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April 5, 2019

ECHA PEG Reviewing Draft Appendix for Nanoforms Applicable to the Guidance on Registration and Substance Identification

Lynn L. Bergeson Carla N. Hutton

The European Chemicals Agency (ECHA) has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification.  The draft guidance is being reviewed by a Partner Expert Group (PEG).  The draft Appendix has been developed to provide advice to registrants preparing registration dossiers that cover nanoforms.  It states that the advice provided covers nanospecific advice for issues related with registration and characterization of nanoforms.  The draft Appendix intends to provide advice specific to nanoforms and does not preclude the applicability of the general principles given in the Guidance on registration and the Guidance on Substance identification.  According to the draft Appendix, the parent guidance documents apply when no specific information for nanoforms has been given in this Appendix.  The aim of the draft Appendix is to provide guidance on how to interpret the term “nanoform” for registration purposes and provide advice on how to create “sets of nanoforms” in a registration dossier.  It also outlines what is expected in terms of characterization of the nanoforms and set of nanoforms in the registration dossier.  Section 2 of the draft Appendix explains general requirements regarding the registration of nanoforms.  Section 3 explains the concept of a nanoform, and how to distinguish a nanoform from another, and Section 4 focuses on how to create and justify sets of different nanoforms.  As reported in our December 4, 2018, blog item, the European Commission (EC) amended several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials.  The information requirements will apply beginning January 1, 2020.