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

Deliverables

Final Report on the barriers (and addressing thereof) to the application of grouping and Safety-by-Design Concepts.

Content: This report will provide an summary of the results from the workshops, the survey and case studies in terms of the barriers to implementation of the SbD concepts how these barriers have been or can be addressed. Impact: SbD concepts can only be successfully introduced if accepted by relevant stakeholders. Early identification of the barriers to implementing such concepts will be critical in the acceptance and ensure that the SbD concepts and tools and SOPs are realistic.

Database/structural model and report describing the relationships between functionality, physicochemical properties and hazard, and allowing for integration in the safe innovation approach

Content : This deliverable will describe the database model/structure that contains information on physicochemical characteristics and toxicity, and physicochemical characteristics and functionality on the other hand. The database will help to gain insight into physicochemical properties optimally leading to best achievable safety levels without compromising functionality. This deliverable will be made in relation with the production of Task 1.6 [D1.5 and D1.8] A first draft willbe deliver at M12, updated at M24 and final at M35.

Document on outlook after TRL 5-6 and how it can be dealt within the Safe Innovation Approach

Content : Prediction report carrying the results of implementing the Safe Innovation Approach to a new level beyond NANoREG and NANoREG II, examining the practical implementation after TRL 5 including recommendations and analysis.

Report on PPPs

Building on the agreement achieved in WP6, a report on PPPs is developed and finalised.

Report on the defined ISA-TAB nano templates

Content: Report Impact: Important for data sharing in particular in a regulatory accepted manner recurrent, (M12, M24, M36)

Report on Regulatory Needs for implementing grouping

Content: Report in the format of a careful review of the existing regulations in the various different sectors (e.g. REACH, biocide, cosmetic etc.). Impact: Ensure that the contents, which will be developed by NanoREG meet the regulatory requirements. This deliverable is PU as an extended consultation process would increase the acceptance.

Public version of D4.4

Public version of D4.4

Final comparative risk assessment for candidate materials after SbD implementation in “hot spots” along the life cycle

Content : Candidate materials will be further assessed after SbD concept implementation following RA rules. This exercise will reveal if SbD has covered gaps identified prior to SbD implementation.

Final version of safe innovation approach, publication

Content : This deliverable will describe the principles and ideas of the Nanoreg II Safe Innovations approach and the implementation of this approach including the steps to achieve this. As starting point for the implementation, the pivotal information to assess the risk potential of new nanomaterials, instruments and standard operational procedures will be proposed for each stage. Besides the implementation of the Safe Innovations approach, a blue print for the creation of trusted environments will presented. This will include a proposal for a pre-regulatory dossier addressing each stage of the industrial innovation process. It will be the final report on the Safe Innovations approach, delivered at the end of the project duration but with a yearly draft starting at M6.

Safe Innovations Guidance manual for decisions per gate

Content : A report describing an analysis of the (changing) role of various actors along the innovation chain and their potential incentives for interaction and information exchange at each stage. This analysis is needed to gain insight in the feasibility that the Safe-by-design approach will be implemented by various stakeholders. A first draft willbe deliver at M12, updated at M24 and final at M35.

Initial standardisation plan

the first version of the Standardisation plan (a report) is ready.

Guidance on the practical implementation of SbD in the nano-technology community

Content: This report will provide an overview of the SbD tools and SOPs developed based on the results of the case studies and other WPs. Impact: These tools and SOPs will provide an critical contribution to the overall acceptance of the SbD concepts.

Impact of the NANoREG II liaisons

Content: Value of the liaison, synergy potential identified and integrated, acceptance of NANoREG’s SAFE INNOVATION approach and Safe-by-Design concept and recommendations to improve the liaisons. Impact: Lessons learned and recommendations to improve the efficiency and collaboration between the liaison partners and NANoREG II. draft m12, update m24, final m36

report on NanoReg2 - OECD conference on grouping

A summary report on the conference with all presentations and a set of recommendations for grouping and its relationship to RA will be prepared. It will be presented as an official peer reviewed set of publications

Document on the feasibility to come to organized pre-regulatory safety dossiers

Content : Report in which the regulatory relevance of specific MNM data has been collated and sorted in such a manner that it can give a prediction of the feasibility of attaining pre-regulatory safety dossiers. It will present the feasibility study of an organized pre-regulatory safety dossier, which may be brought in line with REACH requirements. version at m18, revised and final m36

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

Content: Report on the existing grouping strategies based on ongoing activities in other projects (e.g. NanoREG I, Nanosolution, NanoMile or others) or from organizations like OECD, ECHA, ECETOC. This will be compiled as an state-of the art description. In parallel we will identify available datasets for developing grouping from other finished or nearly finished projects. Impact: This is the basis for our own work to be done in Task 1.4

Report on Validated grouping approach

Content: This work will be done in close collaboration with Task 1.4 (D1.6) and describe the validation of the grouping approaches. Impact: Highly important for regulatory acceptance (according to OECD criteria).

