19 November 2011

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

Substance name:	lead dinitrate	
CAS number:	10099-74-8	
EC number:	233-245-9	

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
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
15	2012/10/18	International NGO
Health and Environment Alliance
Belgium	We support the adoption of this chemical to the Candidate List.	Thank you for providing your opinion.	
14	2012/10/18	Industry or trade association
GIFAS
France	PLEASE REFER TO ATTACHED DOCUMENT	Thank you for your comment and the information on uses and alternatives provided. 

In accordance with REACH Article 59 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. 

The proposal for identifying this substance as SVHC is based on its harmonised classification in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation).  

Please refer to response to comment #6 in the section “specific comments on use, exposure, alternatives and risks”.	
			See also:
Comment 14 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf		
12	2012/10/18	International organisation
ASD AeroSpace and Defence Industries Association of Europe
Belgium	None. The dossier does indicate that the substance meets
 the requirements of an SVHC.
	Thank you for your comment.	
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 dinitrate should be identified as a substance of very high concern and should be included in the Candidate List.
	Thank you for providing 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 dinitrate 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 providing your opinion.	
13	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 providing your opinion.	
4	2012/10/11	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 far reaching measures.
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 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. 

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.	
3	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 providing 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 providing your opinion.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
12	2012/10/18	International organisation
ASD AeroSpace and Defence Industries Association of Europe
Belgium	None	-	
4	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
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
12	2012/10/18	International organisation
ASD AeroSpace and Defence Industries Association of Europe
Belgium	There already is existing legislation in Member States relating to the control of lead and its compounds in the working environment. Making this lead compound a Candidate SVHC would not provide increased protection to workers, the environment or consumers, but would increase uncertainty and costs in the industries which use this compound in their business processes. 

This substance is used in the manufacture of primary explosives. The manufacturing processes are of necessity small scale (Batch sizes less than 10kg), and facilities have suitable extraction and waste collection systems to minimise exposure of lead compounds to workers or the environment. Because of the nature of the product, good housekeeping is essential to all aspects of the manufacturing process. Processing takes place in dedicated facilities, and in many cases these are undertaken by remote processing operations which provide workers with protection from both exposure and the dangers of explosion from the products being manufactured.
	Thank you for your comment and for the additional information on uses. 

As regards your reference to existing legislation, please 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 in the authorisation process.

Please also refer to the response to comment #6 in this section (part “Consideration of information provided”).	
11	2012/10/18	Company
NITROERG S.A., KGHM Polska Miedź S.A. Capital Group
Poland	p. 10
Before the decision is made to include lead dinitrate in the Candidate List, a detailed analysis of risk management should be performed, considering each kind of application separately.	Thank you for your comment and for the additional information on uses, exposure and alternatives. 

Please note that the SVHC identification process, as set out in REACH Article 59(1) is intended to identify substances meeting the criteria referred to in Article 57 and establishing a candidate list of substances for eventual inclusion in Annex XIV. Hence, no further precondition than meeting criteria referred to in Article 57 needs to be fulfilled in order to include a substance in the candidate list in accordance with the procedure set out in Article 59. 

With regards to the need for detailed analysis of risk management, please note that 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.

Regarding the provided information please refer to the response to comment #6 in this section (part “Consideration of information provided).
	
			See also:
Comment 11 attachment (lead dinitrate.pdf).pdf		
9	2012/10/18	Company
France	Lead dinitrate is used in labs as a standard for equipment calibration (routine analysis). Total volume used per year and per lab is very low (few grammes) and it is obvious that there is no alternative available. We then believe that the use of lead dinitrate as an analytical standard in labs should be complely exempt from authorisation. 
	Thank you for your comment and the additional information provided.

Please note that use of substances included in Annex XIV (List of substances subject to authorisation) in Scientific research and development, as defined in Art. 3(23) REACH, is exempted from the authorisation requirement in accordance with Art. 56(3) REACH.

