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.
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).
Status September 2022: Decision making is still ongoing but it is likely that a draft decision refusing authorisation will be prepared in Q1 2023 due to the “non-credible” substitution plan. The draft will be put for a vote before the REACH committee and a qualified majority is needed for the vote to pass.
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.
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
September 2022: Based on information received from the Commission on whether the use of MOCA as described in this application fulfils “intermediate use” criteria, each user should contact their national enforcement authority, present their rationale for why their use is “intermediate use” and ask for confirmation that their use fulfils the criteria and authorisation is not needed.
The rationale is given below and the list of national enforcement authorities is available on the ECHA webpage (contact details on the ECHA website: https://echa.europa.eu/regulations/enforcement/national-inspectorates).
Considerations on whether MOCA use in the manufacture of polyurethane substances at industrial sites fulfils the 3 conditions given in the March 2022 ECHA Guidance on Intermediates
We have carefully considered the draft update of the ECHA guidance on intermediates that was made available in March 2022. The guidance gives the three conditions that must be fulfilled for a use to be considered “intermediate use”.
Considering the 1st condition, the draft guidance states that this condition is fulfilled when the following conditions are met;
- it can be demonstrated that the intermediate substance has been manufactured and used with the intention to be transformed into another substance
- it can be demonstrated that the intermediate substance has been actually transformed into another substance
- Information can be provided on the identify the other substance into which the intermediate has been transformed
These conditions are fulfilled as MOCA is manufactured and supplied to be used as a reactant in the manufacture of polyurethanes. MOCA is consumed in the reaction to yield a polymer substance, polyurethane.
Considering the 2nd condition, the draft guidance states it is fulfilled when the following conditions are met;
- it can be demonstrated that the transformation of the intermediate substance into another substance (link to condition 1) takes place in the context of a chemical process and a specific equipment is used for this process;
- that chemical process is a ‘synthesis’ process;
- it can be demonstrated that, to avoid risks for human health and the environment, the intermediate substance remains contained after its manufacturing throughout the whole chemical process. The containment of the intermediate substance must be ensured by technical means at the site (for an on-site isolated intermediate) or during the transport/storage at the site where it is later used (for a transported isolated intermediate).
These conditions are fulfilled as MOCA is used at industrial sites in dedicated equipment for the manufacture of polyurethanes. The process is synthesis whereby the reactants including MOCA are transformed to a polymer substance, polyurethane. MOCA is transported from the site of manufacture (in Suzhou, China) to the sites of use in sealed drums. At the majority of the sites of use, the drums are opened in glove boxes and fed via closed systems to a casting machine.
Considering the 3rd condition, the draft guidance states that this condition is fulfilled when the following conditions are met;
- it can be demonstrated that the equipment or site where the chemical processing takes place is a controlled environment ensuring the confinement of the intermediate substance through technical means avoiding risks for human health and the environment (link to condition 2) where transformation to another substance takes place (link to condition 1);
- it can be demonstrated that in case the intermediate substance is removed from the equipment during the chemical process, the intermediate substance remains confined to a controlled environment through technical means avoiding risks for human health and the environment (link to condition 2).
These conditions are fulfilled as MOCA is used at industrial sites in dedicated equipment where technical and organisation controls are in place to avoid risks to human health and the environment.
For the reasons outlined above, the use of MOCA in the manufacture of polyurethanes at most use sites described in the 2016 application fulfils the criteria to be considered as intermediate use.