19 November 2011

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

Substance name:	tetralead trioxide sulphate	
CAS number:	12202-17-4	
EC number:	235-380-9	

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	
31	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 #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).

30	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 #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
29	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for your opinion.	
27	2012/10/18	Individual
Germany	HOPPECKE Batterien GmbH & Co. KG is a member of the International Lead Association or the Pb REACH Consortium [ILA]. ILA answer this consultation on behalf of all its members. As a consequence  HOPPECKE Batterien GmbH & Co. KG fully supports and subscribes to the comments made by ILA.	Thank you for your comment.

Please refer to response to comment #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
26	2012/10/18	Company
Austria	Banner GmbH is a member of the International Lead Association or the Pb REACH Consortium. ILA has provided a consolidated response on behalf of members of the Pb REACH consortium. As a consequence, Banner GmbH fully supports and subscribes to the comments made by ILA .	Thank you for your comment.

Please refer to response to comment #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
25	2012/10/18	Company
Berzelius Metall GmbH
Germany	p. 4: summary:
Berzelius does not disagree with the proposal for the lead compounds mentioned above  to be identified as substances meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH) owing to its classification as toxic for reproduction category 1 A.
Berzelius however believes that a detailed analysis of risk management options is required before a decision is made on whether to prioritise these substances for inclusion in Annex XIV. We believe that authorisation would prove to be an inefficient risk management option for these substances. The major use of the substances is in the process undertaken to manufacture lead acid batteries. This is a non-dispersive and controlled use.  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 95% of men working in this sector have blood lead levels below 40µg/dl. 
Berzelius understands the candidate list as a warning list, a clear signal for industry to improve their HSE management technologies and as a demand to check possibilities to further reduce exposure to workers and emissions to the environment.
As the leading manufacturer and recycler of lead in Germany and a forward-looking industrial site we accept the high responsibility for sustainable development and global environmental aspects. The aim of our environmental policy is to reconcile the economic success of our company group and the social safety for our employees and the general public with long-term sustainment of natural resources.	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 describe 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.

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 in the authorisation process.	
			See also:
Comment 25 attachment (Berzelius consultation SVHC.zip).zip		
24	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 tetralead trioxide sulphate should be identified as a substance of very high concern and should be included in the Candidate List.
	Thank you for your opinion.	
23	2012/10/18	Company
EnerSys AD, Targovishte
Bulgaria	EnerSys AD Targovishte, Bulgaria is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, EnerSys AD Targovishte, Bulgaria fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in this section (see below).
	
22	2012/10/18	Individual
Germany	HOPPECKE Batterien GmbH & Co. KG is a member of International Lead Association [ILA] or the Pb REACH Consortium. ILA  answer this consultation on behalf of all its members. As a consequence  HOPPECKE Batterien GmbH & Co. KG fully supports and subscribes to the comments made by ILA.	Thank you for your comment.

Please refer to response to comment #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
21	2012/10/18	Industry or trade association
ANIE-CSI
Italy	ANIE-CSI Battery Group, the Association representing Italian Battery Manufacturer, fully supports and subscribes to the comments made by EUROBAT, the European Association of Automotive and Industrial Battery Manufacturer	Thank you for your comment.

Please refer to response to comment #15 in this section (see below).
	
20	2012/10/18	Company
EnerSys sarl
France	EnerSys sarl France, which employs 750 people, is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, EnerSys sarl France fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in this section (see below).
	
19	2012/10/17	Company
Exide Technologies
Germany	Exide Technologies, with operations in more than 80 countries, has the products and services to meet the world's stored energy needs in transportation and industrial markets. With more than 120 years in the battery business, Exide has the experience, advanced research and development capabilities, and knowledge to provide solutions to various stored energy requirements. 

Exide is a producer of Lead based and Lihium based batteries.

Exide owns and operates R&D and production facilities in 8 European countries

During the production of Lead Acid Batteries, we produce and/or use Lead Monoxide, Lead Tetroxide, Tetralead Trioxide Sulphate and Pentalead Tetraoxide Sulphate.

Exide Technologies is a member of the Pb REACH Consortium. ILA has provided a consolidated response on behalf of members of the Pb REACH consortium. As a consequence, Exide Technologies fully supports and subscribes to the comments made by ILA.

