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NanoREG II SIGNED

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

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EC-Contrib. €

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Partnership

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Project "NanoREG II" data sheet

The following table provides information about the project.

Coordinator
INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS 

Organization address
address: Parc Technologique Alata
city: VERNEUIL EN HALATTE
postcode: 60550
website: www.ineris.fr

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country France [FR]
 Project website http://www.nanoreg2.eu
 Total cost 11˙933˙317 €
 EC max contribution 9˙995˙703 € (84%)
 Programme 1. H2020-EU.2.1.2.2. (Ensuring the safe and sustainable development and application of nanotechnologies)
2. H2020-EU.2.1.2.5. (Developing and standardisation of capacity-enhancing techniques, measuring methods and equipment)
 Code Call H2020-NMP-2014-two-stage
 Funding Scheme RIA
 Starting year 2015
 Duration (year-month-day) from 2015-09-01   to  2019-02-28

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS FR (VERNEUIL EN HALATTE) coordinator 1˙358˙592.00
2    NANOTECHNOLOGY INDUSTRIES ASSOCIATION BE (BRUXELLES) participant 1˙042˙833.00
3    RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU NL (BILTHOVEN) participant 424˙548.00
4    INSTITUTE OF OCCUPATIONAL MEDICINE UK (EDINBURGH) participant 413˙711.00
5    FUNDACION GAIKER ES (ZAMUDIO) participant 405˙252.00
6    JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION BE (BRUSSELS) participant 350˙000.00
7    DET NATIONALE FORSKNINGSCENTER FORARBEJDSMILJO DK (KOBENHAVN) participant 344˙586.00
8    NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO NL (DEN HAAG) participant 344˙150.00
9    BUNDESINSTITUT FUER RISIKOBEWERTUNG DE (BERLIN) participant 322˙030.00
10    LEIBNIZ-INSTITUT FUER NEUE MATERIALIEN GEMEINNUETZIGE GMBH DE (SAARBRUECKEN) participant 320˙250.00
11    UNIVERSITEIT UTRECHT NL (UTRECHT) participant 316˙250.00
12    FONDAZIONE ISTITUTO ITALIANO DI TECNOLOGIA IT (GENOVA) participant 315˙000.00
13    ROUMEN TSANEV INSTITUTE OF MOLECULAR BIOLOGY BULGARIAN ACADEMY OF SCIENCES BG (SOFIA) participant 297˙050.00
14    NANOMAKERS FR (RAMBOUILLET) participant 262˙375.00
15    COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES FR (PARIS 15) participant 250˙515.00
16    KAROLINSKA INSTITUTET SE (STOCKHOLM) participant 239˙355.00
17    NORSK INSTITUTT FOR LUFTFORSKNING STIFTELSE NO (KJELLER) participant 210˙000.00
18    UNIWERSYTET GDANSKI PL (GDANSK) participant 200˙937.00
19    GRUPO ANTOLIN-INGENIERIA SA ES (BURGOS) participant 200˙443.00
20    CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS FR (PARIS) participant 200˙000.00
21    DSM MATERIALS SCIENCE CENTER BV NL (GELEEN) participant 200˙000.00
22    ECAMRICERT SRL IT (MONTE DI MALO) participant 180˙000.00
23    EUROPEAN VIRTUAL INSTITUTE FOR INTEGRATED RISK MANAGEMENT EU VRI EWIV DE (STUTTGART) participant 173˙000.00
24    ISTITUTO SUPERIORE DI SANITA IT (ROMA) participant 171˙522.00
25    ARISTOTELIO PANEPISTIMIO THESSALONIKIS EL (THESSALONIKI) participant 165˙250.00
26    IDEACONSULT LIMITED LIABILITY COMPANY BG (SOFIA) participant 163˙053.00
27    AVANZARE INNOVACION TECNOLOGICA SL ES (NAVARRETE) participant 159˙931.00
28    PINEXT BV NL (VOORBURG) participant 155˙000.00
29    INSTITUTUL DE CHIMIE FIZICA ILIE MURGULESCU RO (BUCHAREST) participant 125˙625.00
30    NANOGAP SUB-NM-POWDER SA ES (AMES A CORUNA) participant 120˙750.00
31    INSTITUTO NACIONAL DE INVESTIGACION Y TECNOLOGIA AGRARIA Y ALIMENTARIA OA MP ES (MADRID) participant 112˙500.00
32    HIQ-NANO SRL IT (Arnesano (Lecce)) participant 105˙000.00
33    NANOTECH PARTNER SRO CZ (PRAHA) participant 102˙000.00
34    ASSOCIATION FRANCAISE DE NORMALISATION FR (SAINT DENIS LA PLAINE) participant 99˙867.00
35    UNIVERSITE CATHOLIQUE DE L'OUEST ASSOCIATION SAINT YVES FR (ANGERS) participant 93˙947.00
36    IDRYMA TECHNOLOGIAS KAI EREVNAS EL (IRAKLEIO) participant 50˙375.00
37    DSM CHEMICAL TECHNOLOGY R & D BV NL (SITTARD) participant 0.00
38    EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT CH (DUBENDORF) participant 0.00
39    HAUTE ECOLE SPECIALISEE DE SUISSE OCCIDENTALE CH (DELEMONT) participant 0.00
40    NORDIC QUANTUM COMPUTING GROUP AS NO (OSLO) participant 0.00
41    TEMAS AG TECHNOLOGY AND MANAGEMENT SERVICES CH (OPFIKON) participant 0.00
42    UNIVERSITAT BASEL CH (BASEL) participant 0.00
43    VENETO NANOTECH SOCIETA CONSORTILEPER AZIONI IT (PADOVA) participant 0.00

