Questions and answers on downstream user reports
Supplementary Questions and Answers relating to downstream users
Questions on obligations
The support section of the ECHA website includes answers to frequently asked questions (FAQs) relating to downstream users and REACH. These answers have been agreed between the national REACH helpdesks (in the EEA), representatives of the European Commission and ECHA. This section presents additional questions and answers (Q&As) to address issues not yet covered in the agreed FAQs.
- Substance is not registered yet;
- Substance is registered below 10 tonnes per year;
- Substance is registered as an intermediate;
- The SDS is provided on a voluntary basis;
- The SDS is required, but the registrant was not obliged to carry out an exposure assessment according to Article 14(4) REACH;
Contact your supplier if you think that an exposure scenario should be provided.
See REACH FAQ 14.2 for details on what to do when your use is not covered.
If the exposure scenarios for a given substance are different from different suppliers, check if you comply with the most restrictive requirements. If not, but you comply with one of the exposure scenarios and consider that it ensures safe use, contact your suppliers to reach a satisfactory resolution.
Questions on downstream user reports
A downstream user is required to report to ECHA when:
- He has to prepare a downstream user chemical safety report; or
- He is exempt from preparing a downstream user chemical safety report because his total use of the substance is less than 1 tonne per year; or
- He is exempt from preparing a chemical safety report because he is using the substance for product and process oriented research and development; or
- His classification of the substance is different to that of his supplier.
Example: you use a substance of total quantity 5 tonnes per year (total use >1 tonne per year) and use 0.8 tonnes per year of it in a spray application process. Your spray application use is not covered in your supplier exposure scenarios, but all other uses are (Particular use <1 tonne per year). You have to prepare a downstream user chemical safety report, but you do not have to report to ECHA.
Example: you use a substance of total quantity 0.8 tonnes per year and use all of it in a spray application process, and your use is not covered. You do not have to prepare a downstream user chemical safety report (total use < 1 tonne), but you do have to report to ECHA that your use is not covered in your supplier exposure scenarios.
If you prepare a chemical safety report, you have to provide the relevant exposure scenarios to the recipients (Article 31(7)).
It might be the case that you generate exposure scenarios for your mixtures voluntarily. This could be for commercial reasons, or for better communication of the appropriate conditions of use. In such cases, the obligation to report to ECHA does not apply.
You need to ensure that the conditions of use in any exposure scenarios you generate are covered in the exposure scenarios you receive. To facilitate this process, you can provide your suppliers with generic exposure scenarios that you or your sector organisation have generated and provide to customers, and request that your supplier covers them.
You do not need to report to ECHA as long as your classification is the same as one or more of your suppliers. However, if you generate an entirely new classification, you shall report to ECHA. You are exempt from reporting to ECHA if you use the substance or mixture in a total quantity of less than one tonne per year, as per Article 38(5).
The reporting procedure is described in Question 17 below. Note that the requirement to report a new classification applies to all substances, registered and not registered.
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.
Questions on submitting the downstream user report
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.
Downstream users should go to the web page on downstream user reports, and select the preferred reporting option:
- 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 use(s) and conditions of use; and
- a proposal for additional testing on vertebrate animals if this is considered necessary.
If using the webform reporting mechanism, the information is provided directly in the tab section called "uses".
If reporting via REACH-IT, ECHA has produced a recommended template as an Annex to Data Submission Manual: How to prepare and submit a Downstream User Report using IUCLID 5. The template can be inserted in Section 13 of IUCLID. The recommended template is available to download on the DU reporting page. Click on "Template for reporting conditions of use".
As a downstream user, you cannot submit a downstream user report on behalf of other legal entities or on behalf of a group of downstream users.
- Prepare a Downstream user report dossier in IUCLID 5 as explained in Data submission manual: How to prepare and submit a Downstream User Report using IUCLID 5 (chapters 2-5).
- In the IUCLID 5 dataset, enter information on your classification and labelling of the substance as explained in Data submission manual: How to Prepare and Submit a Classification and Labelling Notification Using IUCLID (chapter 5.7).
- Create the downstream user report dossier and export it as explained in Data submission manual: How to prepare and submit a Downstream User Report using IUCLID 5 (chapters 6-7).
- Submit the report to ECHA via REACH-IT as explained in Data submission manual: How to prepare and submit a Downstream User Report using IUCLID 5 (chapter 9).
- When submitting the report you are asked about the reasons for submitting the report (Data submission manual: How to prepare and submit a Downstream User Report using IUCLID 5 chapter 9.4). As a workaround until the functionality for Article 38(4) reports is fully implemented in REACH-IT, please fill in as follows:
- Choose this bullet point:
The particular use(s) is/are not covered in the exposure scenarios received from our supplier because we prefer not to provide the information on our uses (and our further supply chain) due to
- Choose this check box:
For the free text field after "Other reason(s)" write: Article 38(4)
- Choose this bullet point:
In the tab for "REASONS"/further information, please tick the box "other reasons" under the tick box "the use is not covered..". In that text box please enter "amending [report number]"or "withdrawing [report number]" as appropriate.
It is necessary for you to fill in the report again. However, if there is lengthy information, you can refer to your original report where the information is the same.
If the report was submitted via REACH-IT, submit an updated IUCLID dossier, indicating that the unsupported use previously reported has been amended or resolved.
When reporting via the REACH-IT option, a submission report will be delivered to your message box in REACH-IT.
Questions on the preparations of an IUCLID dossier for downstream user reports
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.