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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-III
: DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING
CHAPTER-3
: Rules for phase-in-substances
ARTICLE 30
:
Sharing
of
data
involving
tests
ARTICLE 30:
Sharing
of
data
involving
tests
1. Before
testing
is carried out in
order
to
meet
the
information
requirements
for the
purposes
of
registration
, a SIEF
participant
shall inquire whether a
relevant
study
is available by
communicating
within his SIEF. If a
relevant
study
involving
tests
on
vertebrate animals
is available within the SIEF, a
participant
of that SIEF shall
request
that
study
. If a
relevant
study
not involving
tests
on
vertebrate animals
is available within the SIEF, a SIEF
participant
may
request
that
study
. Within one
month
of the
request
, the
owner
of the
study
shall provide
proof
of its
cost
to the
participant
(s) requesting it. The
participant
(s) and the
owner
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 any
cost
sharing
guidance
which is based on those
principles
and is
adopted
by the
Agency
in
accordance
with
Article
77
(2)(g). If they cannot reach such an
agreement
, the
cost
shall be
shared
equally
. The
owner
shall give
permission
to refer to the
full study report
for the
purpose
of
registration
within two
weeks
of
receipt
of
payment
.
Registrants
are only required to
share
in the
costs
of
information
that they are required to submit to satisfy their
registration
requirements
.
2. If a
relevant
study
involving
tests
is not available within the SIEF, only one
study
shall be
conducted
per
information
requirement
within each SIEF by one of its
participants
acting on behalf of the others. They shall take all
reasonable
steps
to reach an
agreement
within a deadline set by the
Agency
as to who is to carry out the
test
on behalf of the other
participants
and to submit a
summary
or robust
study
summary
to the
Agency
. If no
agreement
is reached, the
Agency
shall specify which
registrant
or
downstream user
shall perform the
test
. All
participants
of the SIEF who require a
study
shall
contribute
to the
costs
for the elaboration of the
study
with a
share
corresponding
to the
number
of
participating
potential
registrants
. Those
participants
that do not carry out the
study
themselves shall have the
right
to
receive
the
full study report
within two
weeks
following
payment
to the
participant
that carried out the
study
.
3. If the
owner
of a
study
as referred to in paragraph 1 which involves
testing
on
vertebrate animals
refuses to provide either
proof
of the
cost
of that
study
or the
study
itself to (an)other
participant
(s), he shall not be able to proceed with
registration
until he provides the
information
to the other
participants
(s). The other
participant
(s) shall proceed with
registration
without fulfilling the
relevant
information
requirement
, explaining the
reason
for this in the
registration
dossier
. The
study
shall not be
repeated
unless within 12
months
of the
date of registration
of the other
participant
(s), the
owner
of this
information
has not provided it to them and the
Agency
decides
that the
test
should be
repeated
by them. However, if a
registration
containing this
information
has already been submitted by another
registrant
, the
Agency
shall give the other
participant
(s)
permission
to refer to the
information
in his
registration
dossier
(s). The other
registrant
shall have a
claim
on the other
participant
(s) for an
equal
share
of the
cost
, provided he makes the
full study report
available to the other
participant
(s), which shall be enforceable in the
national
courts
.
4. If the
owner
of a
study
as referred to in paragraph 1 which does not involve
testing
on
vertebrate animals
refuses to provide either
proof
of the
cost
of that
study
or the
study
itself to (an)other
participant
(s), the other SIEF
participants
shall proceed with
registration
as if no
relevant
study
was available in the SIEF.
5. An
appeal
may be brought, in
accordance
with
Articles
91
,
92
and
93
, against
Agency
decisions
under paragraphs 2 or 3 of this
Article
.
6. The
owner
of the
study
who has refused to provide either
proof
of the
cost
or the
study
itself, as referred to in paragraph 3 or 4 of this
Article
, shall be penalised in
accordance
with
Article
126
.
[
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 91
:
Decisions
subject
to
appeal