The European Chemicals Agency (ECHA) had performed compliance checks on four nanomaterial Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossiers (all on silicic acid, aluminum sodium salt) in December 2014, and adopted a Decision requesting that four companies (Evonik Degussa, Rhodia Opérations, JM Huber Finland and Iqesil) submit additional information on:
- Name, molecular and structural formula or other identifier of the Substance
- Composition of the Substance; and
- Description of the analytical methods used to determine the identity and composition of the Substance
In March 2015, the four companies (‘Appellants’) sent a request to ECHA’s Board of Appeal (BoA), asking for an annulment of the Decision.
The Appellants argued that the Decision had “breached the principle of legal certainty”, and they were unable to comply with the Decision due to the uncertainty surrounding the terminology. Specifically, they argued that there is a lack of clarity and definition in REACH regulations and from ECHA regarding the terms ‘forms’, ‘grades’ and ‘nanoforms’.
In considering the Appellant’s plea, the BoA examined whether the terms ‘forms’, ‘grades’ and ‘nanoforms’ employed in the Decision were clear and precise and, if they are not, whether the Appellants were nonetheless able to ascertain what information it must provide to ECHA in order to comply with the Contested Decision. The BoA found that these terms were not defined or clearly described in REACH regulation, in available ECHA guidance, nor in the Decisions. Furthermore, the way ECHA clarified ‘grade’ and ‘form’ to the appellants throughout the decision-making process and appeal proceedings were insufficient to clarify the meaning of the terms.
The Board of Appeal ruled in favor of the appellants, finding that ECHA’s Decision request does not allow the Appellant to clearly ascertain how to ensure compliance with the requests. All four of the Decisions were annulled.