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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-XV
: TRANSITIONAL AND FINAL PROVISIONS
ARTICLE 138
:
Review
ARTICLE 138:
Review
1. By 1 June 2019, the
Commission
shall carry out a
review
to assess whether or not to
extend
the
application
of the
obligation
to perform a
chemical
safety
assessment
and to
document
it in a
chemical
safety
report
to
substances
not covered by this
obligation
because they are not
subject
to
registration
or
subject
to
registration
but
manufactured
or imported in
quantities
of less than 10 tonnes per
year
. However, for
substances
meeting
the
criteria
for
classification
as
carcinogenic
,
mutagenic
or
toxic
for
reproduction
,
category
1 or 2, in
accordance
with Directive 67/548/EEC, the
review
shall be carried out by 1 June
2014. When carrying out the
review
the
Commission
shall take into
account
all
relevant
factors
,
including
:
(a) the
costs
for
manufacturers
and
importers
of drawing up the
chemical
safety
reports
;
(b) the
distribution
of
costs
between
actors
in the
supply chain
and the
downstream user
;
(c) the
benefits
for
human health
and the
environment
.
On the basis of these
reviews
, the
Commission
may, if appropriate, present
legislative
proposals
to
extend
this
obligation
.
2. The
Commission
may present
legislative
proposals
as soon as a practicable and
cost
-
efficient
way of selecting
polymers
for
registration
on the basis of
sound
technical
and
valid
scientific
criteria
can be
established
, and after
publishing
a
report
on the following:
(a) the
risks
posed by
polymers
in comparison with other
substances
;
(b) the need, if any, to
register
certain types of
polymer
, taking
account
of
competitiveness
and
innovation
on the one hand and the
protection
of
human health
and the
environment
on the other.
3. The
report
, referred to in
Article
117
(4), on the
experience
acquired with the
operation
of this
Regulation
shall
include
a
review
of the
requirements
relating to
registration
of
substances
manufactured
or imported only in
quantities
starting at 1 tonne but less than 10 tonnes per
year
per
manufacturer
or
importer
. On the basis of that
review
, the
Commission
may present
legislative
proposals
to modify the
information
requirements
for
substances
manufactured
or imported in
quantities
of 1 tonne or more up to 10 tonnes per
year
per
manufacturer
or
importer
, taking into
account
the latest
developments
, for example in
relation
to alternative
testing
and (
quantitative
)
structure
-
activity
relationships ((Q)SARs).
4. The
Commission
shall carry out a
review
of
Annexes
I, IV and V by 1 June 2008, with a
view
to proposing
amendments
, if appropriate, to them in
accordance
with the
procedure
referred to in
Article
131
.
5. The
Commission
shall carry out a
review
of Annex XIII by 1 December 2008, to assess the adequacy of the
criteria
for
identifying
substances
which are persistent, bioaccumulative and
toxic
or very persistent and very bioaccumulative, with a
view
to proposing an
amendment
to it, if appropriate, in
accordance
with the
procedure
referred to in
Article
133
(4).
6. By 1 June 2012 the
Commission
shall carry out a
review
to assess whether or not to
amend
the
scope
of this
Regulation
to
avoid
overlaps with other
relevant
Community
provisions
. On the basis of that
review
, the
Commission
may, if appropriate, present a
legislative
proposal
.
7. By 1 June 2013 the
Commission
shall carry out a
review
to assess whether or not, taking into
account
latest
developments
in
scientific knowledge
, to
extend
the
scope
of
Article
60
(3) to
substances
identified
under
Article
57
(f) as having endocrine disrupting properties. On the basis of that
review
the
Commission
may, if appropriate, present
legislative
proposals
.
8. By 1 June 2019, the
Commission
shall carry out a
review
to assess whether or not to
extend
the
scope
of
Article
33
to cover other
dangerous
substances
, taking into
account
the
practical
experience
in
implementing
that
Article
. On the basis of that
review
, the
Commission
may, if appropriate, present
legislative
proposals
to
extend
that
obligation
.
9. In
accordance
with the
objective
of
promoting
non-
animal
testing
and the
replacement
,
reduction
or refinement of
animal
testing
required under this
Regulation
, the
Commission
shall
review
the
testing
requirements
of Section 8.7 of Annex VIII by 1 June 2019. On the basis of this
review
, while ensuring a high level of
protection of health
and the
environment
, the
Commission
may
propose
an
amendment
in
accordance
with the
procedure
referred to in
Article
133
(4).
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