ECHA has today, 3rd of December, published two guidance documents applicable for nanoforms of chemical substances under REACH.
The most comprehensive guidance document is the 'Appendix for nanoforms to the Guidance on Registration and Substance Identification' which alignes ECHA’s guidance with the revised REACH annexes for nanomaterials that enter into application on 1 January 2020. The document explains the term nanoform, provides advice on how to build and justify sets of nanoforms and explains what characterisation information needs to be reported.
The other guidance is an update to the 'Appendix for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals'. The updated guidance 'clarifies the differences between creating a set of nanoforms and read-across for justifying the use of hazard data between different (sets of) nanoforms of a substance' according to ECHA.
During 2020 ECHA will embark on updating the existing guidance for human health and environmental information to consider nanoforms of chemical substances.
NIA considers that the published guidance documents are valuable for indstry, but that there remains several challenges and uncertainties, also related to the lack of validated methods for some of the regulatory endpoints.
