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

On 3.10.2023, REACHLaw acting as only representative applicant for Suzhou Xiangyuan New Materials Co., Ltd., requested the withdrawal of its application for authorisation submitted in 2016 for the use of 2,2′-dichloro-4,4′-methylenedianiline (MOCA, MbOCA) (CAS # 101-14-4; EC # 202-918-9)  

• ECHA ID 0094-01: Industrial use of MOCA as a curing agent/chain extender in cast polyurethane elastomer production 

Following the 2017 European Court of Justice ruling on Case C‑650/15 P and the subsequent publication of updated ECHA Guidance on Intermediates in January 2023, the use of MOCA in the manufacture of polyurethane substances as described in the application for most downstream users will fulfil the 3 criteria for “intermediate use”. 

 For reference, these are 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. MOCA is reacted with the other reactants in 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 in compliance with national transpositions of the Industrial Emissions Directive, the Carcinogens and Mutagens Directive and the Chemicals Agents Directive. 

As intermediate uses are exempt from the authorisation requirement, the application was unnecessary.

Details of the history of the application and the relevant court rulings are given below for reference.  

The use of MOCA as curing agent/chain extender in cast polyurethane production was not considered to be “intermediate use” based on the following text in the Annex XV dossier;  

“According to the guidance on intermediates (ECHA 2010) document a substance should not be regarded as intermediate as soon as the main aim of the chemical process is not to manufacture another substance, but rather to achieve another function, specific property, or a chemical reaction as an integrated part of producing articles (semi-finished or finished). In accordance with this statement, the end use described above and the use as curing agent described in section 2.2.1 cannot be regarded as use of MOCA as intermediate.  

Similarly, it appears not possible to consider the use of MOCA as a cross-linking agent as use of the substance as intermediate.” (emphasis added) 

On this understanding, REACHLaw Ltd. acting as REACH Only Representative (OR) for Suzhou Xiangyuan New Materials Co., Ltd. (Suzhou) prepared and submitted an authorization application for downstream use of MOCA as a chain extender in the production of cast polyurethanes.  

• ECHA ID # 0094-001: 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 could 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 opinion of the European Chemicals Agency (ECHA) committees recommending granting authorisation was issued to the European Commission for decision making already in December 2017. There were delays in decision making at the Commission following the annulment of the lead chromate authorisation (Case T837/16) in 2019 and the retrospective request for the submission of a substitution plan with the application. The substitution plan was duly submitted to ECHA in 2020 and was 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 prepared a draft implementing decision agreeing with the ECHA committee opinion that the substitution plan was “not credible”. The draft refuses authorisation as the submission of a substitution plan is considered to be a condition for granting authorisation when the Commission considers that the use has “suitable alternatives generally available”. On the 14th September 2023, the members of the REACH committee voted to pass the draft decision refusing authorisation. The decision would normally be adopted and issued to REACHLaw (as OR for Suzhou) in the coming months.  

October 2023: REACHLaw has requested the Commission to withdraw the application to avoid uncertainty for downstream users who have determined their use fulfils the 3 criteria for “intermediate use” as given in the updated ECHA Guidance on intermediates published in January 2023.  

A ruling by the European Court of Justice in 2017 on Case C650/15 P[1] clarified that ECHA in its 2010 definition on intermediates added a condition that was not in the legal text (namely that there is no “main aim” criterion).  

2017 clarification of “intermediate use” According to the court ruling, 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. 

Note that the court clarification means that the “main aim” reasoning invoked in the MOCA Annex XV dossier for the conclusion that MOCA use as a curing agent/chain extender is not intermediate use is not valid and that solely the 3 criteria given in the court ruling are relevant. 

Applying these 3 criteria to the use of MOCA in the manufacture of polyurethane substances, 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 (a polymer), 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. 

2023 ECHA revised Guidance 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 fulfils the criteria to be considered as intermediate use and is therefore be exempt from the authorisation requirement.  

The application was withdrawn as authorisation is not required for this use in light of the court clarification of the criteria for “intermediate use” and the subsequent update to the ECHA guidance on intermediates published in January 2023.  

It is the responsibility of the users themselves to determine if use of MOCA at their site with their conditions of use fulfils the 3 criteria given above. The rationale for the decision should be available for inspection if requested by national enforcement authorities.

If you need assistance determining whether your use fulfils the “intermediate use” criteria, contact ;for more information.   

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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