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ECHA Provides Updated Guidance on Testing Nanomaterials

By Lynn L. Bergeson & Carla N. Hutton on February 1, 2023
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The European Chemicals Agency (ECHA) announced in its February 1, 2023, ECHA Weekly that it has released an updated appendix for nanomaterials that provides guidance on how to obtain data under the new information requirements for nanoforms. According to ECHA, this includes information on how to perform environmental testing and advice on preparation methods and testing strategies for physico-chemical testing of nanoforms. ECHA notes that the Partner Expert Group (PEG) members “actively contributed to the update.” The changes to Guidance on information requirements and chemical safety assessment: Appendix R7-1 for nanomaterials applicable to Chapter R7a Endpoint specific guidance include:

  • Update of the advisory note on testing and sampling strategy and sample preparation for ecotoxicological endpoints:
  • Update and revision of Section 1.1 and subsections with 1.1.1. Characterisation of test materials, 1.1.2 Sample preparation of test materials, and 1.1.3 General considerations for Fate and (Eco)-Toxicological testing; and
  • Update of Glossary Section;
  • Update of Section 1 for water solubility, granulometry, n-octanol/water partition coefficient (Kow), adsorption/desorption:
  • Addition of subsection for Section 1.2.1 Water solubility with waivers and dissolution rate;
  • Addition of subsection for Section 1.2.2 Partition coefficient n-octanol/water, with waivers and dispersion stability;
  • Addition of subsection for Section 1.2.4 Dustiness; and
  • Addition of subsection for Section 1.2.5 Adsorption/Desorption with waivers and alternative methods to organic carbon-water partition coefficient (Koc).
Photo of Lynn L. Bergeson Lynn L. Bergeson

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…

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 process allows her to develop client-focused strategies whether advocating before Congress, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), or other governance and standard-setting bodies.

Ms. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to conventional, biobased, and nanoscale chemicals, particularly with respect to TSCA, FIFRA, Food Quality Protection Act (FQPA), REACH and REACH-like programs, and Occupational Safety and Health Administration (OSHA) matters.

She served as chair of the American Bar Association Section of Environment, Energy, and Resources, and has served in many Section leadership positions. She has served on the Board of Directors of the Environmental Law Institute, the NanoBusiness Commercialization Association, and the Product Stewardship Society, among other business and law organizations, and lectures and writes frequently on legal, regulatory, and science policy issues. Ms. Bergeson is also President of The Acta Group (Acta®), B&C’s scientific and regulatory consulting arm, which assists chemical and product manufacturers in marketing and sustaining their products globally, and President of B&C Consortia Management, L.L.C., which helps the chemical industry leverage resources and maximize impact by forming consortia to achieve shared research, testing, regulatory, and access goals.

According to the Chambers USA Guide: “The universally highly regarded Lynn Bergeson of Bergeson & Campbell, P.C. has developed an enviable reputation in chemical and pesticide regulatory work, with particular expertise in nanotechnology. ‘She is probably the premier pesticide lawyer in DC,’ notes one impressed commentator. Peers predict that she is set to become ‘one of the most important lawyers in America.'”

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Photo of Carla N. Hutton Carla N. Hutton

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…

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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  • Posted in:
    Technology
  • Blog:
    Nano and Other Emerging Chemical Technologies Blog
  • Organization:
    Bergeson & Campbell, PC
  • Article: View Original Source

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