Towards harmonised test methods for nanomaterials

ended

Ensuring the health and safety of both population and the wider environment has been entrusted to specialist EU and international organisations such as the OECD, who are tasked with setting up Test Guidelines (TGs) and Guidance Documents (GDs) by which a substance can be assessed. Engineered nanomaterials (ENM) pose a particular problem due to difficulties in analysis and data interpretation. Adopted TGs are not always suitable for nanoforms, but these are needed to ensure that standards are met for assessing and approving ENMs e.g. in European regulation such as REACH. NanoHarmony supports the development of a set of scientifically reliable test methods and good practice documents, based on the translation of existing scientific knowledge and data into a form that has regulatory relevance. NanoHarmony focusses on OECD TGs and GDs. 8 nanomaterial test endpoints have been prioritised with the agreement of the OECD WPMN and WNT, ECHA and the Malta Initiative, forming the core of the NanoHarmony CSA project. NanoHarmony will coordinate 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. NanoHarmony will therefore analyse the processes in test method developments to set up a framework structure for seamless and smooth cooperation between all stakeholders for timely developments of test methods ready for regulation. For both, finalisation of test methods and framework development, interviews, open workshops and stakeholder meetings are seen as a core tool in NanoHarmony to enable active participation and contributions. By identifying gaps and obstacles, and developing an adequate framework for possible implementation, e.g. in a Nano Risk Governance Council (as called for in NMBP 13), future needs for regulatory test methods will be identified and methods developed faster.