Exide Technologies is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, Exide Technologies fully supports and subscribes to the comments made by EUROBAT.
	Thank you for your comment.

Please refer to responses to comments #15 in this section (see below) and #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
18	2012/10/17	Company
Exide Technologies 
Germany	Exide Technologies, with operations in more than 80 countries, has the products and services to meet the world's stored energy needs in transportation and industrial markets. With more than 120 years in the battery business, Exide has the experience, advanced research and development capabilities, and knowledge to provide solutions to various stored energy requirements. 

Exide is a producer of Lead based and Lihium based batteries.

Exide owns and operates R&D and production facilities in 8 European countries

During the production of Lead Acid Batteries, we produce and/or use Lead Monoxide, Lead Tetroxide, Tetralead Trioxide Sulphate and Pentalead Tetraoxide Sulphate.

Exide Technologies is a member of the Pb REACH Consortium. ILA has provided a consolidated response on behalf of members of the Pb REACH consortium. As a consequence, Exide Technologies fully supports and subscribes to the comments made by ILA.

Exide Technologies is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, Exide Technologies fully supports and subscribes to the comments made by EUROBAT.
	Thank you for your comment.

Please refer to responses to comments #15 in this section (see below) and #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
17	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 Tetralead trioxide sulphate 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.	
16	2012/10/17	Industry or trade association
ELSA (ESPA)
Belgium	To our astonishment there has been no analysis of the information provided in the registration dossier of this substance. ELSA is of the opinion that such information has to be taken into account. Therefore we have inserted an attachment in Section IV of the commenting form.	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 describe 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 your comment in respect to the recommendation that has been made by the German Competent Authority in their RMO analysis concerning the use of lead compounds in PVC-products, please refer to response to comment #3 in this section (see below).
	
			See also:
Comment 16 attachment (SVHC-Public-Consultation-Oct-2012_ELSA-comments_CAS-12202-17-4.pdf).pdf		
15	2012/10/17	Industry or trade association
EUROBAT
Belgium	Tetralead Trioxide Sulphate is an essential and irreplaceable transition material in the battery manufacturing process.

Tetralead Trioxide Sulphate and Pentalead Tetraoxide Sulphate are produced together during the paste mixing process. The relative proportion of the two substances in the paste mix is dependent upon the processing conditions, with individual battery manufacturers making a decision for the recipe and process which would be most suitable for their different battery specifications. For this reason the battery industry’s response to the public consultation will focus on both substances simultaneously.

The European automotive and industrial battery industry, represented by EUROBAT, believes that making Tetralead Trioxide Sulphate subject to authorisation would significantly undermine the competitiveness of the European Battery Industry and negatively affect research and development activities currently being undertaken to further improve the efficiency of lead-based battery technologies. Such a decision would have severe effects on the economies of many Member States and put thousands of jobs at risk in battery manufacturing and lead recycling industries. It would also run counter to other EU policies, with lead-based batteries exemplifying the principles of a Resource Efficient Europe and playing an important role in lowering overall carbon emissions. 

Please refer to the enclosed battery industry answer for a full elaboration of the European battery industry’s position. 
	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 describe 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.

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 15 attachment (EUROBAT Tetralead Trioxide Sulphate and Pentalead Tetraoxide Sulphate Response - 17-10-12.pdf).pdf		
14	2012/10/17	Company
Germany	Johnson Controls Power Solutions is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, Johnson Controls Power Solutions fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in this section (see above).
	
12	2012/10/17	Company
Enersys sp. z o.o.
Poland	"EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. has answered this consultation on behalf of all its members. EnerSys, which is a member of Eurobat, operates lead acid battery manufacturing plants in Bulgaria, France, Germany, Poland and the UK. EnerSys fully supports and subscribes to the comments made by EUROBAT." 
Enersys sp z o.o. in Poland, employs 600 employees.
	Thank you for your comment.

Please refer to response to comment #15 in this section (see above).
	
11	2012/10/17	Company
EnerSys
United Kingdom	"EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers, has answered this consultation on behalf of all its members. EnerSys Newport, UK, which employs just under 500 employee's is a member of Eurobat, operates a lead acid battery manufacturing plant in Newport UK. EnerSys fully supports and subscribes to the comments made by EUROBAT."	Thank you for your comment.

