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

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the well-known principle of the half-life of facts (Samuel Arbesman, 2012) means that what is an accepted truth now is no longer valid in 20 or 30 years time.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

INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS

Address

Parc Technologique Alata
60550 Verneuil En Halatte

France

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 358 592,50

Participants (42)

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EUROPEAN VIRTUAL INSTITUTE FOR INTEGRATED RISK MANAGEMENT EU VRI EWIV

Germany

EU Contribution

€ 173 000

NANOTECHNOLOGY INDUSTRIES ASSOCIATION

Belgium

EU Contribution

€ 1 042 833,75

TEMAS AG TECHNOLOGY AND MANAGEMENT SERVICES

Switzerland

BUNDESINSTITUT FUER RISIKOBEWERTUNG

Germany

EU Contribution

€ 322 030

RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU

Netherlands

EU Contribution

€ 424 548,75

DET NATIONALE FORSKNINGSCENTER FORARBEJDSMILJO

Denmark

EU Contribution

€ 344 586,25

FUNDACION GAIKER

Spain

EU Contribution

€ 405 252,50

ISTITUTO SUPERIORE DI SANITA

Italy

EU Contribution

€ 171 522,50

UNIVERSITEIT UTRECHT

Netherlands

EU Contribution

€ 316 250

UNIWERSYTET GDANSKI

Poland

EU Contribution

€ 200 937,50

INSTITUTE OF OCCUPATIONAL MEDICINE

United Kingdom

EU Contribution

€ 413 711,25

LEIBNIZ-INSTITUT FUER NEUE MATERIALIEN GEMEINNUETZIGE GMBH

Germany

EU Contribution

€ 320 250

JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION

Belgium

EU Contribution

€ 350 000

NORDIC QUANTUM COMPUTING GROUP AS

Norway

NORSK INSTITUTT FOR LUFTFORSKNING STIFTELSE

Norway

EU Contribution

€ 210 000

VENETO NANOTECH SOCIETA CONSORTILEPER AZIONI

Italy

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE CNRS

France

EU Contribution

€ 200 000

INSTITUTUL DE CHIMIE FIZICA ILIE MURGULESCU

Romania

EU Contribution

€ 125 625

ROUMEN TSANEV INSTITUTE OF MOLECULAR BIOLOGY BULGARIAN ACADEMY OF SCIENCES

Bulgaria

EU Contribution

€ 297 050

ARISTOTELIO PANEPISTIMIO THESSALONIKIS

Greece

EU Contribution

€ 165 250

AVANZARE INNOVACION TECNOLOGICA SL

Spain

EU Contribution

€ 159 931,25

INSTITUTO NACIONAL DE INVESTIGACION Y TECNOLOGIA AGRARIA Y ALIMENTARIA OA MP

Spain

EU Contribution

€ 112 500

KAROLINSKA INSTITUTET

Sweden

EU Contribution

€ 239 355

FONDAZIONE ISTITUTO ITALIANO DI TECNOLOGIA

Italy

EU Contribution

€ 315 000

NEDERLANDSE ORGANISATIE VOOR TOEGEPAST NATUURWETENSCHAPPELIJK ONDERZOEK TNO

Netherlands

EU Contribution

€ 344 150

COMMISSARIAT A L ENERGIE ATOMIQUE ET AUX ENERGIES ALTERNATIVES

France

EU Contribution

€ 250 515

ASSOCIATION FRANCAISE DE NORMALISATION

France

EU Contribution

€ 99 867,50

HIQ-NANO SRL

Italy

EU Contribution

€ 105 000

GRUPO ANTOLIN-INGENIERIA SA

Spain

EU Contribution

€ 200 443,75

UNIVERSITE CATHOLIQUE DE L'OUEST ASSOCIATION SAINT YVES

France

EU Contribution

€ 93 947,50

NANOGAP SUB-NM-POWDER SA

Spain

EU Contribution

€ 120 750

IDEACONSULT LIMITED LIABILITY COMPANY

Bulgaria

EU Contribution

€ 163 053,75

PINEXT BV

Netherlands

EU Contribution

€ 155 000

DSM CHEMICAL TECHNOLOGY R & D BV

Netherlands

DSM MATERIALS SCIENCE CENTER BV

Netherlands

EU Contribution

€ 200 000

NANOTECH PARTNER SRO

Czechia

EU Contribution

€ 102 000

NANOMAKERS

France

EU Contribution

€ 262 375

FOUNDATION FOR RESEARCH AND TECHNOLOGY HELLAS

Greece

EU Contribution

€ 50 375

ECAMRICERT SRL

Italy

EU Contribution

€ 180 000

EIDGENOSSISCHE MATERIALPRUFUNGS- UND FORSCHUNGSANSTALT

Switzerland

UNIVERSITAT BASEL

Switzerland

HAUTE ECOLE SPECIALISEE DE SUISSE OCCIDENTALE

Switzerland

Project information

Grant agreement ID: 646221

Status

Closed project

  • Start date

    1 September 2015

  • End date

    28 February 2019

Funded under:

H2020-EU.2.1.2.2.

H2020-EU.2.1.2.5.

  • Overall budget:

    € 11 933 317,52

  • EU contribution

    € 9 995 703,75

Coordinated by:

INSTITUT NATIONAL DE L ENVIRONNEMENT ET DES RISQUES INERIS

France