... 70.
Adverse effects on
human health and the
environment from
substances of very high
concern should be prevented through the
application of appropriate
risk management measures to ensure that any
risks from the uses of a
substance are adequately controlled, and with a
view to progressively substituting these
substances with a suitable safer
substance.
Risk management measures should be applied to ensure, when
substances are
manufactured, placed on the
market and used, that
exposure to these
substances including discharges,
emissions and losses, throughout the whole
life-cycle is below the
threshold level beyond which
adverse effects may occur. For any
substance for which authorisation has been
granted, and for any other
substance for which it is not possible to
establish a
safe level of
exposure,
measures should always be taken to minimise, as far as technically and practically possible,
exposure and
emissions with a
view to minimising the likelihood of
adverse effects.
Measures to ensure adequate
control should be
identified in any
Chemical Safety Report. These
measures should be applied and, where appropriate, recommended to other
actors down the
supply chain. ...
ARTICLE-6: General obligation to register substances on their own or in preparations [
go to this ARTICLE]
ARTICLE-7: Registration and notification of substances in articles [
go to this ARTICLE]
ARTICLE-8: Only representative of a non-Community manufacturer [
go to this ARTICLE]
ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures [
go to this ARTICLE]
ARTICLE-31: Requirements for Safety Data Sheets [
go to this ARTICLE]
ARTICLE-32: Duty to communicate information down the supply chain for substances on their own or in preparations for which a safety
data sheet is not required [
go to this ARTICLE]
ARTICLE-34: Duty to communicate information on substances and preparations up the supply chain [
go to this ARTICLE]
ARTICLE-37: Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures [
go to this ARTICLE]
... 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. ...
... 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. ...
... 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). ...
... 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). ...
... 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-38: Obligation for downstream users to report information [
go to this ARTICLE]