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REACH - Registration, Evaluation and Authorisation of Chemicals
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alternative substance
[
Global Index
]
PREAMBLE
[
go to this PREAMBLE
]
... 69. To ensure a sufficiently high level of
protection
for
human health
,
including
having
regard
to
relevant
human
population
groups
and possibly to certain
vulnerable
sub-
populations
, and the
environment
,
substances
of very high
concern
should, in
accordance
with the
precautionary principle
, be
subject
to careful
attention
. Authorisation should be
granted
where
natural
or
legal persons
applying for an authorisation demonstrate to the granting
authority
that the
risks
to
human health
and the
environment
arising from the use of the
substance
are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the
socio-economic
benefits
from the use of the
substance
outweigh the
risks
connected
with its use and there are no suitable
alternative substances
or
technologies
that are
economically
and technically
viable
. Taking into
account
the good
functioning
of the
internal market
it is appropriate that the
Commission
should be the granting
authority
. ...
... 72. To
support
the aim of eventual
replacement
of
substances
of very high
concern
by suitable
alternative substances
or
technologies
, all
applicants
for authorisation should provide an
analysis
of alternatives considering their
risks
and the
technical
and
economic
feasibility of substitution,
including
information
on any
research
and
development
the
applicant
is
undertaking
or intends to
undertake
. Furthermore, authorisations should be
subject
to
time
-limited
review
whose
periods
would be
determined
on a
case
-by-
case
basis and normally be
subject
to
conditions
,
including
monitoring
. ...
... 73. Substitution of a
substance
on its own, in a
preparation
or in an
article
should be required when
manufacture
, use or placing on the
market
of that
substance
causes an unacceptable
risk
to
human health
or to the
environment
, taking into
account
the
availability
of suitable safer
alternative substances
and
technologies
, and the
socio-economic
benefits
from the uses of the
substance
posing an unacceptable
risk
. ...
... 74. Substitution of a
substance
of very high
concern
by suitable safer
alternative substances
or
technologies
should be considered by all those applying for authorisations of uses of such
substances
on their own, in
preparations
or for incorporation of
substances
into
articles
by making an
analysis
of alternatives, the
risks
involved in using any alternative and the
technical
and
economic
feasibility of substitution. ...
ARTICLE-55
: Aim of authorisation and considerations for substitution [
go to this ARTICLE
]
... The aim of this Title is to ensure the good
functioning
of the
internal market
while
assuring
that the
risks
from
substances
of very high
concern
are properly controlled and that these
substances
are progressively replaced by suitable
alternative substances
or
technologies
where these are
economically
and technically
viable
. To this end all
manufacturers
,
importers
and
downstream users
applying for authorisations shall analyse the
availability
of alternatives and consider their
risks
, and the
technical
and
economic
feasibility of substitution. ...
ARTICLE-60
: Granting of authorisations [
go to this ARTICLE
]
... 4. If an authorisation cannot be
granted
under paragraph 2 or for
substances
listed in paragraph 3, an authorisation may only be
granted
if it is shown that
socio-economic
benefits
outweigh the
risk
to
human health
or the
environment
arising from the use of the
substance
and if there are no suitable
alternative substances
or
technologies
. This
decision
shall be taken after
consideration
of all of the following elements and taking into
account
the
opinions
of the
Committee
for
Risk Assessment
and the
Committee
for
Socio-economic
Analysis
referred to in
Article
64
(4)(a) and (b): ...
... (d) available
information
on the
risks
to
human health
or the
environment
of any
alternative substances
or
technologies
. ...
... 5. When assessing whether suitable
alternative substances
or
technologies
are available, all
relevant
aspects
shall be taken into
account
by the
Commission
,
including
: ...
ARTICLE-64
: Procedure for authorisation decisions [
go to this ARTICLE
]
... 2. The
Agency
shall make available on its web-
site
broad
information
on uses, taking into
account
Articles
118
and
119
on
access to information
, for which
applications
have been
received
and for
reviews
of authorisations, with a deadline by which
information
on
alternative substances
or
technologies
may be submitted by interested
third parties
. ...
... 3. In preparing its
opinion
, each
Committee
referred to in paragraph 1 shall first check that the
application
includes all the
information
specified in
Article
62
that is
relevant
to its remit. If necessary, the
Committees
shall, in
consultation
with each other, make a
joint request
to the
applicant
for additional
information
to bring the
application
into
conformity
with the
requirements
of
Article
62
. The
Committee
for
Socio-economic
Analysis
may, if it deems it necessary, require the
applicant
or
request
third parties
to submit, within a specified
time
period
, additional
information
on possible
alternative substances
or
technologies
. Each
Committee
shall also take into
account
any
information
submitted by
third parties
. ...
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