A common European approach to the regulatory testing of nanomaterials
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Objective
Based on questions and requirements supplied by regulators and legislators, NANoREG will: (i) provide answers and solutions from existing data, complemented with new knowledge, (ii) Provide a tool box of relevant instruments for risk assessment, characterisation, toxicity testing and exposure measurements of MNMs, (iii) develop, for the long term, new testing strategies adapted to innovation requirements, (iv) Establish a close collaboration among authorities, industry and science leading to efficient and practically applicable risk management approaches for MNMs and products containing MNMs.
The interdisciplinary approach involving the three main stakeholders (Regulation, Industry and Science) will significantly contribute to reducing the risks from MNMs in industrial and consumer products.
NANoREG starts by analysing existing knowledge (from WPMN-, FP- and other projects). This is combined with a synthesis of the needs of the authorities and new knowledge covering the identified gaps, used to fill the validated NANoREG tool box and data base, conform with ECHA's IUCLID DB structure.
To answer regulatory questions and needs NANoREG will set up the liaisons with the regulation and legislation authorities in the NANoREG partner countries, establish and intensify the liaisons with selected industries and new enterprises, and develop liaisons to global standardisation and regulation institutions in countries like USA, Canada, Australia, Japan, and Russia.
Field of Science
/social sciences/sociology/governance/crisis management
/engineering and technology/nanotechnology/nano-materials
/social sciences/economics and business/business and management/commerce
Programme(s)
Funding Scheme
CP-IP - Large-scale integrating project
Coordinator
MINISTERIE VAN INFRASTRUCTUUR EN WATERSTAAT
Address
Rijnstraat 8
2500 Ex Den Haag
Netherlands
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
EU Contribution
€ 1 206 202,67
Administrative Contact
Aart Dijkzeul (Mr.)
Participants (70)
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Belgium
EU Contribution
€ 147 000
BUNDESANSTALT FUER ARBEITSSCHUTZ UND ARBEITSMEDIZIN
Germany
EU Contribution
€ 461 561
DET NATIONALE FORSKNINGSCENTER FORARBEJDSMILJO
Denmark
EU Contribution
€ 292 188
RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
EU Contribution
€ 996 615,02
BUNDESINSTITUT FUER RISIKOBEWERTUNG
Germany
EU Contribution
€ 66 645
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS
France
EU Contribution
€ 122 987
AIT AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH
Austria
EU Contribution
€ 40 873
INSTITUTE OF OCCUPATIONAL MEDICINE
United Kingdom
EU Contribution
€ 51 236
TEMAS AG TECHNOLOGY AND MANAGEMENT SERVICES
Switzerland
EU Contribution
€ 511 632
FUNDACION GAIKER
Spain
EU Contribution
€ 230 213
NANOTECHNOLOGY INDUSTRIES ASSOCIATION
Belgium
EU Contribution
€ 200 000
BASF SE
Germany
EU Contribution
€ 300 000
THE PROVOST, FELLOWS, FOUNDATION SCHOLARS & THE OTHER MEMBERS OF BOARD OF THE COLLEGE OF THE HOLY & UNDIVIDED TRINITY OF QUEEN ELIZABETH NEAR DUBLIN
Ireland
EU Contribution
€ 451 504
KAROLINSKA INSTITUTET
Sweden
EU Contribution
€ 361 437
NORSK INSTITUTT FOR LUFTFORSKNING STIFTELSE
Norway
EU Contribution
€ 252 017
ISTITUTO SUPERIORE DI SANITA
Italy
EU Contribution
€ 267 201,67
AGENZIA NAZIONALE PER LE NUOVE TECNOLOGIE, L'ENERGIA E LO SVILUPPO ECONOMICO SOSTENIBILE
Italy
EU Contribution
€ 252 003
STATENS ARBEIDSMILJOINSTITUTT
Norway
EU Contribution
€ 94 473
ACONDICIONAMIENTO TARRASENSE ASSOCIACION
Spain
EU Contribution
€ 106 062
INSTITUT NATIONAL DE RECHERCHE ET DE SECURITE POUR LA PREVENTION DES ACCIDENTS DU TRAVAIL ET DES MALADIES PROFESSIONNELLES ASSOCIATION
France
EU Contribution
€ 184 400
UNIVERSITE DE NAMUR ASBL
Belgium
EU Contribution
€ 157 500
COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES
