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REACH - Registration, Evaluation and Authorisation of Chemicals
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fair
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PREAMBLE
[
go to this PREAMBLE
]
... 30. The
requirements
for
undertaking
chemical
safety
assessments
by
manufacturers
and
importers
should be defined in
detail
in a
technical
annex to allow them to
meet
their
obligations
. To
achieve
fair
burden
sharing
with their
customers
,
manufacturers
and
importers
should in their
chemical
safety
assessment
address
not only their own uses and the uses for which they
place
their
substances
on the
market
, but also all uses which their
customers
ask them to
address
. ...
... 50. It is in the
public interest
to ensure the quickest possible
circulation
of
test
results on
human health
or
environmental
hazards
of certain
substances
to those
natural
or
legal persons
which use them, in
order
to
limit
any
risks
associated with their use.
Sharing
of
information
should occur where this is requested by any
registrant
, in particular in the
case
of
information
involving
tests
on
vertebrate animals
, under
conditions
that ensure a
fair
compensation
for the
company
that has undertaken the
tests
. ...
... 51. In
order
to strengthen the
competitiveness
of
Community
industry
and to ensure that this
Regulation
is applied as efficiently as possible, it is appropriate to make
provision
for the
sharing
of
data
between
registrants
on the basis of
fair
compensation
. ...
ARTICLE-27
: Sharing of existing data in the case of registered substances [
go to this ARTICLE
]
... 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
. ...
ARTICLE-30
: Sharing of data involving tests [
go to this ARTICLE
]
... 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
. ...
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