Please refer to response to comment #15 in this section (see above).
	
10	2012/10/17	Individual
Germany	Accumulatorenwerke HOPPECKE Carl Zoellner & Sohn GmbH is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answer this consultation on behalf of all its members. As a consequence  Accumulatorenwerke HOPPECKE Carl Zoellner & Sohn GmbH fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in this section (see above).
	
9	2012/10/17	Individual
Germany	HOPPECKE Batterien GmbH & Co. KG is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answer this consultation on behalf of all its members. As a consequence  HOPPECKE Batterien GmbH & Co. KG fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in this section (see above).
	
8	2012/10/17	Individual
Germany	Hawker GmbH is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, Hawker GmbH fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in this section (see above).
	
7	2012/10/17	Company
Midac spa
Italy	“Midac spa is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, Midac spa fully supports and subscribes to the comments made by EUROBAT.”
Midac spa is a member of the International Lead Association or the Pb REACH Consortium. ILA has provided a consolidated response on behalf of members of the Pb REACH consortium. As a consequence, Midac spa fully supports and subscribes to the comments made by ILA .”
	Please refer to responses to comments #15 in this section (see above) and #13 in section “Specific comments on use, exposure, alternatives and risks” (see below).
	
28	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.	
6	2012/10/15	Company
Xstrata Zink GmbH
Germany	Article 58 (3) of the REACh recommends a priorisation of the substances taking into account the criteria PBT, wide spread use and great quantity.
None of these criteria has been assessed in the dossier.
The dossier should be updated accordingly to come to a well founded decision.	Provided that the substance is identified as SVHC, information relevant for the prioritisation exercise will be taken into account at later stages of the authorisation process. 
	
5	2012/10/15	Company
REHAU AG + Co.
Germany	This dossier seems to be written superficially without any reference to recycling material, inclusion of the substance in the matrix of plastics and without any consideration of the voluntary phase out of the use of lead compounds of the PVC-processing industry.	Thank you for your comment.

If the substance is identified as SVHC, the information you are referring to will, where relevant, be taken into account at later stages of the authorisation process.

See also response to comments #16 and #3 in this section.

Please refer also to responses to comment #5 in the other two sections of this document.

4	2012/10/11	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.	
3	2012/10/11	Member State
Germany	According to REACh Regulation it is formally correct to identify substances as SVHC based on their CMR classification listed in Annex VI of the CLP directive solely. However, up to now MS have provided some specific information to identify concerns. Therefore, the instrument of preparing RMOA prior to annex XV preparation has been established e.g. to avoid duplicate work. The German CA would appreciate to continue this practice. This guarantees that relevant substances are prioritised.

Referring to the Risk Management Option Analysis (RMOA) concerning “Lead compounds in PVC-products” carried out and submitted by the German CA we want to comment on the proposal for identification as SVHC of the following substances:

Neutral lead stearate (91031-62-8)
Dibasic lead stearate (12578-12-0)
Dibasic Lead Phthalate (69011-06-9)
Trilead Dioxide Phosphate (12141-20-7)
Tetralead Trioxide Sulphate (12202-17-4)
Pentalead Tetraoxide Sulphate (12065-90-6)
Basic Lead Carbonate (1319-46-6)
Sulfurous Acids, lead salt, dibasic (62229-08-7)

After evaluation of the above mentioned substances, the derivation of their use in the production of PVC-products and extensive discussion with the European stabiliser producers  the RMOA drew the conclusion that no action for these substances concerning the use in PVC is necessary at the moment. As conducted in the RMOA-document, industry has initiated a community-wide self-commitment aiming at the complete phase-out of lead in PVC-products by 2015. The transparency and reliability of the commitment were ensured as the progress was accompanied and rated by independent experts as well as by the EU-commission.

One principle on which Regulation (EC) No. 1907/2006 is based is that manufacturers, importers or downstream users should ensure that their substances have no adverse effects on human health and the environment (article 1(3)) by precautionary action. From the German CAs point of view the European initiative (Vinyl2010, followed by VinylPlus) has taken this responsibility by traceable reducing the use of lead and the introduction of alternatives. Therefore, the German RMOA concluded that the best measure at the moment was to accompany the progress until 2015 and initiate an Annex-XV-process for restriction in case the self-commitment does not reach its desired goals.

