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

Substance name:	1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich	
CAS number:	71888-89-6	
EC number:	276-158-1	

Note: The Response to Comments table (RCOM) has been prepared by the European Chemicals Agency in consultation with the European Commission. The comments were received during the public consultation of the Annex XV dossier. RCOM has not been agreed by the Member State Committee nor has the document been modified as a result of MSC discussions.

Reason of the submission of the Annex XV: CMR

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	2011/04/07	International NGO
Health and Environment Alliance
Belgium	We support the inclusion of 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich on the candidate list, on the basis of information in the Annex XV dossier.  	Thank you for providing your opinion.	
9	2011/04/07	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as toxic for reproduction 1 B.	Thank you for providing your opinion.	
8	2011/04/07	Member State
Germany	The German CA supports the proposal to identify DIHP as SVHC.	Thank you for providing your opinion.	
7	2011/04/06	Member State
Netherlands	The NL-CA supports the proposal to include 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (DIHP) in the candidate list of substances of very high concern. 	Thank you for providing your opinion.	
6	2011/04/06	Member State
Norway	 The Norwegian CA supports that 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for providing your opinion.	
5	2011/04/06	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	DIHP is no longer produced within the EU. We fear that DIHP enters the European market as a plasticiser in PVC. Thus authorisation will be a suitable instrument to avoid DHIP exposition of humans in Europe.
Obviously European industry does not need this reprotoxic substance for its products. Substitution is possible and has to be followed especially in the workplace. Thus also from a socio-economic point of view we support DIHP being identified as a substance of very high concern.
	Thank you for providing your opinion.
Provided the substance is identified as SVHC, the notification obligations for imports of the substance into the EU in articles set out in Article 7(2) will apply 6 months after inclusion of the substance in the Candidate List.
Further, if the substance is included in Annex XIV, the Agency will need to consider in accordance with Article 69(2) as to whether the use of that substance in articles poses a risk to human health or the environment that is not adequately controlled. If the Agency would consider that the risk is not adequately controlled, it would need to prepare a restriction dossier.	
4	2011/04/05	Member State
Belgium	Belgium supports the identification of DIHP as SVHC according to article 57(c).	Thank you for providing your opinion.	
3	2011/04/05	Member State
Sweden	The Swedish CA agrees that 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich, being classified as Repr. 1B, meets the criteria according to Article 57(c) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for providing your opinion.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of 1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich as SVHC.	Thank you for providing your opinion.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/
MSCA)	Comment	Response	
8	2011/04/07	Member State
Germany	Page 6, 1.3 Physico-chemical properties: 
There is no information given in the report. We would like to indicate that the GESTIS data base of IFA contains some physico-chemical data on DIHP: http://biade.itrust.de/biaen/lpext.dll?f=templates&fn=main-hit-h.htm&2.0 	Thank you for providing this reference. However, we decided not to cite the molecular mass given in the data base as it appears not possible to provide a concrete molecular weight for a UVCB substance (i.e. because the composition of the substance and the shares of the different constituents may vary).	
2	2011/04/04	Member State
Ireland	1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich is classified as Repr.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 (c) of REACH.	Thank you for providing your opinion.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich is included in the Trade Union priority List for REACH authorisation (entry No 75)
see http://www.etuc.org/r/830	Thank you for providing this information and reference.	

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	
8	2011/04/07	Member State
Germany	Information on uses:
Page 12, section 1.2.2.1: 
	The listed advantages seem to focus on DIHP. Please replace DINP by DIHP.
	The reference “Exxon Mobil, 2006” is not available on the internet any longer
	Indication of use in air fresheners:
Cohen A., Janssen S., Solomon G., Natural Resources Defense Council Issue Paper (2007)

Exposure information:
Page 19, section 1.2.8.2:
The results of the "German Environmental Survey for Children" indicate a higher concentration of DIHP in house dust: 
Nagorka, R.; Conrad, A.; Scheller, C.; Süßenbach, B.; Moriske, H. J., Gefahrstoffe, Reinhaltung der Luft, 70 (2010) No.3, p.70-76

Information on alternative substances and techniques:
Page 21 ff discusses alternatives. From the application field there seems to be an overlap with DHNUP (CAS 68515-42-4) – currently subject of an Annex XV Dossier from DK. We assume also the alternatives will show overlap in applications and risks. Therefore it would help if the discussion of alternatives in both dossiers would have been more closely matched.	Thank you for providing this supplementary information and references. If the substance is identified as SVHC this information/references may, where relevant, be considered in potential follow-up risk management activities on this substance.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich is among the substances or group of substances related with diseases suspected of being occupational in origin.
See the Annex II from the Commission Recommendation (19/09/2003) concerning the European schedule of occupational diseases C(2003)3297 final	Thank you for providing this information and reference. If the substance is identified as SVHC this information/references may, where relevant, be considered in potential follow-up risk management activities on this substance.