September 28, 2020

Volume X, Number 272

September 28, 2020

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

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.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 22


About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.