Please also consider responses to comments #6 (part “Consideration of information provided) and #5 in this section. 	
6	2012/10/17	Company
France	A)	BACKGROUND.

1.	DAVEY BICKFORD is an important Company specialized in initiation systems. DAVEY BICKFORD is also a primary  Explosives manufacturer, located in HERY, in FRANCE. We have reviewed the Annex XV dossiers submitted by the European Chemical Agency at the request of the European Commission, concerning the lead dinitrate substance (Version October 2012, available on ECHA Webpage). This substance is a lead compound used in the manufacture of primary explosives (lead azide and lead styphnate). We use this substance and have an expert judgement on the storage, transport and use of this substance. These lead compounds are incorporated in explosive items and the final products (detonators, primers, etc), are only sold for industrial applications. 

2.	The above mentioned substance Lead dinitrate has been identified as substance meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH). This identification has been based on their classification as toxic for reproduction. The quantities involved in their uses are very small, a few tons per year. Finally, these substances have not a wide-spread dispersive use.

B)	EXECUTIVE SUMMARY
1.	The risk to workers during manufacture is reduced by risk management measures. 
2.	There is no release to environment during use. 
3.	There are no significant emissions or releases from the use. 
4.	As a consequence of the above mentioned reasons, based on the criteria formu-lated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of this compound in the candidate List (article 58) is not justified. This substance do not meet the criteria because:
-	No wide spread dispersive uses.
-	production volumes are quite small.

1.	REASONS FOR NO-INCLUSION IN CANDIDATE LIST

1) There is no Widespread Dispersive Use
The production sites, that are used this substance as raw material  to make explosive substances are quite few in European Union.
For DAVEY BICKFORD, the use of the substance and the production of the explosive items take place on the same sites.
The subsequent user and the end user will not come into contact with  Lead Compounds because they are completely transformed (in lead azide or lead styphnate ) There is no contact of subse-quent users of explosive items with these Lead Compounds. There is no intended release during fabrication or end use. Any release could occur only as a result of an accident or misuse. 
So it is obvious that there is no widespread dispersive use during the whole lifecycle of lead dini-trate .

2) The Quantities used are Very Low
For DAVEY BICKFORD, the overall tonnage of Lead dinitrate is less than 5 tons/year. Lead dinitrate is only used to produce explosive substances. 
These quantities are very low comparing to other European sources of lead compounds placed in the market by other industries (like are batteries, lead foundries, steelmaking shops, refining of free-machining steels, lead containing common steels, painting materials production, etc).
In comparison with the tonnage of lead compounds placed on the market by other industrial sectors, such as battery production and, the quantities of lead involved in the manufacture of detonators are negligible.

3) No Substance Contact of Subsequent Users of Explosive Items and no Exposure dur-ing Handling and Use of Final Explosive Items.
The subsequent user and the end user will not come into contact with lead dinitrate because it is completely transformed of primary explosives. There is no intended release during fabrication or end use. Any release could occur only as a result of an accident or misuse.

4) No Significant Emissions or Releases from the Manufacture.
There are no significant atmospheric emissions from the use of lead dinitrate. 
Water emissions are not expected because of the destruction of explosives during the waste water treatment. 
Every production site in European Union operates under IPPC environmental permits and most manufacturing sites produce these substances under conditions equal or equivalent to the Best Available Techniques as in BREF-Specialty Inorganic Chemicals (chapter 6.4, SIC Explosives) prepared and adopted by the European Commission.
The key conclusion is that emissions of Explosive Lead Compounds should largely not be ex-pected. 

5) Worker Health Risks are minimized and controlled by Regular Examinations.

The engineering and worker protection measures ensure that the contact with the substance is minimized so that there is no health risk for the worker. This opinion is supported by the regular examinations of the lead content of the blood for the affected employees controlled by the medi-cal service in our company.
Health risks at workplace are minimized and controlled by the manufacturing processes, the im-plementation of good practices and sound working instructions as usual in explosive sector for years. 

