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REACH - Registration, Evaluation and Authorisation of Chemicals
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REACH - Registration, Evaluation and Authorisation of Chemicals
TITLE-VII
: AUTHORISATION
CHAPTER-2
: Granting of authorisations
ARTICLE 64
:
Procedure
for authorisation
decisions
ARTICLE 64:
Procedure
for authorisation
decisions
1. The
Agency
shall acknowledge the
date of receipt
of the
application
. The
Agency
's
Committees
for
Risk Assessment
and
Socio-economic
Analysis
shall give their
draft
opinions
within ten
months
of the
date of receipt
of the
application
.
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
.
4. The
draft
opinions
shall
include
the following elements:
(a)
Committee
for
Risk Assessment
: an
assessment
of the
risk
to
human health
and/or the
environment
arising from the use(s) of the
substance
,
including
the appropriateness and
effectiveness
of the
risk management
measures
as
described
in the
application
and, if
relevant
, an
assessment
of the
risks
arising from possible alternatives;
(b)
Committee
for
Socio-economic
Analysis
: an
assessment
of the
socio-economic
factors
and the
availability
, suitability and
technical
feasibility of alternatives associated with the use(s) of the
substance
as
described
in the
application
, when an
application
is made in
accordance
with
Article
62
and of any
third party
contributions
submitted under paragraph 2 of this
Article
.
5. The
Agency
shall send these
draft
opinions
to the
applicant
by the end of the deadline set out in paragraph 1. Within one
month
of
receipt
of the
draft
opinion
, the
applicant
may provide
written notice
that he wishes to comment. The
draft
opinion
shall be deemed to have been
received
seven
days
after the
Agency
has sent it. If the
applicant
does not wish to comment, the
Agency
shall send these
opinions
to the
Commission
, the
Member States
and the
applicant
, within 15
days
of the end of the
period
within which the
applicant
may comment or within 15
days
of
receipt
of
notice
from the
applicant
that he does not intend to comment. If the
applicant
wishes to comment, he shall send his
written
argumentation to the
Agency
within two
months
of the
receipt
of the
draft
opinion
. The
Committees
shall consider the comments and
adopt
their final
opinions
within two
months
of
receipt
of the
written
argumentation, taking this argumentation into
account
where appropriate. Within a further 15
days
the
Agency
shall send the
opinions
, with the
written
argumentation attached, to the
Commission
, the
Member States
and the
applicant
.
6. The
Agency
shall determine in
accordance
with
Articles
118
and
119
which parts of its
opinions
and parts of any attachments thereto should be made
publicly
available on its website.
7. In
cases
covered by
Article
63
(1), the
Agency
shall treat the
applications
together, provided the deadlines for the first
application
can be met.
8. The
Commission
shall prepare a
draft
authorisation
decision
within three
months
of
receipt
of the
opinions
from the
Agency
. A
final decision
granting or refusing the authorisation shall be taken in
accordance
with the
procedure
referred to in
Article
133
(2).
9.
Summaries
of the
Commission
decisions
,
including
the authorisation
number
and the
reasons
for the
decision
, in particular where suitable alternatives
exist
, shall be
published
in the
Official Journal of the European Union
and shall be made
publicly
available in a database
established
and kept up to
date
by the
Agency
.
10. In
cases
covered by
Article
63
(2), the deadline set out in paragraph 1 of this
Article
shall be shortened to five
months
.
[
Next page
]
Referred by:
ARTICLE 56
:
General provisions
ARTICLE 60
: Granting of authorisations
ARTICLE 61
:
Review
of authorisations
ARTICLE 65
:
Obligation
of holders of authorisations
ARTICLE 118
:
Access to information