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

Substance name:	Disodium 3,3-[[1,1-biphenyl]-4,4-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28)	
CAS number:	573-58-0	
EC number:	209-358-4	

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 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate) (C.I. Direct Red 28) should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support.	
1	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 Red 28 as SVHC, based on article 57(a) of the REACH Regulation due to the classification as Carc. Cat. 1B.	Thank you for your support.	
5	2013/10/15	International NGO
ChemSec
Sweden	ChemSec supports the Dutch proposal to list C.I. Direct Red 28 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. Red 28 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.	
3	2013/10/15	Member State
Germany	The German CA supports the inclusion of Direct Red 28 in the Candidate List.	Thank you for your support.
	
2	2013/09/25	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as a SVHC	Thank you for your support.	

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	Company
Germany	Congo red is used as such or in formulations for scientific R&D, e.g. as stain for tissues.

These applications are routine analytical uses in a laboratory within the scope of scientific R&D. The risk for the environment and consumers is very low. Usually the volumes and the concentration of the substance are low. The disposal of the substance is also controlled.

Additionally, a diagnostic use of congo red is the essential histologic stain for demonstrating the presence of amyloidosis in fixed tissues.

Therefore, the use of congo red as analytical or diagnostic standard should be exempted from authorisation (scientific R&D) as well as the formulation of mixtures for R&D purpose and packaging/refilling of the pure substance and mixtures into small packages for this use.	We are aware of the use of Congo red as a stain and indicator, mostly in laboratory setting, as also described in the SVHC-proposal. 
In the procedure for identification as an SVHC, there is no possibility for making exemptions (a substance is an SVHC or not).  It is stated (with respect to authorisation) in Art. 56 (3) that paragraphs 1 and 2 shall not apply to the use of substances in scientific research and development. Annex XIV shall specify if paragraphs 1 and 2 apply to product and process orientated research and development as well as the maximum quantity exempted. 	
3	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. 	
1	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.