December 18, 2018

December 18, 2018

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December 17, 2018

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EC Review of REACH Examines How REACH Addresses Nanomaterials

On March 5, 2018, the European Commission (EC) announced the availability of a Communication to the European Parliament (EP), the Council of the European Union (EU), and the European Economic and Social Committee on the operation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The Communication includes proposals intended to facilitate further the implementation of REACH.  The scope of the EC’s evaluation includes a review of the ability of REACH to “tackle” nanomaterials.  According to Part 1 of the EC staff working document, although REACH is able to address emerging issues such as the risks from nanoforms of substances, the lack of specific information about nanoforms covered by REACH registration dossiers remains an issue.  The document states that this is largely due to the fact that REACH does not explicitly require registrants to provide separate information for forms of a substance, including the bulk form and different nanoform(s).  Furthermore, REACH does not contain a definition of nanomaterial/nanoform.  The document notes that several compliance check decisions by the European Chemicals Agency (ECHA) on the registrations of substances with nanoforms were appealed to the Board of Appeal, and four were annulled.  According to the document, the proposed revision of the REACH Annexes will address these shortcomings.  As reported in our October 11, 2017, blog item, on October 9, 2017, the EC began a public consultation on a draft regulation that would amend several REACH Annexes to address nanoforms of substances.  The EC will discuss the outcomes and follow-up actions of its REACH review with the EP, EU Member States, and stakeholders at a public conference planned for June 2018.

©2018 Bergeson & Campbell, P.C.


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...

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.