The German CA is aware that the substances concerned in this comment as well as the RMOA are not solely used in plastic products. Tetralead trioxide sulphate and pentalead tetraoxide sulphate are used in lead acid battery production, also. Nevertheless, Germany wants to point out some aspects regarding recycling are of importance once the substances are listed in the Candidate list – especially when thinking further to the prioritisation process for Annex XIV.

Considering the long lifetime of PVC-products (profiles, wires, pipes, flooring etc.) and that the production of lead-free PVC started approximately only 10 years ago, we assume that the major part of volumes used for recycling (800 000 t/a planned for 2020) probably consist of lead-containing PVC. This will consequently lead to a slow dilution of lead in PVC since new lead-free PVC will emerge in the recycling cycle only in the future. Based on our current understanding of the authorisation process companies conducting recycling of lead containing PVC may be obliged to acquire an authorisation for their recycling use. If recycled PVC was subject to authorisation this would clearly contradict sustainability efforts. Similar considerations would also be relevant for lead battery recycling.

The German CA still favours to await the outcome of the self-commitment prior to the initiation of other REACh legislative routes. 
	Thank you for your comment. 

ECHA has received a request from the Commission in accordance with REACH Article 59(2) to prepare an Annex XV dossier proposing the identification of this substance as SVHC.

Preparation of a risk management options analysis (RMOA) before proposing the identification of a substance as SVHC 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. 

The RMOA submitted by the German CA will be taken into consideration before further risk management activities for this substance, beyond identification as SVHC, are initiated.
	
2	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC.
This substance is included in the Trade Union Priority List for REACH authorisation see: http://www.etuc.org/a/6023	Thank you for your opinion.	
1	2012/10/01	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of this substance as SVHC.
This substance is included in the Trade Union Priority List for REACH authorisation see: http://www.etuc.org/a/6023	Thank you for your opinion.	

Specific comments on the justification
#	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
15	2012/10/17	Industry or trade association
EUROBAT
Belgium	The European automotive and industrial battery industry does not disagree with the proposal for Tetralead Trioxide Sulphate to be identified as a substance meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH) owing to its classification as toxic for reproduction category 1 A.	Thank you for providing your opinion.
	
			See also:
Comment 15 attachment (EUROBAT Tetralead Trioxide Sulphate and Pentalead Tetraoxide Sulphate Response - 17-10-12.pdf).pdf		
14	2012/10/17	Company
Germany	Johnson Controls Power Solutions is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, Johnson Controls Power Solutions fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in section “General comments on the SVHC proposal” (see above).	
5	2012/10/15	Company
REHAU AG + Co.
Germany	pages 7 and 8:
The entry in Annex VI, table 3.1 and table 3.2 is a group entry for lead compounds only, not specific for this substance. Several species of lead compounds included in a matrix of PVC cannot be distinguished by analysis easily.	As noted in page 7 of the Annex XV report, the specific lead substance is covered by the group entry in Annex VI, table 3.1 and table 3.2 of the CLP Regulation.

Please note that when a company has to check whether it has obligations according to the Articles 7(2) and 33 of REACH, the suppliers could be asked directly on whether the content of any specific (lead) substance on the Candidate List is above a concentration of 0.1% (w/w).

Regarding recycled materials, please see response to same comment #5 in section “Specific comments on use, exposure, alternatives and risks”. (below)
	
