Helsinki, 2 August 2023 – With the increasing interest in the applications of engineered nanomaterials in a variety of consumer products, the status of the development of nanomaterial-specific approaches to assess their risks to humans has been assessed.
The main aim of the study conducted for the EUON was to collect and provide accurate and transparent information on new approach methodologies (NAMs) available for the human safety assessment of nanomaterials, and to create a comprehensive inventory of these methods. The study also maps the progress of animal-free approaches for testing nanomaterials, identifying methods at various stages of validation.
Although more than 200 NAMs were identified in the study, only eight were found to be nano-specific and accepted for regulatory testing. Thus, there is an urgent need to speed up validation processes for nano-specific NAMs which are currently under development for different endpoints. The possible adaptation of non-nano-specific NAMs for nanomaterials testing was critically analysed as per toxicological endpoint to reveal the development need of the NAM to fulfil nanomaterial specific safety testing requirements. The study also confirmed the need, not limited to nanomaterials, to develop new NAMs for complex endpoints (e.g., neurotoxicity and reproductive toxicity). The results of the report are likely to interest anyone developing or using animal-free test methods for safety assessment of nanomaterials.
The study “Nano-specific alternative methods in human hazard/safety assessment under different EU regulations, considering the animal testing bans already in place for cosmetics and their ingredients” was commissioned by the European Union Observatory for Nanomaterials (EUON), which is hosted and maintained by ECHA. EUON provides information about existing nanomaterials on the EU market and runs studies on relevant topics to address important knowledge gaps. EUON is funded by the European Commission.
The study was conducted by QSAR Lab Ltd, Gdańsk (Poland).
Source: European Union Observatory for Nanomaterials (EUON), "New study identifies status of animal-free test methods for use on nanomaterials," European Chemicals Agency (ECHA), https://euon.echa.europa.eu/de/view-article/-/journal_content/title/new-study-identifies-challenges-of-animal-free-test-methods-application-for-nanomaterials