The CSA links different initiatives and facilitates the integration of results from these initiatives, so that a maximum use of these results can benefit the regulatory process. The CSA is designed to facilitate this process and show European leadership on chemical safety, including nano’s. The aim of this activity is to coordinate and support for risk assessment, management and governance by streamlining data acquisition, collection and management on regulatory orientated toxicology testing of nanomaterials, exposure monitoring, LCA, and disposal and treatment of waste nanomaterials. A number of topics were not included in NANoREG, as they fell outside the scope of that call. The principles enshrined in NANoREG will through PROSAFE be transferred to as many other member states and non-EU states as possible. Nano-safety can be considered to improve significantly when Safe by Design is internationally accepted to guarantee safety. But it lacks agreed definitions, guarantees, and therefore confidence for acceptance. PROSAFE will facilitate and promote the acceptance of Safe by Design within the EU-COM, its Member and Associated states. Consideration is given to regulatory developments including challenges raised by the convergence between nano and biotechnologies. To prepare for the future, after decades of playing EHS catch-up on innovations that became major environmental hazards like lead, asbestos, PCB’s, a shift is needed towards a proactive approach of demonstrating safety and sustainability in pre-commercial innovation. Priorities are: •Move from generalized discussions to case specific differences •Improve characterization of nanomaterials and require reporting on their use •Increase funding for research on ecotoxicology and environmental fate and behaviour •Use value chains assessments when considering environmental impacts •Commit to environmentally sustainable and socially robust innovation.

This proposal describes the third core project of the Graphene Flagship. It forms the fourth phase of the FET flagship and is characterized by a continued transition towards higher technology readiness levels, without jeopardizing our strong commitment to fundamental research. Compared to the second core project, this phase includes a substantial increase in the market-motivated technological spearhead projects, which account for about 30% of the overall budget. The broader fundamental and applied research themes are pursued by 15 work packages and supported by four work packages on innovation, industrialization, dissemination and management. The consortium that is involved in this project includes over 150 academic and industrial partners in over 20 European countries.

This proposal describes the third stage of the EC-funded part of the Graphene Flagship. It builds upon the results achieved in the ramp-up phase (2013 - 2016) and the first core project (2016 - 2018), and covers the period April 2018 - March 2020. The progress of the flagship follows the general plans set out in the Framework Partnership Agreement, and the second core project represents an additional step towards higher technology and manufacturing readiness levels. The Flagship is built upon the concept of value chains, one of which is along the axis of materials-components-systems; the ramp-up phase placed substantial resources on the development of materials production technologies, the first core project moved to emphasise components, and the second core project will move further towards integrating components in larger systems. This evolution is manifested, e.g., in the introduction of six market-motivated spearhead projects during the Core 2 project.

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.