3	2012/10/11	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	
25	2012/10/18	Company
Berzelius Metall GmbH
Germany	p.10: Information on use, exposure, alternatives and risks
Use of the substance in lead acid batteries:
80% of the lead produced in Europe (primary and secondary metal) is used for the production of lead acid batteries. The Berzelius Metall GmbH is a major collector and recycler of these accumulators in Germany. In Germany nearly 100% of lead batteries are collected and material utilization rate is > 90%, which exceeds the requirements of the Battery Directive (2006/66/EC). The manufacture and recycling process is subject to IPPC (Dir 2008/1/EC) and IED (Dir 2010/75/EU) and implementation of BREF notes is mandatory. Related to cars, life cycle emission has been reduced by 99.6% mainly due to increased battery recycling efforts (Ökoinstitut 2010 ). 
Lead monoxide and lead tetraoxide are used in the production of battery pastes and are transformed in the course of the battery manufacturing process into pentalead tetraoxide sulphate and tetralead trioxide sulphate, and then ultimately into Lead Metal (Pb) and Lead dioxide (PbO2). The latter two are the Lead-based active substances present in the battery.
Lead-based batteries are the only feasible technology for all Starter, Light and Ignition (SLI) applications used in automotive vehicles, and are widely used in industrial motive and standby applications; for example in forklift trucks and electric wheelchairs, and as Uninterruptible Power Supply (UPS) for hospitals or IT applications. Lead-based batteries are also playing a significant role in achieving the EU’s carbon emission reduction targets, through start-stop functionality and regenerative braking in micro hybrid vehicles, and for renewable energy storage and grid stabilisation in on- and off-grid electricity systems. 
The lead-based battery is used for SLI functions in all motor vehicles throughout the world. As the lead-based battery is a “standardised product”, even if an alternative battery technology were available, car technology would need to be converted to accommodate a substitute electrochemical system. This would take well over a decade to achieve.
Recycling of lead acid batteries and the recovery of lead is well established in Europe and due to the high value of the metal profitable irrespective of high environmental and occupational standards. The common material recovery of > 90% in Germany is higher than the legal requirement of > 65%. This way waste and especially lead containing waste is prevented. 

Alternative accumulator systems:
As clearly expressed in the REACH Regulation one aim of the authorization process is to substitute SVHCs: “importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution” (Art. 55).
Several other accumulator systems are under discussion as alternatives for lead acid batteries. However, in its review of the current lead acid battery exemption from End of Vehicle Life Directive (2000/53/EC) the EU Commission concluded that there were no mass-market applications available as replacements. The exemption from a ban on use of lead in motor vehicles was granted until 2015 when it is due for review. Even if an alternative battery technology were available today it would take well over a decade for it to become a standardised product in cars. 
In fact authorization might push the development of the required performance for other systems. However, in the case of accumulators pretended less hazardous alternatives contain also heavy metals or other CMR-substances. Even lithium ion systems often contain carcinogenic cobalt and nickel salts or organic solvents with CMR-properties. Nickel metal hydride batteries are based on carcinogenic nickel salts, nickel-cadmium on nickel and cadmium. Furthermore safety problems with lithium ion batteries during transport or after accidents are often reported, since these accumulators may ignite due to improper handling or damage. 
While recycling of heavy metals is normally profitable, it is questionable whether for lithium based used accumulators the goal of 50% material recovery, which is required by the battery Directive for other batteries, will be realised. 
Thus, if only the lead based system is discredited and prioritized for authorization, battery producers and users might switch to other systems which are subject to fewer controls and less efficient material utilisation by still a high content of very hazardous substances.

Existing legislation:
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. 
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 ongoing fall in anthropogenic emissions and environmental levels globally. As a consequence of these marked reductions in industrial emissions, the relative importance of ongoing 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 management measures in relation to REACH.

Industry voluntary initiatives:
Several voluntary initiatives have been launched in lead industry to cope with the challenge of safe use of lead and lead compounds in industry.
In response to a request from the European Commission in 2000 the lead industry committed to undertake a Voluntary Risk Assessment (VRAR) for lead and high production volume lead compounds, including lead monoxide and lead tetroxide.  This initiative was endorsed by the European Union Member State Competent Authorities in 2001. A comprehensive dossier detailing the health and environmental impacts of lead and lead compounds was compiled in accordance with the detailed methodology established in a revised EU Technical Guidance Document on Risk Assessment for New and Existing Substances.  The dossier was then extensively reviewed by EU Member States (via the Technical Committee on New and Existing Substances) over the course of several years.  The VRAR for Lead was finalised in 2008 and web posted by the European Chemicals Agency (ECHA).  A review of the Voluntary Risk Assessment for Lead by the EUs Scientific Committee on Health and Environmental Risks (SCHER) was also conducted.  This extensive and detailed assessment has been considered in multiple health and environmental regulatory initiatives affecting lead and forms the basis of the REACH registration dossiers for the affected substances.
In 2006 European lead battery manufacturers (represented by EUROBAT) developed blood lead reduction programs to reduce blood lead for all employees below 40 µg/dL for all employees and below 30 µg/dL for female employees. This helped in reducing blood lead levels with 19.4 % of workers above 40µg/dL in 2001 compared to 5.1% in 2010.  Furthermore, data is also available for 2011 and the program is still in force and used in the entire industry. Blood lead reduction programs are in place throughout the entire lead industry and feedback confirms continuous improvements in blood lead reductions in all sectors.

