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Safe Implementation of Innovative Nanoscience and Nanotechnology

Final Report Summary - SIINN (Safe Implementation of Innovative Nanoscience and Nanotechnology)

Executive Summary:
ERA-NET SIINN “Safe Implementation of Innovative Nanotechnology and Nanoscience” was a-four-years-programme funded with 1.5 Mio. € under the European Commission’s ERA-NET scheme in the 7th Framework Programme. SIINN started in August 2011 with a duration of 3 years, was extended budget-neutral for an additional year in order to implement a 3rd transnational joint call including US-participation and finished successfully on 31th July 2015. SIINN brought together 19 funding and/or research management organizations from 14 countries responsible for research activities in the area of nanosafety and was coordinated by PtJ at Forschungszentrum Juelich (Germany). ERA-NET SIINN implemented three transnational joint calls with a total funding volume of about 13 Mio. €. The research themes covered knowledge gaps in the field of nanosafety which were selected based on thorough examination of the state of the art. In the 15 funded research projects, more than 60 partners are performing research on specific aspects of characterization methods, exposure, and human and environmental impact of manufactured nanomaterials (MNM).

SIINN supported the networking and community building among national, European and international stakeholders active in management and governance of nanosafety and nanorisk research work. A dedicated data bank in the IUCLID system at the Joint Research Centre of the European Commission has been created for storing relevant data from the projects and validated data from other sources. The participation of three US funding agencies in the 3rd SIINN call has contributed to strengthening of the international community.

By bringing together national and regional resources of 19 partners from 14 European countries and regions, SIINN supported the creation of a sustainable, coordinated, transnational programme of N&N-related RTD work across Europe which is utilising synergies of the national or regional programmes and the genuine desire of their owners to cooperate. Thus, in addition to strengthening the European Research Area itself, SIINN has created an effective network of ministries, funding agencies and academic and industrial institutions active in the N&N fields and in addition expanded the international basis for future transnational cooperations.

SIINN partners have performed an extensive research and validation effort regarding the definitions in the area of nanosafety, data availability, characterization methods and risk assessment. The results are summarized in a Consolidated Framework for EHS of Manufactured Nanomaterials which is a focused presentation of the current state of the art in this area. Further, roadmaps treating future directions of nanosafety research identified the desired efforts on short, medium and long term.

SIINN has disseminated the results in a large number of presentations, articles and other communications using also adequate EU circles like the NanoSafetyCluster. The sustainability of the activities is supported by the transfer of important parts of the knowledge towards the EU-funded Coordinating and Supporting Action ProSafe, where also some of the SIINN partners are participating.

Project Context and Objectives:
Project context

The young field of nanosafety research is very wide and multidisciplinary. It requires a cooperation of many different research disciplines, and an international state-of-the-art technology has to be still established in some of the areas. Because of the complexities of nanomaterial containing systems, however, where the physical and biological impacts of these nanomaterials are highly dependent upon the systems themselves, the problem of the reliability of current physical and biological data for nanomaterials is both real and large. The large number of studies investigating engineered nanomaterials and their effects on the human health and environment also poses problems in terms of data management and reliability.

At the start of the project, national activities in Europe on aspects of environmental and health safety (EHS) for Nanoscience and Nanotechnology (N&N) were largely uncoordinated and fragmented, resulting in sub-optimal use of resources devoted to this subject. Furthermore, the data used for EHS assessments world-wide are often based on toxicological studies of nanomaterials which are to a certain degree unreliable or even contradictory; the data is in many cases gathered for nano-systems which are either ill-defined or not clearly defined.

The diversity and availability of commercial products containing nanomaterials is increasing rapidly, but one important question, the potential risks of MNMs for the environment and human health and safety, remains a substantial barrier to their wide innovative use. The aim of the ERA-NET SIINN is to help create an optimal environment within Europe with which to promote the safe and rapid transfer of innovative N&N research and development into industrial application.
A considerable part of its focus was to remedy the unsatisfactory situation described above. Efforts were put on obtaining sound data for MNMs for nanosafety and EHS risk assessment and management.

Originally, the ERA-NET aimed to publish and handle two joint calls for proposals which were launched in March 2012 and October 2013 respectively. The overall funding for the first call was 2.3 Mio. € provided by funding agencies cooperating in SIINN, and for the second call 4.4 Mio. €. As a result of their success, it was decided to publish a third call, which was launched in October 2014, resulting in 7 projects, funded with about 6 million EUR. The third call included participation of three US funding agencies contributing in total 2 Mio. USD funding. On the three calls participated altogether 432 research teams from 16 countries and regions, which submitted 89 joint project proposals. Most proposals were attracted by the topics concerned with effects on human health and environmental impacts of MNM.

