NanoReg2 activities are broken into seven work packages covering activities ranging from building regulatory capacity to disseminating project results. Work packages 1-4 are the backbone of the project, however, all seven work packages are interlinked and will build off the activities of each other to help NanoReg2 achieve its overall goals.
Links between NanoReg2 Work Packages
Work Packages 1-4 form the backbone of NanoReg2
WP1 - Regulatory orientated activities establishing a framework of grouping approaches
Regulatory orientated activities establishing a framework of grouping approaches will:
- identify, define and harmonize current and prospective regulatory requirements and needs for MNM risk assessment, in order to implement grouping approaches and SbD. Information requirements in different regulatory frameworks such as REACH, biocides and pesticides regulations, cosmetics directive and SCCS, and feed and food regulations will be reviewed.
- develop and apply grouping concepts for MNM and ultimately provide tools applicable for regulatory purposes. First grouping concepts from different sources will be compiled and reviewed. Through co-operations and partner’s contributions, information on data management, testing protocols and MNM characterization will be shared and grouping criteria and concepts will be defined, taking also into account regulatory needs including Analyses of Alternatives and Socio-Economic Analysis. A minimum number of tests will be performed only if important data gaps need to be addressed. Grouping criteria will be verified using various datasets, including those collected and made available to the project by industry.
- combine grouping concepts with other non-testing concepts such as Read-across and QSARs or QSPRs under development in several on-going projects or European initiatives. Then to associate these non-testing concepts with already existing testing concepts like High Throughputs screening, In-vitro models and in-vivo short term assays. All these testing and non-testing concepts will be associated in a general principle named as an Intelligent non-Testing and testing Strategy (ITS).
- build on a data management on well-established expertise developed in NANoREG and the ISA-TAB-Nano template approach.
WP2 - Nanomaterials for industrial markets and their corresponding value chains
Work Package 2, Nanomaterials for industrial markets and their corresponding value chains, will:
- identify and select existing and new materials as candidates for value chain demonstrators in collaboration with WP1, WP3 and WP4. For each of the selected existing and new nanomaterials, develop life cycle maps, identifying existing and potential exposure scenarios.
- develop where possible a structured approach allowing grouping approaches of similar release and exposure scenarios, taking into account the nanomaterial, the product, and the process and environmental conditions.
- evaluate any relative change in environmental and human health risk following process of Safe-by-design (for production process safety and product safety) and carry out risk profiles of selected materials and / or products before and after application of SbD approaches in the case studies, aiming to evaluate the impact of the SbD applied on the product and/or production process in terms of (potential) health and environmental risk and then to estimate any residual risk following SbD and recommend any additional risk mitigation/management measures.
WP3 - Safe by Design
The general aim of this WP is to define a system of tools, guidance and checklists – which in its coherence is referred to as the safe innovation approach - to be used by various actors along innovation chains, supporting improved dealing with new safety issues of innovative nanomaterials and products on one hand but also supporting improved regulatory preparedness on the other hand. The safe innovation approach envisages to be a future proof approach, able to deal with upcoming generations of nanomaterials. Ultimately, this safe innovation approach should also benefit to the public by improved warranting of safety of new products. More specific objectives of WP3 are:
- To develop a coherent set of supportive tools and structures for identifying and integrating efficient hazard and functionality testing during the innovation process (SbD approaches) that aims to minimize uncertainty about health risks to workers, consumers and the environment, to analyse present approaches of SbD over the whole line from basic research to market and to illustrate the added value of experimentally obtained safety data during the innovation process and create coherency among present and developed SbD approaches.
- 2. To expand currently applied stage-gate innovation models stimulating interaction between innovation oriented and regulatory oriented stakeholders, from an early stage on and thereby supporting the most efficient way to prove safety of new and relevant nanomaterials as well as the nano materials defined in NANoREG I and their inspired products. The adapted stage-gate innovation model will be used as core for the safe innovation approach in which the various tools (a.o. guidance, structures and checklists) are described in a coherent way and in view of the roles and incentives of the various stakeholders, like academia, industry, risk assessors and regulators.