Map

 Project 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.

 Deliverables

List of deliverables.
Report on integrated safety assessment framework Documents, reports 2020-04-01 18:41:06
Public version of D4.4 Documents, reports 2020-04-01 18:41:07
perspectives on how regulations can keep pace with innovation (paper) Documents, reports 2020-04-01 18:41:07
report on NanoReg2 - OECD conference on grouping Documents, reports 2020-04-01 18:41:07
Final comparative risk assessment for candidate materials after SbD implementation in “hot spots” along the life cycle Documents, reports 2020-04-01 18:41:06
Initial standardisation plan Documents, reports 2020-04-01 18:41:06
Final Report on the barriers (and addressing thereof) to the application of grouping and Safety-by-Design Concepts. Documents, reports 2020-04-01 18:41:06
Impact of the NANoREG II liaisons Documents, reports 2020-04-01 18:41:06
Training workshop Demonstrators, pilots, prototypes 2020-04-01 18:41:06
Final meeting Demonstrators, pilots, prototypes 2020-04-01 18:41:06
Document on outlook after TRL 5-6 and how it can be dealt within the Safe Innovation Approach Documents, reports 2020-04-01 18:41:06
Document on the feasibility to come to organized pre-regulatory safety dossiers Documents, reports 2020-04-01 18:41:06
Report on the defined ISA-TAB nano templates Documents, reports 2020-04-01 18:41:05
Database/structural model and report describing the relationships between functionality, physicochemical properties and hazard, and allowing for integration in the safe innovation approach Documents, reports 2020-04-01 18:41:03
Safe Innovations Guidance manual for decisions per gate Documents, reports 2020-04-01 18:41:03
Report on Validated grouping approach Documents, reports 2020-04-01 18:41:06
NANoREG II newsletter Websites, patent fillings, videos etc. 2020-04-01 18:41:03
Organisation of a Kick-Off Meeting (All Participants, EC) Demonstrators, pilots, prototypes 2020-04-01 18:41:05
NANoREG II website Websites, patent fillings, videos etc. 2020-04-01 18:41:05
Implementation manual of the Safe Innovations Approach for all users Documents, reports 2020-04-01 18:41:03
Report on existing Grouping Strategies (NANoREG, OECD, ECHA or others) and available datasets from other projects (e.g. NANoREG, NanoTEST, MARINA) State of the Art Analysis Documents, reports 2020-04-01 18:41:03
Final version of safe innovation approach, publication Documents, reports 2020-04-01 18:41:05
Report on Regulatory Needs for implementing grouping Documents, reports 2020-04-01 18:41:06
Organisation of General Assemblies (All participants) Demonstrators, pilots, prototypes 2020-04-01 18:41:03
Overview of barriers and possible solutions for implementation of the Safe Innovations Approach Documents, reports 2020-04-01 18:41:06
Document describing a blueprint for the creation of trusted environments per stage gate to share information among stakeholders/actors Documents, reports 2020-04-01 18:41:06
Guidance on the practical implementation of SbD in the nano-technology community Documents, reports 2020-04-01 18:41:02
Final Standardisation plan Documents, reports 2020-04-01 18:41:01
Progress review reports by industrial technical advisors on the overall progress of the project and on progress within each Workpackage, Delivery (before EC review) Documents, reports 2020-04-01 18:41:02
Report on PPPs Documents, reports 2020-04-01 18:41:02