Another focus of ERA-NET SIINN went beyond what is typical for ERA-NETs. Activities were performed, which covered systematically the terms and definitions and measurements and characterization techniques. Knowledge gaps were analysed which lead to formulation of the themes for the joint calls. SIINN identified the needs for future research activities which have been formulated in roadmaps for short- middle and long-term research activities. All these results of the performed works are well documented in several premium deliverables which were updated during the duration of SIINN.

The broad spectrum of knowledge generated by SIINN has been made available to other interested parties, for which numerous dissemination channels have been opened.

SIINN’s activities included a growing cooperation with various national and international networks, organisations and groupings, including the NanoSafety Cluster, the QualityNano infrastructure, the OECD Working Party on Nanomaterials (WPNM), and the NANOfutures ETIP. Moreover, inputs from SIINN will contribute substantially to the successful operation of the upcoming activities of the EU funded ProSafe CSA aiming at increasing the safety of industrial processes employing nanomaterials.

Objectives

The overarching objective of SIINN has been the creation of a network of national and regional stakeholders in the domain of nanosafety research in Europe for joint discussion of priorities and preparation of actions to realize the necessary measures.

SIINN had two complementary main objectives:

• To implement a sustainable, coordinated, transnational programme of N&N-related RTD work for nanosafety across Europe and beyond, starting with nanotoxicology and EHS risk assessment and management.
• To establish a nanosafety framework for the rapid take-up of N&N research for facilitating the design and manufacturing of the next-generation, high value-added products.

Europe maintains a strong nanotechnology research base, heavily supported by public funding at both European Union and national levels. The transnational cooperative projects supported by SIINN-partners present the initial steps towards joint RTD programmes oriented towards nanosafety of engineered nanomaterials to be developed between the EU Member States and States associated to HORIZON 2020. In the mid-to-long term, due to global dimension of use of products based on MNM joint activities on this field with key countries outside of Europe e.g. the USA should be intensified. The agreement on 3rd SIINN call presents one of the first contributions.

In order to reach the second objective, screening of the available knowledge and identification of the apparent knowledge gaps between the development of N&N and our understanding of how manufactured nanomaterials interact with the environment and the human body were performed. For this task, the SIINN ERA-NET built on joint, transnational cooperation at governmental or regional level within Europe. The joint formulation of recommendations for future research activities aimed on the short term at the determination of topics for joint transnational calls, and on medium-to-long term to establishing of roadmaps giving directions for future research actions. Finally, SIINN presented in June 2015 the“Consolidated framework for EHS of Manufactured Nanomaterials”.
Project Results:
The effort of SIINN ERA-NET was first focused on creating effective programmatic and governance structures permitting performance of joint calls for international research projects. S&T work is of course necessary to prepare a well-founded basis for the formulation of the calls and create a joint platform of knowledge. The six Work Packages (WP) of SIINN have reached the following major results:

Within Work Package 1, important criteria and terms in the area of nanomaterial characterization and toxicology were defined based on an extensive literature search, and a glossary of more than 100 pages summarizes and evaluates the current status of the knowledge. The health and safety relevant information which is currently available within Europe was examined. Based on the analysis of this information, WP1 identified important knowledge gaps with respect to the occurrence and toxicity of manufactured nanomaterials. These provided the basis for formulation of the topics of the three SIINN transnational calls.

Within Work Package 2, an inventory of directed liaisons, initiatives and actions with respect to the national activities of the SIINN partner countries and regions was accomplished. This was necessary to clarify the responsible actors and identify the right openings for conception of calls and involvement of responsible actors. Contacts to the major international organizations active in the field N&N safety were established. The common SIINN database platform makes use of the NANOhub/IUCLID data base of the Commission’s Joint Research Centre in Ispra. These data are compatible with the OECD Working Party on Manufactured Nanomaterials (WPMN) and use the OECD harmonized templates (OHTs). Verified data sets from the literature have been entered into the data base and more data sets are going to be integrated, in particular data stemming from the research projects funded by SIINN. This data base can serve as a tool to support programme owners and implementers in deciding on future research topics. It is made available to all interested stakeholders (government, industry, education, research, standardisation bodies) via the IUCLID data base of the JRC.

One of the biggest achievements of SIINN has been the development a consolidated framework for addressing and managing nanosafety issues. The Consolidated Framework for EHS of manufactured nanomaterials which includes contributions from numerous experts has been first made available to the projects funded by SIINN. It addresses nano-related risks and the management of these risks for humans and the environment by investigating the toxicological behaviour of MNMs. It presents to the reader in a condensed and accessible form a gateway to basic information and definitions for nanomaterials, the identification of best practices, synergy potentials and the elaboration of recommendations for future collaborations on the strategic and operational level addressing MNM EHS. This includes precautionary measures, pre-normative work, steps towards regulations as well as common actions and projects. The finalized version of the Consolidated Framework has been presented during the EuroNanoForum 2015 and is available on the SIINN web-page www.siinn.eu.

