Download rcom_lead_titanium_trioxide_en - ECHA

14 November 2012
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)
13 2012/10/1 Industry or trade
8 association
Belgium
Comment
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.
See also:
Comment 13 attachment
(20121016_FINAL_Position_REACH_Consultation.pdf).pdf
Response
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
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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.
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Topics such as the availability and
suitability of alternatives, socioeconomic 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.
Thank you for providing your opinion.
12 2012/10/1 International NGO We support the adoption of this chemical to the Candidate List.
8 Health and
Environment
Alliance
Belgium
11 2012/10/1 Company
This substance shall not be added to the candidate list, unless an
Thanks for your comment.
8 Austria
exposure scenario and related risk assessment is indicating a risk to
health and environment and interferences with existing legislation
Please refer to response to comment
restricting lead and scrutiny for other risk management options has
#13 (See above).
been applied. Binding Occupational Exposure Limit (OEL) for lead
already exists in the EU.
See also:
Comment 11 attachment (Position_REACH_Consultation.pdf).pdf
8 2012/10/1 Member State
It is recognised globally that lead and its compounds pose a significant Thank you for providing your opinion.
8 Norway
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
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14 November 2012
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").
7 2012/10/1 Company
8 Germany
6 2012/10/1 Industry or trade
8 association
Japan Electronics
& Information
Technology
Industries
Association
Japan
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.
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.
See also:
Comment 7 attachment (Position_REACH_Consultation.pdf).pdf
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.
See also:
Comment 6 attachment (12060_00_3.zip).zip
Thanks for your comment.
Please refer to response to comment
#13 (See above).
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
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14 November 2012
4 2012/10/1 National NGO
7 Naturskyddsföreni
ngen, Swedish
Society for Nature
Conservation
(SSNC)
Sweden
9 2012/10/1 Company
7 Robert Bosch
GmbH
Germany
3 2012/10/1 Industry or trade
7 association
Division of
Electronic
Components and
Systems in ZVEI
Germany
10 2012/10/1 National NGO
6 IEW
Belgium
2 2012/10/1 Member State
2 Germany
The Swedish Society for Nature Conservation (SSNC) supports the
proposal to categorise Lead titanium trioxide as a Substance of Very
High Concern.
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.
Thank you for providing your opinion.
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.
See Attachment
Thank you for your comment.
See also:
Please refer to response to comment
Comment 9 attachment (Bosch-Contribution-for-Stakeholder-for#13 (See above).
ECHA-lead.pdf).pdf
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.
See also:
Comment 3 attachment
(20121016_FINAL_Position_REACH_Consultation.pdf).pdf
We support the nomination of this chemical to the Candidate List as a
substance of very high concern
Thank you for your comment.
Please refer to response to comment
#13 (See above).
Thank you for providing your opinion.
We appreciate ECHA’s efforts to compile SVHC-Dossiers on such short Thank you for your comment.
notice. We do not fully understand the selection criteria, which are
different to the approach taken by the MS for SVHC-identification.
In accordance with REACH Article 59
Even though these substances can easily be put on the candidate list the Member States and the Commission
due to their CMR-classification, careful assessment of the relevance
have the right to propose substances
(tonnage, wide-spread use, exposure, prevention of substitution by
for identification as substances of very
equally hazardous substances) should be carried out for justification of high concern (SVHC) meeting the
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14 November 2012
the SVHC-identification. The RMO analysis is a crucial step in the
criteria of Article 57.
process not only to share and discuss risk management options with ECHA has received a request from the
MS but also to provide a justification for such a far reaching measure. Commission to prepare an Annex XV
dossier proposing the identification of
The substance has not been registered. Not for all substances included this substance as SVHC, which was
in this batch of 37 SVHC-dossiers, like substances which are not
followed by the Agency.
registered, the inclusion on the candidate list and subsequent
inclusion in Annex XIV might be the most appropriate risk
Preparation of a risk management
management option. Without further information on potential risks
options analysis (RMOA) before
that may be related to any other uses of this substance, the reason to proposing the identification of a
identify this substance as SVHC remains unclear.
substance as SVHC is a voluntary step
Therefore, we would suggest that thorough RMO analyses are
in the co-ordination of risk
prepared and shared with MSCAs as soon as possible.
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.
1 2012/09/2 National NGO
6 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.
Please note that contrary to the
statement in the comment the
substance has been registered.
Thank you for providing your opinion.
6
14 November 2012
Specific comments on the justification
Number
Date
Submitted by
Comment
(name,
Organisation/MS
CA)
13 2012/10/1 Industry or trade We recommend ECHA to prove the SVHC justification. Page 10
8 association
indicates that ECHA has not carried out further analysis of this
Belgium
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.
See also:
Comment 13 attachment
(20121016_FINAL_Position_REACH_Consultation.pdf).pdf
6 2012/10/1 Industry or trade On ECHA's "Registered substances" database, in "Toxicity to
8 association
reproduction" section, three experimental data on rat oral
Japan Electronics administration of lead acetate via drinking water are referred, and the
& Information
lowest toxic dose is 250 mg/L. According to "Water solubility" section,
Response
Thank you for your comment.
Please refer to responses to comments
#6 and #13 in the section “general
comments on SVHC proposal”.
Thank you for your comment.
Please refer to response to comment
#6 in the section “general comments
7
14 November 2012
Technology
Industries
Association
Japan
9 2012/10/1 Company
7 Robert Bosch
GmbH
Germany
2 2012/10/1 Member State
2 Germany
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.
See also:
Comment 6 attachment (12060_00_3.zip).zip
See Attachment
See also:
Comment 9 attachment (Bosch-Contribution-for-Stakeholder-forECHA-lead.pdf).pdf
on SVHC proposal”.
Thank you for your comment.
Please refer to response to comment
#13 in the section “general comments
on the SVHC proposal”.
Thank you for your comment.
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
The proposal for identifying the
provide these data directly in the report (and the technical dossier),
substance as SVHC is based on its
so that no further search in a database is necessary.
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.
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14 November 2012
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
Comment
(name,
Organisation/MS
CA)
13 2012/10/1 Industry or trade Uses and RMO: Several EU directives exist aiming on prohibition and
8 association
substitution of lead compounds for the remaining main uses of the
Belgium
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/Ro
HS_final_report_May_2011_final.pdf
ELV (p 184ff):
http://circa.europa.eu/Public/irc/env/elv_4/library?l=/reports/final_ro
hs_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.
See also:
Comment 13 attachment
(20121016_FINAL_Position_REACH_Consultation.pdf).pdf
Response
Thank you for your comment.
Please refer to response to comment
#13 in the section “general comments
on the SVHC proposal”.
9
14 November 2012
6 2012/10/1 Industry or trade
8 association
Japan Electronics
& Information
Technology
Industries
Association
Japan
5 2012/10/1 Company
7 Switzerland
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
See also:
Comment 6 attachment (12060_00_3.zip).zip
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
Thank you for your comment.
Please refer to responses to comments
#6 and #13 in the section “general
comments on SVHC proposal”.
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”.
10
14 November 2012
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
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9 2012/10/1 Company
7 Robert Bosch
GmbH
Germany
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.
See Attachment
Thank you for your comment.
See also:
Comment 9 attachment (Bosch-Contribution-for-Stakeholderfor-ECHA-lead.pdf).pdf
Please refer to response to comment
#13 in the section “general comments
on the SVHC proposal”.
12
14 November 2012
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
13