Take a look to the deliverables list in detail:  detailed list of NanoREG II deliverables.

 Publications

year authors and title journal last update
List of publications.
2017 H. Moche, V. Paget, D. Chevalier, E. Lorge, N. Claude, H. A. Girard, J. C. Arnault, S. Chevillard, F. Nesslany
Carboxylated nanodiamonds can be used as negative reference in in vitro nanogenotoxicity studies
published pages: , ISSN: 0260-437X, DOI: 10.1002/jat.3443
Journal of Applied Toxicology 2020-04-01
2017 Andrew Collins, Naouale El Yamani, Maria Dusinska
Sensitive detection of DNA oxidation damage induced by nanomaterials
published pages: , ISSN: 0891-5849, DOI: 10.1016/j.freeradbiomed.2017.02.001
Free Radical Biology and Medicine 2020-04-01
2016 Naouale El Yamani, Andrew R. Collins, Elise Rundén-Pran, Lise Marie Fjellsbø, Sergey Shaposhnikov, Shanbeh Zielonddiny, Maria Dusinska
In vitro genotoxicity testing of four reference metal nanomaterials, titanium dioxide, zinc oxide, cerium oxide and silver: towards reliable hazard assessment
published pages: 117-126, ISSN: 0267-8357, DOI: 10.1093/mutage/gew060
Mutagenesis 32/1 2020-04-01
2017 Bozena Smolkova, Maria Dusinska, Alena Gabelova
Nanomedicine and epigenome. Possible health risks
published pages: 780-796, ISSN: 0278-6915, DOI: 10.1016/j.fct.2017.07.020
Food and Chemical Toxicology 109 2020-04-01
2018 A. Mech, K. Rasmussen, P. Jantunen, L. Aicher, M. Alessandrelli, U. Bernauer, E. A. J. Bleeker, J. Bouillard, P. Di Prospero Fanghella, R. Draisci, M. Dusinska, G. Encheva, G. Flament, A. Haase, Y. Handzhiyski, F. Herzberg, J. Huwyler, N. R. Jacobsen, V. Jeliazkov, N. Jeliazkova, P. Nymark, R. Grafström, A. G. Oomen, M. L. Polci, C. Riebeling, J. Sandström, B. Shivachev, S. Stateva, S. Tanasescu
Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation
published pages: 1-23, ISSN: 1743-5390, DOI: 10.1080/17435390.2018.1513092
Nanotoxicology September 2018 2020-04-01
2019 Vitalii Patsula, Jana Tulinska, Štěpánka Trachtová, Miroslava Kuricova, Aurelia Liskova, Alena Španová, Fedor Ciampor, Ivo Vavra, Bohuslav Rittich, Monika Ursinyova, Mária Dusinska, Silvia Ilavska, Mira Horvathova, Vlasta Masanova, Iveta Uhnakova, Daniel Horák
Toxicity evaluation of monodisperse PEGylated magnetic nanoparticles for nanomedicine
published pages: 1-17, ISSN: 1743-5390, DOI: 10.1080/17435390.2018.1555624
Nanotoxicology 2020-04-01
2017 C Micheletti, M Roman, E Tedesco, I Olivato, F Benetti
Implementation of the NANoREG Safe-by-Design approach for different nanomaterial applications
published pages: 12019, ISSN: 1742-6588, DOI: 10.1088/1742-6596/838/1/012019
Journal of Physics: Conference Series 838 2020-04-01
2017 Maria Dusinska, Jana Tulinska, Naouale El Yamani, Miroslava Kuricova, Aurelia Liskova, Eva Rollerova, Elise Rundén-Pran, Bozena Smolkova
Immunotoxicity, genotoxicity and epigenetic toxicity of nanomaterials: New strategies for toxicity testing?
published pages: 797-811, ISSN: 0278-6915, DOI: 10.1016/j.fct.2017.08.030
Food and Chemical Toxicology 109 2020-04-01
2018 Emily J. Guggenheim, Silvia Milani, Peter J.F. Röttgermann, Maria Dusinska, Christelle Saout, Anna Salvati, Joachim O. Rädler, Iseult Lynch
