Download rcom_dioxobis-stearato-trilead_en - ECHA

19 November 2011
COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFICATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE
COMMENTS
Substance name: dioxobis(stearato)trilead
CAS number:
12578-12-0
EC number:
235-702-8
The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH
Regulation: Repr. 1A
Disclaimer: comments provided during public consultation are made available in this document as submitted by the
commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain
confidential information.
PART I: Comments and responses to comments on the SVHC proposal and its justification
General comments on the SVHC proposal
#
12
11
10
Date
Submitted by (name,
Organisation/MSCA)
2012/10/18 Individual
Germany
2012/10/18 Individual
Belgium
2012/10/18 International NGO
Comment
Weser-Metall GmbH is a member of the International Lead
Association or the Lead REACH Consortium. ILA has
provided a consolidated response on behalf of members of
the Lead REACH consortium. As a consequence, WeserMetall GmbH fully supports and subscribes to the comments
made by ILA.
Fonderie & Manufacture de Métaux SA is a member of the
International Lead Association or the Lead REACH
Consortium. ILA has provided a consolidated response on
behalf of members of the Lead REACH consortium. As a
consequence, Fonderie & Manufacture de Métaux SA fully
supports and subscribes to the comments made by ILA.
We support the adoption of this chemical to the Candidate
Response
Thank you for your comment.
Please refer to response to comment #6 in section
“Specific comments on use, exposure, alternatives
and risks” (see below).
Thank you for your comment.
Please refer to response to comment #6 in section
“Specific comments on use, exposure, alternatives
and risks” (see below).
Thank you for your opinion.
1
8
Health and Environment
Alliance
Belgium
2012/10/18 Member State
Norway
List.
It is recognised globally that lead and its compounds pose a Thank you for your opinion.
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 dioxobis(stearato)trilead
should be identified as a substance of very high concern
and should be included in the Candidate List.
7
9
2012/10/17 National NGO
Naturskyddsföreningen,
Swedish Society for Nature
Conservation (SSNC)
Sweden
2012/10/17 Industry or trade association
ELSA (ESPA)
Belgium
The Swedish Society for Nature Conservation (SSNC)
supports the proposal to categorise
Dioxobis(stearato)trilead 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.
To our astonishment there has been no analysis of the
information provided in the registration dossier of this
substance. ELSA is of the opinion that such information has
to be taken into account. Therefore we have inserted an
attachment in Section IV of the commenting form.
See also:
Comment 9 attachment (SVHC-Public-Consultation-Oct-
Thank you for your opinion.
Thank you for the information provided.
If the substance is identified as SVHC, this
information, where relevant, will be taken into
account at later stages of the authorisation
process.
2
2012_ELSA-comments_CAS-12578-12-0.pdf).pdf
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 SocioEconomic 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
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conditions applicable to the authorisation, such as
e.g. the length of the time limited review period of
the authorisation.
The current proposal for identifying the substance
as a substance of very high concern (SVHC) is in
accordance with REACH Article 59(2) based on its
harmonised classification in Annex VI of
Regulation (EC) No 1272/2008 (CLP Regulation).
The additional mentioned information is not
relevant for determining whether the substance
meets the criteria for identification as SVHC.
However, when examining whether the substance
should be recommended for inclusion in Annex
XIV, ECHA will indeed have to assess available
information on uses and exposures. In addition,
information on work already done by industry to
identify and assess potential alternatives is used
in defining transitional arrangements in the draft
Annex XIV entries for the recommended
substances. This information will be collected by
ECHA before prioritising the substances and
defining the transitional arrangements for its
recommendation. The generic approaches for
prioritisation and defining the draft Annex XIV
entries
are
available
at:
http://echa.europa.eu/documents/10162/13640/a
xiv_prioritysetting_general_approach_20100701_
en.pdf
and
http://echa.europa.eu/documents/10162/13640/d
raft_axiv_entries_gen_approach_4th_en.pdf.
If ECHA intends to recommend the substance for
Annex XIV inclusion, interested parties can
provide comments on ECHA’s recommendation,
including the suggested transitional arrangements
in accordance with Article 58 of REACH.
Regarding your comment on the preparation of
risk management options analysis (RMOA) before
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proposing the identification of a substance as
SVHC, we note that this 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 coordination of the regulatory risk management
activities between the authorities.
Finally, regarding your comment in respect to the
recommendation that has been made by the
German Competent Authority in their RMO
analysis concerning the use of lead compounds in
PVC-products, please refer to response to
comment #2 in this section (see below).