6) New Product Lines versus Replacement of Explosive Lead Compounds in Older Products
For DAVEY BICKFORD, the suppression of lead dinitrate is related to the replacement of ex-plosive lead compounds. The replacement of Explosive Lead Compounds (and in consequence the use of lead salts as lead dinitrate in manufacture of these explosives compounds) in current products is very cost-intensive and requires a lot of research and development. So the costs of R&D, testing and qualification are out of all proportion to the produced number of pieces.
Most of the European manufacturing companies are working on alternative substances, i.e., lead free explosive compounds and efforts are made to establish these new products on the market. No commercial products are available nowadays. The main application (lead azide) is actually impossible to replace : no substitution product is now  able to assure the same level of reliability and safety than lead azide  loaded in detonators.
 R&D is cost-intensive taking into account the low quantities of substances involved in European market.
Alternative substances require a lot of quality testing and formal certification according to other European legal requirements (Directive 93/15/ECC and many others) and some NATO re-quirements for especial military items. Therefore, the explosives industry needs many years to test the feasibility of any possible chemical alternatives developed at lab scale.
There is no clear indication (at present) on the timeframe of R&D required for the development and qualification of alternative compositions. Irrespective of the significant efforts carried out by european manufacturers, that efforts may be not fruitful for all applications of Explosive Lead Compounds, as mentioned in ECHA proposal reports.
The huge complexity of the scientific and technological aspects involved in obtaining feasible alternatives to Lead Explosive Compounds made extremely difficult the implementation of R&D projects. In consequence there is a high risk of obtaining unsuccessful results in these projects.

8) CONCLUSION: 

No Support for inclusion in Candidate List and No Reason for Prioritization.
According to prioritization criteria included in Article 58 (3) for Inclusion of Substances in the Candidate List of Substances Subject to Authorisation, the priority shall be given to substances with 
-	Widespread dispersive use, or
-	High volumes.
It is absolutely clear that Lead dinitrate do not meet anyone of these priority criteria.
Therefore, we do not support the inclusion of Lead Explosive Compounds, and the raw material used in their manufacture in the Candidate List of Sub-stances Subject to Authorisation.
Finally we kindly ask ECHA to give the lowest possible priority to Lead Dinitrate, be-cause these substances are fully destroyed during use and the risks to workers, users, and the releases to environment are quantitatively negligible during manufacture, storage and transport.
	Thank you for your comment and the information on uses, volumes, releases and alternatives provided. 

Please note that the SVHC identification process, as set out in REACH Article 59(1) is intended to identify substances meeting the criteria referred to in Article 57 and establishing a candidate list of substances for eventual inclusion in Annex XIV. Hence, no further precondition than meeting criteria referred to in Article 57 needs to be fulfilled in order to include a substance in the candidate list in accordance with the procedure set out in Article 59.

Consideration of information provided:
If the substance is identified as SVHC, the information provided, where relevant, will be taken into account at later stages of the authorisation process. 

However, please note that 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.

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.

