The Echa Board of Appeal (BoA) recently issued a Decision in a case regarding REACH evaluation, which is important for registrants facing a substance evaluation check. In these checks, Echa can request REACH registrants to provide information that goes above and beyond registration information requirements.
The BoA acknowledged this point but ultimately concluded that requiring monomer registrants to provide certain polymer-related data in this case went too far. This was particularly the case, because the registrants did not have that information, and could not legally compel downstream companies to provide it.
Back in February 2012, nonylphenol (NP) was included on the community rolling action plan (Corap) for assessment under REACH substance evaluation. The UK Health and Safety Executive (HSE), as the member state competent authority (MSCA), conducted an initial assessment and decided that it wanted more information, particularly on derivative polymers.
Requiring monomer registrants to provide polymer-related data raised serious concerns and objections, both from the registrants and the Echa secretariat. In a proposal to amend the draft Decision, Echa itself told the HSE that “instead of requesting this information from the registrants”, it should “consider doing the assessment themselves”.
Despite all this, in April 2016, Echa adopted a substance evaluation Decision, requiring the monomer registrants to provide information on polymer impurities and polymer degradation products. In previous evaluation Decisions, Echa had made similar requests to registrants, but these registrants had not appealed those Decisions.
During the NP appeal case, Echa argued at length that the monomer registrants were, in its view, legally required to provide information in their registration dossiers on any derivative substance made using a monomer substance, such as polymer substances, if these were not subject to REACH registration.
The agency made the case that such registrants were legally required to provide information on the whole lifecycle of a monomer which, in its view, should not end with polymerisation. One of Echa’s core arguments was that registrants must cover, in their dossiers, every single derivative substance made using the initial monomer substance which had not itself been registered.
In its Decision, the BoA essentially ignored the arguments which Echa made during the case regarding monomer lifecycle. Instead, it reiterated the legal principles established almost ten years ago in a Judgment by the Court of Justice of the European Union (CJEU) in Luxembourg: that a monomer ceases to be a monomer upon polymerisation and becomes a different substance.
REACH substance evaluation provisions are different from registration information requirements. The board therefore homed in on the issue of whether – under the former, not the latter – it was legally possible for Echa to require monomer registrants to provide information on derivative polymer substances.
The BoA specifically noted that, “if appropriate” and proportionate, it was legally possible, in principle, for Echa to require information to clarify a suspected concern. This may relate to risk from, and exposure to, a monomer, even when that monomer was no longer a ‘substance’ for REACH purposes, but an impurity of a polymer substance or a degradation product of a derivative polymer substance.
The appellants had strongly argued that there was no possibility of exposure via certain polymers and that, in any event, there was no suspected or relevant concern in this case. The core issue for the HSE was an alleged difference between the registration tonnages of NP recorded in the dossiers and the levels of emissions it had calculated using modelling data as being released into the environment.
The appellants argued that this method was unreliable. Therefore, they claimed, any purported difference between the registration tonnages and the alleged emissions had not been sufficiently determined and could not constitute a valid ‘concern’. During the substance evaluation, the HSE itself had recognised that exposure to NP from the direct uses of the monomer registrants was insignificant.
Although the board did recite the precautionary principle – which relates to the existence of a ‘specific potential risk’ – in its Decision, the application of the principle to the facts was not fully covered. In any event, the NP registrants’ core reason for bringing the appeal was because they felt strongly that Echa could not legally require them to provide information which they did not have and could not legally oblige the downstream companies to provide. Of the 13 companies involved, only one actually manufactured a polymer using NP.
During the appeal, Echa argued that NP registrants should essentially act as policemen within their own supply chains. They should find out what all the downstream companies’ uses and exact volumes are and update their registration dossiers accordingly. Where downstream companies refused to provide information, registrants should cut them out of their supply chains altogether.
The registrants submitted lengthy arguments in the appeal, contesting that there was no legal obligation for downstream companies supplying a different and separate (polymer) substance and downstream users of the same substance to provide any information to upstream registrants. Forcing them to obtain commercially sensitive information would impinge upon competition law compliance issues, they argued.
In its Decision, the board recognised that these downstream users are under no legal obligation to provide information to upstream entities and that the choice about doing so rests with them. Most significantly, it concluded that a substance evaluation decision cannot “oblige registrants to provide information which they can neither assuredly obtain nor generate themselves”.
The BoA’s Decision did not explore in depth some of the specific pleas that were raised by the appellants and discussed in depth in during the appeal and oral hearing.
The appellants had repeatedly pointed to an apparent contradiction and confusion in the Echa Decision on how the data must be submitted to the agency. Conflicting remarks were made about how polymers should be grouped. They also raised questions on how Echa can require registrants to embark upon a speculative testing regime in the hope of finding a more sensitive species, despite the use of an artificially high assessment factor in the predicted no-effect concentration (Pnec) derivation.
The opportunity to clarify these points was therefore not fully taken. Nonetheless, the board’s Decision does shed some light on the boundary line – and on when it would be too much for Echa to require monomer registrants to provide polymer data in the context of REACH substance evaluation.