ECHA publishes final REACH Guidance for nanomaterials
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. 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 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.
Source: ECHABack to news listing