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

Substance name:	Lead titanium trioxide	
CAS number:	12060-00-3	
EC number:	235-038-9	

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. The Response to Comments table (RCOM) has been prepared by the European Chemicals Agency. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions. The table does not contain any 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	
13	2012/10/18	Industry or trade association
Belgium	Page 10 indicates that ECHA has not carried out further analysis of this information. The first consultation gives the opportunity to provide additional information on lead compounds to indicate whether the justification is correct (part I) and whether authorization under REACH provides the right Risk Management Option given the fact that several EU directives exist aiming on prohibition and substitution of lead compounds (part 2). The specific comment fields below have been filled where appropriate.	Thank you for your comment and the information 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. 

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, use, exposure, alternatives and risks will be taken account of at later stages of the authorisation process.

Even though information provided during public consultation is taken into account, we would like to stress that the registrations are the standard tool and route to communicate information on a substance and its uses to the authorities The registrations are the authorities’ principal source of information when assessing the need of further risk management for a substance or (some of) its uses. Therefore, it is of utmost importance that registrants keep the information provided in the registration dossiers up to date and adequately describe the current use and exposure situation, including the operational conditions and risk management measures in place.
If certain uses are not covered by the provided exposure scenarios, downstream users can either communicate this through supply chain communication (via their suppliers) to the registrants, who then need to update their registrations accordingly, or prepare their specific chemical safety report and submit a downstream user report to ECHA.

Topics such as the availability and suitability of alternatives, socio-economic considerations regarding the benefits of a use or the (adverse) impacts of ceasing a use as well as information on the low level of risk associated to a use are important. Information regarding these topics should be provided as part of the application for authorisation (e.g. in the analysis of alternatives, the chemical safety report or the socio-economic analysis). This information will be taken into account by the Risk Assessment and Socio-Economic Analysis Committees when forming their opinions and by the Commission when taking the final decision. It may impact the decision on granting the applied for authorisation and the conditions applicable to the authorisation, such as e.g. the length of the time limited review period of the authorisation.	
			See also:
Comment 13 attachment (20121016_FINAL_Position_REACH_Consultation.pdf).pdf		
12	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.	
11	2012/10/18	Company
Austria	This substance shall not be added to the candidate list, unless an exposure scenario and related risk assessment is indicating a risk to health and environment and interferences with existing legislation restricting lead and scrutiny for other risk management options has been applied. Binding Occupational Exposure Limit (OEL) for lead already exists in the EU.	Thanks for your comment. 

Please refer to response to comment #13 (See above).
	
			See also:
Comment 11 attachment (Position_REACH_Consultation.pdf).pdf		
8	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 titanium trioxide 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	2012/10/18	Company
Germany	The substances shall not be added to the candidate list, unless an exposure scenario and related risk assessment is indicating a risk to health and environment and interferences with existing legislation restricting lead and scrutiny for other risk management options has been applied. Binding Occupational Exposure Limit (OEL) for lead already exists in the EU.	Thanks for your comment. 

Please refer to response to comment #13 (See above).
	
			See also:
Comment 7 attachment (Position_REACH_Consultation.pdf).pdf		
6	2012/10/18	Industry or trade association
Japan Electronics & Information Technology Industries Association
Japan	In the Annex XV dossier, rational for classification is described as “Lead titanium trioxide is covered by Index number 082-001-00-6 in Regulation (EC) No 1272/2008 and classified in Annex VI, part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) as toxic for reproduction, Repr. 1A (H360: “May damage the unborn child”).”
However, unlike general water soluble lead compounds, very low water solubility of lead titanium trioxide strongly suggest that the proposed classification is not appropriate. When the compound do not release sufficient Pb ion, uptake of the toxic dose Pb by a target organ such as testis will never be occurred.
Therefore, proposed classification as "toxicity to reproduction" is not applicable to lead titanium trioxide.	Thank you for your comment.

The substance is classified as Repr. 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 Art. 59 of the same regulation.

