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

Substance name:	Lead diazide, Lead azide	
CAS number:	13424-46-9	
EC number:	236-542-1	

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

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	
30	2011/10/13	Company
Rheinmetall Waffe Munition GmbH
Germany	no wide dispersive use
only small amounts produced (or used)
time consuming replacement process due to international cooperation	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
29	2011/10/13	Industry or trade association
ATIC - Associação Técnica da Indústria de Cimento
Portugal	Comments are made from a user point of view:
Lead diazide is a substance that:
- Is commonly called as lead primary explosives.
- Is a lead compound having explosive properties and applications.
- Is incorporated in explosive items and the final products (detonators, primers, etc).
As far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
28	2011/10/13	Company
Germany	It is not justified that Lead diazide is identified and classified as SVHC because neither the manufacture of the substance, mixture and articles nor te use of the final products are of high concern.
Thus there is no reason for prioritisation.	Lead diazide is classified as toxic to reproduction 1A according to Annex VI, part 3, Table 3.1 of Regulation (EC) No 1272/2008. Consequently the substance fulfils the criteria of Article 57(c) of the REACH Regulation and can be identified as a Substance of Very High Concern following the procedure set out in article 59 of the same regulation.
We thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 28 attachment (Lead Diazide Comment_DIEHL.doc).doc		
23	2011/10/12	Member State
Belgium	Belgium supports the identification of Lead diazide as SVHC according to article 57 (c)	Thank you for your support	
22	2011/10/12	Company
DAVEY BICKFORD
France	Shall we focus first that such substance has unique and specific explosive properties and only applications in explosive chains to initiate with a very small quantity high explosives as much for civilian uses – quarries, mines and civil works- than in Defence field for military purposes – warheads and propellants firing- . DAVEY BICKFIRD company produces this substance and has developed high skills in the production, storage, transport and use of this substance. 

Lead Azide is incorporated in explosive items and the final products (detonators, primers, etc), are only sold for industrial applications and never placed on the market to public according to security reasons. The numbers of persons who can purchase and implement is very limited and have specialist knowledge; furthermore this number is also limited due to specific authorization required by French administration.

The above mentioned substances (Lead Azide, Lead Styphnate, Lead Dipicrate) have been identified as substances 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. These substances have neither PBT nor vPvB properties. The quantities involved in their uses are very small, less than two tons per year in France so, it must be acknowledged that these substances have not a widespread dispersive use.	As you mentioned lead diazide is classified as toxic for reproduction 1A and can therefore be identified as a Substance of Very High Concern following the procedure set out in article 59 of the same regulation.
We thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
21	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	Again we strongly support grouping in the authorisation process. Especially in the case of lead compounds that have similar dangerous properties. Grouping will fasten and facilitate the authorisation process.
Lead or lead compounds are listed (entry 112) in the Commission Recommendation concerning the European schedule of occupational diseases (2003/670/EC). Substituting them is a main goal in prevention in the workplace.
Further we see the need of putting all three lead compounds of this consultation process on the candidate list to avoid substitution of one lead compound, by one of the others.
The required information on safe use of the articles containing Lead Diazide or as a minimum, the name of that substance, will help DUs and consumers.	Thank you for your support and opinion	
20	2011/10/12	Company
DynITEC GmbH
Germany	Good comprehensive work with many details	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 20 attachment (Comments on Annex15_Lead Azide_DynITEC.pdf).pdf		
19	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	Again we strongly support grouping in the authorisation process. Especially in the case of lead compounds that have similar dangerous properties. Grouping will fasten and facilitate the authorisation process.
Lead or lead compounds are listed (entry 112) in the Commission Recommendation concerning the European schedule of occupational diseases (2003/670/EC). Substituting them is a main goal in prevention in the workplace.
Further we see the need of putting all three lead compounds of this consultation process on the candidate list to avoid substitution of one lead compound, by one of the others.
The required information on safe use of the articles containing Lead Diazide or as a minimum, the name of that substance, will help DUs and consumers.		
18	2011/10/12	Company
Orica Europe Pty Ltd & Co KG
Germany	Please find general comments in the attachement	Lead diazide is classified as toxic for reproduction 1A according to Annex VI, part 3, Table 3.1 of Regulation (EC) No 1272/2008. Consequently the substance fulfils the criteria of Article 57(c) of the REACH Regulation and can be identified as a Substance of Very High Concern and included on the Candidate List following the procedure set out in article 59 of the same regulation.
In addition we thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 18 attachment (Comments on Annex XV dossier - Lead diazide.pdf).pdf		
16	2011/10/12	Industry or trade association
Gremi d'Àrids de Catalunya
Spain	Comments are made from a user point of view:
Lead diazide is a substance that:
- Is commonly called as lead primary explosives.
- Is a lead compound having explosive properties and applications
- Is incorporated in explosive items and the final products (detonators, primers, etc).
As far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
15	2011/10/12	Company
France	The use of lead azide for both civilian and militay uses doesn't meet the criteria of priorisation. Please see the enclosed letter.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 15 attachment (COMMENTS STYPHNATE AZOTURE.zip).zip		
13	2011/10/12	Industry or trade association
SFEPA
France	SFEPA does not support the inclusion of Lead Explosive Compounds in the Candidate List of Substances Subject to Authorisation and is considering that the main reasons are already mentioned in the documents produced by ECHA itself.	Lead diazide is classified as toxic for reproduction 1A according to Annex VI, part 3, Table 3.1 of Regulation (EC) No 1272/2008. Consequently the substance fulfils the criteria of Article 57(c) of the REACH Regulation and can be identified as a Substance of Very High Concern and included on the Candidate List following the procedure set out in article 59 of the same regulation.
In addition we thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 13 attachment (ECHA mail.pdf).pdf		
12	2011/10/12	International NGO
Health and Environment Alliance
Belgium	HEAL supports the nomination of lead diazide to the candidate list based on the inforamtion in the Annex XV dossier.	Thank you for your support	
11	2011/10/11	Individual
Belgium	Comments are made from a user point of view:
Lead dipicrate is a substance that:
- Is commonly called as lead primary explosives.
- Is a lead compound having explosive properties and applications.
- Is incorporated in explosive items and the final products (detonators, primers, etc).
As far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
9	2011/10/11	Member State
Germany	The German CA supports the inclusion of lead diazide in the Candidate list.	Thank you for your support	
8	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of Lead diazide as SVHC.	Thank you for your support	
7	2011/10/10	Company
Spain	The substance does not meet the priority criteria (Article 58(3) REACH) for inclusion in Candidate List. The substance is not PBT nor vPvB. The substance has not a widespread use. The tonnage is very low (European producers have registered the substance having a total tonnage less than 50 t/year of total lead). Please see enclosed document for details.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
					
