19 November 2011

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

Substance name:	6-methoxy-m-toluidine	
CAS number:	120-71-8	
EC number:	204-419-1	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Carc. 1B 

Disclaimer: comments provided during public consultation are made available in this document as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain 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	
5	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for your comment.
	
4	2012/10/18	Member State
Norway	The Norwegian CA supports that 6-methoxy-m-toluidine (p-cresidine) should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for your comment.
	
3	2012/10/17	National NGO
Naturskyddsföreningen, Swedish Society for Nature Conservation (SSNC)
Sweden	The Swedish Society for Nature Conservation (SSNC) supports the proposal to categorise 6-methoxy-m-toluidine (p-cresidine) as a Substance of Very High Concern.
 
The SSNC is the largest and most influential environmental organisation in Sweden, currently with 192,000 members nationwide. The SSNC works to protect the natural environment and human health, and to strengthen global solidarity.	Thank you for your comment.
	
2	2012/10/16	National NGO
IEW
Belgium	We support the nomination of this chemical to the Candidate List as a substance of very high concern	Thank you for your comment.
	
1	2012/10/09	Member State
Germany	The German CA appreciates ECHA´s efforts to compile SVHC-Dossiers on such short notice. 

We do not fully understand the selection criteria, which are different to the approach taken so far for SVHC-identification.

Even though these substances can easily be put on the candidate list due to their CMR-classification, careful assessment of the relevance (tonnage, wide-spread use, exposure, prevention of substitution by equally hazardous substances) should be carried out for justification of the SVHC-identification. The RMO analysis is a crucial step in the process not only to share and discuss risk management options with MS but also to provide a justification for such far reaching measures.

The substance has been registered as intermediate only. Not for all substances included in this batch of 37 SVHC-dossiers, like substances which are registered as intermediates only, the inclusion on the candidate list and subsequent inclusion in Annex XIV might be the most appropriate risk management option. Without further information on potential risks that may be related to any other uses of this substance, the reason to identify this substance as SVHC remains unclear.
Therefore, we would suggest that thorough RMO analyses are prepared and shared with MSCAs as soon as possible.
	Thank you for your comment. 

In accordance with REACH Article 59 the Member States and the Commission have the right to propose substances for identification as substances of very high concern (SVHC) meeting the criteria of Article 57. 
ECHA has received a request from the Commission to prepare an Annex XV dossier proposing the identification of this substance as SVHC, which was followed by the Agency. 

Preparation of a risk management options analysis (RMOA) before proposing the identification of a substance as SVHC is a voluntary step in the co-ordination of risk management activities among the Competent Authorities for REACH but not a requirement of REACH. 

Nevertheless, ECHA agrees on the importance of identifying the most appropriate route(s) for risk management and on the co-operation and co-ordination of the regulatory risk management activities between the authorities. 	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
1	2012/10/09	Member State
Germany	No information about the physical properties is given in the report or in the technical dossier. In the report a link to the Chemical Substance Search on the ECHA website is given instead. It would be better to provide these data directly in the report (and the technical dossier), so that no further search in a database is necessary.	The proposal for identifying the substance as SVHC is based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The physical properties of the substance are in this particular case neither necessary to define the identity of the substance addressed in the dossier nor to demonstrate that it meets criteria set out in Article 57. 

If however information on the physical properties would be required to describe the substance identity or to conclude on its SVHC properties those data should be included in the Annex XV dossier.

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

Specific comments on use, exposure, alternatives and risks
No comments of this type