As the above cited harmonised classification is applicable law at present, it will not be questioned or discussed in the context of the currently ongoing SVHC identification process.

Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification of a substance in Part 3 of Annex VI of Regulation (EC) No 1272/2008 may submit a revision proposal in accordance with the second subparagraph of Article 37(2) of Regulation 1272/2008 to the competent authority in one of the Member States in which the substance is placed on the market.	
			See also:
Comment 6 attachment (12060_00_3.zip).zip		
4	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 titanium trioxide 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.	
9	2012/10/17	Company
Robert Bosch GmbH
Germany	See Attachment	Thank you for your comment. 

Please refer to response to comment #13 (See above).
	
			See also:
Comment 9 attachment (Bosch-Contribution-for-Stakeholder-for-ECHA-lead.pdf).pdf		
3	2012/10/17	Industry or trade association
Division of Electronic Components and Systems in ZVEI
Germany	The substances shall not be added to the candidate list, unless an exposure scenario and related risk assessment is indicating a risk to health and environment and interferences with existing legislation restricting lead and scrutiny for other risk management options has been applied. Binding Occupational Exposure Limit (OEL) for lead already exists in the EU.	Thank you for your comment. 

Please refer to response to comment #13 (See above).

			See also:
Comment 3 attachment (20121016_FINAL_Position_REACH_Consultation.pdf).pdf		
10	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.	
2	2012/10/12	Member State
Germany	We appreciate ECHA’s efforts to compile SVHC-Dossiers on such short notice. We do not fully understand the selection criteria, which are different to the approach taken by the MS for SVHC-identification.
Even though these substances can easily be put on the candidate list due to their CMR-classification, careful assessment of the relevance (tonnage, wide-spread use, exposure, prevention of substitution by equally hazardous substances) should be carried out for justification of the SVHC-identification. The RMO analysis is a crucial step in the process not only to share and discuss risk management options with MS but also to provide a justification for such a far reaching measure.

The substance has not been registered. Not for all substances included in this batch of 37 SVHC-dossiers, like substances which are not registered, the inclusion on the candidate list and subsequent inclusion in Annex XIV might be the most appropriate risk management option. Without further information on potential risks that may be related to any other uses of this substance, the reason to identify this substance as SVHC remains unclear.
Therefore, we would suggest that thorough RMO analyses are prepared and shared with MSCAs as soon as possible.
	Thank you for your comment. 

In accordance with REACH Article 59 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.
 
Please note that contrary to the statement in the comment the substance has been registered.	
1	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	
13	2012/10/18	Industry or trade association
Belgium	We recommend ECHA to prove the SVHC justification. Page 10 indicates that ECHA has not carried out further analysis of this information in the Annex XV dossier and based their justification for SVHC properties on Index number 082-001-00-6 in Regulation (EC) No 1272/2008, classified in Annex VI, part 3, Table 3.1 (list of harmonised classification and labelling of hazardous substances) as toxic for reproduction, Repr. 1A (H360D: “May damage the unborn child”). 
However, Index number 082-001-00-6 classifies “lead and lead compounds” without further evaluation of specific substance properties. According to the registration dossier, the substance is a ceramic substance with a melting point of 1756°C, indicating negligible vapor pressure, and a water solubility of 0.075 mg/L. The NOAEL for reprotoxicity was 250 mg/L drinking water as a result of a study conducted with soluble lead acetate. There is a factor of more than 3300 between the NOAEL of lead compounds and the solubility of the substance. Under the same conditions, a reprotoxicity test with the substance might have lead to no effects on reprotoxicity and no classification as reprotoxic as the low solubility would have prevented a positive result for this specific endpoint. This questions the classification of the substance as Repr. 1A  based on a general harmonized classification of lead compounds and a read across with the soluble substance lead acetate. The literature describes that excretion is the main route of lead compounds with low solubility as they are not metabolized in the body.  In addition, lead and lead compounds have a binding OEL (Occupational Exposure Level) in the EU indicating that a threshold exists for lead and lead compounds. Under these circumstances, ECHA will have to evaluate the registration dossier to clarify if the substance meets the SVHC criteria for classification as toxic for reproduction category 1. 	Thank you for your comment. 