6	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for your support	
5	2011/10/07	Industry or trade association
COMINROC
Spain	Comments are made from a user point of view:
Lead diazide is a substance that:
- Is commonly called as lead primary explosives.
- Is a lead compound having explosive properties and applications.
- Is incorporated in explosive items and the final products (detonators, primers, etc).
As far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
4	2011/10/07	Industry or trade association
ANEFA
Spain	Comments are made from a user point of view:
Lead diazide is a substance that:
- Is commonly called as lead primary explosives.
- Is a lead compound having explosive properties and applications
- Is incorporated in explosive items and the final products (detonators, primers, etc).
As far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
3	2011/10/07	Industry or trade association
Federación de Áridos
Spain	Comments are made from a user point of view:
Lead diazide is a substance that:
- Is commonly called as lead primary explosives.
- Is a lead compound having explosive properties and applications
- Is incorporated in explosive items and the final products (detonators, primers, etc).
As far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
2	2011/10/06	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as toxic to reproduction category 1 A.	Thank you for your support	
1	2011/10/06	Member State
Norway	The Norwegian CA supports that lead diazide should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
32	2011/10/13	Industry or trade association
Mineral Products Association
United Kingdom	The quantities involved in Lead Diazide use are very small, a few tons per year for the total explosives industry.

As explosives users, since Lead Diazide is hermetically closed into detonators, primers, etc, there is no health risk to workers in quarries. Additionally by necessity workers are kept well clear of blasting operations.

No quantity of Lead remains after use because of the high temperatures and huge pressures that occur during the detonation processes in quarries. As primary explosives, Lead Diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); in both explosions, Lead Diazide totally reacts and disappears in an irreversible way. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams of oxides are disseminated within the tons of blasted rocks.

As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for the safety of workers due to misfires during blasting operations that create missed holes with undetonated explosive. These missed holes are one of the worst incidents that can occur during blasting operations leading to unacceptable risks for workers. Indeed such incidents are notifiable to the UK Health and Safety Executive under the UK Reporting of Injuries, Diseases and Dangerous Occurrences Regulations. Finally, these substances have not a widespread dispersive use.