5
4
2012/10/16 National NGO
IEW
Belgium
2012/10/15 Company
REHAU AG + Co.
Germany
We support the nomination of this chemical to the
Candidate List as a substance of very high concern
Thank you for your opinion.
This dossier seems to be written superficially without any
reference to recycling material, inclusion of the substance
in the matrix of plastics and without any consideration of
the voluntary phase out of the use of lead compounds of
the PVC-processing industry.
Thank you for your comment.
If the substance is identified as SVHC, the
information you are referring to will, where
relevant, be taken into account at later stages of
the authorisation process.
See also response to comments #9 and #2 in this
section.
Please refer also to response to comment #5 in
section “Specific comments on the justification”
(see below).
3
2012/10/11 National NGO
Danish Consumer Council
The Danish Consumer Council (DCC) supports the inclusion Thank you for your opinion.
of the substance in the candidate list. The DCC wants
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Denmark
2
2012/10/11 Member State
Germany
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.
According to REACh Regulation it is formally correct to
identify substances as SVHC based on their CMR
classification listed in Annex VI of the CLP directive solely.
However, up to now MS have provided some specific
information to identify concerns. Therefore, the instrument
of preparing RMOA prior to annex XV preparation has been
established e.g. to avoid duplicate work. The German CA
would appreciate to continue this practice. This guarantees
that relevant substances are prioritised.
Referring to the Risk Management Option Analysis (RMOA)
concerning “Lead compounds in PVC-products” carried out
and submitted by the German CA we want to comment on
the proposal for identification as SVHC of the following
substances:
Neutral lead stearate (91031-62-8)
Dibasic lead stearate (12578-12-0)
Dibasic Lead Phthalate (69011-06-9)
Trilead Dioxide Phosphate (12141-20-7)
Tetralead Trioxide Sulphate (12202-17-4)
Pentalead Tetraoxide Sulphate (12065-90-6)
Basic Lead Carbonate (1319-46-6)
Sulfurous Acids, lead salt, dibasic (62229-08-7)
Thank you for your comment.
ECHA has received a request from the Commission
in accordance with REACH Article 59(2) to prepare
an Annex XV dossier proposing the identification
of this substance as SVHC.
Preparation of a risk management options analysis
(RMOA) before proposing the identification of a
substance as SVHC is a voluntary step in the coordination 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 coordination of the regulatory risk management
activities between the authorities.
The RMOA submitted by the German CA will be
taken into consideration before further risk
management activities for this substance, beyond
identification as SVHC, are initiated.
After evaluation of the above mentioned substances, the
derivation of their use in the production of PVC-products
and extensive discussion with the European stabiliser
producers the RMOA drew the conclusion that no action for
these substances concerning the use in PVC is necessary at
the moment. As conducted in the RMOA-document, industry
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has initiated a community-wide self-commitment aiming at
the complete phase-out of lead in PVC-products by 2015.
The transparency and reliability of the commitment were
ensured as the progress was accompanied and rated by
independent experts as well as by the EU-commission.
One principle on which Regulation (EC) No. 1907/2006 is
based is that manufacturers, importers or downstream
users should ensure that their substances have no adverse
effects on human health and the environment (article 1(3))
by precautionary action. From the German CAs point of
view the European initiative (Vinyl2010, followed by
VinylPlus) has taken this responsibility by traceable
reducing the use of lead and the introduction of
alternatives. Therefore, the German RMOA concluded that
the best measure at the moment was to accompany the
progress until 2015 and initiate an Annex-XV-process for
restriction in case the self-commitment does not reach its
desired goals.
The German CA is aware that the substances concerned in
this comment as well as the RMOA are not solely used in
plastic products. Tetralead trioxide sulphate and pentalead
tetraoxide sulphate are used in lead acid battery
production, also. Nevertheless, Germany wants to point out
some aspects regarding recycling are of importance once
the substances are listed in the Candidate list – especially
when thinking further to the prioritisation process for Annex
XIV.
Considering the long lifetime of PVC-products (profiles,
wires, pipes, flooring etc.) and that the production of leadfree PVC started approximately only 10 years ago, we
assume that the major part of volumes used for recycling
(800 000 t/a planned for 2020) probably consist of leadcontaining PVC. This will consequently lead to a slow
dilution of lead in PVC since new lead-free PVC will emerge
in the recycling cycle only in the future. Based on our
current understanding of the authorisation process
7
companies conducting recycling of lead containing PVC may
be obliged to acquire an authorisation for their recycling
use. If recycled PVC was subject to authorisation this would
clearly contradict sustainability efforts. Similar
considerations would also be relevant for lead battery
recycling.