Exposure and risk management:
The risks related to use and exposure of lead and lead compounds have been discussed for years. Aiming at limiting the risks for human beings and the environment, regulations have been implemented in different areas and lead has been substituted in several products. Manufacture, use and recycling have been improved for other products. As a result of these activities a decrease of lead concentration in the environment and a decrease of lead blood levels, which is the main indicator for human exposure, have been reported.
Reprotoxic effects of lead-ion detected in the human body have been widely discussed and accepted and trigger a high standard of risk management in lead industry. This is also reported in the CSR  in the registration framework and the voluntary risk assessment report VRAR ). These documents are already providing valuable information on how risks from lead can be effectively managed, for example in the case of worker health, and industry is committed to implementing these measures. The report is also helping to identify areas where further research is needed and again industry is committed to delivering this.
A DNEL of 40 µg/dL for men and 10 µg/dL for pregnant women has been developed in the REACH Chemical Safety Report. This is indexed to levels of lead in blood and was not developed on a route specific basis. The reason for this is because blood lead levels integrate all exposure routes and further provide a measure of the internal systemic dose that can be associated with different biochemical, preclinical and clinical endpoints. 
Data collected in 2007 on blood lead levels in the battery and stabiliser industries to support the generation of the REACH Chemical Safety report indicated that the 90th percentile of exposures in both sectors was below 40 µg/dL (table 2). Since this date there have been improvements in handling procedures that will no doubt have resulted in further reductions in blood lead values. These industries represent the highest potential for exposure in the existing Industry sectors manufacturing or using the related lead compounds.
On the other hand exposure to lead is still an issue. But exposure of the general population cannot be explained by the use of products containing lead metal. More bioavailable lead compounds are still in use and diffuse sources (agriculture, past pollution, contaminated food) play an imported role in human exposure. To reduce risks related to the latter, completely different measures have to be implemented.
According to a report by Fraunhofer ISI on behalf of the German UBA (UBA 2003 ) there is a basic need for action to reduce the environmental burden due to non-point emissions of lead. As main sources for lead burden traffic (cars) and agriculture have been identified. Reduction potentials are described for lead free brake linings and wheel weights (replacement already ongoing) and measures reducing erosion of soil of agricultural areas (lead input trough mineral fertilizer and other fertilizers). This source is in no way affected by authorization of lead compounds since the concentrations in the fertilizers are far below concentration threshold of 0.1%.
In the past 20 years the blood levels in the general population have been significantly reduced (Kemi 2007 , p. 8, UBA 2007b ). The general population is exposed to lead principally via food. For adults more than 80% of the daily uptake of lead happens via food. The sources are dust deposition on plants and on feeding for animals. Children may take up lead via ingestion of soil and dust particles.	Thank you for your comment.

Please refer to response to comment #25 in section “General comments on the SVHC proposal” (see above).	
			See also:
Comment 25 attachment (Berzelius consultation SVHC.zip).zip		
16	2012/10/17	Industry or trade association
ELSA (ESPA)
Belgium	To our astonishment there has been no analysis of the information provided in the registration dossier of this substance concerning Use, Exposure and Alternatives  and Risks. ELSA is of the opinion that such information is of paramount importance for this substance and that it should thus be taken into account during the process of potential identification of this substance as an SVHC. Therefore we have inserted an attachment in Section IV of the commenting form, which highlights the key points which shall be considered. In this document we do also refer to the comments filed for this substance by ILA, The International Lead Association, and which contains additional, more detailed information on specific topics which we did not repeat in the present attachment.
Note that the comments inserted for this substance are also applicable to 7 other lead compounds (collectively denominated “lead-based stabilisers”) and have been inserted  under each of the individual substances. 
	Thank you for your comment.  