Another important output of SIINN are “Roadmaps for the safe handling of nano-objects, safe processes, safe products and safe transportation of nano products addressing identified gaps”. These roadmaps summarise and consolidate the inputs coming from the sources of information that have been used to build up the SIINN Roadmap: Nanosafety Cluster’s inputs (Grenoble workshop, Compendium 2012 , Compendium 2013 and Strategic Research Agenda) and the specific EU projects like ITS-NANO project, Research Strategy and Nanofutures Roadmap. Priorities and actions have been defined for short-term (up to 2015), medium-term (2015-2020) and long-term (2020-2025) nanosafety research and are accessible on the SIINN web-page as D2.7.

WP3 has prepared an inventory of existing characterisation methods for MNM available as deliverable D3.1 on the SIINN web-page. It contains an extensive overview of the techniques presently available to characterize nanoparticles’ properties, health effects and environmental impacts and a benchmarking of existing methods. Information was collected from scientific papers, peer-reviewed literature and internal documents. In addition, a survey was launched in order to compare the most useful characterization techniques and to validate the current techniques. The survey was extensively launched to European projects taking part in the NanoSafety Cluster, companies and RTO all over Europe. The validation of evidence-based risk assessment for human health has been successfully completed. A data collection with respect to the identification of gaps in evidence-based EHS risk assessment for human health and environmental safety (D3.3) contributed to formulation of topics for the 2nd and 3rd SIINN call. These extensive collections of publications have been evaluated and result in Inventory of Knowledge Gaps available as D3.6 on the SIINN web-page.

In the frame of WP4 three Joint Transnational Calls were prepared, including agreement on procedures and conditions, handling of the numerous proposals including international evaluation and follow-up of the projects. 89 proposals (with an increased number of projects from one call to another) were received involving 432 research teams from 16 countries or regions. In spite of strong marketing some important regions such as northern and eastern Europe (exception: Romania) have not joined the calls. Still also these regions can profit from the published SIINN results and are involved via the European networks in which SIINN is also active.

The research themes for the call have been first identified by the analysis of knowledge gaps performed in the ERA-NET, further the themes were brought to reflection to a specialists group and finally examined for compatibility with the priorities of the national and the EU research. As a result the following five topics have been identified and in more detail specified in the respective call documents:

• Overarching aspects of Nanosafety research: methods for the understanding and prediction of the importance of intrinsic and extrinsic properties of MNMs for their interaction with surrounding matrices;
• Establishment and development of models and methods for analytical tools, theoretical prediction, and characterization;
• Exposure assessment;
• Studies on impacts of MNMs on environment;
• Studies on properties and effects of MNMs on human health.

The evaluation of the projects was carried out by international experts followed by a funding decision by the Call Committee formed by the SIINN partners who contributed to the call. The final budget of each funded project partner was negotiated and provided for by the relevant national funding agency. The EU funds the extra costs for the coordination of the joint activities of the national and regional funding organizations. The first call resulted in three funded projects, the second one in five projects and the third one in 7 projects.

The awarded proposals of the 1st Call (NanoIndex, Nanoheter and NanOxiMet) addressed the assessment of Individual Exposure, exposure focusing MNM’s fate in surface water and prediction metrics for nanomaterials.
The Second Call for proposals in SIINN was launched during the EuroNanoForum conference in Dublin (18th June 2013). The funded proposals cover a wide spectrum of themes, some of them with strong industrial relevance:

• NanoToxClass: “Establishing nanomaterial grouping/classification strategies according to toxicity and biological effects for supporting risk assessment”
• FENOMENO: "Fate and effect of wastewater-borne manufactured nanomaterials in aquatic ecosystems“
• PLATOX: “In vitro and in vivo investigations to generate validated toxicity data of graphene nanoplatelets vs. a carbon black reference”
• NANO_SAFE_LEATHER: “The effect on human health of Ag/TiO2 NM-treated leathers for footwear industry”
• NanoGeCo: “Nanoparticle generation by atomization processes in spray coating”

And finally, for the Third Call the following research themes have been selected:
• Exposure assessment
• Toxicity mechanisms
• Effects of MNMs on human health
• Environmental impacts of MNMs

The procedures for concluding of the funding contracts of the projects resulting from the 3rd call will be finalized in winter 2015/2016, with probably 7 projects with 35 partners from 8 countries. Therefore no exact final indications about the funded projects can be given at the moment of writing this report.

WP5 has investigated the most effective ways of communication and supported strongly the dissemination of the SIINN results. Most important medium has been the SIINN web-page, but also dissemination via numerous publications and lectures has been performed. Important steps to assure the continuation and sustainability of the SIINN network have been undertaken. Several SIINN partners have participated in the preparation of the proposal “Pro-Safe” for Coordinating and Support Activity in call NMP-27 2014. This project started the operation on February 2015. A large amount of relevant knowledge of SIINN will be transferred from SIINN to ProSafe.

