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

Substance name:	 imidazolidine-2-thione (2-imidazoline-2-thiol)	
CAS number:	96-45-7	
EC number:	202-506-9	

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

Disclaimer: Comments provided during the public consultation are made available in this document as submitted by the commenting parties. It was the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any confidential information.

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

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
10	2013/10/17	Member State
Norway	The Norwegian CA supports that imidazolidine-2-thione (2-imidazoline-2-thiol should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for this support	
1	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd, China	All materials supplied to STATS ChipPAC	No question	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
11	2013/10/17	Company
France	p8 :    General Rubber Goods (GRG):  we can consider that IMIDAZOLIDINE-2-THIONE (ETU) is used less than 20 day/year  so less than 4% of the work time by year. 
	Tire: no tire manufacturer uses ETU in EU.
	Some customers use IMIDAZOLIDINE-2-THIONE (ETU) for manufacturing masterbatches: ETU contained in the masterbatches is then totally consumed in the next steps of the supply chain in the GRG industry.
	Some other customers use IMIDAZOLIDINE-2-THIONE (ETU) in no-rubber industry (i.e. electroplating) 
	Thank you for this information. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 11 attachment (131016 comment ETU SVHC MLPC not confidentiel.pdf)
		
9	2013/10/17	Member State
Netherlands	In the RMO-analysis was stated that ETU is listed in the priority list within the EU strategy for endocrine disruptors as a Category 1 endocrine disrupter (at least one study providing evidence of endocrine disruption in an intact organism). This information has not been included in the Annex XV SVHC dossier and it could be considered to add this information. 	Indeed we could have added that information in the Annex. However, the basis for the SVHC identification is the harmonized classification as Repro. Cat 1B.	
8	2013/10/17	Member State 
Germany	The German CA supports the inclusion of Imidazolidine-2-thione in the Candidate List.	Thank you for this support	
5	2013/10/15	Member State Belgium	Belgium supports the proposal to identify Imidazolidine-2-thione as SVHC, based on article 57(c) of the REACH Regulation due to the classification as Repr. Cat. 1B.	Thank you for this support	
4	2013/10/15	International NGO, ChemSec, Sweden	ChemSec supports the Swedish proposal to list Imidazolidine-2-thione; 2-imidazoline-2-thiol
to the REACH candidate list of Substances of Very High Concern (SVHC) on the basis of meeting the criteria for classification as toxic for reproduction (Art. 57 c).

The substance is listed in Annex VI, part 3, Table 3.1 of the CLP Regulation (EC) No 1272 as Repr. 1B.
The listing of Imidazolidine-2-thione; 2-imidazoline-2-thiol on the SVHC candidate list is therefore justified according to Art. 59 (2) of REACH.

We thank the Swedish government for their engagement in environmental and human health protection.	Thank you for this support	
2	2013/09/25	Trade union, European Trade Union Confederation, Belgium	ETUC supports the identification of  Imidazolidine-2-thione (2-imidazoline-2-thiol as a SVHC. The substance is included in the Trade Union Priority List for REAHC authorisation. see:
http://www.etuc.org/a/6023	Thank you for this support	
1	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd, China	All materials supplied to STATS ChipPAC	No question	

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

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
11	2013/10/17	Company
France	p10 : list of the usages -General Rubber Goods (GRG), masterbatches & not rubber usage (electroplating)
p14 : precision of the usage in GRG + mechanism description
p15 : precision on the alternatives 	Thank you for this information. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 11 attachment (131016 comment ETU SVHC MLPC not confidentiel.pdf)
		
7	2013/10/17	Industry or trade association, SNCP, France	Information on alternative substances and techniques

La profession du caoutchouc utilise l'imidazolidine-2-thione comme accélérateur de vulcanisation pour différent mélanges.
En raison de son classement, l'ETU est manipulé par les industriels selon les meilleures gestions de maîtrise des risques. De ce fait de nombreux industriels utilisent l'ETU sous forme empâtée afin de réduire les expositions. De plus les équipements sont sous aspirations.
Plusieurs dizaines de formules sont concernées et cela représente un chiffre d'affaires de plusieurs millions d'euros. 
Au vu de son classement la profession a déjà travaillé à l'identification de solutions alternatives. Si de nombreuses études ont été menées pour les mélanges CR (polychloroprène) et EPDM (copolymère éthylène-propylène-diène), les données pour les mélanges ECO (epichlorhydrine) sont quasiment inexistantes à ce jour. 
Si des solutions ont pu être identifiées lors de ces études, elles-montrent de manière générale des niveaux de compression set sensiblement dégradés et parfois incompatibles avec les spécifications en vigueur (ex : applications joints d’étanchéité). De plus pour certaines applications, les vitesses de vulcanisation ne sont pas satisfaisantes et ne permettent pas d'identifier des solutions alternatives envisageables..
Certaines applications doivent répondre aux normes de l’aéronautique, au secteur militaire mais aussi au classement feu fumée (selon la norme NFT 16-101) dans le secteur du BTP. Des requalifications seront donc à prévoir. 
En conclusion, bien que la profession travaille activement à la substituions de l'ETU dans ses mélanges caoutchouc et bien que certaines solutions aient pu être identifiées, du temps et des investissement notables seront nécessaires afin d'identifier les solutions adéquates pour les différentes applications. 
Pour exemple, des mélanges réalisés pour un procédé par extrusion doivent prendre en compte le gonflement dans la filière d'extrusion. Si le gonflement avec la solution alternative devait être différent, chaque filière devrait alors être changée. Ainsi, pour une usine ayant 200 filières cela représenterait à minima un coût de 200 000€ et plusieurs mois de travaux d'adaptation.	Thank you for this information. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
6	2013/10/15	Company, Lehmann & Voss & Co. KG, Germany	Page 16+17 / Risk-related information:
- Ethylene thiourea (ETU) use as accelerator for curing of Chloroprene rubber is not a wide-spread but more specialized application (low number of marketers, low number of applicants, low number of people involved in ETU-handling within EC)