Please refer to response to comment #16 in section “General comments on the SVHC proposal” (see above).	
			See also:
Comment 16 attachment (SVHC-Public-Consultation-Oct-2012_ELSA-comments_CAS-12202-17-4.pdf).pdf		
15	2012/10/17	Industry or trade association
EUROBAT
Belgium	The European automotive and industrial battery industry believes that a detailed analysis of risk management options is required before a decision is made on whether to prioritise Tetralead Trioxide Sulphate for inclusion in Annex XIV. Authorisation would prove to be an inefficient risk management option for this substance for the following reasons:

•	Exposure: The use of Tetralead Trioxide Sulphate in lead-based battery manufacturing is non-dispersive and controlled, with the Tetralead Trioxide Sulphate not present in the final article (the charged battery). Its use in the workplace is already covered by existing Community legislation.

•	Alternatives: There are no alternatives to the use of Tetralead Trioxide Sulphate in the manufacture of lead-based batteries. Banning Tetralead Trioxide Sulphate would be equivalent to banning the lead-based battery itself.

•	Risks: Widespread and effective Community legislation already imposes minimum requirements related to the protection of human health and the environment across the entire lifecycle of a lead-based battery. If inclusion in Annex XIV is unavoidable, Article 58.2 of the REACH Regulation should therefore apply to the use of Tetralead Trioxide Sulphate in European automotive and industrial battery production.

Please refer to the enclosed battery industry answer for full information on Use, Exposure, Alternatives and Risks for Tetralead Trioxide Sulphate in the Lead-based battery manufacturing process. 
	Thank you for your comment.

Please refer to response to comment #15 in section “General comments on the SVHC proposal” (see above).	
			See also:
Comment 15 attachment (EUROBAT Tetralead Trioxide Sulphate and Pentalead Tetraoxide Sulphate Response - 17-10-12.pdf).pdf		
14	2012/10/17	Company
Germany	Johnson Controls Power Solutions is a member of EUROBAT, the European Association of Automotive and Industrial Battery Manufacturers. EUROBAT answers this consultation on behalf of all its members. As a consequence, Johnson Controls Power Solutions fully supports and subscribes to the comments made by EUROBAT.	Thank you for your comment.

Please refer to response to comment #15 in section “General comments on the SVHC proposal” (see above).	
13	2012/10/17	Industry or trade association
International Lead Association
United Kingdom	THE LEAD REACH CONSORTIUM COMMENTS FOR THE PUBLIC CONSULTATION PROPOSAL TO IDENTIFY TETRALEAD TRIOXIDE SULPHATE (CAS# 12202-17-4) 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.
Further details on uses of tetralead trioxide sulphate, workplace and environmental exposure, alternatives and socio-economic information can be found in the comments provided during this public consultation by the industry associations representing the predominant uses of tetralead trioxide sulphate in the EU:
Association of European Automotive and Industrial Battery Manufacturers (EUROBAT): Batteries
European Lead Stabilizers Association (ELSA): Lead stabiliser producers
SUMMARY
We do not disagree that tetralead trioxide 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 tetralead trioxide 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 tetralead trioxide sulphate is in the process undertaken to manufacture automotive and industrial lead acid batteries. This is a non-dispersive and controlled use in that the tetralead trioxide sulphate is converted into another substance and is not present in the final article. 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 95% of men working in this sector have blood lead levels below 40μg/dL.
2. Use of tetralead trioxide sulphate as a stabiliser in PVC production is the other significant use with approx. 4.5% of the market. This sector already has a voluntary commitment to replace lead stabilisers completely by end of 2015 across the EU-27. In many cases lead stabilisers are replaced by calcium based stabilisers and during the period 2001-2011 lead stabiliser consumption decreased by approximately 82%.
3. Tetralead trioxide 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 lead monoxide 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. According to Article 58(2) of REACH it is possible to exempt from the authorisation requirement uses or categories of uses "provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled." We believe that many existing uses of lead and compounds meet these requirements and should be exempt from authorisation.
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 tetralead trioxide sulphate is 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.
4. The vast majority of lead used in the manufacturing of automotive and industrial lead acid batteries is routinely recycled at the end of life due to the intrinsic properties and value of lead (more than 97%), making it one of the most efficiently recycled materials in the EU. Breaking the recycling loop by eliminating some of the major uses of lead will result in an oversupply situation that will require vast quantities of lead being sent for waste disposal. This will create a significant problem in that landfill of lead is prohibited in the EU.
	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 describe 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 account of at later stages of the authorisation process.	
			See also:
Comment 13 attachment (Public consultation document Tetralead trioxide sulphate CAS 12202-17-4.pdf).pdf		
6	2012/10/15	Company
Xstrata Zink GmbH
Germany	Page 10
There is only reference made to the registration dossier without any analysis and conclusions. 
All industrial and professional uses contain PROC1 or PROC 3 (the substance is used in a closed process). There is no direct consumer use of the substance. All consumer uses are uses of materials, which contain the substance or a chemical produced from the substance. The articles are batteries or plastic materials. A contact of the consumer with the lead compound contained in the articles can be excluded. 
The risk for human health is very low. This conclusion should explicitely added to the dossier.	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 describe 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.
	