8	2012/10/17	Industry or trade association
Switzerland	 On the basis of the following section of EU legislation that regulates semiconductor factory operations and products, the semiconductor industry believes that these substrance are appropriately regulated already. In addition any potential future nomination or inclusion in the candidate list of lead compounds for semiconductor usage should identify an exemption for the semiconductor sector from an authorisation or future potential restriction proposal for usage as being the most effective and appropriate measure .  
–Restriction of Hazardous Substances
RoHS recast article 6, states that the review and amendment of the list of restricted substances in Annex II shall be coherent with other legislation related to chemicals, in particular Regulation (EC) No 1907/2006 so there should be no overlaps, as restrictions of the specific use of substances in EEE under RoHS, should not also be duplicated by being addressed in REACH. This nomination of substances contradicts the proportionality principle.
–End of Life Vehicle Directive 2000/53/EC
The End-of-Life Vehicles (ELV) Directive ‘lays down measures which aim, at first priority, at the prevention of waste from vehicles as well as at the improvement in environmental performance of all the economic operators involved in the life cycle of vehicles’ (Article 1). Under this remit, the ELV Directive ensures that regular reviews on the use of Lead in automotive is carried out. The Oeko Institute’s report concluded that ‘the short-term substitution by lead-free alternatives would reduce the functionality and reliability of vehicles, the use of lead in this function is hence unavoidable at the time being and in the near future’. The next review of this Directive is scheduled for 2014.
- Protection of Workers: Occupational Exposure Limits and industry standards
European Occupational Exposure Limit for Lead and Lead Compounds (Directive 98/24/EC) Lead and lead compounds have a Binding Occupational Exposure Limit in Europe of 70μg/dL blood, 0.15mg/m3 (8hr time weighted average) air. This sets a minimum standard that is mandatory in all EU Member States to control occupational exposures. In the semiconductor industry there is no exposure to the workers to lead due to the contained nature of the process manufacturing systems.
The highly sophisticated and detailed risk management measures employed in the semiconductor industry  in Europe for this substance alongside the highly controlled workplace exposure and the relevant industrial hygiene measurements used in the semiconductor industry, and the de minimis environmental emissions to air ensure a rigorous and strictly managed usage of the remaining lead compounds.

Additionally relevant legislation
–IPPC / Industrial Emissions Directive
–Water Framework Directive
–Waste Shipment Regulation
–Chemical Agents Directive
Regulation of Emissions to the Environment:
–Restriction of Hazardous Substances
-Batteries Directive (collection and recycling)
–End of Life Vehicle Directive

Lead Nitrate is found in some chemicals used in the semiconductor manufacturing in Nickel Eless deposition processes as deposition speed controller. 
Usage in Europe is limited to < 50 kg/h at a concentration of 10 %.
Industrial exposure is < 0.0003 mg/m3
Lead Nitrate is not found in the article and it is not released to the environment thanks to the typical environmental management of chemical materials in the semiconductor industry
	Thank you for your comment and the information provided.

Please refer to the response to comment #12 in this section.
	
5	2012/10/17	Company
Germany	Lead (II) nitrate is used in a mixture or solution as an analytical standard for test and measuring instruments, e.g. as calibration standard for ICP and AAS by industrial and professional users. Additionally it serves as oxidising agent for R&D purposes.
These applications are laboratory uses within the scope of scientific R&D. The risk for the environment and consumers is very low. Usually the volumes and the concentration of the substance in the mixtures are low. All formulations mentioned in the uses described above are used in the laboratory by industrial and professional users that are well-trained.
The packaging/refilling of the pure substance as well as the formulation/packaging/refilling of the mixtures for scientific R&D purposes into small packages should be exempted from authorisation.
	Thank you for your comment and for the information provided.

Please note that although uses for scientific research and development of a substance are exempted from the authorisation requirement in accordance with Article 56(3) this appears to only apply to its final use for SRD purposes under the conditions defined in Article 3(23).

However, use of a CMR substance included in Annex XIV, on its own or in a mixture (above the lowest of the concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP Regulation)), for e.g. formulation of test kits or analytical standards with the intention to supply them for SRD purposes, would therefore probably require authorisation.

As lead dinitrate is toxic for reproduction, there is a strong societal interest to protect humans, in particular workers handling the substance, from risks potentially arising from its uses. An authorisation requirement for lead dinitrate will accordingly ensure that the health of workers in the EU involved in the uses of this substance is protected.

Please also consider responses to comments #6 (part “Consideration of information provided) and #9 in this section.

Attachments

Comment number	Public attachment	
11	

Comment 11 attachment (lead dinitrate.pdf).pdf	
14	
Comment 14 attachment (20017_2012_Echa_54 SVHC consultation.pdf).pdf