COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	2,2-dichloro-4,4-methylenedianiline (MOCA)	
CAS number:	101-14-4	
EC number:	202-918-9	

The substance is identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: CMR

Disclaimer: The Response to Comments table (RCOM) has been prepared by the European Chemicals Agency. The comments were received during the public consultation of the Annex XV dossier. RCOM has not been agreed by the Member State Committee nor has the document been modified as a result of MSC discussions.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Num-ber	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
16	2011/10/13	Company
France	MOCA is a very specific product used in a particular industry segment for specific industrial application. It is no longer present as a monomer in the final articles. Careful processing of MOCA is in place for years and well monitored.
It is suspected to be carcinogenic. However no study has shown evidence of carcinogenicity. To date, the French guide values for the exposure of employees are the lowest in the world.
The Company COURBIS Synthèse designs, manufactures and sales polyurethane products since 40 years. The MbOCA is used as a hardener in the preparation and give performance and economic characteristics of the product.
Our company in its use is subject to strict rules to protect the environment and operators.
This amine is essential in the development of polyurethanes and does, in some families Polyurethane can be no substitute for reasons of cost or mainly for implementation work or performance of the final product
In addition, the effects of MbOCA is because of its ranking, very well known. Such effects are mainly by skin contact. It is therefore easy to protect themselves. Use alternative products with lesser-known effects can simplify administration of websites, but may pose new problems with the protection of employees. But the search for substitutes of Moca is on permanent sites.
	
Regarding the carcinogenicity of MOCA:

The substance is classified as a carcinogen, Carc. 1B, according to Annex VI, part 3, Table 3.1 of Regulation (EC) No 1272/2008. Consequently the substance fulfils the criteria of Article 57(a) of the REACH Regulation and can be identified as a Substance of Very High Concern following the procedure set out in article 59 of the same regulation.
Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
14	2011/10/13	National Authority
RIVM
Netherlands	NL supports the proposal to include MOCA in the candidate list of substances of very high concern. 	Thank you for providing your opinion.
	
12	2011/10/12	Member State
Belgium	Belgium supports the identification of 2,2'-dichloro-4,4'-methylenedianiline (MOCA) as SVHC according to article 57 (a)	Thank you for providing your opinion	
11	2011/10/12	International NGO
Health and Environment Alliance
Belgium	HEAL supports the nomination of MOCA to the candidate list based on the information in the Annex XV dossier.	Thank you for providing your opinion	
10	2011/10/12	Company
France	MOCA is mainly used in Europe in the hot cast elastomer processing.	Thank you for the submitted information. 

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process. 	
9	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	We support 2,2'-dichloro-4,4'-methylenedianiline entering the authorisation process. Different possible less concerning alternatives are presented within the Annex XV-Dossier. MOCA in the candidate list will help to find suitable substitutes faster and to minimise residuals in the final articles produced from MOCA.	Thank you for providing your opinion	
8	2011/10/12	Company
France	MOCA is used as a monomer by industry in closed systems, thus, this application of MOCA is exempt from authorization.
MOCA does not meet the priority criteria according to the ECHA general approach for prioritization of substances of very high concern.

MOCA is a well-known chemical, which has been used a monomer for the production of high-resilient elastomers for many decades.
 MOCA has been identified as potentially hazardous, methods of safe handling are fully available and operational and the quasi totality of its use concentrated in the hot cast polyurethane moulding industry sector.
In the synthesis process, MOCA is fully reacted in a reaction involving excess of NCO and articles are made out of the resulting polymers are used in very specific industrial applications not destined for the general population.
	Thank you for the submitted information. 

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process. 

Regarding the intermediate status of MOCA in your uses, please consult the relevant REACH guidance document in order to assess whether your uses would indeed be exempted from the authorisation requirement in  case the substance is identified as SVHC and at a later stage of the risk management process included in Annex XIV. 	
7	2011/10/12	Member State
Germany	Based on the classification as a carcinogen (Carc 1B; (EC) No 1272/2008, Annex VI, Part 3, Table 3.1), the German CA supports the identification of this substance as SVHC
 	Thank you for providing your opinion and the submitted information.

Provided that the substance will be identified as SVHC, the information submitted may, where relevant, be considered at later stages of the risk management process.	
5	2011/10/10	Industry or trade association
British Rubber and Polyurethane Products Association
United Kingdom	See attached document	Thank you for the submitted information. 

