Project

Main objective of NanoValid is the development of new reference methods and certified reference materials, including methods for characterization, detection/quantification, dispersion control and labelling, as well as hazard identification, exposure and risk assessment of ENs. In cooperation with other relevant projects (in particular MARINA, QNano and within the EU Nanosafety cluster), relevant standardization and regulatory bodies, the most suitable test materials and methods will be selected and tested, and new nanomaterials synthesized, characterized and stabilized for final method validation.

NanoValid has mobilized the critical mass of excellence, expertise and skills available in Europe and beyond, to achieve these objectives and to provide input to ongoing policy and regulatory developments (through EC committees, the EU Parliament, OECD), standards (through CEN and ISO) and industrial R&D strategy (through European Technology Platforms and industrial associations).

The project is organized in five technical workpackages (WPs), and three non-technical (operational management, dissemination/exploitation and scientific coordination) WPs, as follows:

WP1      Project management
WP2      Fabrication of test materials and selection of test methods
WP3      Validation of p c methods, in vitro, in vivo and computational methods (in silico)
WP4      Application of validated methods to risk (RA) and life cycle assessment (LCA)
WP5      Development of reference methods and certfified reference materials
WP6      Case studies to assess the feasibility of validated methods
WP7      Dissemination, exploitation, training, networking and clustering
WP8      Scientific coordination

Short description of work plan, tasks and methodology:

Work package 1 (WP1) will organize and coordinate the consortium and the planned work to achieve project objectives, implement tasks, mobilize the necessary personnel and resources, process and evaluate collected and generate new data, and ensure reporting and quality assurance, according to main topics of the Call, scope of the work, time schedule, and costs. The project management will build upon direct and free communication among participants, and with the Commission, and on a smooth information flow, including regular project meetings and monitoring, progress control and risk evaluation, and strict compliance with milestones and deadlines for deliverables.

Work package 2 (WP2) will provide the project with a constant and updated review of the existing knowledge and data about nanomaterial fabrication and characterization methods. This will be realized by preparing critical periodic reviews of the relevant literature and of specific databases, which will be distributed to all the partners. Based on the evaluation of obtained results, relevant and most promising test materials and methods will be selected by partners involved in this WP. A group of high-priority industrial nanomaterials will be prepared and synthesized comprising a range of different sizes, structures, coatings and compositions. These materials will be fully characterized in WP2 before being used for validation (WP3), applicability testing (WP4), reference method and material development (WP5) and assessment of their feasibility (WP6). Finally, this WP will provide and evaluate a suite of screening biotests for initial profiling of toxicological properties of the prepared NPs.

Work package 3 (WP3) will be the main validation work package, acting as a link between WP2, where materials and methods will be selected, and subsequent WPs, where the validated materials and methods will be utilised in applications. In summary, WP3 will instigate inter laboratory cross checking of protocols, methods, materials and results (round-robins) aiming to generate cross-referenced and fully validated materials, media and methods across the full spectrum of nanosafety (synthesis, characterization, stabilization, human toxicology and environmental toxicology testing). The focus will be on potentially innovative methods relevant and dedicated to nanosafety. A particular necessity for this task is the participation of several state-of-the-art laboratories with suitable facilities and experience.

Work package 4 (WP4) will evaluate the potential of the methods selected under WP3 to perform hazard and risk assessment (HA and RA) and life cycle analyses (LCA) for the ENs selected and characterized under WP2. This includes the refinement of test strategies for HA, RA and LCA with regard to ENP, as the respective procedures are developed for chemicals and may need modification/adaptation to deliver meaningful results for ENPs. From the results of HA, RA and LCA, feedback is given to WP5 regarding potential hazards and risks of ENPs as well as to WP6 regarding applicability of test methods validated and selected under WP3.

Work package 5 (WP5) will provide reference methods and materials (Certified Reference Materials, CRM) for toxicological testing, ENP exposure assessment, assessment of the ENP impact on human and environmental health in order to underpin hazard and risk assessment related to new and known ENPs. Methods identified under WP2 and validated under WP3 will be evaluated for their potential to be developed as reference methods for a special task. Reference methods developed under WP5 will be specifically characterized by uncertainty considerations and traceability. Traceability for measurands will be established through certified reference materials (CRM) when possible. For those measurands where no CRM is available and for method defined measurements (which are often in use in the toxicology community), comparability will be established by method specific convention parameters. Agreed convention parameters will be obtained through inter-laboratory comparisons. The goal is to “deliver” these reference methods, which will provide reproducible and comparable data, for use under WP4 and WP6 activities. Finally WP5 results will directly underpin standardization activities under WP7.

Work package 6 (WP6) will perform case studies to assess the feasibility of validated methods by applying a battery of test systems and modeling tools to assess the safety of nanomaterials in real and simulated working environments. Tests will be either on-site or will use collected materials to be tested in participating laboratories. The case studies will also include accident simulations to develop proper risk management systems. They will allow to make specific recommendations for managing risks deriving from engineered nanoparticles. These recommendations will be set down in the form of reports, good practice documents and guidelines.

Work package 7 (WP7) will provide the project results in a suitable format for the wider community to access and use; through regular news and information streams, reports, new standardised protocols, training events, and networking opportunities. It will also afford the wider community (industry, academia, regulatory agencies, relevant NGOs) the opportunity to interact with the consortium and influence the development of the consortium’s work.

A global dissemination and exploitation strategy including internet-based interfaces will be implemented for all relevant stakeholders (academia, industry, regulatory authorities policy-makers, the public) and events organized at different levels around the project to foster the take-up and exploitation of project results already during the course of the project.

Work package 8 (WP8) will use measures to ensure a high quality of performance with regard to the planned tasks and methodology, equipment and required expertise, to reach the scientific objectives by the methods as described and developed in WP2-6 (see below) according to the work programme and within the time schedule. The scientific coordinator will produce a monthly update report of the scientific-technical work in close cooperation with the responsible Work Package Leaders, review and evaluate achievements, and make them immediately available to all project partners by means of short protocols summarizing main results, progress and problems.

Although each individual WP has its own distinct focus, function, objectives, tasks, deliverables and milestones, all WPs will closely interact with, support and complement each other in an overarching holistic approach required to adequately address the complexity and multidisciplinarity of the planned research and development work. A bottom up approach will be used to gradually link tasks that start with a lower level of complexity (e. g. primary data generation, method and material survey and selection in WP2) with tasks of increasingly higher levels of mutual interaction (e. g. validation of methods and testing their applicability to RA and LCA (in WP3 and WP4), until the intended objectives (verified by specific deliverables and milestones) are achieved and results generated (e.g., establishing reference methods and materials in WP5 and proving their applicability in WP6).

Main interdependencies, flow of data and information within the project, and interactions between different WPs components in relation to their expected outcome are summarized as follows:

Work Package Flow Chart