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

Substance name:	Lead(II) bis(methanesulfonate)	
CAS number:	17570-76-2	
EC number:	401-750-5	

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

Disclaimer: comments provided during public consultation are made available in this document as submitted by the webform. It was in the “interested parties” own responsibility to ensure that no confidential information was included in the comments. In addition, ECHA is not responsible for the content of the responses prepared by Member States.

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	
9	2012/04/12	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 B. 	Thank you.	
6	2012/04/11	Member State
Sweden	The Swedish CA agrees that lead (II) bis(methanesulfonate), 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.	
5	2012/04/11	Member State
Germany	The German CA supports the identification of Lead (II) methansulphonate as SVHC.	Thank you.	
4	2012/04/11	Member State
Norway	The Norwegian CA supports that lead(II) bis(methanesulfonate)should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you.	
3	2012/04/06	Member State
Belgium	Belgium supports the identification of Lead(II) bis(methanesulfonate) as SVHC according to article 57 (c)	Thank you.	
2	2012/03/30	Member State
United Kingdom	From the data provided we do not think this substance should be prioritised for inclusion in Annex XIV.		
1	2012/03/22	Company
Schloetter Co. ltd.
United Kingdom	Schlotter Co.Ltd. has been producing Lead Methane Sulphonate since 1989 when we submitted a dossier under the NONS 1982 legislation Ref No. 89-06-0154-00 detailing all the necessary physical and animal tests demanded for base set approval . This has since been transferred to a REACH registration number 01-0000015159-68-0002 submitted and completed in Nov 2008  for quantities up to 10 tonnes per annum. 

There are two main substances used for  Lead plating , Tin/Lead plating and Lead / Tin / Copper plating .   Lead Fluoborate and Lead Methane Sulphonate are  the only sensible  options for soluble Lead compounds  .  Lead Methane Sulphonate became preferred as the electronic devices became more sophisticated and the Fluoborate versions were more aggressive to the constructional glasses used .  Lead Fluoborate remains the main soluble Lead compound used in the manufacture of bearing surfaces and is used far more prolifically than Lead Methane Sulphonate and as the justification in the proposal for the toxicokinetics is deduced from inorganic Lead  we can not see why the Lead Methane Sulphonate has been listed wheras Lead Fluoborate has not.	Thank you.
Lead(II) bis(methanesulfonate) was chosen for Annex XV dossier for the following reasons:
- Lead(II) bis(methanesulfonate) is classified under CLP as a CMR substance
- it is unclear, if the workers exposure is adequately controlled in EU
- available Registration dossier does not provide additional relevant information on use and exposure.

Lead Fluoborate is not classified under CLP as such. For this substance general classification for lead compounds is applicable. Lead Fluoborate may be listed in the future together with other compounds for which this general classification rule applies. See Appendix 1 for all classified lead substances.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
7	2012/04/11	Member State
Ireland	Lead(II) bis(methanesulfonate) 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.	
2	2012/03/30	Member State
United Kingdom	We agree that lead (II) bis(methanesulfonate) meets the hazard criteria for inclusion on to the Candidate List.

However it is not clear why this particular lead compound has been singled out for regulatory action.
	Thank you.
Lead(II) bis(methanesulfonate) was chosen for Annex XV dossier for the following reasons:
- Lead(II) bis(methanesulfonate) is classified under CLP as a CMR substance
- it is unclear, if the workers exposure is adequately controlled in EU
- available Registration dossier does not provide additional relevant information on use and exposure.	
1	2012/03/22	Company
Schloetter Co. ltd.
United Kingdom	The Annex XV dossier submitted by the competent authority of the Netherlands seems to be unaware of our presence as an authorised  manufacturer within the EU  and that a 4 week oral (Gavage) Toxicity study  was carried out on 5 male and 5 female rats according to the annex V ( limit test) . 2000mg/Kg resulted in "no treatment related abnormalities to the organs" being observed. The test documentation should be a matter for public record within ECHA, but if required both the test documentation and section slides are available in our archive. 	Thank you.
Study you have mentioned is not present in the registration dossier. 
This information will not be added into the supporting document as we cannot verify your conclusion based on the provided information, suggesting a NOAEL of 2000 mg/kg bw/day.	

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	
8	2012/04/12	Company
Switzerland	P 11, 12, 14
Lead methane sulfonate uses in tin lead plating in Europe at semiconductor industry manufacturing sites 
Sector of use (SU) SU 3	Industrial manufacturing  SU 16 Manufacturing of computer, electronic and optical product, electrical equipment
Chemical product category (PC) 	PC 33	Semi-conductor 	PC 15 Non-metal-surface treatment products
Process category (PROC)	PROC 2 	Use in closed, continuous process with occasional controlled exposure (e.g. sampling) - Industrial setting ; 
PROC 13 Treatment of articles by dipping and pouring 
Article category (AC)	 Not applicable

