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August 03, 2020

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ECHA Releases New, Updated Guidance Documents for Registering Nanoform Substances

The European Chemicals Agency (ECHA) announced on December 3, 2019, that it has developed a new Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification.  According to ECHA, it aligns ECHA’s guidance with the amended annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation that will apply to nanomaterials and enter into force on January 1, 2020.  The new guidance document explains the term nanoform, provides advice on how to build and justify sets of nanoforms, and explains what characterization information needs to be reported.  ECHA updated the Appendix for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals to reflect the advice of the new guidance document.  ECHA states that the update also clarifies the differences between creating a set of nanoforms and read-across for justifying the use of hazard data between different (sets of) nanoforms of a substance.  ECHA notes that it will keep updating the existing guidance for human health and environmental information requirements during 2020.  To support potential registrants in meeting the new information requirements, an updated overview of available test guidelines and other recognized methods and standards is available on the European Union Observatory for Nanomaterials (EUON)

©2020 Bergeson & Campbell, P.C.National Law Review, Volume IX, Number 337

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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...

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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.

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