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

Substance name:	2-Methoxyaniline; o-Anisidine	
CAS number:	90-04-0	
EC number:	201-963-1	

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

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	
11	2011/10/13	International NGO
Health and Environment Alliance
Belgium	HEAL supports the placement of this substance onto the Candidate List based on the information in the Annex XV dossier.	Thank you for support.	
10	2011/10/13	Member State
Austria	o-Anisidine fulfils the SVHC criteria laid down under Article 57 (a) of the REACH Regulation and therefore the Austrian CA supports the inclusion of the substance into the candidate list. This measure is connected with obligations within the supply chain (REACH article 33) which are targeted to avoid or reduce the risk to downstream users or consumers using articles which may contain that substance. Furthermore, due to the obligation for notification according to Article 7, information about the uses of o-anisidine may increase.  	Thank you for supporting comment. 	
9	2011/10/13	National Authority
RIVM
Netherlands	NL supports the proposal to include o-Anisidine  in the candidate list of substances of very high concern.	Thanks for support.	
7	2011/10/13	Member State
Sweden	The Swedish CA agrees that o-anisidine, being classified as Carc. 1B, meets the criteria according to Article 57(a) in REACH and is thus eligible for identification as a substance of very high concern.	Noted. Thank you.	
6	2011/10/13	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	O-Anisidine is registered as transported isolated intermediate under strictly controlled conditions. This should assure safe handling on an industrial level but the substance appears in tattooing ink. SVHCs with permanent skin contact have to be banned!
Thus we support o-Anisidine entering the authorisation process.
	Thank you for your support.	
5	2011/10/12	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as carcinogen category 1B.	Thank you for the support.	
4	2011/10/12	Member State
Belgium	Belgium supports the identification of 2-Methoxyaniline; o-Anisidine as SVHC according to article 57 (a) 	Thanks for support.	
3	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of : 2-Methoxyaniline; o-Anisidine as SVHC.	Thank you for the support.	
2	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for the support.	
1	2011/10/06	Member State
Norway	The Norwegian CA supports that 2-Methoxyaniline; o-Anisidine should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for the support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
8	2011/10/13	Member State
Ireland	O-anisidine is classified as Carc. 1B according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) of REACH.	Noted. Thank you.	

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	
6	2011/10/13	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	P19, 2 ALTERNATIVES
O-Anisidine based colorants are widely substituted by less concerning alternatives. To ensure the resolutions of the European Council (ResAP (2003) 2 and ResAP (2008) 1 in all European Member States (not exclusively Germany and the Netherlands) o-Anisidine should be regulated by REACH. European industry associations have already banned the product and o-Anisidine on the candidate list will also ensure that there is no competitive disadvantage compared to companies outside the EEA. 
	Noted