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ECHA PEG Reviewing Draft Appendix for Nanoforms Applicable to the Guidance on Registration and Substance Identification

The European Chemicals Agency (ECHA) has posted the draft version of a guidance document, Appendix for nanoforms applicable to the Guidance on Registration and substance identification.  The draft guidance is being reviewed by a Partner Expert Group (PEG).  The draft Appendix has been developed to provide advice to registrants preparing registration dossiers that cover nanoforms.  It states that the advice provided covers nanospecific advice for issues related with registration and characterization of nanoforms.  The draft Appendix intends to provide advice specific to nanoforms and does not preclude the applicability of the general principles given in the Guidance on registration and the Guidance on Substance identification.  According to the draft Appendix, the parent guidance documents apply when no specific information for nanoforms has been given in this Appendix.  The aim of the draft Appendix is to provide guidance on how to interpret the term “nanoform” for registration purposes and provide advice on how to create “sets of nanoforms” in a registration dossier.  It also outlines what is expected in terms of characterization of the nanoforms and set of nanoforms in the registration dossier.  Section 2 of the draft Appendix explains general requirements regarding the registration of nanoforms.  Section 3 explains the concept of a nanoform, and how to distinguish a nanoform from another, and Section 4 focuses on how to create and justify sets of different nanoforms.  As reported in our December 4, 2018, blog item, the European Commission (EC) amended several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials.  The information requirements will apply beginning January 1, 2020.

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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...

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

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