France
EU Contribution
€ 329 011
GEOCHEM RESEARCH BV
Netherlands
EU Contribution
€ 36 857,86
Department of Health
United Kingdom
EU Contribution
€ 48 300
CENTRUM VOOR ONDERZOEK IN DIERGENEESKUNDE EN AGROCHEMIE - CODA
Belgium
EU Contribution
€ 119 812
UNIVERSIDAD AUTONOMA DE BARCELONA
Spain
EU Contribution
€ 170 100
FONDAZIONE ISTITUTO ITALIANO DI TECNOLOGIA
Italy
EU Contribution
€ 210 288
ASOCIACION DE INVESTIGACION DE LAS INDUSTRIAS DE LA CONSTRUCCION
Spain
EU Contribution
€ 42 494
STICHTING WAGENINGEN RESEARCH
Netherlands
EU Contribution
€ 42 000
CONSIGLIO NAZIONALE DELLE RICERCHE
Italy
EU Contribution
€ 159 666,33
UNIVERSITE CATHOLIQUE DE L'OUEST ASSOCIATION SAINT YVES
France
EU Contribution
€ 53 201
NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO
Netherlands
EU Contribution
€ 34 711
INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS
France
EU Contribution
€ 95 903
AGENCE NATIONALE DE LA SECURITE SANITAIRE DE L ALIMENTATION DE L ENVIRONNEMENT ET DU TRAVAIL
France
EU Contribution
€ 103 361
BIONANONET FORSCHUNGSGESELLSCHAFT MBH
Austria
EU Contribution
€ 117 380
LUNDS UNIVERSITET
Sweden
EU Contribution
€ 71 400
GENOK - SENTER FOR BIOSIKKERHET
Norway
EU Contribution
€ 42 001
UNIVERSITETET I BERGEN
Norway
EU Contribution
€ 167 222
EIDGENOESSISCHES DEPARTEMENT DES INNERN
Switzerland
EU Contribution
€ 84 803
VENETO NANOTECH SOCIETA CONSORTILEPER AZIONI
Italy
EU Contribution
€ 145 722,45
INSTITUTO TECNOLOGICO DEL EMBALAJE, TRANSPORTE Y LOGISTICA
Spain
EU Contribution
€ 100 800
UNIVERSIDAD DE LLEIDA
Spain
EU Contribution
€ 62 986
STIFTELSEN SINTEF
Norway
EU Contribution
€ 83 987
UNIVERSITAET LEIPZIG
Germany
EU Contribution
€ 94 000
NPL MANAGEMENT LIMITED
United Kingdom
EU Contribution
€ 67 935
LABORATOIRE NATIONAL DE METROLOGIE ET D'ESSAIS
France
EU Contribution
€ 63 000
LABORATORIO IBERICO INTERNACIONAL DE NANOTECNOLOGIA
Portugal
EU Contribution
€ 41 978
TYOTERVEYSLAITOS
Finland
EU Contribution
€ 42 000
NORGES MILJO-OG BIOVITENSKAPLIGE UNIVERSITET
Norway
EU Contribution
€ 65 100
FUNDACION TEKNIKER
Spain
EU Contribution
€ 69 367
CHALMERS TEKNISKA HOEGSKOLA AB
Sweden
EU Contribution
€ 52 497
INSTITUTO DE SOLDADURA E QUALIDADE
Portugal
EU Contribution
€ 70 550
TURVALLISUUS JA KEMIKAALIVIRASTO
Finland
EU Contribution
€ 50 407
COVESTRO DEUTSCHLAND AG
Germany
ARKEMA FRANCE SA
France
STORA ENSO OYJ
Finland
UPM-KYMMENE OYJ
Finland
RISE RESEARCH INSTITUTES OF SWEDEN AB
Sweden
EU Contribution
€ 62 995
UNIVERSITY OF LEEDS
United Kingdom
ENVICAT CONSULTING SPRL
Belgium
EU Contribution
€ 65 260
COMET BIOTECH AS
Norway
EU Contribution
€ 36 890
INSTITUT PASTEUR DE LILLE FONDATION
France
EU Contribution
€ 17 504
HERIOT-WATT UNIVERSITY
United Kingdom
Public Health England an Executive Agency of the Dept of Health
United Kingdom
USTAV EXPERIMENTALNI MEDICINY AKADEMIE VED CESKE REPUBLIKY VEREJNA VYZKUMNA INSTITUCE
Czechia
EU Contribution
€ 16 000
VYSOKA SKOLA BANSKA - TECHNICKA UNIVERZITA OSTRAVA
Czechia
EU Contribution
€ 30 000
INSTITUTE OF PUBLIC HEALTH OSTRAVA
Czechia
EU Contribution
€ 4 000
IDRYMA TECHNOLOGIAS KAI EREVNAS
Greece
"NATIONAL CENTER FOR SCIENTIFIC RESEARCH ""DEMOKRITOS"""
Greece
ECAMRICERT SRL
Italy
EU Contribution
€ 74 760
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Unlocking the market potential of nanomaterials
Nanomaterials are full of possibility yet, because of ongoing concerns about their safety, rules and regulations have prevented them reaching their full potential. ‘The innovative and economic potential of Manufactured Nano Materials is threatened by a limited understanding of the related EHS (Environmental Health and Safety) issues,’ says NANOREG Project Manager Aart Dijkzeul. ‘While toxicity data is continuously becoming available, the relevance to regulators is often unclear or unproven, and the shrinking time to market of new materials makes the need for action by regulators increasingly urgent.’ To remedy this, Dijkzeul and his team of researchers provided regulators and legislators with a scientific evaluation of current data and testing methods. ‘By working hand-in-hand with global regulatory institutions, we successfully developed a toolbox for assessing the safety of nanomaterials,’ he says. Dispelling uncertainty Nanomaterials are chemical substances or materials that are manufactured at an incredibly small scale – down to 10 000 times smaller than the diameter of a human hair – and they are already being used in hundreds of products ranging from batteries and paint to anti-bacterial clothing and medical equipment. However, to capitalise on the full market potential of nanomaterials, their safety must be guaranteed. ‘This means dispelling any scientific uncertainty about their effects on either humans or the environment,’ says Dijkzeul. ‘As these nanomaterials are often unique and have never been on the market before, assessments must be done on a case-by-case basis using globally recognised and approved methods.’ A practical toolbox The project started by analysing existing knowledge and combining this with a study of the needs of regulatory authorities. This enabled researchers to identify knowledge gaps, including: characteristics that influence the risk of nanomaterials in the environment of humans; standardised methods to determine these characteristics; and nano-specific risk assessment strategies and approaches. From these three main gaps, 16 regulatory needs were generated. These then formed the basis for researchers to develop the next generation of reliable and comparable experimental data on the environmental, health and safety aspects of nanomaterials. ‘The very-practical NANOREG toolbox, which contains relevant instruments to aid risk assessment, toxicity testing and exposure measurements, is meant to help organisations involved in the standardisation and regulation of nanomaterials,’ says Dijkzeul. Getting nanomaterials to market In order to ensure closer collaboration between regulatory authorities, industry and researchers, the toolbox was created in close cooperation with the European Chemicals Agency (ECHA), the European Committee for Standardisation (CEN) and the International Organisation for Standardisation (ISO). The project also created an international network of global standardisation institutions in the US, Canada, Australia, Japan and Russia. ‘We see this cross-border interdisciplinary approach as being one of the project’s greatest legacies, one that will significantly contribute to removing risk from the use of nanomaterials in industrial and consumer products,’ adds Dijkzeul. Thanks to the work of NANOREG, the innovative and economic potential of nanomaterials will no longer be jeopardised simply because health and safety issues were not being fully addressed. ‘NANOREG has made it easier for regulatory and legislative bodies to do their jobs effectively based on scientific data and test protocols,’ concludes Dijkzeul. ‘Our more efficient risk management approaches ensure that the time it takes to get new nanomaterials to market will continue to shorten – with obvious benefits for consumers and manufacturers.
Keywords
NANOREG, nanomaterials, nanotechnology, REACH, EHS, ECHA
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Discover other articles in the same domain of application
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Final Report Summary - NANOREG (A common European approach to the regulatory testing of nanomaterials)
The R&D results of the project are impressive in terms of quantity and quality. Partners produced a large set of well-defined experimental nanoEHS data. This dataset is of great value in- and outside the project since the data on exposure and effects are linked to accurate physical-chemical data. These are required for meaningful QSAR approaches and in silico correlational studies regarding the toxicological mode of action of nanomaterials.
