A shortened online CARACAL meeting at the end of March addressed the submission of nanomaterials dossiers following the REACH Annex update which came into force on January 1st, 2020.
ECHA reported 86 unique submissions for 34 substances covering nanomaterials received by Jan 1, with 19 submission subsequently received, according to its report 'Nanomaterials and REACH – An ECHA Update' published on March 17. This number was lower than predicted, based on market estimates of between 200-2000 engineered substances at the nanoscale. Of these dossiers, 45% failed completeness checks for a wide range of reasons, including missing lead registrant, insufficient justification of nanoform sets and basic administrative issues.
Responses to the report were submitted from Member States, NGOs and Industry Associations. Strong feedback was given from an industrial perspective on the lateness of guidance publication (November), the need for flexibility in addressing such a substantial change in regulatory content and language and the lack of robust and accessible methodologies for companies. The accuracy of predicted numbers was also scrutinised, and suggested as rather high compared to market reality, especially given the 1 tonne threshold for REACH.
NIA and Members have taken part in two webinars with ECHA dedicated to applicant support for the submission of nanoform dossiers, with slides and Q&A available to members in the Member library and is also supporting the development of a web platform from ECETOC that helps create and justify nanoform sets according to ECHA guidance. The ECETOC platform will be available later in 2020.
