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January 22, 2018

ECHA Management Board Reviews Strategy on Substances in Nanoforms

Lynn L. Bergeson Carla N. Hutton

During its December 14-15, 2017, meeting, the Management Board of the European Chemicals Agency (ECHA) discussed ECHA’s strategy on substances in nanoforms.  According to the strategy, following recent rulings of the Board of Appeal, the “possibility for using dossier and substance evaluation under the current legal text of [the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation] to verify safe use of nanomaterials on the EU market has become increasingly challenging and resource intensive,” making revision of the REACH annexes “even more urgent than before.”  As reported in our March 6, 2017, blog item, in March 2017, the Board of Appeal annulled a contested decision that would have required the lead registrant to provide detailed substance identity information on the crystal phases, nanoforms, and surface treatment of nanoforms covered by its registration of titanium dioxide.  On June 30, 2017, the Board of Appeal published two decisions related to nanomaterials, largely upholding the appeals and annulling most of the requests for information, as reported in our July 5, 2017, blog item.  In the strategy, ECHA states that in the current situation, it “cannot effectively and systematically verify whether safe use of nanomaterials in the supply chain is demonstrated, and whether additional regulatory risk management measures are needed.”  ECHA notes that “[t]hese developments, however, do not eliminate the responsibility of industry in ensuring the safe use of substances, in whatever form.”  The preliminary conclusions for the meeting state that the Management Board welcomed ECHA’s progress and invited the EC “to conclude as a matter of urgency the revision of the annexes to REACH on the information requirements of nanomaterials.”