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Risk Governance of Nanotechnology

Objective

Engineered nanomaterials (ENMs) are covered by REACH/CLP regulations; the general opinion is that the risk assessment (RA) approach routinely used for conventional chemicals is also applicable to ENMs. However, as acknowledged by OECD and ECHA, the OECD and ISO Test Guidelines (TGs) and Standard Operating Procedures (SOPs) need to be verified and adapted to be applicable to ENMs. RiskGONE will support the standardization and validation process for ENM by evaluating, optimizing and pre-validating SOPs and TGs and integrating them into a framework for risk governance (RG) of ENMs. The framework will comprise modular tools and will rely heavily on current strategies for the RA of conventional chemicals, complemented by methods for estimating environmental, social and economic benefits. It will incorporate ethical aspects and societal risk perception and will manage acceptable and unacceptable risks through transfer or mitigation. The focus of RiskGONE will be to produce nano-specific draft guidance documents for application to ENM RA; or, alternatively, to suggest ameliorations to OECD, ECHA, and ISO/CEN SOPs or guidelines. Rather than producing assays and methods ex novo, this will be achieved through Round Robin exercises and multimodal testing of OECD TGs and ECHA methods supporting the “Malta-project”, and on methods not yet considered by OECD. This process will be accelerated by guidance documents for data storage/curation/accessibility optimisation, applied to well-characterized reference ENMs typifying the main physicochemical and toxicological features of ENMs. A transparent, self-sustained RG council, representing EU stakeholders, member states, industry and civil society, will be established. The RG framework and methods developed by RiskGONE will be transferred to the RG council, which will act as a science-based governance body for ENMs safety and provide responsible 2-way communication with stakeholders and civil society, based on high quality information.
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Coordinator

NORSK INSTITUTT FOR LUFTFORSKNING STIFTELSE

Address

Instituttveien 18
2027 Kjeller

Norway

Activity type

Research Organisations

EU Contribution

€ 861 616

Participants (22)

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LUXEMBOURG INSTITUTE OF SCIENCE AND TECHNOLOGY

Luxembourg

EU Contribution

€ 297 266,25

Institut za medicinska istrazivanja i medicinu rada

Croatia

EU Contribution

€ 99 440

AGENCIA ESTATAL CONSEJO SUPERIOR DEINVESTIGACIONES CIENTIFICAS

Spain

EU Contribution

€ 159 545

UNIVERSITETET I BERGEN

Norway

EU Contribution

€ 249 396,25

THE UNIVERSITY OF BIRMINGHAM

United Kingdom

EU Contribution

€ 303 125

SWANSEA UNIVERSITY

United Kingdom

EU Contribution

€ 295 557,50

QSAR LAB SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA

Poland

EU Contribution

€ 208 125

KATHOLIEKE UNIVERSITEIT LEUVEN

Belgium

EU Contribution

€ 238 855

UNIVERSITA CA' FOSCARI VENEZIA

Italy

EU Contribution

€ 180 435

FRAUNHOFER GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V.

Germany

EU Contribution

€ 219 427,50

EUROPEAN ENVIRONMENTAL CITIZENS ORGANISATION FOR STANDARDISATION

Belgium

EU Contribution

€ 151 500

IDEACONSULT LIMITED LIABILITY COMPANY

Bulgaria

EU Contribution

€ 198 131,25

FUNDACION CIDETEC

Spain

EU Contribution

€ 128 125

UNIVERSITEIT MAASTRICHT

Netherlands

EU Contribution

€ 221 270

NOVAMECHANICS LIMITED

Cyprus

EU Contribution

€ 277 500

MALSCH NEELINA

Netherlands

EU Contribution

€ 65 155

TRANSGERO LIMITED

Ireland

EU Contribution

€ 199 804

DECHEMA GESELLSCHAFT FUER CHEMISCHE TECHNIK UND BIOTECHNOLOGIE E.V.

Germany

EU Contribution

€ 179 375

IRAN NANOTECHNOLOGY INITIATIVE COUNCIL

Iran

EU Contribution

€ 51 350

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

United States

EU Contribution

€ 30 000

FACTOR SOCIAL - CONSULTORIA EM PSICO - SOCIOLOGIA E AMBIENTE LDA

Portugal

EU Contribution

€ 221 681,25

AGENCE NATIONALE DE LA SECURITE SANITAIRE DE L ALIMENTATION DE L ENVIRONNEMENT ET DU TRAVAIL

France

EU Contribution

€ 163 300

Project information

Grant agreement ID: 814425

Status

Ongoing project

  • Start date

    1 January 2019

  • End date

    28 February 2023

Funded under:

H2020-EU.2.1.3.

H2020-EU.2.1.2.

  • Overall budget:

    € 4 999 980

  • EU contribution

    € 4 999 980

Coordinated by:

NORSK INSTITUTT FOR LUFTFORSKNING STIFTELSE

Norway