The German CA still favours to await the outcome of the
self-commitment prior to the initiation of other REACh
legislative routes.
1
2012/10/01 Trade union
European Trade Union
Confederation
Belgium
ETUC supports the identification of this substance as SVHC. Thank you for your opinion.
This substance is included in the Trade Union Priority List
for REACH authorisation see: http://www.etuc.org/a/6023
Specific comments on the justification
#
4
Date
Submitted by (name,
Organisation/MSCA)
2012/10/15 Company
REHAU AG + Co.
Germany
Comment
Response
pages 7 and 8:
The entry in Annex VI, table 3.1 and table 3.2 is a group
entry for lead compounds only, not specific for this
substance. Several species of lead compounds included in a
matrix of PVC cannot be distinguished by analysis easily.
As noted in page 7 of the Annex XV report, the
specific lead substance is covered by the group
entry in Annex VI, table 3.1 and table 3.2 of the
CLP Regulation.
Please note that when a company has to check
whether it has obligations according to the Articles
7(2) and 33 of REACH, the suppliers could be
asked directly on whether the content of any
specific (lead) substance on the Candidate List is
above a concentration of 0.1% (w/w).
Regarding recycled materials, please see response
to comment #4 in section “Specific comments on
use, exposure, alternatives and risks”.
2
2012/10/11 Member State
Germany
No information about the physical properties is given in the The proposal for identifying the substance as
report or in the technical dossier. In the report a link to the SVHC is based on its harmonised classification in
8
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.
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
would be
identity or
those data
dossier.
information on the physical
required to describe the
to conclude on its SVHC
should be included in the
properties
substance
properties
Annex XV
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PART II: Comments and responses to comments on uses, exposures, alternatives and risks
Specific comments on use, exposure, alternatives and risks
#
9
6
Date
Submitted by (name,
Organisation/MSCA)
2012/10/17 Industry or trade association
ELSA (ESPA)
Belgium
Comment
To our astonishment there has been no analysis of the
information provided in the registration dossier of this
substance concerning Use, Exposure and Alternatives and
Risks. ELSA is of the opinion that such information is of
paramount importance for this substance and that it should
thus be taken into account during the process of potential
identification of this substance as an SVHC. Therefore we
have inserted an attachment in Section IV of the
commenting form, which highlights the key points which
shall be considered. In this document we do also refer to
the comments filed for this substance by ILA, The
International Lead Association, and which contains
additional, more detailed information on specific topics
which we did not repeat in the present attachment.
Note that the comments inserted for this substance are also
applicable to 7 other lead compounds (collectively
denominated “lead-based stabilisers”) and have been
inserted under each of the individual substances.
See also:
Comment 9 attachment (SVHC-Public-Consultation-Oct2012_ELSA-comments_CAS-12578-12-0.pdf).pdf
2012/10/16 Industry or trade association THE LEAD REACH CONSORTIUM COMMENTS FOR THE
International Lead Association PUBLIC CONSULTATION PROPOSAL TO IDENTIFY
United Kingdom
DIOXOBIS(STEARATO)TRILEAD (CAS# 12578-12-0) AS A
SVHC
About the ILA The International Lead Association is a
membership body that supports companies involved in the
mining, smelting, refining and recycling of lead. The ILA
represents the producers of about 3 million tons of lead and
almost two thirds of lead production in the western world.
As secretariat to the Lead (Pb) REACH Consortium, ILA
Europe (a regional branch of the International Lead
Response
Thank you for your comment.
Please refer to response to comment #9 in section
“General comments on the SVHC proposal” (see
above).
Thank you for the information provided.
If the substance is identified as SVHC, this
information, where relevant, will be taken into
account 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
10
Association) is acting on behalf of the Lead Registrants for
several lead substances.
These comments represent the view of the consortium
member companies which are discussed in more detail in
the attached document. A list of the consortium members
has been provided in Appendix A of the attached document.
