Article 37
Downstream user chemical safety assessments and
duty to identify, apply and recommend risk reduction measures
1.
A downstream user or distributor may provide information to assist in
the preparation of a registration.
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).
4.
A downstream user of a substance on its own or in a preparation shall
prepare a chemical safety report in accordance with Annex XII for any use
outside the conditions described in an exposure scenario or if appropriate a
use and exposure category communicated to him in a safety data sheet or for any
use his supplier advises against.
A downstream user need not prepare
such a chemical safety report in any of the following cases:
(a)
a safety data
sheet is not required to be communicated with the substance or preparation in
accordance with Article 31;
(b)
a chemical safety
report is not required to be completed by his supplier in accordance with
Article 14;
(c)
the downstream
user uses the substance or preparation in a total quantity of less than one tonne
per year;
(d)
the downstream
user implements or recommends an exposure scenario which includes as a minimum
the conditions described in the exposure scenario communicated to him in the
safety data sheet;
(e)
the substance is
present in a preparation in a concentration lower than any of the
concentrations set out in Article 14(2);
(f)
the downstream
user is using the substance for the purposes of product and process oriented
research and development, provided that the risks to human health and the
environment are adequately controlled in accordance with the requirements of
legislation for the protection of workers and the environment.
5.
Any downstream user shall
identify, apply and where suitable, recommend, appropriate measures to adequately
control risks identified in any of the following:
(a)
the safety data sheet(s) supplied
to him;
(b)
his own chemical safety
assessment;
(c)
any information on risk management
measures supplied to him in accordance with Article 32.
6.
Where a downstream user does not prepare a chemical safety report in
accordance with paragraph 4(c), he shall consider the use(s) of the substanceand identify and apply any appropriate risk management measures needed to
ensure that the risks to human health and the environment are adequately
controlled. Where necessary, this information shall be included in any
safety data sheet prepared by him.
7.
Downstream users shall keep their chemical safety report up to date and
available.
8.
A chemical safety report prepared in accordance with paragraph 4 of this
Article need not include consideration of the risks to human health from the
end uses set out in Article 14(5).
Obligation for downstream users to report
information
1.
Before commencing or continuing
with a particular use of a substance that has been registered by an actor up
the supply chain in accordance with Articles 6 or 18, the downstream user shall
report to the Agency the information specified in paragraph 2 of this Article,
in the following cases:
(a)
the downstream
user has to prepare a chemical safety report in accordance with Article 37(4);
or
(b)
the downstream user is relying on the
exemptions in Article 37(4)(c) or (f).
2.
The information reported by the downstream user shall include the
following:
(a)
his identity and
contact details as specified in Section 1.1 of Annex VI;
(b)
the registration
number(s) referred to in Article 20(3), if available;
(c)
the identity of
the substance(s) as specified in Section 2.1 to 2.3.4 of Annex VI;
(d)
the identity of
the manufacturer(s) or the importer(s) or other supplier as specified in
Section 1.1 of Annex VI;
(e)
a brief general
description of the use(s), as specified in Section 3.5 of Annex VI, and of the
conditions of use(s);
(f)
except where the downstream user is
relying on the exemption in Article 37(4)(c), a proposal for additional testing
on vertebrate animals, where this is considered necessary by the downstream userto complete his chemical safety assessment.
3.
The downstream user shall update this information without delay in the
event of a change in the information reported in accordance with paragraph 1.
4.
A downstream user shall report to the Agency if his classification of a
substance is different to that of his supplier.
5.
Except where a downstream user is relying on the exemption in Article
37(4)(c), reporting in accordance with paragraphs 1 to
4 of this Article shall not be required in respect of a substance, on its own
or in a preparation, used by the downstream user in quantities of less than one
tonne per year for that particular use.
Article 39
Application of downstream user obligations
1.
Downstream users shall be required to comply with the requirements of
Article 37 at the latest 12 months after receiving a registration numbercommunicated to them by their suppliers in a safety data sheet.
2.
Downstream users shall be required
to comply with the requirements of Article 38 at the latest six months after
receiving a registration number communicated to them by their suppliers in a
safety data sheet.