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

Substance name:	trilead diarsenate	
CAS number:	3687-31-8	
EC number:	222-979-5	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: 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	
10	2011/10/13	National Authority
RIVM
Netherlands	NL supports the proposal to include trilead diarsenate in the candidate list of substances of very high concern.	Thank you for your support.	
8	2011/10/13	Member State
Sweden	The Swedish CA agrees that trilead diarsenate, being classified as Carc. 1A and Repr. 1A, meets the criteria according to Article 57(a)and 57(c) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for your support.	
7	2011/10/12	Member State
Belgium	Belgium supports the identification of trilead diarsenate as SVHC according to article 57 (a) and (c)	Thank you for your support.	
6	2011/10/12	International NGO
Health and Environment Alliance
Belgium	HEAL supports the nomination of trilead diarsenate to the Candidate List based on the information in the Annex XV dossier.	Thank you for your support.	
5	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	Again we strongly support grouping in the authorisation process. Especially in the case of arsene containing compounds that have similar dangerous properties. Grouping will fasten and strengthen the authorisation process.
Arsenic or compounds thereof (entry 101) in the Commission Recommendation concerning the European schedule of occupational diseases (2003/670/EC). Substituting them is a main goal in prevention in the workplace.
	We agree that a grouping approach is preferable. For the identification of SVHCs each substance of a group entry must be identified according to feedback from ECHA.	
4	2011/10/12	Member State
Germany	The group approach for arsenic compounds should be put into focus of the dossier.

To avoid substitution of other arsenic compounds with this substance, identification as SVHC might be useful.

Although the CMR properties of the substance (Carc 1A, Repr 1A) justify identification as an SVHC, it is not clear to us if this substance is really produced and marketed as such, or if it is just an impurity that originates somewhere in the production process and cannot even be identified as a discrete substance in the mixture of metals and metal salts.

We would suggest to consider approaching the issue of arsenic impurities by a substance in substance approach. 

This would also remove the inconsistencies in the dossier where most hazards and risk information refer to arsenic trioxide already and not to the substance identified in the dosser.

	We agree that a grouping approach is preferable. For the identification of SVHCs each substance of a group entry must be identified according to feedback from ECHA.

We agree to the importance of avoiding substitution with other arsenic substances.

As the substance, according to industry, is part of a complex matrix consisting of different chemical compounds (i.e. special preparation /mixture) it cannot be considered merely as an impurity but as a constituent of the raw materials for the process. 
According to the available information the substance can be isolated from the matrix as a discrete substance. 
According to information from the Arsenic Consortium trilead diarsenate is present in complex raw materials from smelting and refining of nonferrous metals. It is also partly imported from countries outside Europe as part of complex materials i.e. byproducts from nonferrous metallurgical processes. Trilead diarsenate is not intentionally formed from other arsenic compounds during the process and it seems the process cannot be considered manufacture of trilead diarsenate as such. However, as trilead diarsenate is part of the imported complex materials (see also flow chart in confidential attachement) the import is not exempted from registration. 
The question about whether the substance fulfils the definition of intermediate (transported isolated) is not relevant for the identification of the substance as SVHC and should be considered in the further process of prioritisation for Annex XIV  
As far as we know, the issue of substance in substance approach is still under discussion.
We cannot see that most hazard information concerning trilead diarsenate refer to arsenic trioxide (see e.g. Appendix 1 and 2 to Annex XV dossier). However, concerning trends, use and alternatives relevant information from arsenic trioxide were referred. 	
3	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of trilead diarsenate as SVHC.	Thank you for your support.	
2	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for your support.	
1	2011/10/07	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as carcinogen 1A and toxic for reproduction category 1A.	Thank you for your support.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
11	2011/10/13	Member State
Ireland	Trilead diarsenate is covered by the group entries for both “arsenic acid and its salts” and “lead compounds...” (index numbers 033-005-001-1 and 082-001-00-6 of Regulation (EC) No. 1272/2008, 
respectively) and so is classified as Carc. 1A and Repr. 1A. Therefore, the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (a) and (c) of REACH.

We note that a specific concentration limit (Repr. 2 H361f; C ≥ 2.5%, which may need to be corrected in a future ATP to CLP) applies for the lead entry in Annex VI and therefore any corrected specific concentration limit should be carried forward to the candidate list entry for trilead diarsenate.
	Thank you for your support.

