November 27, 2020

Volume X, Number 332

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November 25, 2020

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EC Amends REACH Annex II to Include SDS Requirements for Nanoforms

On June 26, 2020, the European Commission (EC) published a regulation in the Official Journal of the European Union that amends Annex II of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  Annex II describes the requirements for compiling safety data sheets (SDS).  The EC notes that specific requirements for nanoforms of substances took effect on January 1, 2020, and that information related to those requirements is to be provided in SDSs.  The Annex II amendments include the following provisions regarding nanoforms:

  • If the SDS pertains to one or more nanoforms, or substances that include nanoforms, this must be indicated by using the word “nanoform”;

  • If the substance is registered and it covers a nanoform, the particle characteristics that specify the nanoform, as described in Annex VI, must be indicated;

  • If the substance is not registered, but the SDS covers nanoforms, the particle characteristics of which have impact on the safety of the substance, those characteristics must be indicated;

  • If the substance as used in the mixture is in nanoform and is as such registered or addressed by the downstream user chemical safety report, the particle characteristics that specify the nanoform, as described in Annex VI, must be indicated. If the substance as used in the mixture is in nanoform but is not registered or addressed by the downstream user chemical safety report, the particle characteristics that impact the safety of the mixture must be provided;

  • As regards nanoforms, the dissolution rate in water or in other relevant biological or environmental media must be indicated in addition to the water solubility; and

  • As regards nanoforms of a substance for which the n-octanol/water partition coefficient does not apply, the dispersion stability in different media must be indicated.

Other Annex II amendments include aligning the SDS requirements with the sixth and seventh editions of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  The Annex II amendments will apply beginning January 1, 2021.  SDSs not complying with the amended Annex II requirements may be used until December 31, 2022.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 183
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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
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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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