Further details on uses of dioxobis(stearato)trilead,
workplace and environmental exposure, alternatives and
socio-economic information can be found in the comments
provided during this public consultation by the Industry
Associations representing the predominant uses of
dioxobis(stearato)trilead in the EU:
European Lead Stabilizers Association (ELSA): Lead
stabiliser producers
SUMMARY
We do not disagree that dioxobis(stearato)trilead could be
identified as a substance meeting the criteria of Article 57
(c) of Regulation (EC) 1907/2006 (REACH) owing to its CLP
Annex VI classification toxic for reproduction category 1 A
for lead compounds (INDEX no. 082-001-00-6), with the
exception of those specified elsewhere.
The Pb REACH Consortium however believe that a detailed
analysis of risk management options should be performed
prior to candidate listing and only substances for which
authorisation can be demonstrated to be the most
appropriate risk management option should be proposed for
the list. The fact that no such documentation has
accompanied the current proposal is deeply regrettable.
However in such circumstances it is crucial that the RMO
analysis be conducted before a decision is made on whether
to prioritise dioxobis(stearato)trilead for inclusion in Annex
XIV. We believe that authorisation would prove to be an
inefficient risk management option for this substance for
the following reasons:
1. Lead based stabilisers are already subject to a voluntary
phase out by end of 2015.
2. The major use of dioxobis(stearato)trilead is in the in
PVC processing in the stabiliser sector. It has a non-
substance and its uses to the authorities The
registrations are the authorities’ principal source
of information when assessing the need of further
risk management for a substance or (some of) its
uses. Therefore, it is of utmost importance that
registrants keep the information provided in the
registration dossiers up to date and adequately
describing the current use and exposure situation,
including the operational conditions and risk
management measures in place.
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 SocioEconomic 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.
11
dispersive and controlled use in that the
dioxobis(stearato)trilead in the final article is bound into the
matrix of plastics. It’s use in the workplace is already
covered by existing Community legislation that imposes
minimum requirements such as a binding occupational
exposure limit and industry data indicates that the 90th
percentile for exposure is below the blood lead DNEL of 40
μg/dL.
3. Dioxobis(stearato)trilead is not interchangeable with
other lead compounds in any of its existing uses.
There are a number of additional points that should be
considered when evaluating prioritisation for inclusion of
dioxobis(stearato)trilead onto Annex XIV that are related to
lead in general.
1. Extensive lead specific EU-wide Community legislation
has been successfully implemented to control human and
environmental exposures throughout its lifecycle from
manufacturing to end of life and recycling. According to
Article 58(2) of REACH it is possible to exempt from the
authorisation requirement uses or categories of uses
"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." We believe that many existing uses of
lead and compounds meet these requirements and should
be exempt from authorisation.
2. This existing Community legislation has been successful
in reducing human and environmental exposure to lead and
compounds. Some examples of this include:
a. There have been significant reductions in the blood lead
values of European children with, about 60% reduction
between 1995 and 2007. This has predominantly been due
to elimination of lead exposure from fuel (both in gasoline
and energy production) which was the most significant
contributor.
b. There has been a significant decrease in emissions from
industry which is consistent across 26 of the EU Member
States, with 22 reporting reductions of greater than 85%
The current proposal for identifying the substance
as a substance of very high concern (SVHC) is in
accordance with REACH Article 59(2) based on its
harmonised classification in Annex VI of
Regulation (EC) No 1272/2008 (CLP Regulation).
The additional mentioned information is not
relevant for determining whether the substance
meets the criteria for identification as SVHC.
However, when examining whether the substance
should be recommended for inclusion in Annex
XIV, ECHA will indeed have to assess available
information on uses and exposures. In addition,
information on work already done by industry to
identify and assess potential alternatives is used
in defining transitional arrangements in the draft
Annex XIV entries for the recommended
substances. This information will be collected by
ECHA before prioritising the substances and
defining the transitional arrangements for its
recommendation. The generic approaches for
prioritisation and defining the draft Annex XIV
entries
are
available
at:
http://echa.europa.eu/documents/10162/13640/a
xiv_prioritysetting_general_approach_20100701_
en.pdf
and
http://echa.europa.eu/documents/10162/13640/d
raft_axiv_entries_gen_approach_4th_en.pdf.
If ECHA intends to recommend the substance for
Annex XIV inclusion, interested parties can
provide comments on ECHA’s recommendation,
including the suggested transitional arrangements
in accordance with Article 58 of REACH.
Regarding your comment on the preparation of
risk management options analysis (RMOA) before
proposing the identification of a substance as
SVHC, we note that this is a voluntary step in the
co-ordination of risk management activities
among the Competent Authorities for REACH but
12
4
2012/10/15 Company
REHAU AG + Co.
