Objective
One of the greatest challenges facing regulators in the ever changing landscape of novel nano-materials is how to design and implement a regulatory process which is robust enough to deal with a rapidly diversifying system of manufactured nanomaterials (MNM) over time. Not only does the complexity of the MNM present a problem for regulators, the validity of data decreases with time, so that the well-known principle of the half-life of facts (Samuel Arbesman, 2012) means that what is an accepted truth now is no longer valid in 20 or 30 years time. The challenge is to build a regulatory system which is flexible enough to be able to deal with new targets and requirements in the future, and this can be helped by the development and introduction of Safe by Design (SbD) principles.
The credibility of such a regulatory system, underpinned by the implementation of SbD, is essential for industry, who while accepting the need for regulation demand it is done in a cost effective and rapid manner.
The NANoREG II project, built around the challenge of coupling SbD to the regulatory process, will demonstrate and establish new principles and ideas based on data from value chain implementation studies to establish SbD as a fundamental pillar in the validation of a novel MNM.
It is widely recognized by industries as well as by regulatory agencies that grouping strategies for NM are urgently needed. ECETOC has formed a task force on NM grouping and also within the OECD WPMN a group works on NM categorisation. However, so far no reliable and regulatory accepted grouping concepts could be established. Grouping concepts that will be developed by NanoREG II can be regarded as a major innovation therefore as guidance documents on NM grouping will not only support industries or regulatory agencies but would also strongly support commercial launch of new NM.
Fields of science
Keywords
Programme(s)
- H2020-EU.2.1.2. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies Main Programme
- H2020-EU.2.1.2.2. - Ensuring the safe and sustainable development and application of nanotechnologies
- H2020-EU.2.1.2.5. - Developing and standardisation of capacity-enhancing techniques, measuring methods and equipment
Funding Scheme
RIA - Research and Innovation actionCoordinator
60550 Verneuil En Halatte
France
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Participants (42)
70599 Stuttgart
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1150 Bruxelles / Brussel
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8152 Opfikon
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10589 Berlin
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3721 MA Bilthoven
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2100 Kobenhavn
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48170 Zamudio
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00161 Roma
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3584 CS Utrecht
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80-309 GDANSK
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EH14 4AP Edinburgh
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66123 Saarbruecken
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1049 Bruxelles / Brussel
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0349 Oslo
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2027 Kjeller
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35131 Padova
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75794 Paris
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060021 Bucharest
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1113 Sofia
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546 36 THESSALONIKI
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26370 Navarrete
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28006 Madrid
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17177 Stockholm
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16163 Genova
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2595 DA Den Haag
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75015 PARIS 15
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93571 Saint Denis La Plaine
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73010 Arnesano (Lecce)
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09007 Burgos
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49005 Angers
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15895 Ames A Coruna
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1000 Sofia
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
2274KB Voorburg
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
6167 RD Geleen
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
6129EL Urmond
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110 00 Praha
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78120 Rambouillet
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70013 Irakleio
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36030 Monte Di Malo
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8600 Dubendorf
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4051 Basel
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2800 Delemont
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