19 November 2011

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

Substance name:	Lead oxide sulfate	
CAS number:	12036-76-9	
EC number:	234-853-7	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Repr. 1A

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
#	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
12	2012/10/18	Individual
Belgium	Fonderie & Manufacture de Métaux SA is a member of the International Lead Association or the Lead REACH Consortium. ILA has provided a consolidated response on behalf of members of the Lead REACH consortium. As a consequence, Fonderie & Manufacture de Métaux SA fully supports and subscribes to the comments made by ILA.	Thank you for your comment.

Please refer to response to comment #6 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
11	2012/10/18	Individual
Germany	Weser-Metall GmbH is a member of the International Lead Association or the Lead REACH Consortium. ILA has provided a consolidated response on behalf of members of the Lead REACH consortium. As a consequence, Weser-Metall GmbH fully supports and subscribes to the comments made by ILA.	Thank you for your comment.

Please refer to response to comment #6 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
10	2012/10/18	Member State
Norway	It is recognised globally that lead and its compounds pose a significant risk to human health and the environment and that there remains a need for a continued focus on reducing the risks posed by these substances. The concerns for lead compounds are their reprotoxic/neurotoxic properties. The Committee for Risk Assessment under REACH has stated that no threshold for the adverse effect of lead has been identified in humans.  We would also like to stress that the long lasting harmful effects to the environment are of serious concern (cf. classification of lead compounds in general and a number of specific lead compounds in CLP concerning environmental hazard;  "Aquatic Acute 1" ("Very toxic to aquatic life") and  "Aquatic Chronic 1" ("Very toxic to aquatic life with long lasting effects"). 

The Norwegian CA supports that lead oxide sulfate (basic lead sulfate) should be identified as a substance of very high concern and should be included in the Candidate List.
	Thank you for your opinion.	
9	2012/10/18	Company
Britannia Refined Metals Ltd.
United Kingdom	Britannia Refined Metals Ltd. is a member of the International Lead Association and the Pb REACH Consortium. ILA has provided a consolidated response on behalf of members of the Pb REACH consortium. As a consequence, Britannia Refined Metals Ltd. fully supports and subscribes to the comments made by ILA.	Thank you for your comment.

Please refer to response to comment #6 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
8	2012/10/18	Member State
Belgium	The BE MSCA supports this proposal  from ECHA to identify  the substance as SVHC as the proposal is based on article 57 (c) of the REACH Regulation. We regret however the very limited amount of information available in the dossier.	Thank you for your opinion.	
7	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 Lead oxide sulfate (basic lead sulfate) 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 opinion.	
5	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 opinion.	
4	2012/10/12	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 a far reaching measure.

The substance has not been registered. Not for all substances included in this batch of 37 SVHC-dossiers, like substances which are not registered, the inclusion on the candidate list and subsequent inclusion in Annex XIV might be the most appropriate risk management option. Without further information on potential risks that may be related to any other uses of this substance, the reason to identify this substance as SVHC remains unclear.
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 only 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. 

Finally, regarding your comment on the preparation of risk management options analysis (RMOA) before proposing the identification of a substance as SVHC, we note that this 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. 

Please note that contrary to your statement in the comment, the substance has been registered.
	
3	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC.	Thank you for your opinion.	
2	2012/09/26	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 opinion.	

Specific comments on the justification
#	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
4	2012/10/12	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 the 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
#	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
6	2012/10/16	Industry or trade association
International Lead Association
United Kingdom	THE LEAD REACH CONSORTIUM COMMENTS FOR THE PUBLIC CONSULTATION PROPOSAL TO IDENTIFY BASIC LEAD SULPHATE (CAS# 12036-76-9) AS A SVHC

About the ILA The International Lead Association is a membership body that supports companies involved in the mining, smelting, refining and recycling of lead. The ILA represents the producers of about 3 million tons of lead and almost two thirds of lead production in the western world. As secretariat to the Lead (Pb) REACH Consortium, ILA Europe (a regional branch of the International Lead Association) is acting on behalf of the Lead Registrants for several lead substances.

These comments represent the view of the consortium member companies which are discussed in more detail in the attached document. A list of the consortium members has been provided in Appendix A of the attached document.