Quantity used in 2011 60 kg of lead methane sulfonate plating solution, at 10 %  of lead methane sulfonate adding to a total of 7.2 kg of lead methane sulfonate 
Exhaust plating bath is fed to waste water treatment plant. Outgoing waste water has measured Pb content < 0.01 mg/l
Tin lead plating is used to manufacture semiconductor devices for automotive market under ELV Directive exemptions, therefore on the article Pb only may be found. No Lead exposure is expected from final customers.
In door environment where lead methane sulfonate is used is monitored regularly. Concentration in working environment is < 0. 05 mg/m3
Exposed employees are undergoing to regular bio monitoring checks, all values reported are below  135 microg/l
The highly sophisticated and detailed risk management measures employed in manufacturing environment at our premises in Europe for this substance alongside 
•	the highly controlled workplace environment  
•	the relevant industrial hygiene measurements used in the our manufacturing plants,  
•	the limited annual consumption  
•	the rigorous waste management in place

ensure a rigorous and strictly managed usage of lead methane sulfonate

	Thank you for this information. We advise industry to update the registration dossier as well.

 	
5	2012/04/11	Member State
Germany	Page 12: The definition of the lead compounds covered by the respective Directives may be more precise:
- EU Directive 98/24/EC, Annex I, lists inorganic lead and its compounds with an occupational exposure limit value 8h (measured or calculated in relation to a reference period of eight hours, time-weighted average: 0.15mg/m³
- EU Directive 98/24/EC, Annex II, lists the binding biological limit value of lead and its ionic compounds: 70µg Pb/100ml blood
Page 13: According to the Ariel Website the national OELs of certain members states for 8 hours limit value differ between 0.1 and 0.15 mg/m³ (for example in Ireland) and the only national short term limit value (STEL) is 0.4mg/m³ (Austria). It might be helpful to crosscheck which information is relevant. 
	Thank you for this information. 
	
2	2012/03/30	Member State
United Kingdom	Section 1.2 Exposure – No information is provided on how workers are exposed and to what levels and hence it is impossible to understand the level or scale of risks involved. The list of OELs given in the document does not make it clear that the EU has Binding Limits for both inhalation and biological monitoring. Nor is the 2002 recommendation from SCOEL mentioned, which proposed a reduction in the levels of these limits.

Section 3 Risk related information – none is provided. This would have been helpful to help understand the impetus for the regulatory action and the resulting expected benefits.
	Thank you.
We do not have any information on the workers exposure concentrations or other risk related information, and this is why they are not included.
	
1	2012/03/22	Company
Schloetter Co. ltd.
United Kingdom	The Restriction of Hazardous Substances legislation has effectively removed Lead from all consumer electronic components and subsequently the demand for Lead Methane Sulphonate has fallen to a relatively low level of around 2 tonnes per annum. But the applications for this limited quantity are very important. It is used for overhauling submarine batteries, in electronic assemblies used by the space programme where the crystalline stability of the solder joint is critical when operating at very low temperatures and on high specification printed circuit boards for the ESA European space programme where melting profiles of holes and tracks have a very high specification to ensure reliability  and whisker growth could cause catastrophic device failures in remote space environments.  We know of no alternative technology that can be applied to these applications (other than to possibly consider Lead Fluoborate which would be illogical to change as it would present the same soluble Lead hazard in a more aggressive media.)

Ever since we have been making Lead Methane Sulphonate we have been monitoring our employees in contact with the process  for Lead in Blood levels annually and have not had any test recorded at higher than 5 microgramms / dL of blood . We are told by health professionals that this is lower than the normal background levels in the population . 
Our production is in a closed liquid environment with no waste discharges , and we have risk assessment records  of atmosphere sampling  on the employee  during manufacture.

Our customers would use Lead Methane Sulphonate in an electroplating bath which does not get incorporated into an article . The result of electroplating is either pure Lead metal on battery parts , Tin / Lead metal on solderable parts or metallic Lead/Tin/ Copper  on bearing surfaces . We have no user  evidence to prove it,  but all responsible electroplaters use PPE , RPE and LEV to control any emissions  or contact . The current efficiency of the liquid lead- or tin-lead electrolytes is high, they are used cold and without air agitation ,therefore  no aerosols are  formed.

If Lead Methane Suphonate proceeds to being an SVHC then we would have no commercial justification to continue production , we would therefore leave the ESA demand and the submarine battery repair shops with no EU alternative supplier , high specification boards would then have to be  imported . This would take away the expertise currently held within the EU, transferring the  overall technology knowledge overseas.
	Thank you. 

According to the Article 58.2 of the REACH law: Uses or categories of uses may be exempted from the authorisation requirement 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. The European union banned the use of lead in most consumer products (DIRECTIVE 2002/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment). 

New laws exclude from this restriction some medical equipment and space flight hardware, which can still use solders which contain lead. Detailed information is available in Review of Directive 2002/95/EC (RoHS) Categories 8 and 9 – Final Report (2006), available at:
http://ec.europa.eu/environment/waste/pdf/era_study_final_report.pdf
We suggest checking the recent status on exemptions from Restriction of Hazardous Substances Directive (2002/95/EC), which uses of solders containing lead are still allowed, and which were forbidden previously. 

ECHA should take this information into account for the prioritisation of this substance.	

Appendix 1: All classified lead substances.