Grouping, Read-Across, CharacterIsation and classificatiOn framework for regUlatory risk assessment of manufactured nanomaterials and Safer design of nanoenabled products
The H2020 GRACIOUS project started in January 2018 and ended in September 2021. Twenty-three partners collaborated to develop a Framework for Grouping and Read-Across for Nanomaterials and to apply this to a number of cases. Grouping and read-across are approaches in risk assessment to fill in data gaps for a specific material by using existing information from one or more similar materials. A scientifically adequate substantiation of such an approach is very important. In addition to chemical properties, for nanomaterials, this requires also addressing form, size and surface properties as these also determine how a nanomaterial behaves. Stakeholders, for example, ECHA, EFSA, SCCS and industry, have been consulted throughout the project to align the Framework to their needs.
The GRACIOUS Framework for Grouping and Read-Across of Nanomaterials and Nanoforms guides the user to apply or develop a hypothesis for grouping and read-across. In total, 41 pre-defined hypotheses have been developed with corresponding Integrated Approaches for Testing and Assessments (IATAs), that outline in a stepwise manner the information and potential test assays needed to decide whether grouping can be applied according to the hypothesis. Similarity approaches were developed to quantitatively determine how similar different nanomaterials are for the different key aspects of an IATA. The hypotheses and IATAs cover the different exposure routes for human health (inhalation, oral, dermal) and different environmental compartments (water, soil, sediment). The Framework has been applied to 14 cases. Ultimately this should result in more nanomaterials for which adequate information is available to allow for risk assessment, for example, needed to comply with regulations, while at the same time limiting the use of animal tests as much as possible.
Further information on the Framework, including a ‘Guidance in a nutshell’, case studies, and publications, can be found on the GRACIOUS website.
GRACIOUS involved first-class scientists from large companies, government, small and medium enterprises and academia.
Role of RIVM
RIVM had a substantial contribution to the conceptual development of the grouping and read-across Framework. RIVM was also involved in stakeholder consultation and in developing and applying several hypotheses and IATAs that indicate the information needed to substantiate the grouping. We were work package and task leader and part of the projects management team. Agnes Oomen coordinated the project at RIVM, as several colleagues from the RIVM Centre for Safety of Substances and Products were involved.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 760840.