On March 2, 2017, the European Chemicals Agency (ECHA) announced that its Board of Appeal issued its decision in Case A-011-2014, which concerns a Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) dossier evaluation for titanium dioxide. See https://echa.europa.eu/-/board-of-appeal-decision-in-an-appeal-concerning-the-registration-requirements-for-nanoforms-published In its evaluation, ECHA considered only the substance identity information required and not the information requirements for human health and environmental effects. The Contested Decision required Huntsman P&A UK Ltd (formerly Tioxide Europe Limited), the lead registrant and one of the nine appellants, to provide detailed substance identity information on the crystal phases, nanoforms, and surface treatment of nanoforms covered by its registration. The appellants raised eight pleas in law in support of their appeal. The Board of Appeal first examined the appellants’ third plea, that ECHA acted outside its competence and breached REACH. The appellants argued that information on phases, nanoforms, and surface treatment of nanoforms is not information required for a registration under REACH Annex VI Section 2. According to the appellants, it is up to them to define the substance that they intend to register. It then falls to ECHA to perform a compliance check of the relevant registrations to determine whether the “hazard and risk data” required for a registration have been provided. The titanium dioxide registration dossier met the requirements of Section 2, which does not currently call for a more detailed identification of a registered substance if it is a nanomaterial. The appellants note that the legislator is considering amending the REACH Annexes to address nanomaterials specifically, and that there is no current requirement to provide more specific substance identity information on nanoforms than on other forms of a substance.
ECHA, and the French REACH Competent Authority, who intervened in support of ECHA, maintained that a registration must, in principle, separately address the toxicological and ecotoxicological properties of every crystal phase and/or nanoform covered by a registration dossier. Alternatively, a registrant can establish scientifically that differences in physical properties between different crystal phases and/or nanoforms do not result in different toxicological and ecotoxicological properties. ECHA, supported by the intervenor, argued that knowledge of the precise crystal phases and/or nanoforms covered by the registration “is therefore an implicit ‘prerequisite’ for assessing the hazards and risks posed by the Substance, regardless of whether a ‘form-by-form’ or a ‘grouping’ approach is adopted.” According to ECHA and the intervenor, a strictly literal interpretation of Annex VI Section 2 “would defeat the purpose of that provision, leading to the unacceptable consequence that manufacturers and importers of nanoforms of substances would not be required to assess the relevant hazards and risks.”
The Board of Appeal states that, in the present case, the registration dossier uses a very broad definition of titanium dioxide, including the bulk form and all nanoforms of various crystal phases of titanium dioxide, including rutile and anatase. To comply with REACH, the registration dossier must include toxicological and ecotoxicological information covering both the nanoforms and bulk forms of the rutile and anatase crystal phases of titanium dioxide. To reach a decision on the third plea, the Board of Appeal states that it must examine whether Annex VI Section 2 requires registrants to submit the information at issue when registering a substance. The Section 2 requirements “are worded with such technical precision and clarity that they leave no scope for doubt as to their meaning,” and “[n]one of these points mention the need to provide information on crystal phases and/or nanoforms.” The Board notes that Section 2 does not contain an openly worded information requirement such as a reference to “any other information necessary to identify the registered substance,” and the terms nanoforms and nanomaterials are not mentioned in REACH. The Board concluded that the wording of Section 2 is clear and “cannot be interpreted in the light of its purpose and context with regard to the information requests in the Contested Decision.”
According to the Board of Appeal, the procedures available to ECHA allow for information concerning the toxicological and ecotoxicological properties, and potentially other information, to be considered to ensure that sufficient information is available regarding the hazards and risks posed by the substance. In the present case, the literal interpretation of Section 2 does not endanger the protection of human health and the environment. The toxicological and ecotoxicological information in the registration dossier must satisfy the registration requirements set out in REACH with regard to all the bulk forms and crystal phases and/or nanoforms of titanium dioxide covered by the registration. The Board of Appeal concluded that a literal interpretation of the wording of Section 2 of Annex VI does not lead to an unreasonable result. The alleged contradiction in this case between the purpose and the wording of Section 2 does not stem from the wording of that provision. It derives, according to the Board, from the compliance check in the present case being limited to substance identity information only. The Board of Appeal annulled the requests for information on the crystal phases and/or nanoforms of titanium dioxide. As the requirement to submit information on nanoforms must be annulled, the Board states that there is no need to examine the requirement to submit information on the surface treatment of such nanoforms.