November 13, 2019

November 13, 2019

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November 12, 2019

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November 11, 2019

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EUON Study Finds EU Regulatory Framework Ready for Next Generation Nanomaterials

On September 19, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the results of a study it commissioned to examine “next generation” nanomaterials and determine whether the current terminology used in the EU chemicals regulations, as well as the implementation of the current legal requirements for identifying nanomaterials, are likely to pose technical challenges.  The objectives of the study were to:

  • Collect existing definitions of generations of nanomaterials;
  • Refine these definitions to allow the sorting of different nanomaterials into different generations unambiguously;
  • Establish an inventory of second or higher generation nanomaterials on the market or close to the market; and
  • Assess the suitability of the terms “substance,” “mixture,” and “article” and of the identification and characterization parameters included in the revised Annex VI of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to describe the next generation nanomaterials found.

According to EUON, the study findings “indicate that although the regulatory framework is well-equipped to handle these materials in the near future, further guidance would benefit companies registering nanomaterials” under REACH.  The study recommends further clarifications for some parameters characterizing both nanomaterials and their uses and that the guidelines on how to determine whether an object is an article under REACH could be complemented with specific examples of different nanomaterials, from simple nanoparticles to more complex assembly structures.  EUON states that the European Chemicals Agency (ECHA) is updating its guidance on the identification of nanomaterials following the amendments to the REACH Annexes.  The updated guidance is expected to be published later in 2019.

©2019 Bergeson & Campbell, P.C.

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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

Owner of Bergeson & Campbell, P.C. (B&C®), 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...

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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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