Please refer to responses to comments #6 and #13 in the section “general comments on SVHC proposal”.	
			See also:
Comment 13 attachment (20121016_FINAL_Position_REACH_Consultation.pdf).pdf		
6	2012/10/18	Industry or trade association
Japan Electronics & Information Technology Industries Association
Japan	On ECHA's "Registered substances" database, in "Toxicity to reproduction" section, three experimental data on rat oral administration of lead acetate via drinking water are referred, and the lowest toxic dose is 250 mg/L. According to "Water solubility" section, water solubility of lead titanium trioxide is 0.075 mg/L (Temp. 25 °C pH > 6.2 < 6.8), significantly lower than that of lead acetate, so there are certainly no chance for lead titanium trioxide to achieve such high lead concentration in water as for lead acetate.
Also, as far as we know, reliable reproduction toxicity data for lead titanium trioxide is not available neither through ECHA's database nor general scientific literature database such as PubMed. Without reliable toxicity data, lead titanium trioxide should not be classified as reproductive toxicant.	Thank you for your comment. 

Please refer to response to comment #6 in the section “general comments on SVHC proposal”.	
			See also:
Comment 6 attachment (12060_00_3.zip).zip		
9	2012/10/17	Company
Robert Bosch GmbH
Germany	See Attachment	Thank you for your comment. 

Please refer to response to comment #13 in the section “general comments on the SVHC proposal”.	
			See also:
Comment 9 attachment (Bosch-Contribution-for-Stakeholder-for-ECHA-lead.pdf).pdf		
2	2012/10/12	Member State
Germany	No information about the physical properties is given in the report or in the technical dossier. In the report a link to the Chemical Substance Search on the ECHA website is given instead. It would be better to provide these data directly in the report (and the technical dossier), so that no further search in a database is necessary.	Thank you for your comment.

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	
13	2012/10/18	Industry or trade association
Belgium	Uses and RMO: Several EU directives exist aiming on prohibition and substitution of lead compounds for the remaining main uses of the substance in the EU. ECHA might want to evaluate that sufficient Risk Management Options exist and that non-covered uses might better qualify for restriction under Annex XVII. The following is covered:
Automotive industry 2000/53/EC (ELV): Vehicles put on the market after 1 July 2003 do not contain lead and lead compounds other than authorized with time-limitation and a sunset date in Annex II. The Commission shall amend Annex II regularly and delete materials and components of vehicles if the use of lead compounds is avoidable (Amendment: 2011/37/EC). Review of Annex II by the Commission; experts review substitutes to phase out lead and lead compounds. The ELV Directive qualifies as existing specific Community legislation.
Electronic Industry 2011/65/EC (RoHS recast) / 2002/95/EC (RoHS) and Battery Industry (Batteries Directive 2006/66/EC) are covering lead compounds similarly to the ELV.
Alternatives: A comprehensive evaluation of alternatives is available for both ELV and RoHS (commissioned by the European Commission; provided by Öko-Institut e.V. and Fraunhofer Institute for Reliability and Microintegration IZM).
All findings are documented in publically available reports:
RoHS (p 14 ff): http://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_IV/RoHS_final_report_May_2011_final.pdf
ELV (p 184ff): http://circa.europa.eu/Public/irc/env/elv_4/library?l=/reports/final_rohs_2010pdf/_EN_1.0_&a=d
Exposure and Risks: In addition, lead and lead compounds have a Binding Occupational Exposure Limit in Europe of 70μg/dl blood, 0.15mg/m3 and many of the listed substances have a low water solubility and low vapour pressure.	Thank you for your comment. 

Please refer to response to comment #13 in the section “general comments on the SVHC proposal”.
	
			See also:
Comment 13 attachment (20121016_FINAL_Position_REACH_Consultation.pdf).pdf		
6	2012/10/18	Industry or trade association
Japan Electronics & Information Technology Industries Association
Japan	In general, based on very low water solubility, reproductive toxicity classification based on data of very water soluble lead acetate, is not applicable for lead titanium trioxide, because toxic dose will never be achieved by oral administration via drinking water. Reliable and applicable reference should be referred when classifying the substance as hazard, if any.
Furthermore, Canadian Environmental Protection Agency is classifying the substance as "Meets Human Health Categorization Criteria: No".
And also epidemiological study in Ontario1) shows that "Although air lead levels were high in most plant areas, 82 workers not exposed to lead oxide but to LTZ in the process had normal blood lead levels." As LTZ is mixed crystal of lead titanium trioxide and lead zirconium trioxide, this means that absorption of lead to the human body will not be significant even if lead titanium trioxide exposure is high, and the results strongly suggest that lead titanium trioxide will not be classified as hazardous, including reproductive toxicity.
"
1) Worker exposure to lead titanate zirconate in an Ontario company.
Roy ML, Siu S, Waddell W, Kennedy P
J Occup Med. 1989, Dec; 31(12):986-9	Thank you for your comment.

Please refer to responses to comments #6 and #13 in the section “general comments on SVHC proposal”.	
			See also:
Comment 6 attachment (12060_00_3.zip).zip		
5	2012/10/17	Company
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 titanium trioxide is embedded into the semiconductor device for specific electronics application like PZT capacitors . 
Usage in Europe is limited to 150 kg/y and it will found at a concentration of 0.2 % in article (semiconductor device).   
Industrial exposure as measured as lead is < 0.032 mg/m3
There is no release to the environment from the article (semiconductor device) under normal conditions of use 

There is a clear unavailability of alternatives for some semiconductor device applications. The European commission has accepted this fact within the review of an exemption request under both ROHS and ELV directives. The technical consultants and the Commission have recommended granting the exemption with the identical wording recommended for Annex II of the ELV Directive: “Lead in PZT based dielectric ceramic materials for capacitors being part of integrated circuits or discrete semiconductors”
 Report under the Adaptation to Scientific and Technical Progress under Directive 2002/95/EC -  the evaluation of new requests for existing exemptions Okoinstitut and Fraunhofer - Final recommendation for exemption request no. 2 „Lead in PZT based dielectric ceramic materials for capacitors being part of integrated circuits or discrete semiconductors” August 2010)
Lead and these substances are used due to functional properties. Up to now the potential alternatives have not the required level of performance necessary in the product application or the manufacturing process to be implemented. Many of the potential alternatives also have higher or equivalent negative health and environmental characteristics than lead. This is not a simplistic process and there are no drop in replacements any potential alternatives have to be tested to work in the individual processes and this may require new process systems and many requalification rounds.	Thank you for your comment and the information provided. 
Please refer to response to comment #13 in the section “general comments on the SVHC proposal”.

	
9	2012/10/17	Company
Robert Bosch GmbH
Germany	See Attachment	Thank you for your comment. 

Please refer to response to comment #13 in the section “general comments on the SVHC proposal”.	
			See also:
Comment 9 attachment (Bosch-Contribution-for-Stakeholder-for-ECHA-lead.pdf).pdf		

Attachments

Comment number	Public attachment	
3	
Comment 3 attachment (20121016_FINAL_Position_REACH_Consultation.pdf).pdf	
6	
Comment 6 attachment (12060_00_3.zip).zip	
7	
Comment 7 attachment (Position_REACH_Consultation.pdf).pdf	
9	
Comment 9 attachment (Bosch-Contribution-for-Stakeholder-for-ECHA-lead.pdf).pdf	
11	
Comment 11 attachment (Position_REACH_Consultation.pdf).pdf	
13	
Comment 13 attachment (20121016_FINAL_Position_REACH_Consultation.pdf).pdf