The appendix for nanomaterials has been developed in order to provide guidance to registrants preparing registration dossiers that cover “nanoforms”. The advice provided covers nano-specific issues related with registration and characterisation of nanoforms.
The aim of the document is to provide guidance on how to interpret the term “nanoform” for registration purposes and provide advice on how to create “sets of nanoforms” for the purpose of registration. It also outlines what is expected in terms of characterisation of the nanoforms and sets of nanoforms in the registration dossier. Finally, it gives important information related to the joint submission of data on nanoforms as well as on confidentiality aspects.
An updated version of the appendix was published January 2022 and is available here.