ECHA

No. If the substance is not registered, the supplier does not have to provide an SDS with an exposure scenario. The usual obligation to provide an SDS (main body only) still applies.

There can be several reasons why the SDS for a substance does not include exposure scenarios:

• 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;

If the SDS you receive is for a mixture containing one or more registered substances, the reason you did not receive exposure scenarios could be that the relevant information from the exposure scenario is incorporated in the main body of the SDS.

In general, you should follow the safety advice in the SDS, unless it is inappropriate. In such an event, you are obliged to inform your supplier of the reason why you consider their advice to be inappropriate.

Contact your supplier if you think that an exposure scenario should be provided.

Tips and examples on how to check whether your use is covered by the supplier's extended safety data sheet are given in ECHA's Practical Guide 13: How downstream users can handle exposure scenarios. If you are still uncertain, then the best way to proceed is to contact the supplier directly and ask for clarification.

See REACH FAQ 14.2 for details on what to do when your use is not covered.

If you change or add a new supplier, you should check if your use is covered, or will be covered, by your new supplier's exposure scenarios.

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.

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 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.

This is called a "downstream user report". Questions 12 onwards of these Q&A are about how to submit a downstream user report.

You need to prepare a downstream user chemical safety report when the total use of the substance exceeds 1 tonne per year (and you choose not to take any other appropriate action such as implementing the conditions of use). You do not have to report to ECHA if the particular use not covered in the exposure scenarios received is less than one tonne per year.

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.

You do not need to prepare a downstream user chemical safety report when the total use of the substance is less than 1 tonne. However, according to Article 38 of REACH, you are obliged to report to ECHA your uses that are not covered in the exposure scenarios you received (these uses will all be below 1 tonne).

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.

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.

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.

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.

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.

Downstream users should go to the web page on downstream user reports, and select the preferred reporting option:
http://echa.europa.eu/web/guest/support/dossier-submission-tools/reach-it/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 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).

Information on the conditions of use helps ECHA and other authorities to focus their attention on those unsupported use(s) that may require further assessment. This is required in accordance with Article 38(2)(e) of REACH.

The information for conditions of use should give a brief description of the use not covered and the key operational conditions and risk management measures.

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".

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.

This reporting is done with IUCLID 5 and REACH-IT. Please take the following steps:

1. 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).
2. 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).
3. 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).
4. 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).
5. 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:
   1. 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
   2. Choose this check box:
      
      Other reason(s):
      
      For the free text field after "Other reason(s)" write: Article 38(4)

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).

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.

When reporting using the webform option, a summary of your submission is generated when the form is submitted. This can be stored and/or printed.

When reporting via the REACH-IT option, a submission report will be delivered to your message box in REACH-IT.

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 3.2 of the Data Submission Manual: How to prepare and submit a Downstream User Report using IUCLID 5.

Downstream users have to provide all the information as required by Article 38 of the REACH Regulation. The colour code in IUCLID is only an indication of the sections that need to be filled in. Therefore, it is advised to follow the instructions included in Data Submission Manual: How to prepare and submit a Downstream User Report using IUCLID 5 when filling in the IUCLID information.

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.

You are correct in that the downstream user reports are not subject to technical completeness checks. However, REACH-IT checks the incoming submissions to ensure that they can be processed. This check is referred to as the ‘enforce rules check' (also known as ‘business rules check'). We advise you to run the TCC plug-in, because it also simulates the ‘enforce rules check' that is performed on the downstream user report. This enables you to identify any deficiencies in your file.