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REACH - Registration, Evaluation and Authorisation of Chemicals
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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-VI
: EVALUATION
CHAPTER-2
: Substance evaluation
ARTICLE 44
:
Criteria
for
substance
evaluation
ARTICLE 44:
Criteria
for
substance
evaluation
1. In
order
to ensure a harmonised approach, the
Agency
shall in
cooperation
with the
Member States
develop
criteria
for prioritising
substances
with a
view
to further
evaluation
. Prioritisation shall be on a
risk
-based approach. The
criteria
shall consider:
(a)
hazard
information
, for instance
structural
similarity of the
substance
with known
substances
of
concern
or with
substances
which are persistent and
liable
to bio-accumulate, suggesting that the
substance
or one or more of its transformation
products
has properties of
concern
or is persistent and
liable
to bio-accumulate;
(b)
exposure
information
;
(c)
tonnage
,
including
aggregated
tonnage
from the registrations submitted by several
registrants
.
2. The
Agency
shall use the
criteria
in paragraph 1 for the
purpose
of compiling a
draft
Community
rolling
action
plan
which shall cover a
period
of three
years
and shall specify
substances
to be evaluated each
year
.
Substances
shall be
included
if there are grounds for considering (either on the basis of a
dossier
evaluation
carried out by the
Agency
or on the basis of any other appropriate
source
,
including
information
in the
registration
dossier
) that a given
substance
constitutes a
risk
to
human health
or the
environment
. The
Agency
shall submit the first
draft
rolling
action
plan
to the
Member States
by 1 December 2011. The
Agency
shall submit
draft
annual
updates to the rolling
action
plan
to the
Member States
by 28 February each
year
. The
Agency
shall
adopt
the final
Community
rolling
action
plan
on the basis of an
opinion
from the
Member State
Committee
set up under
Article
76
(1)(e) (hereinafter referred to as "the
Member State
Committee
") and shall
publish
the
plan
on its website,
identifying
the
Member State
who will carry out the
evaluation
of the
substances
listed therein as
determined
according to
Article
45
.
[
Next page
]
Referred by:
ARTICLE 41
:
Compliance
check of registrations
ARTICLE 42
: Check of
information
submitted and follow-up to
dossier
evaluation
ARTICLE 135
:
Transitional
measures
regarding
notified substances