- ETU is not present in the end-article but ‘consumed’ during the destinated CR-cure application, i.e. converted into less hamful substances

- according to a physical laboratory study (based on DIN),  ETU masterbatches are not able to generate hazardous volatile dusts of ETU under mechanical wear (this has been tested by an accredited laboratory on our behalf)	Thank you for this information. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
3	2013/10/11	Industry or trade association, Chloroprene Rubber Technical Committee, Synthetic Rubber Industory Association, Japan	1. Use of ETU (p.14–15)
Ethylene thiourea (ETU) is used principally as an accelerator for vulcanizing chloroprene rubber (CR, or polychloroprene) in the manufacture of numerous articles. ETU shows significant performance as an accelerator for vulcanization. No alternatives to and with the same performance as ETU are available in the market or permitted for use under the regulations. 

2. Residual ETU (p.17)
ETU is added to CR together with other materials in the process of manufacturing articles. As vulcanization proceeds, ETU is chemically changed to ethylene urea (CAS No. 120-93-4), such that the residual ETU in the manufactured article after vulcanization is far below 0.1 % (see the attached analytical data: Comment 3 attachment (Quantitative Analysis of Residual ETU.pdf)).

According to analytical data, the residual ETU in an article of mercaptan-modified CR is from 0.0007% through 0.0035% and that in an article of sulfur-modified CR is from 0.0297% through 0.0783%. Given the market constitution of these two types of CR, the weighted average of the residual ETU in all CR articles is approximately 0.01%.

3. Estimated annual consumption of ETU(p.15)
It is assumed under the following conditions that the annual consumption of ETU around the world is 1,500 metric tons (t) at most.

Annual consumption of ETU = Annual consumption of CR x Ratio of ETU used x Ratio of ETU added 
Annual consumption of CR:
Assumed annual consumption of CR is 300,000 metric tons.
Ratio of ETU used: 
It is assumed that ETU is added to 50% of the CR consumed annually. 
   (CR applications not in need of vulcanization, such as adhesives, or for which vulcanization accelerators other than ETU are used are excluded.) 
Ratio of ETU added:
   It is assumed that 1% of ETU is added to CR.
300,000 t x 50% x 1% = 1,500 t

Note:
Accurate information of ETU consumption should be provided by ETU manufacturers.

It needs to be carefully noted that 1,500 metric tons is the estimated annual global consumption of ETU. As stated earlier, ETU substantially disappears in manufactured articles following vulcanization. Since the weighted average of residual ETU in CR articles is 0.01%, the annual volume of residual ETU in CR articles worldwide is only 0.15 t. 

4. Exposure (p.16–17)
ETU, as stated previously, dissipates as vulcanization proceeds, leaving little residual ETU in manufactured articles containing CR, which have superb durability with little degradation. As such, it should be acknowledged that workers involved in the manufacture of CR articles and, after the CR article manufacturing process, consumers and the environment are exposed to negligible amounts of ETU. 

Most CR is used in industrial applications, such as automotive parts and adhesives. We believe that the amount of CR used for such consumer applications as wetsuits is less than 3% of total global CR consumption. Again, consumer exposure is limited.  

A dossier from the Swedish Chemicals Agency mentions consumer applications for CR other than wetsuits. But we have no knowledge that CR in such consumer applications as T-shirts, socks, bathing shoes, flip-flop and other sandals, wrist braces, elbow and thigh supports, and kayaking gloves and hoods.

Consequently, the exposure to ETU is limited to (1) the exposure of the workers engaged in manufacturing ETU, (2) the exposure of workers during the transportation and storage of ETU, and (3) the exposure of workers involved in the manufacturing process for CR articles.

1) Exposure of workers engaged in manufacturing ETU
As far as we know, ETU is manufactured utilizing a closed process and is packed in a closed system, such as a flexible container. There is a possibility of exposure caused by the scattering of ETU during packaging, but an oil component in the amount of about 5% is added to ETU to suppress scattering. In addition, regulations prescribe such preventative measures as ventilation systems and personal protective equipment, including masks, in the working environment where scattered ETU particles are expected, thereby strictly controlling and minimizing the exposure of workers to ETU.

2) Exposure of workers during the transportation and storage of ETU
As far as we know, the transportation and storage of ETU occurs within a closed system. The possibility of worker exposure to ETU is thereby minimized. 

3) Exposure of workers involved in the manufacturing process for CR articles
As far as we know, where the manufacturers of CR articles use sealed-type kneading machines during the compounding process the scattering of ETU is prevented and the exposure of workers negligible. Even where CR articles are made using open-type kneading machines, manufacturers take every precaution to prevent the scattering of ETU and operate under strict regulatory preventative measures that call for appropriate ventilation and for such personal protective equipment as masks to control and minimize the exposure of workers to ETU.	Thank you for this information. 

Comments regarding use, exposure, alternatives and risks may, where relevant, be considered at later stages of the risk management process.	
1	2013/09/22	Company
ANDA Technology(Suzhou)
Co.,Ltd, China	All materials supplied to STATS ChipPAC	No question	

Attachments

Comment number	Public attachment	
11	

Comment 11 attachment (131016 comment ETU SVHC MLPC not confidentiel.pdf)	
3	
Comment 3 attachment (Quantitative Analysis of Residual ETU.pdf)