REACHLaw as only representative applicant for authorisation for SUZHOU XIANGYUAN NEW MATERIALS CO., LTD. for:

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 22^nd 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 February 2023: The draft decision is scheduled for “discussion followed by written vote” in the 26 – 27 April 2023 REACH Committee meeting. Our current understanding is that the draft decision will refuse authorisation. The draft will be put for a vote before the REACH committee and a qualified majority is needed for the vote to pass. If the draft decision passes, the decision comes into force when it is issued to REACHLaw (as OR for Suzhou). This may be in Q3 or Q4 depending on the timing.  

What does this mean for users and suppliers of MOCA? 

Once the decision comes into force, transitional arrangements end and users must stop their use if they do not have an own authorisation in place or are otherwise exempted from the authorisation requirement (e.g. intermediate use). Suppliers may only supply MOCA for authorised or exempted uses.  Users must communicate their authorisation number with the supplier or that their use is exempted from the authorisation requirement. Note it is the responsibility of the users to determine if their use is exempted from the authorisation requirement.  

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[1]. 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 may now 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.

ECHA published its updated guidance on Intermediates in January 2023.2 Annex A4.3 gives the conditions of use of substances as intermediates. MOCA use in the manufacture of polyurethane substances may fulfil the conditions as given below; 

1. 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.  
2. 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. 
3. MOCA is used at industrial sites in dedicated equipment where technical and organisational 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 may fulfil the criteria to be considered as intermediate use and may therefore be exempt from the authorisation requirement.  

It is the responsibility of the users to determine if use of MOCA at their site with their conditions of use fulfils the criteria given above. The rationale for the decision should be available for inspection if requested by national enforcement authorities.  

__________________________________________________________

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    

Footnote: 2.  https://echa.europa.eu/guidance-documents/guidance-on-reach