As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead Diazide compounds in the Candidate List (article 58) is not justified. This substance does not meet the criteria because:
-	it is not a PBT nor vPvB substances.
-	it does not have wide spread dispersive uses.
-	it’s production volume in Europe is very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
31	2011/10/13	Member State
Ireland	Lead diazide is classified as Repr. 1A according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (c) of REACH. 	Thank you for your opinion	
24	2011/10/13	Member State
Sweden	The Swedish CA agrees that lead diazide, being classified as Repr. 1A, meets the criteria according to Article 57(c) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for your opinion	
20	2011/10/12	Company
DynITEC GmbH
Germany	It is DynITEC’s firm conviction that it is not justified to classify Lead Azide as a substance of very high concern (SVHC). 	See answer to the general comment above	
			See also:
Comment 20 attachment (Comments on Annex15_Lead Azide_DynITEC.pdf).pdf		
16	2011/10/12	Industry or trade association
Gremi d'Àrids de Catalunya
Spain	- The quantities involved in Lead diazide uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead diazide is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead diazide remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosives, Lead diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead diazide totally react and disappear in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers. Finally, these substances have not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead diazide compounds in the Candidate List (article 58) is not justified. This substances do not meet the criteria because:
-	They are not PBT nor vPvB substances.
-	They have not wide spread dispersive uses.
-	Their production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
13	2011/10/12	Industry or trade association
SFEPA
France	Total quantities implemented are very low.Lead substances for primary explosives are fully destroyed during use, risks to workers, users, and the releases to environment are quantitatively negligible during manufacture, storage and transport. 	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 13 attachment (ECHA mail.pdf).pdf		
11	2011/10/11	Individual
Belgium	- The quantities involved in Lead dipicrate uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead dipicrate is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead dipicrate remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosives, Lead dipicrate explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead dipicrate /  totally react and disappear in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers. Finally, these substances have not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead dipicrate compounds in the Candidate List (article 58) is not justified. This substances do not meet the criteria because:
-	They are not PBT nor vPvB substances.
-	They have not wide spread dispersive uses.
-	Their production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
5	2011/10/07	Industry or trade association
COMINROC
Spain	See below in part II	See response to the comment in part II	
4	2011/10/07	Industry or trade association
ANEFA
Spain	See below in part II	See response to the comment in part II	
3	2011/10/07	Industry or trade association
Federación de Áridos
Spain	See below in part II	See response to the comment in part II	

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	
33	2011/10/13	Company
Rheinmetall Waffe Munition GmbH
Germany	All articles intended to be used by military personnel (detonators, munitions) need to be especially reliable and meet specific requirements concerning stability in a wide temperature range as well as long shelf life and stability in contact with other substances. These data typically set by relevant authorities/defence agencies and apply NATO wide due to international cooperation and standardization procedures (STANAG). 	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
					
32	2011/10/13	Industry or trade association
Mineral Products Association
United Kingdom	The quantities involved in Lead Diazide use are very small, a few tons per year for the total explosives industry.

As explosives users, since Lead Diazide is hermetically closed into detonators, primers, etc, there is no health risk to workers in quarries. Additionally by necessity workers are kept well clear of blasting operations.
No quantity of Lead remains after use because of the high temperatures and huge pressures that occur during the detonation processes in quarries. As primary explosives, Lead Diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); in both explosions, Lead Diazide totally reacts and disappears in an irreversible way. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams of oxides are disseminated within the tons of blasted rocks.

As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for the safety of workers due to misfires during blasting operations that create missed holes with undetonated explosive. These missed holes are one of the worst incidents that can occur during blasting operations leading to unacceptable risks for workers. Indeed such incidents are notifiable to the UK Health and Safety Executive under the UK Reporting of Injuries, Diseases and Dangerous Occurrences Regulations. Finally, these substances have not a widespread dispersive use.

