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December 4, 2018

EC Amends REACH to Require Information on Nanomaterials

Lynn L. Bergeson Carla N. Hutton

The European Commission (EC) announced on December 3, 2018, that it adopted amendments to several Annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation to clarify the information requirements for nanomaterials.  The EC notes that REACH “has always applied to nanomaterials, but did not contain specific provisions for them, which is why companies often did not know how to register these ‘substances in nanoform.’”  According to the EC, the modifications and new requirements will help close the knowledge gap concerning which nanomaterials are placed on the market and in what quantities.  The EC states that “[t]he new provisions will have to be implemented for all substances in nanoform that fall within the scope of REACH, from the already widely used and registered ‘legacy’ nanomaterials in all their product grades and variations to the specifically engineered nanomaterials placed on the market by the newly founded SMEs.”  The European Chemicals Agency’s (ECHA) December 3, 2018, press release states that nanoforms of substances are those covered by the EC’s recommendation for a definition of a nanomaterial.  ECHA “strongly encourages registrants of nanoform substances to familiarise themselves with the amendments and assess what action they need to take to comply.”  ECHA is currently assessing the need to update existing guidance or issue new guidance to help registrants comply with the new requirements.  The information requirements will apply beginning January 1, 2020.