A group of titanium dioxide producers have won an appeal against an Echa Decision asking them to give detailed information about the substance's nanoform as part of the information required on substance identity.
The Echa Board of Appeal ruling makes it clear that while information on the hazards of a substance's nanoform should be addressed by the scientific information provided in a registration dossier, the agency cannot demand such information on the grounds that the dossier fails to provide enough information on substance identity.
Echa sent the Decision to lead registrant Tioxide Europe in 2014. It required it to give detailed substance identity information on the crystal phases, nanoforms and surface treatment of nanoforms covered by the registration.
The agency accepted that the text of the relevant annex of the REACH Regulation does not include an explicit provision for the information it was seeking. But, backed by the French REACH competent authority, it argued that a registration must, in principle, address separately the toxicological and ecotoxicological properties of every crystal phase and nanoform covered by a dossier.
Alternatively, Echa and the French authority argued, a registrant could establish scientifically that differences in physical properties between different crystal phases or nanoforms do not result in different different toxicological and ecotoxicological properties.
But the BoA rejected this argument. It ruled that if the wording of a provision of EU law is clear and precise – as it decided it was in this case – its contextual meaning or apparent purpose must be applied according to its wording, and could not be interpreted by the agency to require the detailed substance information it was seeking.
It also rejected Echa's argument that a literal interpretation of the wording would prevent a high level of health and environmental protection. A registrant, it said, can give a broad definition of the substance it intends to register, for example, by including both its bulk and nanoforms – but if it does so, the hazards posed by all possible forms must be addressed by the toxicological and ecotoxicological information provided in the dossier.
The text of the REACH Regulation does allow the agency to require this information in a dossier, says the BoA – but it would have to go about it in a different way.
Different approach would work
For example, the BoA says, a compliance check of the toxicological and ecotoxicological information submitted, rather than substance identity information only, will allow the agency to consider whether all the required information regarding, inter alia, the human health and environmental effects of the substance have been submitted.
Furthermore, the BoA adds, a decision taken under the REACH substance evaluation process could request further information that is needed to clarify a potential concern.
Asked what action it intends to take in light of the ruling, Echa said it will assess the reasons set out in the document and consider their impact on regulatory strategy for nanomaterials.
However, it noted "the board considered the obligations of registrants defining broadly their substances and said that the registrants must demonstrate the safe use of all the forms possibly covered by the broad definition."