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October 25, 2016

ECHA Board of Appeal Annuls Four Decisions Requesting Substance Identity Information on a Nano Structured Substance

Lynn L. Bergeson Carla N. Hutton

In cases A-008-2015A-009-2015A-010-2015, and A-011-2015, the European Chemicals Agency (ECHA) Board of Appeal examined appeals against compliance check decisions made by ECHA requesting further substance identity information from four registrants of a “nano structured” substance.  As reported in our July 29, 2015, blog item, ECHA adopted the contested decisions on December 17, 2014, following a compliance check under the dossier evaluation procedure of the submitted registration.  In each contested decision, ECHA found that the registration did not comply with the requirements of Article 10(a)(ii), as well as Annex VI, Section 2 of the Registration, Evaluation, Authorization and Restriction of Chemicals Regulation (REACH).  ECHA requested that each appellant submit the following information:

  • Name, molecular, and structural formula, or other identifier of the substance (Annex VI, 2.1 and 2.2);
  • Composition of the substance (Annex VI, 2.3); and
  • Description of the analytical methods used (Annex VI, 2.3.7).

ECHA announced in its October 12, 2016, ECHA Weekly that the Board of Appeal found that the contested decisions “breached the principle of legal certainty as some of the terms used, specifically ‘grades’, ‘forms’ and ‘nanoforms’, were not clearly defined and did not allow the Appellants to clearly ascertain what information they were required to provide in order to comply with the Agency decisions.”  The Board of Appeal annulled the contested decisions.  The appellants raised other pleas (e.g., whether ECHA could legally require them to submit further information to allow for a more detailed identification of the nanoforms of the registered substance).  The Board of Appeal concluded that since it is not clear from the contested decisions what information the appellants are required to provide, it was not possible to decide on the legality of those requests.