Numerous Standard Operation Protocols (SOPs) have been developed and tested regarding their reliability, reproducibility and relevance. Their status varies from “proof of concept” to “validated” by inter laboratory comparison. New insights have been developed regarding the importance of a standardized way of preparing dispersions, the need to characterize test media before and during experiments, the applicability of in vitro tests, the use of high throughput screening (HTS) and the importance of harmonized data reporting formats (ISA-TAB based), just to name a few. The results and knowledge acquired has been condensed in overarching deliverables such as the NANoREG Framework and accompanying NANoREG Toolbox providing, among others, a risk assessment (RA) scheme that supports a more cost-efficient RA of nanomaterials.
The NANoREG Framework (D1.11) provides a detailed overview of how the safety of NMs should be addressed / assessed in the context of the European REACH Regulation (Part I of the document). It also presents forward-looking strategies aiming at making safety assessment more practical and economically efficient (Part II).
The NANoREG Toolbox (D1.12) supports the implementation of the NANoREG Framework by providing an overview of test methods, datasets, models etc., applicable in a regulatory context. Just like the Framework, it will be a building block for the ProSafe White Paper.
All results together have been translated into Answers on the Regulatory Questions that formed the demand side of the project (D1.09).
To be able to combine and compare experimental data, a set of core nanomaterials was selected that all partners had to use. A web ordering system provided partners with the core nanomaterials from known selected suppliers (D2.01).
For all NANoREG materials, a state-of-the-art physico-chemical characterization was done with the aim to cover as many of the key endpoints of the OECD WPMN sponsorship program as technically and practically possible (D2.02). Dispersion SOPs and minimum requirements for characterization for toxicological studies were established and laid down in a Guidance Document, thus supporting reliability and comparability of data. It was mandatory for the partners to perform their experiments in accordance with the Guidance Document. During the course of the project, those fundamental requirements were further refined.
A policy for NANoREG data management was established comprising a standardized way of data logging, mandatory uploading of data to the NANoREG data platform and opening up the data at the end of the project. This dataset is now available to- and exploitable by the nanosafety community.
The NANoREG consortium has proven that it is feasible to come to a concerted action regarding the materials to be tested, test methods and cell lines to be applied, quality checks, etc. Such concerted action is an absolute must for generating meaningful data. The project also has proven that the basic willingness of partners to collaborate can be used to come to an agreement (possibly for the first time) to make data and deliverables publically available. This makes it possible for other projects to build on the results of NANoREG. In this context, it can be noted that NanoReg2 and caLIBRAte will further elaborate on the data generated in the project. It would be a major step forward if other nanosafety projects would copy the example NANoREG has set, with respect to opening up the results. All NANoREG results are available in the NANoREG Results Repository.
For an extensive description of the NANoREG project and its results, see the NANoREG Final Report Part 1.
Project Context and Objectives:
For a description of the project context and the main objectives see section 2.1 'Project context and objectives' of the NANoREG Final Report Part 1.
Project Results:
For a description of the project main S & T results / foregrounds see Chapter 3 'Project achievements and management' of the NANoREG Final Report Part 1.
Potential Impact:
For a description of the impact of the roject on a general level see section 2.2.5 Expected results and their impact of the NANoREG Final Report Part 1.
On a work package level, a description of impact has been included in Chapter 3 of the NANoREG Final Report Part 1.
For an evaluation and update of the impact chapter of the DoW, see NANoREG Final Report Part 2 Annex 1. Final Report Part 2 is available via CIRCABC, Annex 1 is available in the attached document.
List of Websites:
www.nanoreg.eu with a hyperlink to the NANoREG Results Repository
a list of collaboration partners has been included in the NANoREG Final Report Part 1.
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Deliverables
Deliverables not available
Publications
Datasets
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
News
Project information
NANOREG
Grant agreement ID: 310584
Status
Closed project
-
Start date
1 March 2013
-
End date
28 February 2017
Funded under:
FP7-NMP
-
Overall budget:
€ 49 586 318,23
-
EU contribution
€ 10 000 000
