July 15, 2019

July 15, 2019

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SweNanoSafe Reports on ECHA Workshop on REACH Requirements for Nanomaterials

The Swedish National Platform for Nanosafety (SweNanoSafe) has posted a report on the European Chemicals Agency’s (ECHA) November 8-9, 2018, workshop on the upcoming Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) information requirements for nanomaterials.  As reported in our April 26, 2018, blog item, the European Commission (EC) REACH Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials.  The workshop was a preparatory step before the formal start of the update of ECHA’s guidance documents for nanomaterials through the Partner Expert Group (PEG).  The formal start date depends on the publication of the revised REACH Annexes for nanomaterials in the Official Journal of the European Union, which is expected before the end of 2018.  According to the report, around 55 delegates representing different stakeholders such as industry, European Union (EU) Member State authorities, and non-governmental organizations (NGO) participated at the workshop.  The report states that four main areas need new guidance:

  • Guidance on nanoforms — registration and Substance IDentification (SID) issues;

  • Guidance on grouping and read-across;

  • Guidance on Information Requirements (IR) — environmental endpoints; and

  • Guidance on Information Requirements (IR) — human health endpoints

PEG members may be officially nominated by industrial associations, Member State Competent Authorities, or NGOs.  Once the PEGs are established, ECHA will develop a draft proposal document for each area and circulate it for discussion and revision by the PEGs.  Typically this process would include several comment and revision rounds, including several virtual and face-to-face meetings.  The timeframe for the work will be short as the finally agreed proposals should be adopted by the EC around November 2019.  Thereafter, ECHA will publish the updated nanomaterial guidance on their homepage for immediate use.

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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...