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Development and implementation of Grouping and Safe-by-Design approaches within regulatory frameworks

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the well-known principle of the half-life of facts (Samuel Arbesman, 2012) means that what is an accepted truth now is no longer valid in 20 or 30 years time.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.

Call for proposal

H2020-NMP-2014-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS
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Parc Technologique Alata
60550 Verneuil En Halatte
France
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Research Organisations
EU contribution
€ 1 358 592,50

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EUROPEAN RISK & RESILIENCE INSTITUTE (EU-VRI) EWIV
Germany
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€ 173 000
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Fangelsbachstrasse 14
70178 Stuttgart
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NANOTECHNOLOGY INDUSTRIES ASSOCIATION
Belgium
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Avenue De Tervueren 143
1150 Bruxelles
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TEMAS AG TECHNOLOGY AND MANAGEMENT SERVICES
Switzerland
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€ 0
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Alpenstrasse 3
8152 Opfikon
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BUNDESINSTITUT FUER RISIKOBEWERTUNG
Germany
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€ 322 030
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Max Dohrn Strasse 8-10
10589 Berlin
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Research Organisations
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
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€ 424 548,75
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Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
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DET NATIONALE FORSKNINGSCENTER FORARBEJDSMILJO
Denmark
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Lerso Parkalle 105
2100 Kobenhavn
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FUNDACION GAIKER
Spain
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Parque Tecnologico De Vizcaya, Edificio 202
48170 Zamudio
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ISTITUTO SUPERIORE DI SANITA
Italy
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Viale Regina Elena 299
00161 Roma
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UNIVERSITEIT UTRECHT
Netherlands
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Heidelberglaan 8
3584 CS Utrecht
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UNIWERSYTET GDANSKI
Poland
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Ul. Bazynskiego 8
80309 Gdansk
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INSTITUTE OF OCCUPATIONAL MEDICINE
United Kingdom
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€ 413 711,25
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Research Avenue North, Riccarton 45
EH14 4AP Edinburgh
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LEIBNIZ-INSTITUT FUER NEUE MATERIALIEN GEMEINNUETZIGE GMBH
Germany
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Campus D2 2
66123 Saarbruecken
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JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Belgium
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Rue De La Loi 200
1049 Brussels
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NORDIC QUANTUM COMPUTING GROUP AS

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Norway
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Oslo Innovation Center
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NILU STIFTELSEN NORSK INSTITUTT FORLUFTFORSKNING
Norway
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Instituttveien 18
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VENETO NANOTECH SOCIETA CONSORTILEPER AZIONI

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Italy
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Piazza Salvemini 13
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CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
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Rue Michel Ange 3
75794 Paris
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INSTITUTUL DE CHIMIE FIZICA ILIE MURGULESCU
Romania
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ROUMEN TSANEV INSTITUTE OF MOLECULAR BIOLOGY BULGARIAN ACADEMY OF SCIENCES
Bulgaria
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Acad G. Bonchev 21
1113 Sofia
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Greece
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€ 165 250
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Kedea Building, Tritis Septemvriou, Aristotle Univ Campus
54636 Thessaloniki
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Carretera De La Coruna Km7.5
28040 Madrid
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KAROLINSKA INSTITUTET
Sweden
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Nobels Vag 5
17177 Stockholm
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FONDAZIONE ISTITUTO ITALIANO DI TECNOLOGIA
Italy
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Via Morego 30
16163 Genova
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NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO
Netherlands
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Anna Van Buerenplein 1
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ASSOCIATION FRANCAISE DE NORMALISATION
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HIQ-NANO SRL
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Place Andre Leroy 3
49005 Angers
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NANOGAP SUB-NM-POWDER SA
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€ 120 750
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Rua Da Xesta Nave 78A2
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PINEXT BV
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