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

Substance name:	Disodium 4-amino-3-[[4-[(2,4-diaminophenyl)azo][1,1-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38)	
CAS number:	1937-37-7	
EC number:	217-710-3	

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	
7	2013/10/17	Member State
Norway	The Norwegian CA supports that disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo][1,1'-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (C.I. Direct Black 38) should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support. 	
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd
China	All materials supplied to STATS ChipPAC	Due to lack of detail we cannot assess the  relevance of this comment, with STATS ChipPAC being a private company according to internet.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
6	2013/10/15	Member State
Belgium	Belgium supports the proposal to identify C.I.Direct Black 38 as SVHC, based on article 57(a) of the REACH Regulation due to the classification as Carc. Cat. 1B.	Thank you your support.	
5	2013/10/15	International NGO
ChemSec
Sweden	ChemSec supports the Dutch proposal to list C.I. Direct Black 38 to the REACH candidate list of Substances of Very High Concern (SVHC) on the basis of its carcinogenic properties (Art. 57 a).

The substance is classified in Annex VI, part 3, Table 3.1 of the CLP Regulation (EC) No 1272 as Carc. 1B.
The listing of C.I. Black 38 on the SVHC candidate list is therefore justified according to Art. 59 (2) of REACH.

We thank the Dutch government for their engagement in environmental and human health protection. Despite the fact that the substance is not registered within REACH, the official listing as a SVHC will enable identification of its presence in imported article(s) (uses in imported articles have been identified in the Annex XV report) and promote upstream substitution within the supply chain.	Thank you for your support.	
4	2013/10/15	Member State
Germany	The German CA supports the inclusion of Direct Black 38 in the Candidate List.	Thank you for your support.

Please note that this dossier is for Direct Black 38. For your comments with respect to Direct Red we would like to refer to the RCOM file for Direct Red 28. 	
3	2013/09/25	Trade union
European Trade Union Confederation
Belgium	ETUh supports the identification of this substance as SVHC.	Thank you for your support.	
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd
China	All materials supplied to STATS ChipPAC	Due to lack of detail we cannot assess the  relevance of this comment, with STATS ChipPAC being a private company according to internet.	

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	
4	2013/10/15	Member State
Germany	P.17 f
The SVHC dossier contains an „indicative“ exposure assessment in order to derive estimates of “potential worst case consumer exposure”. The input parameters and models for the exposure assessment should be fully documented in the SVHC Dossier. For further details, see confidential attachment.	Exposure assessment is not included in the support document. Therefore, the suggestion cannot be taken into account at this stage. 

Please note that this dossier is for Direct Black 38. For your comments with respect to Direct Red we would like to refer to the RCOM file for Direct Red 28.	
2	2013/09/22	Company
ANDA Technology(Suzhou)Co.,Ltd
China	All materials supplied to STATS ChipPAC	Due to lack of detail we cannot assess the  relevance of this comment, with STATS ChipPAC being a private company according to internet.