The European Chemicals Agency (ECHA) announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. ECHA published two new guidance documents:
- 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): The appendix advises registrants on how to justify the use of hazard data between nanoforms (and non-nanoforms) and within groups of nanoforms of the same substance; and
- How to prepare registration dossiers that cover nanoforms — best practices: The document provides recommendations for distinguishing between different nanoforms of a substance, and how to report information on nanoforms consistently in the dossiers. ECHA states it originally intended this to be a guidance document, but as a consequence of the Board of Appeal decision in Case A-011-2014, ECHA is publishing it as an advisory best practice document. More information on the Board of Appeal decision is available in our March 6, 2017, blog item.
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.