TITLE V
DOWNSTREAM USERS

 

 

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).

 

 

Article 38

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.