As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead Diazide compounds in the Candidate List (article 58) is not justified. This substance does not meet the criteria because:
-	it is not a PBT nor vPvB substances.
-	it does not have wide spread dispersive uses.
-	it’s production volume in Europe is very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
30	2011/10/13	Company
Rheinmetall Waffe Munition GmbH
Germany	All articles intended to be used by military personnel (detonators, munitions) need to be especially reliable and meet specific requirements concerning stability in a wide temperature range as well as long shelf life and stability in contact with other substances. These data typically set by relevant authorities/defence agencies and apply NATO wide due to international cooperation and standardization procedures (STANAG). 	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
29	2011/10/13	Industry or trade association
ATIC - Associação Técnica da Indústria de Cimento
Portugal	- The quantities involved in Lead diazide uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead diazide is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead diazide remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosive, Lead diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead diazide totally reacst and disappears in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers. Finally, this substance has not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead  diazide compounds in the Candidate List (article 58) is not justified. This substance does not meet the criteria because:
-	It is not a PBT nor a vPvB substance.
-	It has not wide spread dispersive uses.
-	Its production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
28	2011/10/13	Company
Germany	The replacement of Lead diazide in current products requires a lot of R&D and thus is very cost-intensive as due to the qualification an homologation processes for military applications a lot of governmental authorities and supra-national agencies such as NATO and NAMSA will have to be informed, will require tests and qualification data and finally must all agree to changes made to products that are used by more than one nation.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 28 attachment (Lead Diazide Comment_DIEHL.doc).doc		
25	2011/10/13	Industry or trade association
GIFAS
France	Please refer to attachment (2 pages)	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 25 attachment (20033_2011_Echa_SVHCconsultation.pdf).pdf		
22	2011/10/12	Company
DAVEY BICKFORD
France	No significant harmful effect at production level:
The risk to workers during manufacture is reduced by risk management measures. 
The manufacture of the substances, the formulation of the mixtures and the production of the explosive items take place on the same sites. The production sites are quite few (less than 4 in France). 
There are no significant atmospheric emissions or releases from the manufacture of Lead Azide , as mentioned in ECHA proposal reports.
Water emissions are not expected because of the destruction of explosives during the waste water treatment, as mentioned in ECHA proposal reports. 
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. For instance, a sufficient distance and / or physical barriers between the workers and the operations (preparation, mixing, production, packaging...) with primary explosives are always insured for safety reasons. When closer operations are required, direct skin contact with these substances is avoided by using impermeable packaging for example.

No harmful effect during handling:
 The subsequent user and the end user will not come into contact with Lead Azide  because it is captive within the closed components (detonators, primers, etc). There is no contact of subsequent users of explosive items with this Explosive. There is no intended release end use. So it is obvious that there is no widespread dispersive use during the whole lifecycle of Lead Azide. Emissions of this Explosive should largely not be expected.
 
No harmful effect at final use:
There is no release to environment during use. The explosive compounds detonate during use in order to obtain their commercial value as suppliers of expansive energy to demolish rocks in mining and civil works and other applications including safety systems for defense and aerospace sectors. The primary explosives totally react during detonation processes and the chemical reaction is complete and irreversible.
The conclusion is that emissions of Lead Azide should largely not be expected. 

ALTERNATIVES SOLUTIONS:
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. R&D is cost-intensive taking into account the low quantities of substances involved in European market.
Alternative substances require a lot of qualification testing and formal certification according to other European legal requirements (Directive 93/15/ECC and many others) and some NATO requirements for military items. 
Therefore, the explosives industry needs many years to test the feasibility of any possible chemical alternatives developed at lab scale. Few candidates already tested do not meet 

