TITLE V / DOWNSTREAM USERS
Article 37
Downstream user chemical safety assessments and duty to identify, apply and recommend risk reduction measures
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.
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).
A downstream user need not prepare such a chemical safety report in any of the following cases:
a safety data sheet is not required to be communicated with the substance or ►M3 mixture ◄ in accordance with Article 31;
a chemical safety report is not required to be completed by his supplier in accordance with Article 14;
the downstream user uses the substance or ►M3 mixture ◄ in a total quantity of less than one tonne per year;
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;
the substance is present in a ►M3 mixture ◄ in a concentration lower than any of the concentrations set out in Article 14(2);
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.
Any downstream user shall identify, apply and where suitable, recommend, appropriate measures to adequately control risks identified in any of the following:
the safety data sheet(s) supplied to him;
his own chemical safety assessment;
any information on risk management measures supplied to him in accordance with Article 32.
Article 38
Obligation for downstream users to report information
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:
the downstream user has to prepare a chemical safety report in accordance with Article 37(4); or
the downstream user is relying on the exemptions in Article 37(4)(c) or (f).
The information reported by the downstream user shall include the following:
his identity and contact details as specified in Section 1.1 of Annex VI;
the registration number(s) referred to in Article 20(3), if available;
the identity of the substance(s) as specified in Section 2.1 to 2.3.4 of Annex VI;
the identity of the manufacturer(s) or the importer(s) or other supplier as specified in Section 1.1 of Annex VI;
a brief general description of the use(s), as specified in Section 3.5 of Annex VI, and of the conditions of use(s);
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 user to complete his chemical safety assessment.