The overarching aim of the EU project NanoHarmony was to deliver an important contribution to the adaptation of OECD Test Guidelines (TGs) and Guidance Documents (GDs) for nanomaterials. Eight endpoints have been identified as regulatory priorities by considering recommendations from
ECHAshort forEuropean Chemicals Agency NMEG (Nanomaterials Expert Group), OECD WPMN and the Malta Initiative.
The
BfRshort forGerman Federal Institute for Risk Assessment participated as co-lead in two of the endpoints, work on a GD on the determination of solubility and dissolution rate of nanomaterials in water and relevant synthetic biological media (WNT Project 1.5) and in work on a GD on the identification and quantification of the surface chemistry and coatings on nano- and microscale materials (WNT Project 1.6).
During the project on the determination of solubility and dissolution rate of nanomaterials available data and methods were assessed and new data generated through organising an inter-laboratory comparison (ILC) and consulting relevant stakeholders. The
BfRshort forGerman Federal Institute for Risk Assessment was co-lead for the organization of the ILC and was responsible for the statistical data analysis and data interpretation of the results from the ILC. A GD will continue to be developed with submission for endorsement by the WNT planned for 2026.
For the project on the identification and quantification of the surface chemistry and coatings on nano- and microscale materials a tiered approach with standard operating procedures (SOPs) was developed using a range of suitable analytical techniques and the organisation of an ILC to validate this has been undertaken during the project.
BfRshort forGerman Federal Institute for Risk Assessment was co-lead for both activities and was responsible for the statistical data analysis and data interpretation of the results from the ILC. The GD will continue to be developed, endorsement by the WNT is planned for 2026.
Overall, NanoHarmony coordinated the collection and use of available data and information to support the finalisation of the test method development and to organise a sustainable network for the needed exchange, also for future regulatory development needs.