mandatory requirements for use in initiating chains and have most often very high sensitivity to electrostatic discharges that could induce accident at final system level.
There is no clear indication (at present) on the timeframe of R&D required for the development and qualification of alternative compositions. Significant efforts are carried out by industries involved but efforts may be not fruitful for all applications of Explosive Lead Azide as mentioned in ECHA proposal reports.
Some alternative technologies to initiate secondary explosives have been developed for Defense and Space applications such as slapper detonator or exploding foil initiator but are very expensive, not easily implemented and not accessible for civilian market and can be used only in a few applications even in military field.
Currently a large majority of Defense systems still use initiating explosive chains with Lead Azide . In case of severe restrictions on explosive chain architecture, delocalization would probably be for actors of Defense field, the only outcome as it is possible to purchase out of Europe sub components including detonator or initiator, as percentage of lead azide will below 0,1%. 
Today and also during nest ten years, maybe more, DAVEY BICKFORD has no solution to replace Lead azide and inclusion of this substance in annexe XIV will cause many problems to the company and to his customers.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
21	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	P27, 3.5.2 Worker Exposure
2 Companies did provide information on. This information differs from data delivered by the Federation of European Explosives Manufacturers. 
P28, Table 3.7: (Input and Results – Inhalation Exposure Estimates during the Manufacture of Lead Diazide)
The predicted workers exposure – in a worst case scenario – results in an exceedance of OEL. Especially handling the dry material leads to high exposure levels. This 
P58, Alternatives
A lot of suitable and lead-free alternatives can be found in the dossier. This strict regulation shall be possible in short time.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
20	2011/10/12	Company
DynITEC GmbH
Germany	Once filled and loaded in articles/devices (e.g. blasting caps, detonators) subsequent users and the end users will not get in contact with Lead Azide because it is captive within the closed components. There is no intended release during fabrication or end use. Any release only occurs accidentally or as a result of misuse 	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 20 attachment (Comments on Annex15_Lead Azide_DynITEC.pdf).pdf		
19	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	P27, 3.5.2 Worker Exposure
2 Companies did provide information on. This information differs from data delivered by the Federation of European Explosives Manufacturers. 
P28, Table 3.7: (Input and Results – Inhalation Exposure Estimates during the Manufacture of Lead Diazide)
The predicted workers exposure – in a worst case scenario – results in an exceedance of OEL. Especially handling the dry material leads to high exposure levels. This 
P58, Alternatives
A lot of suitable and lead-free alternatives can be found in the dossier. This strict regulation shall be possible in short time.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
17	2011/10/12	European institution
Laboratorio Oficial Madariaga (LOM)
Spain	•	From the contributions of Annex XV, the necessity to identify these lead explosive compounds as substance meeting the criteria of Article 57 (c) of Regulation (EC) 1907/2006 (REACH) is not strictly necessary.
•	The replacement of Explosive Lead Compounds for another similar product is very cost-intensive and requires a lot of research, development, and a lot of safety testing and formal certification according to other European legal requirements of Directive 93/15/ECC.	Lead diazide is classified as toxic for reproduction 1A according to Annex VI, part 3, Table 3.1 of Regulation (EC) No 1272/2008. Consequently the substance fulfils the criteria of Article 57(c) of the REACH Regulation and can be identified as a Substance of Very High Concern and included on the Candidate List following the procedure set out in article 59 of the same regulation.
In addition we thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 17 attachment (INFORME LOM Annexe XV_eng.doc).doc		
16	2011/10/12	Industry or trade association
Gremi d'Àrids de Catalunya
Spain	- The quantities involved in Lead diazide uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead diazide is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead diazide remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosives, Lead diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead diazide totally react and disappear in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers. Finally, these substances have not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead diazide compounds in the Candidate List (article 58) is not justified. This substances do not meet the criteria because:
-	They are not PBT nor vPvB substances.
-	They have not wide spread dispersive uses.
-	Their production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
15	2011/10/12	Company
France	Very low quantities produced.
Very low probability of exposure during all the life cycle.
No immediat and possible alternatives exist.
Please see the enclosed letter	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 15 attachment (COMMENTS STYPHNATE AZOTURE.zip).zip		
14	2011/10/12	Company
Sweden	p. 18	3.2 Production Sites and Volumes
Saab Dynamics produces << 1 tonne lead diazide annually. Location: Sweden.
p. 22	3.5.2 Worker Exposure
Only a few workers at Saab Dynamics work with lead diazide. These workers are regularly tested for blood lead. The results show that blood lead levels are well below 0.8 μmol/l, which is the limit given by the Work Environmental Authority in Sweden.

The accident referred to in the Dossier about an employee who was seriously injured when a 5 g charge of dextrinated lead diazide detonated in her hand, has nothing to do with the classification of lead diazide as a CMR-substance. This accident could happen with any other primary explosive.

Lead substances have been used in military products for many years, and the knowledge about how to control exposure to the workers is very high. The alternatives may also pose different risks that are more difficult to control. The knowledge of appropriate preventive measures may be lower. Experience of the exposure to workers, in different scenarios, can be insufficient. The alternative must be defined as an explosive substance, which always is a risk for the workers, irrespectively of the health classification.
p. 33	4 Information on uses
Saab Dynamics uses lead diazide as a primary explosive in different military munitions. The substance is used in its “dry” form.
p. 68 & 69	6.3 Experiences of EU industry with Alternatives
Saab Dynamics has developed and introduced alternatives to lead diazide in some of our products. These alternatives have not been deemed to be viable for all of our applications.

