The European Chemicals Agency (ECHA) has published five documents that will help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline. The documents, which have undergone a comprehensive consultation process, include two new pieces of guidance as well as recommendations and updates of the existing guidance on nanomaterials.

 

ECHA Document 2017 1.	Nano-specific Appendix to Chapter R.6 of the Guidance on Information Requirements and Chemical Safety Assessment

 

Nano-specific Appendix to Chapter R.6 of the Guidance on Information Requirements and Chemical Safety Assessment (QSARs and grouping of chemicals), Version 1.0, May 2017. (PDF, 900 KB)
It advises registrants on how to justify the use of hazard data between nanoforms (and the non-nanoforms) and within groups of nanoforms of the same substance.

 

 

ECHA Document 2017 How to prepare registration dossiers that cover nanoforms - best practices.

 

 

How to prepare registration dossiers that cover nanoforms: best practices, Version 1.0, May 2017. (PDF, 500 KB)
This document gives recommendations for distinguishing between different nanoforms of a substance, and how to report information on nanoforms consistently in the dossiers. This document was originally intended to be a guidance document, but as a consequence of the Board of Appeal decision in Case A-011-2014, ECHA is publishing this as an advisory best practice document.

 

 

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