Final Standardisation plan

the final version of the standardisation plan is ready.

Overview of barriers and possible solutions for implementation of the Safe Innovations Approach

overview of the barriers to implementation of Safe by design, and list of potential solutions

Progress review reports by industrial technical advisors on the overall progress of the project and on progress within each Workpackage, Delivery (before EC review)

Progress review reports by industrial technical advisors on the overall progress of the project and on progress within each Workpackage, Delivery (before EC review)

perspectives on how regulations can keep pace with innovation (paper)

perspectives on how regulations can keep pace with innovation (paper)

Report on integrated safety assessment framework

Content : This deliverable will produce a set of conclusions derived from D2.2 and D2.3 on risk mitigation and management prior and after SbD applications.

Document describing a blueprint for the creation of trusted environments per stage gate to share information among stakeholders/actors

Content : Report in which an analysis of required conditions and organization to create an environment in which stakeholders can share information relevant for decision making, each from their point of view, in how to proceed with new nanomaterials. The report will contain a template or blueprint for each stage gate, describing identifiable boundaries and tolerances (including IP issues) which provide interested stakeholders and actors with incontrovertible data for decision making at each gate. draft m12, update m24 final m36

NANoREG II newsletter

NANoREG II regularly sends out a newsletters in electronic form to (a) people that sign up on the NANoREG II website to receive news, (b) NANoREG II liaison partners, and (c) any additional recipients deemed relevant. updates every 6 months from m6 to m36

NANoREG II website

the NANoREG II website will be launched

Final meeting

Organisation of the Final NANoREG II meeting (All participants, EC, invited speakers)

Training workshop

a training workshop is organised and held by INERIS.

Organisation of a Kick-Off Meeting (All Participants, EC)

A kick off meeting will be made at the starting of the project, based on a 2 days schedule, combining general assemblees and technical sessions.

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Publications

Implementation of Safe-by-Design for Nanomaterial Development and Safe Innovation: Why We Need a Comprehensive Approach

Author(s): Annette Kraegeloh, Blanca Suarez-Merino, Teun Sluijters, Christian Micheletti
Published in: Nanomaterials, Issue 8/4, 2018, Page(s) 239, ISSN 2079-4991
DOI: 10.3390/nano8040239

Nanomedicine and epigenome. Possible health risks

Author(s): Bozena Smolkova, Maria Dusinska, Alena Gabelova
Published in: Food and Chemical Toxicology, Issue 109, 2017, Page(s) 780-796, ISSN 0278-6915
DOI: 10.1016/j.fct.2017.07.020

Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation

Author(s): 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
Published in: Nanotoxicology, Issue September 2018, 2018, Page(s) 1-23, ISSN 1743-5390
DOI: 10.1080/17435390.2018.1513092

Immunotoxicity, genotoxicity and epigenetic toxicity of nanomaterials: New strategies for toxicity testing?

Author(s): Maria Dusinska, Jana Tulinska, Naouale El Yamani, Miroslava Kuricova, Aurelia Liskova, Eva Rollerova, Elise Rundén-Pran, Bozena Smolkova
Published in: Food and Chemical Toxicology, Issue 109, 2017, Page(s) 797-811, ISSN 0278-6915
DOI: 10.1016/j.fct.2017.08.030

Implementation of the NANoREG Safe-by-Design approach for different nanomaterial applications

Author(s): C Micheletti, M Roman, E Tedesco, I Olivato, F Benetti
Published in: Journal of Physics: Conference Series, Issue 838, 2017, Page(s) 012019, ISSN 1742-6588
DOI: 10.1088/1742-6596/838/1/012019

Fate modelling of nanoparticle releases in LCA: An integrative approach towards “USEtox4Nano”

Author(s): Beatrice Salieri, Roland Hischier, Joris T.K. Quik, Olivier Jolliet
Published in: Journal of Cleaner Production, Issue 206, 2019, Page(s) 701-712, ISSN 0959-6526
DOI: 10.1016/j.jclepro.2018.09.187

Investigating a transcriptomic approach on marine mussel hemocytes exposed to carbon nanofibers: An in vitro/in vivo comparison

Author(s): Andrew Barrick, Nicolas Manier, Pierre Lonchambon, Emmanuel Flahaut, Nisrine Jrad, Catherine Mouneyrac, Amélie Châtel
Published in: Aquatic Toxicology, Issue 207, 2019, Page(s) 19-28, ISSN 0166-445X
DOI: 10.1016/j.aquatox.2018.11.020

Life cycle assessment of manufactured nanomaterials: Where are we?

