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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-VI
: EVALUATION
CHAPTER-3
: Evaluation of intermediates
ARTICLE 49
: Further
information
on
on-site isolated intermediates
ARTICLE 49:
Further
information
on
on-site isolated intermediates
For
on-site isolated intermediates
that are used in strictly controlled
conditions
, neither
dossier
nor
substance
evaluation
shall apply. However, where the
competent authority
of the
Member State
in whose
territory
the
site
is located considers that a
risk
to
human health
or the
environment
,
equivalent
to the level of
concern
arising from the use of
substances
meeting
the
criteria
in
Article
57
, arises from the use of an
on-site isolated intermediate
and that
risk
is not properly controlled, it may:
(a) require the
registrant
to submit further
information
directly related to the
risk
identified
. This
request
shall be accompanied by a
written
justification;
(b) examine any
information
submitted and, if necessary, recommend any appropriate
risk
reduction
measures
to
address
the
risks
identified
in
relation
to the
site
in
question
.
The
procedure
provided for in the first paragraph may be undertaken only by the
competent authority
referred to therein. The
competent authority
shall inform the
Agency
of the results of such an
evaluation
, which shall then inform the
competent authorities
of the other
Member States
and make the results available to them.
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