As far as we know no concentration limits are included in the Candidate list yet. The issue of concentration limits and obligations according to the Candidate list seems to be taken care of according to general provisions in REACH (e.g. Article 7.2, 31.1, 33)	

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	
9	2011/10/13	Industry or trade association
WirtschaftsVereinigung Metalle
Germany	Comments on the proposals to identify Trilead diarsenate as a Substances of Very High Concern

Substance name:	Trilead diarsenate
CAS Number: 	3687-31-8
EC Number: 	222-979-5

WirtschaftsVereinigung Metalle (WVM), the German Non-Ferrous Metals’ Association, represents the German non ferrous (NF) metals industry towards politics and economy. We support our members in regulatory, occupational health & safety affairs in order to maintain and establish measures at a very high level. Today, WVM has 658 member companies, including producers and processors of rare metals and compounds.

Some of our members also produce and handle arsenic and arsenic compounds as arsenic- bearing minerals are natural component of several non ferrous metal ores and concentrates. In addition, we represent one of the leading producers of arsenic metal. Therefore, we took over the role of being the secretariat for an arsenic consortium. Trilead diarsenate is within the scope of this consortium on arsenic and arsenic compounds. In principle, we appreciate the involvement of stakeholders in the process of harmonized classification and would like to take the opportunity to bring our argumentation forward during this phase of internet consultation.

At first we want to express the companies’ awareness of their duties in safe handling hazardous substances and in establishing appropriate risk management measures. Industry also takes full responsibility to fulfil their obligations under the relevant Community and national legislation.

Secondly we want to point out, that Trilead arsenate is not a substance manufactured on its own, but is a constituent of complex recovered materials essentially produced during recycling, through hydrometallurgical processes, of lead, arsenic and other base metals bearing by-products. The complex materials represent only a small yearly tonnage in comparison with the total amount of lead and arsenic contained in concentrates and other recyclables treated in the non-ferro refining industry. Recycled to secondary smelters in order to recover the base metals, these complex materials loose their chemical identity in the smelting process where other complex substances are produced, e.g. a copper matte and a lead slag which contain arsenic mostly in other chemical forms. The original complex material is transformed to another substance, it fulfills the definition of an isolated intermediate, which are exempt from authorization.

As no public uses of this substance is involved, the potential risk of exposure to general public is of course irrelevant. Potential levels of exposure during industrial applications of both substances are similar to other lead and arsenic compounds present in some specific raw materials of the base metals industry and must be managed in accordance with other regulations related to occupational exposure, exploitation permits, et cetera. 

A mass balance has been attached under the confidential portion of this public consultation for the application of Trilead diarsenate and Calcium arsenate compounds in complex base metals which are provided as additional information, which demonstrates that the quantities involved are small in comparison with the total amount of arsenic involved.
	Thank you for the detailed information.

The question about whether the substance fulfils the definition of intermediate (transported isolated) is not relevant for the identification of the substance as SVHC and should be considered in the further process of prioritisation for Annex XIV. See also response provided to comment no 4.  

Other EU legislation mentioned is relevant, but does not preclude an inclusion of a SVHC substance into the Candidate list or into Annex XIV.

Thank you for this information.
	
5	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	P14, 6 CURRENT KNOWLEDGE ON ALTERNATIVE
There are a few less concerning alternative substances for diarsenic trioxide. Being a candidate will fasten the process of searching alternative substances processes for the uses of this Pb- and As-containing compound.

P16, 6.1 Alternatives to diarsenic trioxide
As a fact special glass has to be grinded, polished etc. to become optical glass (lenses etc). In these production steps fine dust particles containing Arsenic are liberated and are potentially inhaled by workers. 
This very relevant possible exposure to workers is not mentioned in the dossier.
It cannot be presumed that all workplaces are well exhausted and all workers are protected properly against exposure of arsenic compounds at the workplace.

	The identification of trilead diarsenate as SVHCs for the Candidate list will hopefully speed up the process of substitution with less hazardous substances.

The exposure assessment was copied from the CSR (as stated in the Annex XV document) only for information purposes. We agree that such exposure should be taken into account (in particular in the CSR and in connection with the Authorisation process).	
4	2011/10/12	Member State
Germany	Exposure information:	
P. 15: “Occupational Exposure: Arsenic is measured in different workplaces in the plant, but the exposure cannot be allocated to the specific manufacturing and use of trilead diarsenate“. Because the Norwegian CA aims to regulate arsenic compounds by a group approach the occupational exposure to arsenic itself would be more valuable.

Information on alternative substances and techniques:	
P. 16 If the aim is to replace arsenic compounds, this group approach should be stated more clearly. This may also help to get an idea about the risk potential of potential alternatives.

	We anticipate that better documentation will be required, e.g. in connection with an application for authorisation. For the purpose of the identification as a SVHC it is not needed. 

The identification as SVHCs for the Candidate list will hopefully speed up the process of substitution with less hazardous substances.