19 November 2011

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

Substance name:	o-Toluidine	
CAS number:	95-53-4	
EC number:	202-429-0	

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	
10	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.
	
9	2012/10/18	Member State
Norway	The Norwegian CA supports that o-Toluidine; 2-Aminotoluene should be identified as a substance of very high concern and should be included in the Candidate List. 	Thank you for your comment.
	
8	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-Toluidine; 2-Aminotoluene acid 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.
	
7	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.
	
6	2012/10/11	Member State
Germany	We appreciate 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 by the MS 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.

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. 	
5	2012/10/08	Company
Lanxess Deutschland GmbH
Germany	LANXESS Deutschland GmbH is the Lead Registrant of the substance o-Toluidine.

We registered o-Toluidine according to Art. 18 as intermediate within the tonnage band > 1000 t/a and according to Art. Art. 10 only within the tonnage band 1-10 t/a exclusively for laboratory use.

Therefore, o-Toluidine produced by Lanxess is almost exclusively used as intermediate in closed systems under strictly controlled conditions. Only minor volumes are used as laboratory agent. The actual volume for this use has been below <1 t/a for the last 3 years. 

Due to Articles 2 and 56 the uses:

-	as an on-site isolated intermediate or a transported isolated intermediate  and 
-	the laboratory use for scientific research and development  

are automatically exempt from the requirements of authorization.

Consequently the registered uses of o-Toluidine will remain unaffected by the authorization process.

In regard to the intermediate use, all our global customers provided an Art. 18 declaration concerning the use as intermediate under strictly controlled conditions.

According to our knowledge all other registrants in our joint submission submitted only Art. 18 dossiers. 

	Thank you for 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.

Please note that although uses for scientific research and development of a substance are exempted from the authorisation requirement in accordance with Article 56(3) this appears to only apply to its final use for SRD purposes under the conditions defined in Article 3(23).

However, use of a CMR substance included in Annex XIV, on its own or in a mixture (above the lowest of the concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP Regulation)), for e.g. formulation of test kits or analytical standards with the intention to supply them for SRD purposes, would therefore probably require authorisation.

As o-toluidine is a carcinogen, there is a strong societal interest to protect humans, in particular workers handling the substance, from risks potentially arising from its uses. An authorisation requirement for o-toluidine will accordingly ensure that the health of workers in the EU involved in the uses of this substance is protected.	
			See also:
Comment 5 attachment (o-Toluidin_Comment on the Annex XV dossier_20121008.pdf).pdf		
4	2012/10/02	Company
Germany	o-Toluidine is exclusively used in our company as an intermediate to be consumed in a chemical synthesis	Thank you for your comment. 

Regarding further information on uses provided: 

See response to comment 5 above
	
3	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC.
This substance is included in the Trade Union Priority List for REACH authorisation see: http://www.etuc.org/a/6023	Thank you for your comment.
	
2	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	
6	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 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	
5	
Comment 5 attachment (o-Toluidin_Comment on the Annex XV dossier_20121008.pdf).pdf