Agreement) Right framework: Get the right standardization partner on board! ¾ Who? – National or European Standards Bodies ¾ How? contact CEN-CENELEC [email protected] – Don’t get ‘lost in standardization’ . – Put standardization in the right place, project- and budget-wise! ¾ Where? – usually dissemination WP 3. STANDARDIZATION CONTEXT RELATED TO NANOTECHNOLOGIES Standardization needs for engineered nanoparticles ¼ CEN, has started standardization work on ¼ classification, terminology and nomenclature ¼ metrology, measurement and characterization (including procedures for calibration), ¼ health, safety and environmental issues, ¼ and nanotechnology products and processes. ¼ EC mandates to CEN & CENELEC: ¼ Mandate M/409 for the elaboration of a programme of standards to take into account the specific properties of nanotechnology and nanomaterials (report dated May 2008). ¼ Mandate M/461 requesting to develop the standardization deliverables listed in Annexes I and II of the mandate, and in particular (2010) Standardization needs for engineered nanoparticles Mandate M/461 identifies four areas for standards development: ¼ Methodologies for nanomaterial characterization in the manufactured form and before toxicity and eco-toxicity testing; ¼ Sampling and measurement of workplace, consumer and environment exposure ¼ Methods to simulate exposures to nanomaterials ¼ H, S & E (health, safety and the environment) The first three of which are covered in Annex I and the fourth in Annex II of the mandate M/461. Standardization needs for engineered nanoparticles • 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. Execution of mandate M/461 List of TC • • • • • • CEN/TC 137 Assessment of workplace exposure to chemical &biological agents CEN/TC 138 Non-destructive testing CEN/TC 162 Protective clothing including hand and arm protection and lifejackets CEN/TC 195 Air filters for general air cleaning CEN/TC 230 Water analysis CEN/TC 352 Nanotechnologies • • • • • • ISO/TC 24/SC4 Particle characterization ISO/TC 142 Cleaning equipment for air and other gases ISO/TC 194 Biological evaluation of medical devices ISO/TC 201 Surface chemical analysis ISO/TC 202 Microbeam analysis ISO/TC 229 Nanotechnologies • IEC/TC113 Nanotechnology standardisation for electrical and electronic products and systems Perspectives ¼ Still necessary to promote standardization activities in the research community ¼ Provide support to researchers to orient themselves in the standardization activities ¼ “Close the gulf” between research and standardization by providing more opportunities for linkage ¼ In concrete: ¼ Implement / Use the STAIR approach ¼ Develop a platform to inform, connect and start standardization activities based on research results 24 © 2009 CEN – all rights reserved 24/05/2012 4. OPPORTUNITIES OF THE NANOSTAIR PROJECT project • Title: Establishing a process and a platform to support standardization for nanotechnologies implementing the STAIR approach • From Sept. 2012 to March 2014 (tentative) • …to build a sustainable process and platform in the field of nanotechnologies to support the transfer of knowledge gained through research to documentary standards in the context of the STAIR approach project • Scope: All nanotechnologies with opportunities related to“Characterization of and exposure from nanomaterials” and “Health, Safety, and Environment” • Barriers addressed: Taxonomy of barriers in the transfer from research to standardization (from INTEREST project D05) project project • Scope: All nanotechnologies with opportunities related to“Characterization of and exposure from nanomaterials” and “Health, Safety, and Environment” CONCLUSIONS Conclusions ¼Standardization related to the safety of nanoparticles will support the spreading of good practices and rationalize the communication between the authorities and the industry, and other stakeholders ¼The European Standardization Bodies and the European Commission encourage the development of standards linked with research performed at EU level ¼In the field of the safety of nanoparticles, the Mandate M461 is an opportunity to coordinate the work ¼NANODEVICE, NanoFutures, Nanosafety Cluster, ETPIS and other projects have decided to be proactive and coordinate their efforts behind nanoSTAIR Relevant references • • • • • • • EXPRESS Report: http://ec.europa.eu/enterprise/policies/europeanstandards/files/express/exp_384_express_report_final_distrib_en.pdf STAIR Approach: http://www.cen.eu/cen/Services/Innovation/STAIR/Pages/default.aspx Mandate M/461 ftp://ftp.cencenelec.eu/CENELEC/EuropeanMandates/M_461.pdf Nanodevice project: http://www.nano-device.eu/ European Technology Platform on Industrial Safety http://www.industrialsafety-tp.org/ NanoFutures http://www.nanofutures.eu/ Nanosafetycluster http://www.nanosafetycluster.eu/ Further Information Commission Nanotechnologies homepage http://cordis.europa.eu/nanotechnology/ http://ec.europa.eu/nanotechnology/index_en.html nanoSTAIR http://www.nanostair.eu-vri.eu/