ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [
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... 2. Any
downstream user shall have the
right to make a use, as a
minimum the brief
general description of use, known in
writing (on
paper or electronically) to the
manufacturer,
importer,
downstream user or
distributor who
supplies him with a
substance on its own or in a
preparation with the aim of making this an
identified use. In making a use known, he shall provide sufficient
information to allow the
manufacturer,
importer or
downstream user who has supplied the
substance, to prepare an
exposure scenario, or if appropriate a use and
exposure category, for his use in the
manufacturer,
importer or
downstream user's
chemical safety assessment.
Distributors shall pass on such
information to the next
actor or
distributor up the
supply chain.
Downstream users in
receipt of such
information may prepare an
exposure scenario for the
identified use(s), or pass the
information to the next
actor up the
supply chain. ...
... 3. For
registered substances, the
manufacturer,
importer or
downstream user shall comply with the
obligations laid down in
Article 14 either before he next
supplies the
substance on its own or in a
preparation to the
downstream user making the
request referred to in paragraph 2 of this
Article, provided that the
request was made at least one
month before the
supply, or within one
month after the
request, whichever is the later. For
phase-in substances, the
manufacturer,
importer or
downstream user shall comply with this
request and with the
obligations laid down in
Article 14 before the
relevant deadline in
Article 23 has expired, provided that the
downstream user makes his
request at least 12
months before the deadline in
question. Where the
manufacturer,
importer or
downstream user, having assessed the use in
accordance with
Article 14, is
unable to
include it as an
identified use for
reasons of
protection of
human health or the
environment, he shall provide the
Agency and the
downstream user with the
reason(s) for that
decision in
writing without
delay and shall not
supply downstream user(s) with the
substance without
including these
reason(s) in the
information referred to under
Articles 31 or
32. The
manufacturer or
importer shall
include this use in section 3.7 of Annex VI in his update of the
registration in
accordance with
Article 22(1)(d). ...
ARTICLE-49: Further information on on-site isolated intermediates [
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ARTICLE-64: Procedure for authorisation decisions [
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ARTICLE-69: Preparation of a proposal [
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... 4. If a
Member State considers that the
manufacture, placing on the
market or use of a
substance on its own, in a
preparation or in an
article poses a
risk to
human health or the
environment that is not adequately controlled and needs to be addressed it shall notify the
Agency that it
proposes to prepare a
dossier which conforms to the
requirements of the
relevant sections of Annex XV. If the
substance is not on the
list maintained by the
Agency referred to in paragraph 5 of this
Article, the
Member State shall prepare a
dossier which conforms to the
requirements of Annex XV within 12
months of the
notification to the
Agency. If this
dossier demonstrates that
action on a
Community-
wide basis is necessary, beyond any
measures already in
place, the
Member State shall submit it to the
Agency in the format outlined in Annex XV, in
order to initiate the
restrictions process. The
Agency or
Member States shall refer to any
dossier,
chemical safety report or
risk assessment submitted to the
Agency or
Member State under this
Regulation. The
Agency or
Member States shall also refer to any
relevant risk assessment submitted for the
purposes of other
Community Regulations or Directives. To this end other
bodies, such as
agencies,
established under
Community law and carrying out a similar task shall provide
information to the
Agency or
Member State concerned on
request. The
Committee for
Risk Assessment and the
Committee for
Socio-economic Analysis shall check whether the
dossier submitted conforms to the
requirements of Annex XV. Within 30
days of
receipt, the respective
Committee shall inform the
Agency or the
Member State suggesting
restrictions, as to whether the
dossier conforms. If the
dossier does not conform, the
reasons shall be given to the
Agency or the
Member State in
writing within 45
days of
receipt. The
Agency or the
Member State shall bring the
dossier into
conformity within 60
days of the
date of receipt of the
reasons from the
Committees, otherwise the
procedure under this
Chapter shall be terminated. The
Agency shall
publish without
delay the
intention of the
Commission or of a
Member State to instigate a
restriction procedure for a
substance and shall inform those who submitted a
registration for that
substance. ...
ARTICLE-87: Rapporteurs of Committees and use of experts [
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ARTICLE-88: Qualification and interests [
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ARTICLE-92: Persons entitled to appeal, time-limits, fees and form [
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