Overview
On October 12, 2016, the Board of Appeal (BoA) of the European Chemicals Agency (ECHA) issued, for the first time, four decisions on the evaluation of nanomaterial dossiers under REACH.
The BoA annulled four compliance check decisions issued by ECHA on silicic acid, aluminum sodium salt (the Substance).
In the annulled decisions, ECHA had requested the appellants (Evonik Degussa, Rhodia Opérations, J.M. Huber Finland, and Iqesil) to provide additional information identifying the Substance in so far as “grades,” “forms,” and “nanoforms” were concerned. The four appellants, represented by Steptoe, submitted that they had provided sufficient information for the correct identification of the Substance, and that the Agency had failed to define the terms “grades,” “forms,” and “nanoforms” clearly – as a result of which they were placed in a position of legal uncertainty, and unable to understand what information was sufficient to ensure compliance with the decisions.
The BoA ruled in favor of the appellants on the grounds that the contested decisions breached the principle of legal certainty. In particular:
- The BoA found that the requirement to submit information on “grades” and “forms” of the Substance was unclear. The terms “grades” and “forms” (i) are not defined in REACH or Guidance; (ii) were not clearly defined in the contested decisions or during the compliance check procedure; (iii) were used inconsistently in the contested decisions; (iv) were defined differently in the contested decisions and during the appeal proceedings before the BoA; and (v) could not be clarified by ECHA during the proceedings to identify exactly the information that had to be provided.
- The BoA also found that the requirement to submit information on “nanoforms” of the Substance ignored the information in the dossier and communicated during the compliance check procedure that the Substance was only registered as a nanomaterial. Since all information in the registration dossier related to the Substance as a nanomaterial, the contested decisions created uncertainty as to what additional information the appellants had to provide. The BoA noted that ECHA had not been able to clarify this request and that the Guidance on IUCLID 5 does not require nanomaterials to be registered differently from substances in the bulk form.
In light of these considerations, the BoA decided to annul all four contested decisions in their entirety.
This ruling is significant because it confirms that ECHA must identify the information it requests registrants to provide under dossier evaluation clearly, but also because the BoA acknowledges that the current ECHA guidance does not require registrants to submit different substance identity information for nanomaterials than for substances in the bulk form.
For questions on this ruling or to discuss further, please contact Ruxandra Cana at +32 626 0571, Eléonore Mullier at +32 626 0563, or Craig Simpson at +32 2 626 0559.