Germany
since 1990.
c. Occupational exposures in manufacturing and use of
dioxobis(stearato)trilead are well controlled below the EU
binding airborne lead limit of 0.15 mg/m3 and the biological
exposure limit of 70 μg/dL and even stricter limits set by
the different member states. The 90th percentile of
occupational exposure is below the DNEL of 40 μg/dL.
3. Regulation introduced to limit the use of lead to only its
more essential applications, particularly bans introduced on
use in petrol and paint, has resulted in a marked and ongoing fall in anthropogenic emissions and environmental
levels globally. As a consequence of these marked
reductions in industrial emissions, the relative importance
of on-going natural emissions and re-circulation of preexisting environmental deposits of lead arising from
historical human activity, together with transboundary
pollution from outside of Europe, are of growing significance
when considering the extent of future European exposures
and the impact of risk potential management measures in
relation to REACH.
4. This would jeopardize the decade-long efforts and
success of the VinylPlus consortium (formerly Vinyl 2010) in
developing a significant recycling chain.
See also:
Comment 6 attachment (Public consultation document
Dioxobis(stearato)trilead CAS 12578-12-0.pdf).pdf
page 10
The inclusion of this substance in the candidate list 2 years
before effective date of the voluntary phase out of the use
of lead-containing additives would not lead to an essential
reduction of risk. From REHAU’s point of view it would
cause severe problems for articles produced from postconsumer PVC-recycling-material, because most of recycled
material contains more than 0.1% of lead compounds. The
obligation to inform customers about lead compounds
would apply to articles containing recycled material
although we wouldn’t know which of the 30 listed lead
compounds are contained. It is analytical impossible to
identify the exact lead compounds and due to this the given
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 coordination of the regulatory risk management
activities between the authorities.
Finally, regarding the information provided on
controls for this substance under other legislation
note that the current proposal only concerns
identifying the substance as a substance of very
high concern (SVHC) in accordance with REACH
Article 59(2). However, if the substance is
identified as SVHC, information in relation to
controls under other legislation will be taken into
account at later stages of the authorisation
process.
Thank you for your opinion.
It may indeed be difficult to know which of the
Candidate List’s lead substances used in the
production of PVC articles - and at which exact
concentration – are contained in articles made of
recycled PVC. Therefore in those cases the
substance’s name information, which is among the
information that needs to be provided where
Articles 7(2) and 33 of REACH apply, may, as you
mention, to some extent be speculative. If
companies cannot draw and document a
conclusion that the articles contain less than 0.1%
13
information will be speculative to some extent. The
information will presumably make our customers insecure
to buy articles produced from recycled post consumer PVC
although the lead compounds are included the matrix. The
bureaucracy connected with the obligation to inform
customers will jeopardize the rates for recycling of post
consumer PVC aspired by association Vinyl Plus because
this obligation applies along the whole supply chain and
especially wholesale-companies try to avoid any
bureaucracy related to substances listed in candidate list.
According to our opinion it would be the better way to issue
a restriction for all lead compounds effective from beginning
2016 and to allow per derogation lead compounds
introduced per recycling material up to a content of 3%
(measured as metal). In return for this restriction the
suggested inclusion of the 30 single lead containing
substances in the candidate list should be waived.
(w/w) of any of Candidate List substances,
companies should strive to fulfil the obligations in
Articles 7(2) and 33 of REACH. Information on the
lead content could be given in case there is
uncertainty regarding which exact substances give
rise to the presence of lead. It is up to the
companies to assess whether the obligations
foreseen in Articles 7(2) and 33 REACH may
apply; ECHA suggests to document the procedures
followed during such assessment in case of
enforcement.
Regarding your reference to the impact of the
inclusion of lead substances in the Candidate List,
on PVC recycling rates, ECHA would like to
highlight that one of the purposes of Art. 33 of
REACH is to enable customers to make more
informed choices. Article 33 sets that for articles
containing substances of very high concern
(included in the Candidate List) information should
be provided to allow safe use by customers. One
way of doing this in practice could be to inform
about the lead content of the articles.
Finally, regarding alternative risk management
options, please refer to the response to comment
#2 in section “General comments on SVHC
identification”.
14
Attachments
Comment
number
Public attachment
6
Comment 6 attachment (Public consultation document Dioxobis(stearato)trilead CAS 12578-12-0.pdf).pdf
9
Comment 9 attachment (SVHC-Public-Consultation-Oct-2012_ELSA-comments_CAS-12578-12-0.pdf).pdf
15