19 November 2011

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

Substance name:	4-o-tolylazo-o-toluidine	
CAS number:	97-56-3	
EC number:	202-591-2	

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	
8	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.	
7	2012/10/18	Industry or trade association
GIFAS
France	PLEASE REFER TO ATTACHED DOCUMENT	Regarding further information provided: 

Thank you for your comments and the information provided. 

As regards the quality of the dossiers, please note that the current proposal for identifying the substance as a substance of very high concern (SVHC) is in accordance with REACH Article 59(2) based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The additional mentioned information is not relevant for determining whether the substance meets the criteria for identification as SVHC. However, when examining whether the substance should be recommended for inclusion in Annex XIV, ECHA will indeed have to assess available information on uses and exposures. In addition, information on work already done by industry to identify and assess potential alternatives is used in defining transitional arrangements in the draft Annex XIV entries for the recommended substances. This information will be collected by ECHA before prioritising the substances and defining the transitional arrangements for its recommendation. The generic approaches for prioritisation and defining the draft Annex XIV entries are available at: http://echa.europa.eu/documents/10162/13640/axiv_prioritysetting_general_approach_20100701_en.pdf and http://echa.europa.eu/documents/10162/13640/draft_axiv_entries_gen_approach_4th_en.pdf.
If ECHA intends to recommend the substance for Annex XIV inclusion, interested parties can provide comments on ECHA’s recommendation, including the suggested transitional arrangements in accordance with Article 58 of REACH.

Regarding the information provided:

If the substance is identified as SVHC, this information, where relevant, will be taken into account at later stages of the authorisation process.

Even though information provided during public consultation is taken into account, we would like to stress that the registrations are the standard tool and route to communicate information on a substance and its uses to the authorities The registrations are the authorities’ principal source of information when assessing the need of further risk management for a substance or (some of) its uses. Therefore, it is of utmost importance that registrants keep the information provided in the registration dossiers up to date and adequately describe the current use and exposure situation, including the operational conditions and risk management measures in place.

If certain uses are not covered by the provided exposure scenarios, downstream users can either communicate this through supply chain communication (via their suppliers) to the registrants, who then need to update their registrations accordingly, or prepare their specific chemical safety report and submit a downstream user report to ECHA.

Topics such as the availability and suitability of alternatives, socio-economic considerations regarding the benefits of a use or the (adverse) impacts of ceasing a use as well as information on the low level of risk associated to a use are important. Information regarding these topics should be provided as part of the application for authorisation (e.g. in the analysis of alternatives, the chemical safety report or the socio-economic analysis). This information will be taken into account by the Risk Assessment and Socio-Economic Analysis Committees when forming their opinions and by the Commission when taking the final decision. It may impact the decision on granting the applied for authorisation and the conditions applicable to the authorisation, such as e.g. the length of the time limited review period of the authorisation.
	
			See also:
Comment 7 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf		
6	2012/10/18	Member State
Norway	The Norwegian CA supports that o-aminoazotoluene should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for your comment.	
5	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 o-aminoazotoluene 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.	
4	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.	
3	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.	
2	2012/10/11	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 not been registered. Not for all substances included in this batch of 37 SVHC-dossiers, like substances which are not registered, 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. 	
1	2012/09/25	National NGO
Danish Consumer Council
Denmark	The Danish Consumer Council (DCC) supports the inclusion of the substance in the candidate list. The DCC wants dangerous chemicals in consumer products to be banned or at least minimized to the lowest possible levels. The inclusion of this substance to the candidate list is a strong signal to producers that the use of this substance should in time be stopped, and substituted with a less dangerous one.	Thank you for your comment.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
2	2012/10/11	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

Attachments

Comment number	Public attachment	
7	
Comment 7 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf