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March 12, 2018

EC Review of REACH Examines How REACH Addresses Nanomaterials

Lynn L. Bergeson Carla N. Hutton

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.