Analyses conducted in this WP will pick up grouping concepts developed in WP1 as well as materials identified as relevant for industrial markets in WP2. The defined properties and parameters will be fed into WP4 in order to define barriers of the concept of design of safe innovations. Moreover, the development of the safe innovation approach will gain view on other than technology driven barriers to warrant the safety of innovative products like nanomaterials.
WP4: Demonstration and verification of Safe by Design concepts
Work Package 4, Demonstration and verification of Safe by Design concepts, will:
- identify barriers to the application of Safe-by-Design (SbD) concepts and adequate address such barriers under consideration of grouping principles and Risk Management (RM) requirements, with a view to ultimately eliminate/reduce the barriers and provide examples of guidance towards achieving SbD.
- demonstrate the integration of the SbD approaches to the innovation process of the industrial partners.
- establish commercially viable grouping and Safe-by-Design concepts, through the provision of industrial SbD-Tools and SOPs.
WP5 - Liaison and network activities
The primary objectives of this work package are to establish and strengthen strategic and operational liaisons, active interactions and networks with: a) Member States and Associated Countries; b) International organisations; c) EU and other organisations, d) FP7 and H2020 project consortia; e) Industries and Industry associations.
The liaisons will provide actual information exchange with regulatory authorities, innovation funding organizations, industry and its organizations, the research community, as well as the society about: a) actual and future needs and b) project results about safe-by-design concepts, c) organized dossiers shared by stakeholders of pre-regulatory robust nano safety data, d) standard operational procedures as well as e) other knowledge and skills. In addition, liaisons will provide the liaised partners with proved methods and sound knowledge and training on these topics.
Liaisons through experts active in this project and in NANoREG I and ProSafe, as well as with future H2020 projects addressing nano safety e.g.: legislation and regulation of nanomaterials and products, self-responsibility of industry, precautionary measures such as safe-by-design, etc. will foster complementary activities and prevent unnecessary duplication of efforts on the same topics. A dedicated support will be provided to H2020 projects for the implementation of SAFE INNOVATION approaches and safe-by-design concepts and respective approaches in industries innovation processes.
WP6 - Knowledge management, dissemination and exploitation
WP6 is addressing the management of the knowledge and the dissemination of new knowledge from external sources into the project and from the project to its relevant stakeholder groups. Partners participating in WP6 have been selected due to their strong background in knowledge management and dissemination, their experience in the strategic planning and conduct of dissemination activities, and their existing liaisons and partnerships with external stakeholder that are central to the furthering of knowledge dissemination in the nanotechnology community and the provision of training to the community, where the impact of this workpackage will be evaluated. While the general public is not amongst the immediate target groups of the NANoREG II project, the public face of NANoREG II will be created and maintained with issues of societal awareness in mind: true to its name, NANoREG II will highlight the safety-aspect of nanotechnology and thus strengthen the societal awareness of nanotechnology as a ‘key enabling solution’ to grand societal challenges.
While the general public is not amongst the immediate target groups of the NANoREG II project, the public face of NANoREG II will be created and maintained with issues of societal awareness in mind: true to its name, NANoREG II will highlight the safety-aspect of nanotechnology and thus strengthen the societal awareness of nanotechnology as a ‘key enabling solution’ to grand societal challenges. The management of the knowledge will include several complementary objectives:
- Creation, implementation and management of an INTERNAL dissemination plan
- Creation, implementation and management of an external dissemination plan and Corporate Design; this plan will include the Plan for Use and Dissemination of the Foreground
- Creation of strong information flow from the project to the nano-safety community through channels forged by WP5 liaisons, in order to ultimately create a Safe-by-Design network of regulators, risk-assessors, standardisation officials, academia and industries.
- Monitoring of impact of the project’s internal and external dissemination plan, including the choice of criteria (visibility, usefulness) and indicators
- Provision of standardisation and training stewardship.
- Definition of stable activities beyond the project through the building of public-private partnerships.
WP7 - Project Management and Scientific Coordination
Work Package 7, Project Management and Scientific Coordination, will:
- Effectively manage the project, coordinate efforts of the partners and promote dissemination of new knowledge between the work packages and partners
- Maintain communications with the EC on behalf of the project partners
- Manage project finances.
- Prepare periodic activity reports and management reports.
- Oversee IPR matters, update the implementation and exploitation plans
- Promote gender equality in the project.