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A downstream user chemical safety report documents the results of the chemical safety assessment undertaken by the downstream user. The assessment establishes conditions to ensure that the risk for the use(s) not covered in the received exposure scenarios is adequately controlled. The downstream user chemical safety report itself does not need to be submitted to ECHA.
A downstream user report is a report by a DU to ECHA when:
- He has to prepare a downstream user chemical safety report or is claiming exemption
- His classification of the substance is different to that of his supplier
- A downstream user notification is required when a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers the use.
A downstream user can make a testing proposal. ECHA examines this proposal and decides on appropriate testing in accordance with Article 40 of REACH. It is the responsibility of the downstream user to perform the test, unless other downstream users or registrants are also interested in carrying out such a test.The interested parties can agree on who will perform the test on behalf of all of them. If agreement is not reached, the Agency shall designate one of the parties to perform the test on behalf of all. All parties concerned share the cost of the study.
It is possible that a reference substance does not exist in the downloadable reference substance list. In this case, you will need to create the reference substance yourself. The reference substance needs to be included in the substance dataset. You can find more information on how to create a reference substance in section 6.1 of the manual How to prepare registration and PPORD dossier at: http://echa.europa.eu/manuals
Downstream users have to provide all the information as required by Article 38 of the REACH Regulation.Section 1.3 of IUCLID is where you provide the supplier's registration number for the substance, as required by Article 38(2)(b). If the registration number is not available to you, you must provide a justification for this in the same section.
Additionally, when updating a downstream user report, you should also include in this section the downstream user report's reference number.
Therefore, it is advised to follow the instructions included in the Manual: How to prepare a downstream user report at: http://echa.europa.eu/manuals.
- Option (i): The webform is the simpler option. It is recommended for most downstream users, especially those who have not used IUCLID before.
- Option (ii): Reporting via REACH-IT is recommended for downstream users who already use IUCLID and want to maintain all their report records in the REACH-IT/IUCLID system.Downstream users who need to report if their classification is different to that of their supplier can only use option (ii), via REACH-IT.
- the identity and contact details of the downstream user;
- the registration number of the substance, if available;
- the identity of the substance;
- the identity of the supplier;
- a brief general description of the unsupported use(s) and conditions of use; and
- a proposal for additional testing on vertebrate animals if this is considered necessary.
A tutorial is available on using the webform.
- Prepare a Downstream user report dossier in IUCLID 6 as explained in the manual: How a downstream user report at: http://echa.europa.eu/manuals.
- In the IUCLID 6 dataset, enter information on your classification and labelling of the substance as explained in the manual How to prepare a classification and labelling notification at: http://echa.europa.eu/manuals
- Create the downstream user report dossier and export it as explained in the downstream user manual
- Submit the report to ECHA via REACH-IT
No fee is charged for the submission of a downstream user report. ECHA fees and charges for services and their amounts are stated in the REACH Regulation and in Regulation (EC) No. 340/2008 (Fee Regulation).