Author(s): Beatrice Salieri, David A. Turner, Bernd Nowack, Roland Hischier
Published in: NanoImpact, Issue 10, 2018, Page(s) 108-120, ISSN 2452-0748
DOI: 10.1016/j.impact.2017.12.003

Refining in vitro models for nanomaterial exposure to cells and tissues

Author(s): Emily J. Guggenheim, Silvia Milani, Peter J.F. Röttgermann, Maria Dusinska, Christelle Saout, Anna Salvati, Joachim O. Rädler, Iseult Lynch
Published in: NanoImpact, Issue 10, 2018, Page(s) 121-142, ISSN 2452-0748
DOI: 10.1016/j.impact.2018.02.008

Towards the development of a high throughput screening approach for Mytilus edulis hemocytes: A case study on silicon-based nanomaterials

Author(s): Andrew Barrick, Catherine Mouneyrac, Nicolas Manier, Loïc De Lantivy, Nisrine Jrad, Amélie Châtel
Published in: Marine Environmental Research, Issue 142, 2018, Page(s) 306-318, ISSN 0141-1136
DOI: 10.1016/j.marenvres.2018.10.014

The role of high-throughput screening in ecotoxicology and engineered nanomaterials

Author(s): Andrew Barrick, Amélie Châtel, Mélanie Bruneau, Catherine Mouneyrac
Published in: Environmental Toxicology and Chemistry, Issue 36/7, 2017, Page(s) 1704-1714, ISSN 0730-7268
DOI: 10.1002/etc.3811

Toxicity evaluation of monodisperse PEGylated magnetic nanoparticles for nanomedicine

Author(s): 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
Published in: Nanotoxicology, 2019, Page(s) 1-17, ISSN 1743-5390
DOI: 10.1080/17435390.2018.1555624

Usefulness of fish cell lines for the initial characterization of toxicity and cellular fate of graphene-related materials (carbon nanofibers and graphene oxide)

Author(s): Judit Kalman, César Merino, María L. Fernández-Cruz, José M. Navas
Published in: Chemosphere, Issue 218, 2019, Page(s) 347-358, ISSN 0045-6535
DOI: 10.1016/j.chemosphere.2018.11.130

Drug Delivery Nanosystems for Cardiovascular Stents

Author(s): V. Bakola, V. Karagkiozaki, F. Pappa, A.R. Tsiapla, E. Pavlidou, I. Moutsios, A.Laskarakis, S. Logothetidis
Published in: Materials Today: Proceedings, Issue 4/7, 2017, Page(s) 6869-6879, ISSN 2214-7853
DOI: 10.1016/j.matpr.2017.07.016

NanoGenotoxicology: present and the future

Author(s): Shareen H. Doak, Maria Dusinska
Published in: Mutagenesis, Issue 32/1, 2016, Page(s) 1-4, ISSN 0267-8357
DOI: 10.1093/mutage/gew066

Sensitive detection of DNA oxidation damage induced by nanomaterials

Author(s): Andrew Collins, Naouale El Yamani, Maria Dusinska
Published in: Free Radical Biology and Medicine, 2017, ISSN 0891-5849
DOI: 10.1016/j.freeradbiomed.2017.02.001

In vitro genotoxicity testing of four reference metal nanomaterials, titanium dioxide, zinc oxide, cerium oxide and silver: towards reliable hazard assessment

Author(s): Naouale El Yamani, Andrew R. Collins, Elise Rundén-Pran, Lise Marie Fjellsbø, Sergey Shaposhnikov, Shanbeh Zielonddiny, Maria Dusinska
Published in: Mutagenesis, Issue 32/1, 2016, Page(s) 117-126, ISSN 0267-8357
DOI: 10.1093/mutage/gew060

In Vitro Approaches for Assessing the Genotoxicity of Nanomaterials

Author(s): Maria Dusinska, Espen Mariussen, Elise Rundén-Pran, Alexandra Misci Hudecova, Elisabeth Elje, Alena Kazimirova, Naouale El Yamani, Nils Dommershausen, Julian Tharmann, Dagmar Fieblinger, Frank Herzberg, Andreas Luch, Andrea Haase
Published in: Nanotoxicity - Methods and Protocols, Issue 1894, 2019, Page(s) 83-122
DOI: 10.1007/978-1-4939-8916-4_6

Chapter 6. Health Hazard and Risk Assessment of Nanoparticles Applied in Biomedicine

Author(s): Martina Drlickova, Bozena Smolkova, Elise Runden-Pran, Maria Dusinska
Published in: Nanotoxicology - Experimental and Computational Perspectives, 2017, Page(s) 151-173
DOI: 10.1039/9781782623922-00151