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REACH - Registration, Evaluation and Authorisation of Chemicals
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evidence
[
Global Index
]
PREAMBLE
[
go to this PREAMBLE
]
... 53. In
order
to allow a
potential
registrant
of a
phase-in substance
to proceed with his
registration
, even if he cannot reach
agreement
with a previous
registrant
, the
Agency
, on
request
, should allow use of any
summary
or robust
study
summary
of
tests
already submitted. The
registrant
who receives these
data
should be obliged to
pay
a
contribution
to the
costs
to the
owner
of the
data
. For non-
phase-in substances
, the
Agency
may ask for
evidence
that a
potential
registrant
has
paid
the
owner
of a
study
before the
Agency
gives
permission
for the
potential
registrant
to use that
information
in his
registration
. ...
ARTICLE-3
: Definitions [
go to this ARTICLE
]
... (b) it was
manufactured
in the
Community
, or in the
countries
acceding
to the
European Union
on 1 January 1995 or on 1 May 2004, but not placed on the
market
by the
manufacturer
or
importer
, at least once in the 15
years
before the
entry into force
of this
Regulation
, provided the
manufacturer
or
importer
has
documentary
evidence
of this; ...
... (c) it was placed on the
market
in the
Community
, or in the
countries
acceding
to the
European Union
on 1 January 1995 or on 1 May 2004, before
entry into force
of this
Regulation
by the
manufacturer
or
importer
and was considered as having been notified in
accordance
with the first indent of
Article
8(1) of Directive 67/548/EEC but does not
meet
the
definition
of a
polymer
as set out in this
Regulation
, provided the
manufacturer
or
importer
has
documentary
evidence
of this; ...
ARTICLE-57
: Substances to be included in Annex XIV [
go to this ARTICLE
]
... (f)
substances
- such as those having endocrine disrupting properties or those having persistent, bioaccumulative and
toxic
properties or very persistent and very bioaccumulative properties, which do not fulfil the
criteria
of points (d) or (e) - for which there is
scientific evidence
of probable
serious
effects
to
human health
or the
environment
which give rise to an
equivalent
level of
concern
to those of other
substances
listed in points (a) to (e) and which are
identified
on a
case
-by-
case
basis in
accordance
with the
procedure
set out in
Article
59
. ...
ARTICLE-69
: Preparation of a proposal [
go to this ARTICLE
]
... 5. The
Agency
shall maintain a
list
of
substances
for which a
dossier
conforming to the
requirements
of Annex XV is planned or underway by either the
Agency
or a
Member State
for the
purposes
of a proposed
restriction
. If a
substance
is on the
list
, no other such
dossier
shall be prepared. If it is proposed by either a
Member State
or the
Agency
that an
existing
restriction
listed in Annex XVII should be re-examined a
decision
on whether to do so shall be taken in
accordance
with the
procedure
referred to in
Article
133
(2) based on
evidence
presented by the
Member State
or the
Agency
. ...
ARTICLE-72
: Submission of an opinion to the Commission [
go to this ARTICLE
]
... 3. The
Agency
shall provide the
Commission
and/or
Member State
on
request
with all
documents
and
evidence
submitted to or considered by it. ...
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