Registration of REACH "intermediates"?
The General Court of the European Union ("General Court") has clarified the concept of REACH "intermediates" in a judgment delivered on 25 September 2015 in Case T-268/10 RENV, PPG and SNF SAS v ECHA.
According to the General Court, where a substance is not used "with the aim of manufacturing (…) other substance" but the main purpose of the chemical process and reaction is to obtain a specific functionality of a substance, the use cannot be considered "intermediate" for the purposes of the REACH Regulation.
Context of the judgment
The question as to whether the substance – acrylamide – amounted to an "intermediate" under the REACH Regulation arose in the context of a decision of the European Chemicals Agency (ECHA) to identify acrylamide as a substance of very high concern ("SVHC") and thus to place it on the so-called Candidate List. The placing of a substance on the Candidate List may entail the inclusion of a substance on the authorisation list, which, in turn, can see the use of such a substance becoming subject to a prior authorisation granted by the European Commission.
The applicants – an association representing the producers and importers of polyelectrolytes, polyacrylamide and other polymers containing acrylamide, and a manufacturer of acrylamide and polyacrylamide – sought to argue that as acrylamide was used exclusively as an intermediate, it was, as such, exempted inter alia from the authorisation process, including the precursory stages of SVCH identification and Candidate List inclusion.
Concept of an "intermediate" under the REACH Regulation
In accordance with Article 3(15) of the REACH Regulation, an "intermediate" is a substance "manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis)".
In accordance with Article 2(1)(c) of the REACH Regulation, the provisions of the regulation do not apply to "non-isolated intermediates" (as defined in Article 3(15)(a) of the same). At the same time, "on-site isolated intermediates" and "transported isolated intermediates", as defined in Article 3(15)(b)-(c) of the REACH Regulation, are exempted from the general registration obligation and the REACH authorisation process, as foreseen by Article 2(8) of the regulation. Instead, as a general rule, reduced information requirements apply to the registration of these latter types of intermediates.
The applicants argued that the substance was manufactured and imported in order to be consumed or used in the synthesis of another substance, namely water-impervious polymer, and thus constituted an intermediate.
General Court's interpretation of the concept of "intermediate"
The General Court sided with ECHA in disagreeing with the applicant's characterisation of the substance's use as an "intermediate". The General Court observed that while acrylamide-based grouting agent is used in the manufacture of another substance, it is itself transformed during the manufacturing process into such other substance, namely a polymer. However, no synthesis occurs within the meaning of Article 3(15) of the REACH Regulation. Accordingly, the substance is not used with the aim of manufacturing another substance but rather the main purpose of the chemical process is to obtain a sealing function that occurs when the acrylamide grouting agent polymerises. Thus, the General Court concluded that the use of acrylamide as a grouting agent could not be considered an intermediate use but rather an end-use.
In reaching its conclusion, the General Court referred to the "Definition of intermediates as agreed by Commission, Member States and ECHA on 4 May 2010" and noted that where a substance, used by a manufacturer or a downstream user, chemically reacts in a process other than the manufacturing of another substance, the substance in question cannot be an intermediate. Similarly, where the main aim of the chemical process is not to produce another substance but to achieve another function, specific property or a chemical reaction, the substance used in such activity should not be considered an intermediate. In this context, the fact that all registrants of acrylamide had identified the substance as an intermediate or that in a specific end-use acrylamide was transformed into another substance, were not considered decisive.
Identification of acrylamide as a substance of very high concern
As regards to the applicants' claim that acrylamide could not be identified as a SVHC given that Article 2(8)(b) of the REACH Regulation exempts certain intermediates from the REACH authorisation provisions, the General Court disagreed again.
The General Court noted, referring to the general definition of "substance" contained in Article 3(1) of the REACH Regulation, that "substances" are defined by their intrinsic properties. As acrylamide constituted a substance within the meaning of the said provision, the General Court considered that it could be the subject of a procedure identifying SVHCs. Conversely, the characterisation of a substance as an "intermediate" depends on the intended purpose of its manufacture and use. It followed, according to the General Court, that the status of an intermediate could not exempt a substance from the process of identifying SVHCs.
Registrants of intermediates to verify that conditions for "intermediate" use are fulfilled
The General Court's judgment has provided some clarification of what constitutes an "intermediate" under the REACH Regulation. Registrants of intermediates are encouraged to verify that substances, which have been registered as intermediates fulfil the REACH Regulation criteria. ECHA has in the past actively verified that substances registered as intermediates fulfil the strict criteria set in the legislation, including, in particular, as regards to the use, and it has referred cases to Member States enforcement authorities where identified discrepancies in the characterisation have not been addressed.