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

Substance name:	1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters	
CAS number:	68515-42-4	
EC number:	271-084-6	

Reason of the submission of the Annex XV: CMR
Disclaimer: The European Chemicals Agency is not responsible for the content of this document. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. 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 result of the MSC discussions.  

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	2011/04/07	International NGO
Health and Environment Alliance
Belgium	We support the inclusion of 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters on the candidate list, on the basis of information in the Annex XV dossier. 	Acknowledged	
10	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.	Acknowledged	
9	2011/04/06	Member State
Norway	The Norwegian CA supports that 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters  should be identified as a substance of very high concern and should be included in the Candidate list.	Acknowledged	
8	2011/04/06	Member State
Netherlands	The NL-CA supports the proposal to include 1,2-Benzenedicarboxylic acid, di-C7-11 -branched and linear alkyl esters (DHNUP) in the candidate list of substances of very high concern. 	Acknowledged	
7	2011/04/06	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	Worldwide there is a significant decline in the use of DHNUP. Within the Annex XV dossier one can read that there was no information on alternatives by the contacted companies. This seems contradictory to us because use of plastics did not decline within the last years. Furthermore the dossier describes a lot of phthalate and non-phthalate substitutes.
According to the Annex XV dossier the substance has not been registered yet, i.e. DHNUP is not imported or manufactured by any company in a larger amount than one ton per year at present time. These non-high-volume uses can be substituted. Therefore we strongly agree that DHNUP is included into Annex XIV very soon.
	Acknowledged	
6	2011/04/06	Member State
Germany	- The German CA supports the proposal to identify the substance as SVHC.

- p.7 It is stated that: "DHNUP was pre-registered under REACH with indication of registration by 30 November 2010. However, the substance does not seem to have been registered". 
Since the registration status is an important issue, the status should be clarified and stated definitely in the Annex XV dossier.

- With respect to occupational exposure, DE has no readily available information on use, exposure and alternatives.

Comments on the IUCLID File:

- 1.2 composition: No information is provided. At least the information provided in the report should be added.

- 4 physical and chemical properties: No information is provided even though some properties are stated in the report. At least these data should be added to the IUCLID file, including information about e.g. reference and method.	Acknowledged

Part II of the Annex XV report will not be updated; however it is indicated in the SD that no registration dossier is submitted.

The IUCLID file will not be updated.	
5	2011/04/05	Member State
Belgium	Belgium supports the identification of DHNUP as SVHC according to article 57(c).	Acknowledged	
4	2011/04/05	Member State
Sweden	The Swedish CA agrees that 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters, 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.	Acknowledged	
2	2011/03/30	Company
Austria	The substance in question is unclear / not clear enough.
The broadness of substance definition is inappropriate.	The substance proposed for the candidate list is the substance that is already included in the list of harmonised classifications (Annex VI to the CLP Regulation). The same substance ID is used.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of 1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters as SVHCs.
	Acknowledged	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
3	2011/04/04	Member State
Ireland	DHNUP 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.	Acknowledged	
2	2011/03/30	Company
Austria	I wish to make 2 points:

I) The Denish Annex 15 SVHC-Dossier attempts to identify a substance with EC-number 271-084-6 "1,2-Benzenedicarboxylic acid, di-C7-11 -branched and linear alkyl esters" as SVHC, and from the wording of the text it seems what is intended to be included is DHNUP being "Di(heptyl, nonyl, undecyl) phthalate". However, 271-084-6 has a much broader scope. Moreover, suitable alternatives to DHNUP are said to be DINP (di-isononyl phthalate) and DIDP (di-isodecyl phthalate). The listing of DINP as alternative to DHNUP is a contradiction in terms: DHNUP includes nonyl in its name and DIDP is a branched di-nonyl-phthalate. So DINP is within the scope of DHNUP and at the same time it is said to be an alternative.

II) The IUCLID dataset to EINECS / EG-number 271-084-6 takes into account several phthalates, including "Diisodecylphthalate" (DIDP) for substance tests for various endpoints. So, the IUCLID dataset for 271-084-6 clearly comprises DIDP, not jsut DHNUP. The present SVHC-Dossier lists DIDP as valid alternative to 271-084-6 DHNUP, which is another contradiction in terms.

So, the defintion of the substance that should be identified as SVHC is unclear. It would be highly desirable not to include broad definitions like "C7-9, branched and linear". It would be appropriate to include the individual substances such as
* Di-heptyl-phthalate (branched and linear)
* Di-nonyl-phthalate (branched and linear)
* Di-undecyl-phthalate (branched and linear)
with much more well defined substance identity into the SVHC-list.
As a last resort, it would be absolutely necessary to specifically exclude DINP and DIDP from the scope, as it is the intention of the SVHC-Dossier.

The substance proposed is indeed "1,2-Benzenedicarboxylic acid, di-C7-11 -branched and linear alkyl esters" (EC 271-084-6). DHNUP is one of more synonyms and is used for ease in the Annex XV report.

The data in the IUCLID data set on the ex-ECB website are provided by industry and it is assumed that these are applicable for the substance in question for the current proposal. 

The two specified substances (DINP, DIDP) are not comprised by the proposal.	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters are included in the Trade Union Priority List for REACH authorisation.
See http://www.etuc.org/a/6023
1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters is entry No 75 in the ETUC list.	Thank you for the information.	

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	2011/04/06	Member State
Germany	Page 8 ff discusses alternatives. From the application field there seems to be an overlap with DIHP (CAS 71888-89-6) – currently subject of an Annex XV Dossier from ECHA. We assume also the alternatives will show overlap in application and risks. Therefore it would help the overview if the discussion of alternatives in both dossiers would be more closely matched.	Part II of the Annex XV report will not be updated. However, the issue of possible alternatives should be considered both in relation to prioritisation for inclusion in Annex XIV and, eventually, in relation to future applications for authorisation.	
2	2011/03/30	Company
Austria	Different Alkyl-phthalates show vastly different chemical properties as is evident from the difference between e.g. Dibutylphthalate and Diisodecylphthalate. Therefore it seems inappropriate to include a broad definition of a whole substance group "C7-11, branched and linear" into the annex. The differences are such that is would be justified to deal with each phthalate separately.

Assuming from the definition of EG-Number 271-084-6 as in the IUCLID-dataset that DINP and DIDP are also covered by this dossier, I would like to point out that
* the EU-risk report on DIDP (available at http://www.didp-facts.com/upload/documents/document5.pdf) concludes clearly, as I am sure you are aware of, "that there is no need for any further measures to regulate the use of DIDP."
* The same holds true for DINP, where the commission states in 2006/C90/04 that "the risk assessment shows that risks are not expected. Risk reduction measures already being applied are considered sufficient."

In the light of this report, the subjection of DINP and DIDP under the REACH-authorisation regime is clearly disproportionate, as it clearly contradicts the EU's own risk assessment.

Some substances covered by EG-number 271-084-6 do not constitue substances of very high concern.	

See responses above. 	
1	2011/03/15	Trade union
European Trade Union Confederation
Belgium	1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters are substances or group of substances related with diseases suspected of being occupational in origin.
see Annex II from Commission Recommendation (19/09/2003) concerning the European Schedule of occupational diseases C(2003)3297 final	Thank you for the information.