REACHLaw Ltd. acts as REACH Only Representative (OR) for Suzhou Xiangyuan New Materials Co., Ltd. (Suzhou) for 2,2′-dichloro-4,4′-methylenedianiline (MOCA, MbOCA) (CAS # 101-14-4; EC # 202-918-9) both for its registration obligations and authorization application. An entry for MOCA was included on Annex XIV of the REACH Regulation (the Authorization List) in August 2014 and the Sunset Date of 22nd of November 2017 was specified in the entry. This means that after this date, use of MOCA is banned unless authorised or otherwise exempted.
REACHLaw as OR for Suzhou prepared and submitted an authorization application for downstream use of MOCA as a chain extender in the production of cast polyurethanes.
- Use 1: Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production
This application was submitted before the so called “Latest Application Date” meaning that downstream users of MOCA may continue this use after 22.11.2017 under Transitional Arrangements as laid down in Article 58(1)(c)(ii) of the REACH Regulation, pending a decision from the European Commission.
The Authorisation application was submitted in May 2016 and the compiled opinion from the European Chemicals Agency (ECHA) committees was issued to the European Commission for decision making already in December 2017. The Opinion recommends granting authorisation review period of four years. The review period only comes into force once the decision granting authorisation is issued to the applicant. However due to delays in decision making at Commission level, the Commission has not yet issued its decision. In the meantime, use of MOCA is covered by transitional arrangements provided that the use is within the scope of the application and the user is in the Suzhou supply chain.
Decision making is still ongoing for the application. The European Commission required the submission of a substitution plan report for the application in 2020 (as a consequence of a court ruling on a different authorisation application). The report was submitted in 2020 and assessed by the ECHA committee during 2020-2021. The outcome of their assessment was issued to the European Commission in July 2021 as an addendum to their original opinion from 2017. Their conclusion was that the substitution plan was “not credible”.
The Commission will now take the original ECHA committee opinion and the new addendum into account when taking a decision on the application. The application is scheduled for discussion in the June 2022 REACH Committee meeting.
Details of the application reports and the committee opinions are available on the ECHA website at https://echa.europa.eu/fi/applications-for-authorisation-previous-consultations (application ID 0094-01).
MOCA use in the manufacture of polyurethanes may be fulfil the definition for “intermediate use” as clarified in a ruling by the European Court of Justice in 2017 on Case C‑650/15 P. The court ruled that ECHA in its 2010 definition on intermediates added a condition that was not in the legal text.
Considering this ruling in the context of MOCA use in the manufacture of polyurethane, MOCA use also fulfils the definition of intermediate use. Applying the rationale given in the court decision, three conditions need to be fulfilled for the use of a substance to be capable of being regarded as use of an intermediate. The first of those conditions concerns the intended purpose at the time of the manufacture and use of a substance as an intermediate, which consists of transforming that substance into another. The second condition concerns the technical means by which that processing takes place, namely a chemical process known as ‘synthesis’. The third condition restricts the scope of the definition of ‘intermediate’ to uses of a substance which remains confined to a controlled environment, which may be either the equipment within which synthesis takes place, or the site in which the manufacturing and synthesis takes place or to which that substance is transported, ‘site’ being defined in Article 3(16) of the REACH Regulation as a ‘single location’ in which infrastructure and facilities are installed.
Applying these criteria to the use of MOCA in the manufacture of polyurethanes, it can be seen that as the intended use at the time of the manufacture and use of MOCA is to transform it into another substance, the first of these three conditions is satisfied. MOCA is used in the manufacture of another substance during which it is itself transformed into that other substance, namely polyurethane. The use of MOCA to manufacture polyurethane at industrial sites also fulfils the other two criteria; namely that the reaction can be described as synthesis and is confined to a controlled environment.
Consequently, the use of MOCA in the manufacture of polyurethanes may be intermediate use meaning that authorisation is not required for this use. Use as an intermediate is exempt from the authorisation requirement.
The Commission has been asked for it view on this.
Footnote: 1.Judgment of the Court (First Chamber) of 25 October 2017, Polyelectrolyte Producers Group GEIE (PPG) and SNF SAS v European Chemicals Agency, Case C-650/15, available at http://curia.europa.eu/juris/document/document.jsf?text=&docid=195945&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=596449