5	2012/10/15	Company
REHAU AG + Co.
Germany	page 10:
The inclusion of this substance in the candidate list 2 years  before effective date of the voluntary phase out of the use of lead-containing additives would not lead to an essential reduction of risk. From REHAU’s point of view it would cause severe problems for articles produced from post-consumer PVC-recycling-material, because most of recycled material contains more than 0.1% of lead compounds. The obligation to inform customers about lead compounds would apply to articles containing recycled material although we wouldn’t know which of the 30 listed lead compounds are contained. It is analytical impossible to identify the exact lead compounds and due to this the given information will be speculative to some extent. The information will presumably make our customers insecure to buy articles produced from recycled post consumer PVC although the lead compounds are included the matrix. The bureaucracy connected with the obligation to inform customers will jeopardize the rates for recycling of post consumer PVC aspired by association Vinyl Plus because this obligation applies along the whole supply chain and especially wholesale-companies try to avoid any bureaucracy related to substances listed in candidate list.

According to our opinion it would be the better way to issue a restriction for all lead compounds effective from beginning 2016 and to allow  per derogation lead compounds introduced per recycling material up to a content of 3% (measured as metal). In return for this restriction the suggested inclusion of the 30 single lead containing substances in the candidate list should be waived.
	Thank you for your opinion.

It may indeed be difficult to know which of the Candidate List’s lead substances used in the production of PVC articles - and at which exact concentration – are contained in articles made of recycled PVC. Therefore in those cases the substance’s name information, which is among the information that needs to be provided where Articles 7(2) and 33 of REACH apply, may, as you mention, to some extent be speculative. If companies cannot draw and document a conclusion that the articles contain less than 0.1% (w/w) of any of  Candidate List substances, companies should strive to fulfil the obligations in Articles 7(2) and 33 of REACH. Information on the lead content could be given in case there is uncertainty regarding which exact substances give rise to the presence of lead. It is up to the companies to assess whether the obligations foreseen in Articles 7(2) and 33 REACH may apply; ECHA suggests to document the procedures followed during such assessment in case of enforcement.

Regarding your reference to the impact of the inclusion of lead substances in the Candidate List, on PVC recycling rates, ECHA would like to highlight that one of the purposes of Art. 33 of REACH is to enable customers to make more informed choices. Article 33 sets that for articles containing substances of very high concern (included in the Candidate List) information should be provided to allow safe use by customers. One way of doing this in practice could be to inform about the lead content of the articles. 

Finally, regarding alternative risk management options, please refer to the response to comment #3 in section “General comments on SVHC identification”.	

Attachments

Comment number	Public attachment	
13	
Comment 13 attachment (Public consultation document Tetralead trioxide sulphate CAS 12202-17-4.pdf).pdf	
15	
Comment 15 attachment (EUROBAT Tetralead Trioxide Sulphate and Pentalead Tetraoxide Sulphate Response - 17-10-12.pdf).pdf	
16	
Comment 16 attachment (SVHC-Public-Consultation-Oct-2012_ELSA-comments_CAS-12202-17-4.pdf).pdf	
25	
Comment 25 attachment (Berzelius consultation SVHC.zip).zip