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REACH - Registration, Evaluation and Authorisation of Chemicals
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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-II
: REGISTRATION OF SUBSTANCES
CHAPTER-1
: General obligation to register and information requirements
ARTICLE 12
:
Information
to be submitted depending on
tonnage
ARTICLE 12:
Information
to be submitted depending on
tonnage
1. The
technical
dossier
referred to in
Article
10
(a) shall
include
under points (vi) and (vii) of that
provision
all physicochemical, toxicological and ecotoxicological
information
that is
relevant
and available to the
registrant
and as a
minimum
the following:
(a) the
information
specified in Annex VII for non-
phase-in substances
, and for
phase-in substances
meeting
one or both of the
criteria
specified in Annex III,
manufactured
or imported in
quantities
of 1 tonne or more per
year
per
manufacturer
or
importer
;
(b) the
information
on physicochemical properties specified in Annex VII, section 7 for
phase-in substances
manufactured
or imported in
quantities
of 1 tonne or more per
year
per
manufacturer
or
importer
which do not
meet
either of the
criteria
specified in Annex III;
(c) the
information
specified in
Annexes
VII and VIII for
substances
manufactured
or imported in
quantities
of 10 tonnes or more per
year
per
manufacturer
or
importer
;
(d) the
information
specified in
Annexes
VII and VIII and
testing
proposals
for the
provision
of the
information
specified in Annex IX for
substances
manufactured
or imported in
quantities
of 100 tonnes or more per
year
per
manufacturer
or
importer
;
(e) the
information
specified in
Annexes
VII and VIII and
testing
proposals
for the
provision
of the
information
specified in
Annexes
IX and X for
substances
manufactured
or imported in
quantities
of 1 000 tonnes or more per
year
per
manufacturer
or
importer
.
2. As soon as the
quantity
of a
substance
per
manufacturer
or
importer
that has already been
registered
reaches the next
tonnage
threshold
, the
manufacturer
or
importer
shall inform the
Agency
immediately of the additional
information
he would require under paragraph 1.
Article
26
(3) and (4) shall apply adapted as necessary.
3. This
Article
shall apply to
producers
of
articles
adapted as necessary.
[
Next page
]
Referred by:
ARTICLE 11
:
Joint
submission of
data
by multiple
registrants
ARTICLE 20
:
Duties
of the
Agency
ARTICLE 22
: Further
duties
of
registrants
ARTICLE 24
:
Notified substances
ARTICLE 41
:
Compliance
check of registrations
ARTICLE 77
: Tasks
ARTICLE 111
: Formats and
software
for submission of
information
to the
Agency
ARTICLE 124
: Other
responsibilities