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process. 	
			See:
Comment 5 attachment (SVHC MOCA Dossier_BRPPA Response.pdf).pdf		
4	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of 2,2'-dichloro-4,4'-methylenedianiline (MOCA) as SVHC.	Thank you for providing your opinion.	
3	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for providing your opinion.	
2	2011/10/06	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification owing to its classification as carcinogen category 1B.	Thank you for providing your opinion.	
1	2011/10/06	Member State
Norway	The Norwegian CA supports that 2,2'-dichloro-4,4'-methylenedianiline (MOCA) should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for providing your opinion.	

Specific comments on the justification
Num-ber	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
15	2011/10/13	Member State
Ireland	MOCA is classified as Carc. 1B according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) of REACH. 	Thank you for providing your opinion.	
13	2011/10/13	Member State
Sweden	The Swedish CA agrees that MOCA, being classified as Carc. 1B, meets the criteria according to Article 57(a) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for providing your opinion.	
8	2011/10/12	Company
France	
MOCA has been used by industry in closed systems for the production of polyurethane elastomers. MOCA has not been used by consumers or professionals (craftsmen). 
 
The role of MOCA in the industrial synthesis of polyurethane polymers can be described as follows:
In this process, the isocyanate terminated prepolymer is reacted with MOCA with, in general, a stoichiometry (molar ratio) of less than 1 with an excess of isocyanate functions.

MOCA acts as a monomer (within the meaning of the REACH definition) in the reaction with a diisocyanate to form repeating urea groups in a polymer. This reaction leads to polyurethane chains were MOCA becomes a covalently bound monomer unit in the polymer matrix. During this chemical reaction, MOCA is consumed and transformed into another substance, the polymer. The urea group can react with the surplus of NCO groups leading to a high molecular cross-linked polymer matrix by forming biuret structures. Owing to the fact that a surplus of isocyanates/NCO-groups are typically used in the production process, the presence of significant traces of free molecules of MOCA (without any of the two NH2 function reacted) in the final polymer is not to be expected ( see 3.2.2). The reaction between MOCA and NCO-groups starts immediately after mixing in the liquid phase, which cannot be considered to be an article. The reacting mixture is then poured into a mould where it remains until it is sufficiently cured and solidified for de-moulding. Only after de-moulding the polyurea product can be considered an article. The above process is carried out by trained workers in a well-controlled industrial environment (closed systems).

Additionally, an important aspect is the fact that polyurethanes made out of TDI prepolymers and MOCA are mainly destined to specific industrial applications such as industrial rollers, wheels, mining equipment which are not used by the general population.
Comments on p. 17 (2.2.5 Intermediate status of MOCA in polyurethane uses)
Conclusion: 
In this process MOCA is acting as a monomer and thus as an intermediate which is exempt from the Authorisation process.
	See response to comment 8 in previous section.	
5	2011/10/10	Industry or trade association
British Rubber and Polyurethane Products Association
United Kingdom	See attached document	See response to comment 5 in previous section.	
			See also:
Comment 5 attachment (SVHC MOCA Dossier_BRPPA Response.pdf).pdf		
4	2011/10/10	Trade union
European Trade Union Confederation
Belgium	2,2'-dichloro-4,4'-methylenedianiline (MOCA)is included in the Trade Union Priority List for REACH authorisation.
see http://www.etuc.org/a/6023
	Thank you for the submitted information. 

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process. 	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Num-ber	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
16	2011/10/13	Company
France	1. The use of MOCA in EU is probably not more than a few hundred tons.
2.1 The use of MOCA could not be considered as very dispersive as its main use is related to PU hot cast elastomer processing which is done by highly specialized moulding companies. When reacted into the polyurethane matrix, MOCA is no longer available. Moreover the parts are going into specific industrial applications and not destined to general population.
MOCA is not “used as an additive in the polyol blend”. MOCA is used as a chain extender which is fully reacted in the process.
2.2 The large majority of MOCA  usage in EU is hot cast elastomer moulding. In this process the isocyanate terminated prepolymer is reacted with MOCA with, in general, a stochiometry (molar ratio) of less than 1 (excess of isocyanate functions).
At the end of the moulding process, after chain extension and crosslinking, the presence of free molecules of MOCA in the final polymer is not anticipated.
3.2 Moca is a well known substance for which worker exposure has been monitored for years. Biological monitoring is done according to well established protocols and demonstrates that even very low  exposure limits could be achieved with the suitable process, protection devices and inclosed transfer and processing equipments.
3.2.2 The polyurethane cast elastomer process is not using water and consequently not generating water possibly contaminated with MOCA.	Thank you for the submitted information. 

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process. 
	