WP6 concentrated on management. Most visible results were the realization of the Fast Track procedure for the 1st Call published only 8 months after the start of the ERA-NET-project. Further major issue has been the initiation and realization of the participation of three US funding agencies in the third SIINN call with a contribution of 2 Mio. USD. This is of particular importance in the area of N&N research, where formulation of global standards and validated data and processes are of high importance.

Potential Impact:
The commercial application of products containing nanomaterials is increasing rapidly, but one important question, the potential risks of MNMs for the environment and human health and safety (EHS), remains a substantial barrier to their wide innovative use. National research activities in Europe in N&N EHS remain largely fragmented, resulting in the sub-optimal use of available resources, such as human resources, research funding and research infrastructures.

The ERA-NET SIINN contributed to numerous improvements and synergies in the field of safety of MNMs. They include:
• Strengthening of the European Research Area in nanoscience and nanotechnology;
• Decrease in RTD fragmentation and improvement in the coordination and exploitation of synergies between the owners of national funding programmes. Within SIINN, three joint transnational calls were implemented. The SIINN funded high-quality projects complement to FP7 and H2020 funded projects by covering various expertise areas which are not addressed in those calls. Funded projects of ERA-NETs have the possibility to be more specific and to go more into depth due to the framework set by the Call partners of the ERA-NETs.
• The SIINN funded projects will generate among other things set of data which could allow defining reliable guidelines for the development of legal frameworks (e.g. precautionary measures and steps towards regulations) in order to increase safety and reduce risks through all stages of a product’s life-cycle.
• The efficient identification of knowledge gaps from this data set, helping to clearly and efficiently specify goals for current and future transnational research programmes in the area of N&N safety and security;
• Efficient use and leverage of resources (such as knowledge, capital and investment at European level) through common calls, thereby avoiding duplicity in projects (unless specifically required) and enhancing the common use of knowledge, capital and investment at European level;
• The findings generated in the SIINN projects can hopefully contribute in a later stage to activities which support and improve assessment and management of potential risks and thus helping in setting higher standards for the safety of MNMs.

Spin-off-effects resulting from SIINN activities include identification of needed improvements in the characterization methods for MNM in diverse media and environments, clarification of toxicity reactions mechanisms caused by the selected important types of nanoparticles, knowledge of transport mechanisms in the environment and also in the organisms.

The dissemination activities have been mostly oriented towards scientists and engineers active in the field of nanoresearch and nanotechnology, but also the general public has been addressed in printed media. The Article “Safety first” in September 2012 edition of Paneuropean Networks: Science and Technology or “Europäische Nano-Sicherheitsforschung” in the supplement of “Die Welt” on 8 March 2012 are examples.

The information directed to the scientific and technological community as a target group has been distributed via internet, in printed media and in lectures and workshops. The SIINN web-page has been intensively visited in particular after the publication of the calls, where about 5000 clicks have been registered for 2nd and 3rd call. Strong interest has been registered also for the items Projects and Results, and Partners.

Flyers were prepared and printed for each call, further a Roll-up-Screen for poster presentations. Partners have spread this material to target groups during conferences, road-show presentations, round tables at European and national/regional level.

The extensive presentations of SIINN and its status in the NanoSafety Cluster – Compendium 2012, 2013, 2014 and 2015 which is a central European source of currents activities in the area of nanosafety have made the information accessible to interested community.

• Numerous presentations at Conferences and Expert workshops have disseminated information targeted to specific groups of researchers active in the field of nanosafety. To name only a few contributions to the outreach of SIINN:
• Joint Workshop with NanoSafety Cluster organized by CEA in Grenoble End of May 2012,
• International Conference Nanotoxicology in September 2012 in Beijing,
• Conference on nanotoxicology in Prague organized by the QNano EU project end of February 2013,
• EuroNanoForum June 2013 in Dublin,
• US-EU Nano-Workshop in December 2013, Arlington, USA
• Common booth at the Industrial Technologies Conference 2014 in Athens (SIINN together with NANoREG, MERA.NET and MANUNET)
• Joint Workshop with NanoReg and ProSafe in connection with the EuroNanoForum in Riga on July 12 2015. Here the results of SIINN have been presented including also the first results of the projects of the first SIINN call.

List of Websites:
http://www.siinn.eu

Dr Show-Ling Lee-Müller
Coordinator of ERA-NET SIINN
Project Management Jülich (PtJ)
Forschungszentrum Jülich GmbH
D-52425 Jülich
Germany

Phone: + 49 2461 61 4471
Fax: + 49 2461 61 2398
E-Mail: s.l.lee-mueller@fz-juelich.de
Web: www.siinn.eu


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