The documents include two new pieces of guidance as well as recommendations and updates of the existing guidance on nanomaterials. The new publications are:

• Nano-specific appendix to Chapter R.6 of the Guidance on information requirements and chemical safety assessment (IR&CSA) (quantitative structure-activity relationships (QSAR) and grouping of chemicals): 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.
• How to prepare registration dossiers that cover nanoforms — best practices: 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.

In addition, ECHA published updates to three of its existing guidances on nanomaterials — the appendices for nanomaterials to Chapters R.7a, R.7b, and R.7c of the Guidance on IR&CSA (endpoint specific guidance).  ECHA states that these three documents provide nano-specific advice to help registrants meet the information requirements set out in REACH Annexes VI-XI.  ECHA notes that the scope of the updates covers human health and environment related endpoints and incorporates new developments in the scientific understanding of hazard/risk assessment of nanomaterials.  It also takes account of ECHA’s experience from compliance checks and substance evaluation.