On the 24th of May 2017, ECHA published five documents that aim to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline.
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 (QSARs 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 has published updates to three of its existing guidance on nanomaterials, which are the appendices for nanomaterials to Chapter R.7a, R.7b and R.7c of the Guidance on IR&CSA (Endpoint specific guidance). These latter three documents provide nano-specific advice to help registrants meet the information requirements set out in Annexes VI-XI to the REACH Regulation.
The scope of the update 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.
All these documents have been developed to give the best possible support to registrants of substances that include nanoforms.
Source and further information on the ECHA website.