Refining in vitro models for nanomaterial exposure to cells and tissues
published pages: 121-142, ISSN: 2452-0748, DOI: 10.1016/j.impact.2018.02.008
NanoImpact 10 2020-04-01
2018 Beatrice Salieri, David A. Turner, Bernd Nowack, Roland Hischier
Life cycle assessment of manufactured nanomaterials: Where are we?
published pages: 108-120, ISSN: 2452-0748, DOI: 10.1016/j.impact.2017.12.003
NanoImpact 10 2020-04-01
2018 Annette Kraegeloh, Blanca Suarez-Merino, Teun Sluijters, Christian Micheletti
Implementation of Safe-by-Design for Nanomaterial Development and Safe Innovation: Why We Need a Comprehensive Approach
published pages: 239, ISSN: 2079-4991, DOI: 10.3390/nano8040239
Nanomaterials 8/4 2020-04-01
2017 V. Bakola, V. Karagkiozaki, F. Pappa, A.R. Tsiapla, E. Pavlidou, I. Moutsios, A.Laskarakis, S. Logothetidis
Drug Delivery Nanosystems for Cardiovascular Stents
published pages: 6869-6879, ISSN: 2214-7853, DOI: 10.1016/j.matpr.2017.07.016
Materials Today: Proceedings 4/7 2020-04-01
2018 Andrew Barrick, Catherine Mouneyrac, Nicolas Manier, Loïc De Lantivy, Nisrine Jrad, Amélie Châtel
Towards the development of a high throughput screening approach for Mytilus edulis hemocytes: A case study on silicon-based nanomaterials
published pages: 306-318, ISSN: 0141-1136, DOI: 10.1016/j.marenvres.2018.10.014
Marine Environmental Research 142 2020-04-01
2017 Andrew Barrick, Amélie Châtel, Mélanie Bruneau, Catherine Mouneyrac
The role of high-throughput screening in ecotoxicology and engineered nanomaterials
published pages: 1704-1714, ISSN: 0730-7268, DOI: 10.1002/etc.3811
Environmental Toxicology and Chemistry 36/7 2020-04-01
2019 Judit Kalman, César Merino, María L. Fernández-Cruz, José M. Navas
Usefulness of fish cell lines for the initial characterization of toxicity and cellular fate of graphene-related materials (carbon nanofibers and graphene oxide)
published pages: 347-358, ISSN: 0045-6535, DOI: 10.1016/j.chemosphere.2018.11.130
Chemosphere 218 2020-04-01
2019 Andrew Barrick, Nicolas Manier, Pierre Lonchambon, Emmanuel Flahaut, Nisrine Jrad, Catherine Mouneyrac, Amélie Châtel
Investigating a transcriptomic approach on marine mussel hemocytes exposed to carbon nanofibers: An in vitro/in vivo comparison
published pages: 19-28, ISSN: 0166-445X, DOI: 10.1016/j.aquatox.2018.11.020
Aquatic Toxicology 207 2020-04-01
2019 Beatrice Salieri, Roland Hischier, Joris T.K. Quik, Olivier Jolliet
Fate modelling of nanoparticle releases in LCA: An integrative approach towards “USEtox4Nano”
published pages: 701-712, ISSN: 0959-6526, DOI: 10.1016/j.jclepro.2018.09.187
Journal of Cleaner Production 206 2020-04-01
2016 Shareen H. Doak, Maria Dusinska
NanoGenotoxicology: present and the future
published pages: 1-4, ISSN: 0267-8357, DOI: 10.1093/mutage/gew066
Mutagenesis 32/1 2020-04-01

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The information about "NANOREG II" are provided by the European Opendata Portal: CORDIS opendata.

More projects from the same programme (H2020-EU.2.1.2.2.;H2020-EU.2.1.2.5.)

NanoREG II (2015)

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

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