For some of our markets the alternatives have not been accepted since they have not been qualified by our customers. This generates a substantial cost, not only for Saab Dynamics but also for our customers. Since not all of our competitors are based within the EU, a potential prohibition on the use of lead diazide would result in a considerable trade barrier and competitive disadvantage for Saab Dynamics on the international market.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
					
13	2011/10/12	Industry or trade association
SFEPA
France	Uses are unique in explosive field and replacement is not accessible for a very large majority of implementations.							Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 13 attachment (ECHA mail.pdf).pdf		
11	2011/10/11	Individual
Belgium	- The quantities involved in Lead dipicrate uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead dipicrate is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead dipicrate remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosives, Lead dipicrate explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead dipicrate totally react and disappear in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers. Finally, these substances have not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead dipicrate compounds in the Candidate List (article 58) is not justified. This substances do not meet the criteria because:
-	They are not PBT nor vPvB substances.
-	They have not wide spread dispersive uses.
-	Their production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
10	2011/10/11	Industry or trade association
TEDAE
Spain	No Substance Contact of Subsequent Users of Explosive Items and no Exposure during Handling and Use of Final Explosive Items.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
			See also:
Comment 10 attachment (ECHA comments.doc).doc		
7	2011/10/10	Company
Spain	The substance is encapsulated inside a closed container. The substance totally decomposed during use. Lead diazide is only used as an explosive material and therefore the substance detonate and produce high pressure and temperature. No quantity of substance remains after detonation. There is no exposure to environment.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
					
5	2011/10/07	Industry or trade association
COMINROC
Spain	- The quantities involved in Lead diazide uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead diazide is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead diazide remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosives, Lead diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead diazide totally react and disappear in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers
Finally, these substances have not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead diazide compounds in the Candidate List (article 58) is not justified. This substances do not meet the criteria because:
-	They are not PBT nor vPvB substances.
-	They have not wide spread dispersive uses.
-	Their production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
4	2011/10/07	Industry or trade association
ANEFA
Spain	- The quantities involved in Lead diazide uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead diazide is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead diazide remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosives, Lead diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead diazide totally react and disappear in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers
Finally, these substances have not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead diazide compounds in the Candidate List (article 58) is not justified. This substances do not meet the criteria because:
-	They are not PBT nor vPvB substances.
-	They have not wide spread dispersive uses.
-	Their production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	
3	2011/10/07	Industry or trade association
Federación de Áridos
Spain	- The quantities involved in Lead diazide uses are very small, a few tons per year for the total explosives industry

- As explosives users, since Lead diazide is hermetically closed into detonators, primers, etc.), no risk for health exists for workers in quarries

- No quantity of Lead diazide remains after use because of the high temperatures and huge pressures that occurs in the industrial use (detonation processes in quarries, mining, civil works, etc). As primary explosives, Lead diazide explodes in the initial moment of blasting (primary explosion) initiating the chemical and thermal reaction of the explosive used in the operation (secondary explosion); In both explosions, Lead diazide totally react and disappear in an irreversible way, producing the expansive energy. In that reaction, Lead and Nitrogen Oxides are produced in infinitesimal amount due to the fact that the quantity of lead is lower than a gram by blast hole. These few grams oxides are disseminated within the tons of blasted rocks.

- As mentioned above, as far as we know, no substitution is possible with the same level of safety when blasting. Substitution can cause high risk for safety of workers due to failures in blasting operations creating missed holes with undetonated explosive. These missed holes are one of the worst incidents that con occur during blasting operations leading to unacceptable risks for workers
Finally, these substances have not a widespread dispersive use.

- As a consequence of the above mentioned reasons, based on the criteria formulated in Article 58 (3) REACH and the corresponding score system prioritization, the inclusion of Lead diazide compounds in the Candidate List (article 58) is not justified. This substances do not meet the criteria because:
-	They are not PBT nor vPvB substances.
-	They have not wide spread dispersive uses.
-	Their production volumes in Europe are very small.	Thank you for the submitted information. Provided that the substance will be identified as SVHC, this information may, where relevant, be considered at later stages of the risk management process.	

Attachments

Comment number	Public attachment	
10	
Comment 10 attachment (ECHA comments.doc).doc	
13	
Comment 13 attachment (ECHA mail.pdf).pdf	
15	
Comment 15 attachment (COMMENTS STYPHNATE AZOTURE.zip).zip	
17	
Comment 17 attachment (INFORME LOM Annexe XV_eng.doc).doc	
18	
Comment 18 attachment (Comments on Annex XV dossier - Lead diazide.pdf).pdf	
20	
Comment 20 attachment (Comments on Annex15_Lead Azide_DynITEC.pdf).pdf	
25	
Comment 25 attachment (20033_2011_Echa_SVHCconsultation.pdf).pdf	
28	
Comment 28 attachment (Lead Diazide Comment_DIEHL.doc).doc