10	2011/10/12	Company
France	Part II, 2.1 overview of uses, 4 uses of MOCA are mentioned but these uses seem to come from academic available literature and not from the practice. In most cases, MOCA is used as a chain extender in cast elastomer process, while “curing agent” is a generic term.
3.2 MOCA biological monitoring is made for decades and regular testing of workers are done and checked by medical/health administration. Target values in France are very low (20µg/l).
The main exposure route is dermal and adapted equipment and procedure allow now a very good protection as described in 3.2.1. 
In polyurethane cast elastomer, MOCA is fully reacted during the “in mold”phase and no longer available as a single molecule into the solid part.
3.4 and 3.5 It is important to note that articles are used only in specific industrial applications due to the very high resistance of the polymer substantial degradations are not expected and in any case the release will be part of the polyurethane matrix and not free MOCA molecules.	Thank you for the submitted information. 

Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process. 
	
9	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	P20, 3.2 Releases and occupational exposure in industrial settings
Unfortunately confidential information on releases and exposure from registration dossiers and industry questionnaires is just presented in the confidential Annex. Thus we cannot comment on this issue in suitable detail.
Workers’ exposure will be reduced dramatically if closed systems are in use. Thus we strongly demand that if uses are granted only such uses will be granted that guarantee exposure levels as low as possible.	Thank you for providing your opinion. 	
8	2011/10/12	Company
France	1)	Comments on 3.2 Releases and occupational exposure in industrial settings

Occupational exposure limits based on biological monitoring in particular post shift urinary concentrations, are well known and in place for decades.
Values mentioned in the report are from Japan and UK but as far as EU is concerned it  is interesting to mention also the very strict limit value1  (20 µg/l, equivalent to 30 µg/l of total MOCA and 15 µg/l of free MOCA) set up in France for several years.

As a summary the criteria #12 should have a score close to 0 based on the fact that MOCA does not fulfill PBT/vPvB criteria and has only limited C or M properties with a favourable context due to the experience already acquired in protection and biomonitoring.

1 Biological monitoring of employees exposed to 4-4’ Methylene-bis -2 orthochloroaniline. A. Robert, P. Ducos, JM. Francin, INRS – Int Arch Occup Environ Health (1999) 72: 222 – 223.
2 Based on ECHA document : “General approach for prioritisation of substances of very high concern (SVHC’s) for inclusion in the list of substances subject to authorization” dated 28 May 2010.

2)	Wide dispersive use
The use of MOCA for the production of polyurethane elastomers is NOT related to wide spread professional (craftsmen) or consumer use according the definitions in the REACH Guidance on information requirements and chemical safety assessment; Chapter R.12: Use descriptor system (Version 2, March 2010), but it is used in industry only.

In 2.2.2 or 2.2.3 for example, the applications listed correspond to the same technical application field of hot cast polyurethane. According to EXIMIUM, the very large majority of MOCA is used in Europe for hot cast polyurethane elastomer applications. 

Additionally, an important aspect is the fact that polyurethanes made out of TDI prepolymers and MOCA are mainly destined to specific industrial applications such as industrial rollers, wheels, mining equipment which are not used by the general population.

3)	Comments concerning 3.4 Consumer exposure
The statement (page 24): “Regarding the general population, IARC (2010) reports that the public can be exposed to MOCA in areas contaminated with MOCA or upon consumption of root crops grown in MOCA-contaminated soil. Also, family members of exposed workers have been reported to be exposed indirectly (IARC, 2010).” is based on a study conducted in the USA in 1986. The relevance of this study is questionable and should not be considered in the context of REACH.  

It is mentioned in §3.4 and §3.5 that the polymers made with TDI/MOCA formulations are extremely resistant, the releases of MOCA during their use are expected to be very low as well as their degradation with hydrolysis.

Due to the low stoichiometry level, only reacted MOCA molecules which are combined into urea or biuret functions are subject to a potential degradation, urea or biuret molecules do not represent the same hazard and do not meet any of the critical criteria.

4)	Comments concerning point 3,5
It is not realistic to assume that MOCA-containg waste water is generated during the  MOCA/NCO-reaction and the following moulding process because no water is used.
MOCA is fully reacted with isocyanate with a fully enclosed process which does not generate significant waste. 
As a conclusion, MOCA does not meet the wide dispersive use criteria#22 
in Europe.
-	Mostly used in hot cast polyurethane technical parts for industrial applications, not for general population.
-	Closed process, not generating waste, with in general isocyanate excess leading to fully reacted structure.
-	Low tendency to bioaccumulate despite persistent properties (conclusion of §6.1).

5)	High volumes
Several figures are mentioned in the report.

In part II, 1.2 – Import, export and use quantities, it is mentioned a net volume used within the EU in 2010 between 1000 and 10000 tones.
A more precise and realistic figure might be present in Annex II.
Based on the total TDI based PU consumption the total amount of MOCA in EU is most probably around 700 to 800 tones and in any case inferior to 1000t.

