Q&A info

Downstream users can use substances, irrespectively of whether they have been registered or not. In this regard use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation. Placing on the market is however not to be regarded as a use. See Q&A 40 for further information.

Please note that for the use of substances (whether registered or not) certain requirements related to restrictions, authorisation and risk management may apply. Guidance on how to comply with these requirements is provided in the Guidance for downstream users available on the ECHA website.

Downstream users may make uses known to the suppliers in their supply chain, before the manufacturer or importer submits his registration, with the aim of making these uses identified uses. This right is enshrined in Article 37(2) of the REACH Regulation. When registrants base their assessment on information from downstream users, this helps to ensure that the advice they receive is directly applicable and that the handling of exposure scenarios is easier.

The information to registrants flows most efficiently through sector organisations, many of whom are developing use maps that describe the typical uses of their sector. Use maps describe the typical uses and conditions of use in an agreed template. Downstream users should check whether their sector organisations are preparing a sector use map that covers their use(s). Individual companies can also use these templates if they need to communicate any niche applications to registrants.

http://echa.europa.eu/csr-es-roadmap/use-maps

If a substance is subject to authorisation (Annex XIV):

• You must use the substance according to the conditions laid down in the authorisation granted for that specific use to an actor up your supply chain or apply for an authorisation yourself if the authorisation of your supplier does not cover your use(s);
• You must notify to ECHA within 3 months after first supply, the use of the substance subject to authorisation.

If a substance is subject to restrictions (Annex XVII):

• Comply with the restrictions for placing on the market or use of substances as listed in Annex XVII of the REACH Regulation.

Suppliers must include information on authorisation and restriction in Section 15 of the safety data sheet or in other information provided in accordance with Article 32 of the REACH Regulation.

If your suppliers are located outside the EU and decide to appoint an only representative, they will confirm this to all the importers. You should preferably also obtain confirmation in writing from the only representative that your imported tonnage and use is indeed covered by the registration dossier.

This would not only provide you with a contact point with whom you can make your use known, but would also clearly document that your imports are indeed covered by the registration of the only representative.

You need to keep exact documents on which imported quantities of the substance are covered by the only representative registration and which imported quantities are not. For further information see the Guidance on registration, chapter 2.1.2.5 "Only representative of a non-EU manufacturer".

If a safety data sheet (SDS) is required for your substance, you will continue to receive it. However, when the SDS is updated after registration, you will see the registration number under section 1.1. You should also notice a change in that the updated SDS may contain one or more exposure scenarios as annexes, if your supplier has registered the substance for 10 tonnes/year or more. These exposure scenarios outline the conditions of safe use of the substance for specific uses.

You need to identify which exposure scenario(s) apply to your use(s) and check whether your conditions of use are in line with them. You will also need to take this information into account when communicating on safe use for the products that you place on the market.

Note that the exact time for updating the SDS is not defined under REACH and will depend, among other things, on whether any new information on the hazards and risk management measures have been generated in the course of the registration process.

According to the legal text the 12 months starts as soon as the DU receives an SDS containing a REACH registration number (Article 39(1) REACH). Nonetheless, it is understood that the DU requires an ES to be attached to the SDS, or at least for “uses advised against” to be included in Section 1 of the SDS, in order to determine if their uses are indeed included or excluded in the registration dossier. In cases where the required information has not been provided in the SDS, it is advisable that the DU communicates with his supplier to check why, record this communication, and the date when they receive an ES.

If a downstream user uses the substance (as such or in a mixture) under conditions that are not communicated by the supplier in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, they may choose one of the following options:

1. Ask your supplier to include your use or conditions of use in their chemical safety report and to provide you with an exposure scenario for it. You need to make sufficient information available to your supplier to enable them to carry out your Chemical Safety Assessment (CSA). Your sector organisation may have developed a convenient means of supplying this information specifically to your sector.
2. Implement the conditions of use described in the exposure scenario you have received. This option may require an adaptation of your processes to meet the conditions described in the eSDS.
3. Substitute your substance with a safer alternative.
4. Find another supplier who can provide the substance with a safety data sheet and an exposure scenario covering your use.
5. Carry out your own chemical safety assessment and prepare your own downstream user chemical safety report (DU CSR) for your uses and conditions of use, unless exemptions apply – see our practical guide How to prepare a downstream user chemical safety report for details. Notify your use, including the information specified in Article 38(2) of the REACH Regulation to ECHA.

If a downstream user holds information that puts into question the hazard or risk management information received from the supplier, they should communicate such information upstream to the supplier.

For further information, we advise to consult the Guidance for downstream users:

1. An overview of how to decide whether or not your use is covered by the exposure scenario can be found in Section 4 Downstream users and exposure scenarios
2. Information on how to make a downstream user chemical safety report is given in Section 5 Use not covered: preparing a downstream user chemical safety report (DU CSR)

More information is also available in the Downstream user responsibilities section and the practical guide How downstream users can handle exposure scenarios (section 2.2.2 What to do if the use and/or conditions of use are not covered by the exposure scenario).

You have to report to ECHA within 6 months of receipt of the safety data sheet for a registered substance when you:

• Need to prepare a downstream user chemical safety report; or
• Wish to benefit from the exemption to prepare a chemical safety report either because:
• you use the substance in total less than 1 tonne per year; or
• You use the substance for product and process oriented research.

You also have to  report to ECHA  if your classification of a substance differs from that of all of your suppliers. Reporting is not required if the downstream user uses the substance or mixture in a total quantity of less than one tonne per year.

If you use a substance included in the Authorisation List, for which an authorisation has been granted that covers your use, you have to notify ECHA of your use within three months of the first supply of the substance.

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.

• 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.

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).

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. 

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.