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REACH

Relazioni degli utilizzatori a valle

Downstream user report

What is the difference between a downstream user chemical safety report and a downstream user report?

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.
We are formulators. We routinely generate exposure scenarios for our mixtures to communicate to our customers. What are our legal obligations relating to the exposure scenarios?
When your customer use is not covered in the supplier exposure scenarios, and you decide to include it, you have to take action to ensure it is covered. The options include communicating with your supplier or preparing a downstream user chemical safety report.
 
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.
I purchase chemicals from several suppliers. The classification of the same chemical is sometimes different from different suppliers. Do I need to report to ECHA under Article 38(4) of REACH?
Article 38(4) states that "a downstream user shall report to the Agency if his classification of a substance is different to that of his supplier". This is taken to refer to all of his suppliers.
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.
If a downstream user, as part of his own chemical safety assessment, concludes that a study on vertebrate animals is needed to complete the assessment and makes a testing proposal, who conducts the study?

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.

Preparations of an IUCLID dossier for downstream user reports

Is it possible that a reference substance is not included in the reference substance inventory?

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 

Why does a downstream user have to fill in Section 1.3 - Identifiers in IUCLID?

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.

Submitting the downstream user report

How do I submit a downstream user report?
Two options are available for submitting a Downstream User report, (i) a Webform and (ii) via REACH-IT/IUCLID.
  • 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.
A downstream user notification (when a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers the use) can be submitted using a webform.
 
Downstream users should go to the web page on downstream user reports, and select the preferred reporting option:
 
 
What data has to be submitted in a downstream user report?
The information to be provided for unsupported uses (uses not covered in the supplier's extended safety data sheet) includes:
  • 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.
 
Note that a proposal for additional testing is not required for substances falling under the exemption of Article 37(4)(c) of REACH (< 1 tonne/year total use).
Is it possible to create one downstream user report for multiple substances, multiple uses, multiple legal entities or multiple sites?
A downstream user can only report on one substance per downstream user report. Nonetheless, a downstream user can include multiple uses and multiple sites, belonging to the same legal entity, in one report.
 
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.
I need to report my new classification to ECHA according to Article 38(4) of REACH. How do I do this?
This reporting is done with IUCLID 6 and REACH-IT. Please take the following steps:
  1. 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.
  2. 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
  3. Create the downstream user report dossier and export it as explained in the downstream user manual
  4. Submit the report to ECHA via REACH-IT

 

Is the submission of a downstream user report to the Agency subject to a fee?

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).

How do I withdraw or amend my downstream user report?
If the report was submitted using the webform, it is necessary to submit a new downstream user report.
 
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.

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