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 research@cencenelec.eu
– 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
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•
•
•
•
•
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
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•
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•
•
•
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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/