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REACH
'Substances of Very High Concern'
are substances that warrant consideration as to whether they
should be added to the Authorization List/ Annex XIV
and require
prior approval for each use. |
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The minimum criteria for SVHCs are set forth in Article 57: |
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(a)
Carginogenic
category 1 or 2 per Directive 67/548/EEC
(see list in
Appendices 1 & 2) |
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(b)
Mutagenic
category 1 or 2 per Directive 67/548/EEC
(see list in Appendices 3 & 4) |
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(c) Toxic for
reproduction
category 1 or 2 per Directive 67/548/EEC
(see list in
Appendices 5 & 6) |
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(d) Persistent, bioaccumulative & toxic
(PBT) per criteria in Annex XIII
(substances not listed) |
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(e) Very persistent & very bioaccumulative
(vPvB) per criteria in Annex XII
(substances not listed) |
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(f) Substances
whose probable serious effects for human health or the
environment (e.g. endocrine disruption) give rise to an equivalent level of concern
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Step One: SVHC
Identification |
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These substances
are
under study to see whether they meet
the SVHC criteria in Article 57. Currently, there are
fourteen substances listed in the Registry of Intentions.
Eight of these dossiers are scheduled to be submitted by 1/30/2011. SVHC evaluations are
conducted by the European Chemicals Agency (ECHA) and follow these steps: |
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Proposed by an EU
Member State or the European Commission and published in the
Registry of Intentions |
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Dossier prepared by
a Member State or ECHA per Annex XV instructions and
published online |
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Public consultation
period of 45 days for interested parties to submit comments and
additional information to ECHA; comments are published online |
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Opinion issued by ECHA Member State
Committee |
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Decision issued by ECHA adding
substances to Candidate List |
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Step Two:
Candidate List |
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These substances
have been formally identified
by ECHA as meeting the SVHC criteria in Article 57. To date,
73 substances have been placed on the Candidate List.
Manufacturers/producers/importers of substances on the Candidate
List have the following REACH obligations: |
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Substances 'in themselves' on the Candidate List: |
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Safety data sheet must be provided to
industrial and commercial users from date of inclusion. There is no
quantity threshold |
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Preparations containing
substances on the Candidate List: |
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Safety data sheet must be provided to
industrial and commercial users if concentration of SVHC is at least
0.1% by weight for non-gaseous preparations or 0.2% by volume for
gaseous preparations. Required from date of inclusion. There is no quantity
threshold |
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Articles containing
substances on the Candidate List: |
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Safe use information per
Article 33 must be provided to industrial and commercial
users if concentration of SVHC in article is above 0.1% by
weight. Required from date of inclusion. There is no quantity
threshold |
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Notification per
Article
7(2) must be submitted to ECHA if concentration of SVHC in
article is above 0.1% by weight; producer/importer's quantity is over 1 tonne per year
in the EU; and no-one has
registered the SVHC for that specific use. Effective date is
six months after SVHC is placed on candidate list, but not prior
to June 1, 2011. Separate
notification not needed if registration is required |
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Step Three: Annex XIV
Prioritization |
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These
Candidate List substances are under study to see whether they
should be added to Annex XIV (the Authorization List).
There are currently
no substances in the
pipeline. Annex XI evaluations
are conducted by ECHA and follow these steps: |
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Draft recommendation of the proposed Annex XIV
language specifying substances, SVHC 'intrinsic
properties', proposed sunset & application dates, and any uses
to be exempted from authorization; prepared by ECHA and
published online |
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Public consultation
period of 3 months for interested parties to submit comments and
additional information to ECHA; comments are published online |
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Opinion issued by ECHA Member State
Committee |
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Annex XIV Recommendation issued by ECHA |
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Step Four:
Annex XIV Recommendation |
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These
substances have been formally recommended for inclusion in
Annex XIV by ECHA and await legislative action by the EU.
Currently, there
are
twenty-one substances in the pipeline. Substances are
added to Annex XIV by using the "regulatory procedure with scrutiny": |
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Recommendation
is considered by European Commission (executive branch of EU): |
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Opinion issued by Regulatory Procedure with Scrutiny
Committee |
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Recommendation
is considered by the Council and the European Parliament (the two EU legislative
chambers): |
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If opposed by either the Council or
European Parliament, substances are not added to the
Authorization List |
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If adopted (or not acted upon) by
the Council and European Parliament, substances are added to to
the Authorization List and published in the Official Journal
of the European Communities |
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Step Five:
Authorization List (Annex XIV)
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Currently,
six
substances have been listed in Annex XIV. Manufacturers/
producers/ importers must receive an
authorization for use from the
European Commission (not ECHA) prior to using the
substance: |
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Authorization
is granted only if the risk to human health or the environment
is adequately controlled per
Annex I, Section 6.4 |
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If substance is
PBT, vPvB or safe use thresholds cannot be determined,
authorization is granted only if
socio-economic analysis demonstrates the benefits of use
outweigh the risks to human health/environment |
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An authorization to someone in
your supply chain for your specific use allows you to
use the substance |
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The application
must be submitted at least 18 months in
advance of the 'sunset date' (effective date when
authorization is needed) |
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Authorizations
are granted for a limited time,
usually with conditions of use (including monitoring), and
subject to review |