This will generate a volume score “relatively high” (100 -1000 t/year).

Conclusion: 
MOCA does not meet the priority criteria according to the ECHA general approach for prioritisation of substances of very high concern

MOCA is a well-known chemical, which has been used a monomer for the production of high-resilient elastomers for many decades.
 MOCA has been identified as potentially hazardous, methods of safe handling are fully available and operational and the quasi totality of its use concentrated in the hot cast polyurethane moulding industry sector.
In the synthesis process, MOCA is fully reacted in a reaction involving excess of NCO and articles are made out of the resulting polymers are used in very specific industrial applications not destined for the general population.	See response to comment 8 in part I of this document.	
7	2011/10/12	Member State
Germany	Information on uses:	
- P. 14: In view of the stoichiometry involved in a typical PU crosslinking reaction, a residual amount of 4 wt% of MOCA in the final polymer seems extreme and unlikely to occur (also see p. 21 where industry claims 0 % and 100 ppm is given as a reasonable estimate.). 
- P. 15: Although figure 2 undoubtedly visualizes different curing processes, without supporting data we fail to see how “As shown in Figure 2, the curing process improves the structure within the polymer matrix”. The figure can be deleted without harming the line of argument.

Exposure information:
P. 23, 3.3
As stated in the Dossier it seems likely that professional workers are exposed to MOCA/ MOCA-containing products even though no data are currently available. Therefore it would be helpful to estimate the occupational exposure (for example arising from the use of a bicomponent resin) in professional settings using a modelling approach. 

Information on risks related to the substance:
P. 22: We highly appreciate the information presented in Tables 9 and 10, indicating that workers are exposed. In combination with public DMELs (see below), could these data be used to estimate risks during occupational exposure?
P. 22: The exposure data could have mentioned the DMELs derived in the registration dossier. These are part of the published data on the ECHA website. However, we agree that the RCR values are correctly placed in the confidential Annex IV.	Thank you for your opinion regarding use and exposure of MOCA and the proposals made regarding the report. 

Provided that the substance is identified as SVHC, these proposals may, where relevant, be considered at later stages of the risk management process. 
	
6	2011/10/11	Company
Chemtura Belgium N.V.
Belgium	Page 21. Section 3.2.1. 
In order to minimise risk of exposure to workers involved in the handling of the MOCA (CAS 101-14-4) kegs during transportation, storage at our warehouses in Europe and when delivered to our customers warehouses, Chemtura Europe has implemented a number of key steps since 2007:
Firstly special barrier inner liners for MOCA kegs are specified packaging requirements from all our suppliers. These inner liners are made from LLDPE/PET and work carried out by Chemtura has shown that these liners prevent the migration of MOCA through the liner during transport from suppliers who are all located in Asia-Pacific region. It is more common for MOCA suppliers to use standard LDPE liners. Our work has shown that MOCA can permeate through these standard LDPE liners and thus be a potential source of dermal exposure when PU processors are handling the MOCA kegs.

Secondly, polycoated fibre kegs are specified and each of our suppliers are requested to wash (decontaminate) the outside of the kegs to remove any possible traces surface contamination by MOCA dust.

Thirdly, Chemtura Europe requires each of our MOCA suppliers to carry out swipe testing on a minimum of 10% of the kegs from each lot shipped to Europe to demonstrate that the kegs are free from surface MOCA contamination prior to shipment.

Finally, Chemtura Europe then has an independent testing body SWYPE test a minimum of 10% of the kegs from each lot received into Europe to again ensure that the risk of delivering kegs with surface contamination is minimised.

Page 21 Section 3.2.2
Work carried out by Chemtura Europe has shown that the choice of glove material is important to reduce the risk of dermal exposure.  The tests indicated that nitrile or butyl rubber gloves were more effective in delaying migration of MOCA through the glove than the more commonly used latex gloves found in workplaces.	Thank you for the information submitted. 

Provided that the substance is identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 6 attachment (Annex XV comments DSB.docx).docx		
5	2011/10/10	Industry or trade association
British Rubber and Polyurethane Products Association
United Kingdom	See attached document	See response to comment 5 in part I of this document.	
			See also:
Comment 5 attachment (SVHC MOCA Dossier_BRPPA Response.pdf).pdf		

Attachments

Comment number	Public attachment	
5	
Comment 5 attachment (SVHC MOCA Dossier_BRPPA Response.pdf).pdf	
6	
Comment 6 attachment (Annex XV comments DSB.docx).doc