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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-III
: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
CHAPTER-2
: Rules for non-phase-in substances and registrants of phase-in substances who have not pre-registered
ARTICLE 27
:
Sharing
of
existing
data
in the
case
of
registered
substances
ARTICLE 27:
Sharing
of
existing
data
in the
case
of
registered
substances
1. Where a
substance
has previously been
registered
less than 12
years
earlier as referred to in
Article
26
(3), the
potential
registrant
:
(a) shall, in the
case
of
information
involving
tests
on
vertebrate animals
; and
(b) may, in the
case
of
information
not involving
tests
on
vertebrate animals
,
request
from the previous
registrant
(s) the
information
he requires with
respect
to
Article
10
(a)(vi) and (vii) in
order
to
register
.
2. When a
request
for
information
has been made according to paragraph 1, the
potential
and the previous
registrant
(s) as referred to in paragraph 1 shall make every effort to reach an
agreement
on the
sharing
of the
information
requested by the
potential
registrant
(s) with
respect
to
Article
10
(a)(vi) and (vii). Such an
agreement
may be replaced by submission of the matter to an
arbitration
board
and
acceptance
of the
arbitration
order
.
3. The previous
registrant
and
potential
registrant
(s) shall make every effort to ensure that the
costs
of
sharing
the
information
are
determined
in a
fair
,
transparent
and non-
discriminatory
way. This may be facilitated by following
cost
sharing
guidance
based on those
principles
which is
adopted
by the
Agency
in
accordance
with
Article
77
(2)(g).
Registrants
are only required to
share
in the
costs
of
information
that they are required to submit to satisfy their
registration
requirements
.
4. On
agreement
on the
sharing
of the
information
, the previous
registrant
shall make available to the new
registrant
the
agreed
information
and shall give the new
registrant
the
permission
to refer to the previous
registrant
's
full study report
.
5. If there is failure to reach such an
agreement
, the
potential
registrant
(s) shall inform the
Agency
and the previous
registrant
(s) thereof at the earliest one
month
after
receipt
, from the
Agency
, of the
name
and
address
of the previous
registrant
(s).
6. Within one
month
from the
receipt
of the
information
referred to in paragraph 5, the
Agency
shall give the
potential
registrant
permission
to refer to the
information
requested by him in his
registration
dossier
,
subject
to the
potential
registrant
providing, upon
request
by the
Agency
,
proof
that he has
paid
the previous
registrant
(s) for that
information
a
share
of
cost
incurred. The previous
registrant
(s) shall have a
claim
on the
potential
registrant
for a proportionate
share
of the
cost
incurred by him. Calculation of the proportionate
share
may be facilitated by the
guidance
adopted
by the
Agency
in
accordance
with
Article
77
(2)(g). Provided he makes the
full study report
available to the
potential
registrant
, the previous
registrant
(s) shall have a
claim
on the
potential
registrant
for an
equal
share
of the
cost
incurred by him, which shall be enforceable in the
national
courts
.
7. An
appeal
may be brought, in
accordance
with
Articles
91
,
92
and
93
, against
Agency
decisions
under paragraph 6 of this
Article
.
8. The
registration
waiting
period
in
accordance
with
Article
21
(1) for the new
registrant
shall be
extended
by a
period
of four
months
, if the previous
registrant
so
requests
.
[
Next page
]
Referred by:
ARTICLE 10
:
Information
to be submitted for
general
registration
purposes
ARTICLE 17
:
Registration
of
on-site isolated intermediates
ARTICLE 18
:
Registration
of
transported isolated intermediates
ARTICLE 21
:
Manufacturing
and
import
of
substances
ARTICLE 26
:
Duty
to inquire
prior
to
registration
ARTICLE 91
:
Decisions
subject
to
appeal