We do not disagree that basic lead sulphate could be identified as a substance meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH) owing to its CLP Annex VI classification toxic for reproduction category 1 A for lead compounds (INDEX no. 082-001-00-6), with the exception of those specified elsewhere.
The Pb REACH Consortium however believe that a detailed analysis of risk management options should be performed prior to candidate listing and only substances for which authorisation can be demonstrated to be the most appropriate risk management option should be proposed for the list. The fact that no such documentation has accompanied the current proposal is deeply regrettable. However in such circumstances it is crucial that the RMO analysis be conducted before a decision is made on whether to prioritise basic lead sulphate for inclusion in Annex XIV. We believe that authorisation would prove to be an inefficient risk management option for this substance for the following reasons:
1. The major use of basic lead sulphate is in the coating for mirror backing. It’s use in the workplace is already covered by existing Community legislation that imposes minimum requirements such as a binding occupational exposure limit and industry data indicates that 100% of men working in this sector have blood lead levels below 40μg/dL (mean 8 μg/dL).
2. Basic lead sulphate is not interchangeable with other lead compounds in any of its existing uses
There are a number of additional points that should be considered when evaluating prioritisation for inclusion of Basic lead sulphate onto Annex XIV that are related to lead in general.
1. Extensive lead specific EU-wide Community legislation has been successfully implemented to control human and environmental exposures throughout its lifecycle from manufacturing to end of life and recycling.THE LEAD REACH CONSORTIUM COMMENTS FOR THE PUBLIC CONSULTATION PROPOSAL TO IDENTIFY BASIC LEAD SULPHATE (CAS# 12036-76-9) AS A SVHC
About the ILA The International Lead Association is a membership body that supports companies involved in the mining, smelting, refining and recycling of lead. The ILA represents the producers of about 3 million tons of lead and almost two thirds of lead production in the western world. As secretariat to the Lead (Pb) REACH Consortium, ILA Europe (a regional branch of the International Lead Association) is acting on behalf of the Lead Registrants for several lead substances.
The following companies are members of the Pb REACH Consortium (please refer to Appendix A).
These comments represent the view of consortium member companies.
SUMMARY
We do not disagree that basic lead sulphate could be identified as a substance meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH) owing to its CLP Annex VI classification toxic for reproduction category 1 A for lead compounds (INDEX no. 082-001-00-6), with the exception of those specified elsewhere.
The Pb REACH Consortium however believe that a detailed analysis of risk management options should be performed prior to candidate listing and only substances for which authorisation can be demonstrated to be the most appropriate risk management option should be proposed for the list. The fact that no such documentation has accompanied the current proposal is deeply regrettable. However in such circumstances it is crucial that the RMO analysis be conducted before a decision is made on whether to prioritise basic lead sulphate for inclusion in Annex XIV. We believe that authorisation would prove to be an inefficient risk management option for this substance for the following reasons:
1. The major use of basic lead sulphate is in the coating for mirror backing. It’s use in the workplace is already covered by existing Community legislation that imposes minimum requirements such as a binding occupational exposure limit and industry data indicates that 100% of men working in this sector have blood lead levels below 40μg/dL (mean 8 μg/dL).
2. Basic lead sulphate is not interchangeable with other lead compounds in any of its existing uses
There are a number of additional points that should be considered when evaluating prioritisation for inclusion of Basic lead sulphate onto Annex XIV that are related to lead in general.
1. Extensive lead specific EU-wide Community legislation has been successfully implemented to control human and environmental exposures throughout its lifecycle from manufacturing to end of life and recycling.
2. This existing Community legislation has been successful in reducing human and environmental exposure to lead and compounds. Some examples of this include:
a. There have been significant reductions in the blood lead values of European children with, about 60% reduction between 1995 and 2007. This has predominantly been due to elimination of lead exposure from fuel (both in gasoline and energy production) which was the most significant contributor.
b. There has been a significant decrease in emissions from industry which is consistent across 26 of the EU Member States, with 22 reporting reductions of greater than 85% since 1990.
c. Occupational exposures in manufacturing and use of basic lead sulphate are well controlled below the EU binding airborne lead limit of 0.15 mg/m3 and the biological exposure limit of 70 μg/dL and even stricter limits set by the different member states. The 90th percentile of occupational exposure is below the DNEL of 40 μg/dL.
3. Regulation introduced to limit the use of lead to only its more essential applications, particularly bans introduced on use in petrol and paint, has resulted in a marked and on-going fall in anthropogenic emissions and environmental levels globally. As a consequence of these marked reductions in industrial emissions, the relative importance of on-going natural emissions and re-circulation of pre-existing environmental deposits of lead arising from historical human activity, together with transboundary pollution from outside of Europe, are of growing significance when considering the extent of future European exposures and the impact of risk potential management measures in relation to REACH.  
	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 describing 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.

Topics such as the availability and suitability of alternatives, socio-economic considerations regarding the benefits of a use or the (adverse) impacts of ceasing a use as well as information on the low level of risk associated to a use are important. Information regarding these topics should be provided as part of the application for authorisation (e.g. in the analysis of alternatives, the chemical safety report or the socio-economic analysis). This information will be taken into account by the Risk Assessment and Socio-Economic Analysis Committees when forming their opinions and by the Commission when taking the final decision. It may impact the decision on granting the applied for authorisation and the conditions applicable to the authorisation, such as e.g. the length of the time limited review period of the authorisation.

The current proposal for identifying the substance as a substance of very high concern (SVHC) is in accordance with REACH Article 59(2) based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). The additional mentioned information is not relevant for determining whether the substance meets the criteria for identification as SVHC. However, when examining whether the substance should be recommended for inclusion in Annex XIV, ECHA will indeed have to assess available information on uses and exposures. In addition, information on work already done by industry to identify and assess potential alternatives is used in defining transitional arrangements in the draft Annex XIV entries for the recommended substances. This information will be collected by ECHA before prioritising the substances and defining the transitional arrangements for its recommendation. The generic approaches for prioritisation and defining the draft Annex XIV entries are available at: http://echa.europa.eu/documents/10162/13640/axiv_prioritysetting_general_approach_20100701_en.pdf and http://echa.europa.eu/documents/10162/13640/draft_axiv_entries_gen_approach_4th_en.pdf.
If ECHA intends to recommend the substance for Annex XIV inclusion, interested parties can provide comments on ECHA’s recommendation, including the suggested transitional arrangements in accordance with Article 58 of REACH.

Regarding your comment on the preparation of risk management options analysis (RMOA) before proposing the identification of a substance as SVHC, we note that this 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.

Finally, regarding the information provided on controls for this substance under other legislation note that the current proposal only concerns identifying the substance as a substance of very high concern (SVHC) in accordance with REACH Article 59(2). However, if the substance is identified as SVHC, information in relation to controls under other legislation will be taken into account at later stages of the authorisation process.	
			See also:
Comment 6 attachment (Public consultation document Basic lead sulphate CAS 12036-76-9.pdf).pdf		

Attachments

Comment number	Public attachment	
6	
Comment 6 attachment (Public consultation document Basic lead sulphate CAS 12036-76-9.pdf).pdf