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January 22, 2020

ECHA Publishes Q&A from Webinar on Revised REACH Annexes for Nanomaterials

Lynn L. Bergeson Carla N. Hutton

As of January 1, 2020, companies must provide more information on nanomaterials on the European Union (EU) market under the updated Annexes to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA organized a webinar on November 12, 2019, on the revised annexes and how companies can prepare to meet the new requirements.  ECHA states that the first part of the webinar explained what a nanoform is and how to build a set of similar nanoforms.  It also explained how to fulfill data requirements for the characterization of nanoforms.  The second part introduced new International Uniform Chemical Information Database (IUCLID) fields for reporting the characterization parameters of nanoforms and gave some practical examples on how to use the different fields.  During the webinar, participants had the chance to ask questions from ECHA experts.  In December 2019, ECHA published a questions and answers (Q&A) document that compiles and groups Q&As received during the webinar.  In the document, ECHA further elaborated on the replies and complemented them with additional advice intended to support registrants.  Topics addressed by the Q&A document include:

  • Support documentation;
  • Registration obligation;
  • Definition of a nanoform;
  • Set of similar nanoforms;
  • Particle size distribution;
  • Shape including aspect ratio and assembly structure;
  • Surface functionalization/treatment;
  • Specific surface area (SSA);
  • Reporting and submission;
  • Joint submission;
  • Annex VII-XI information requirements;
  • Chemical safety assessment and supply chain communication;
  • Inquiry; and
  • Challenges.