Q&As

Want to search for the relevant question and answer in your own language? Change the language in the dropdown menu above.

Back

Back

REACH

Downstream users

A. Downstream users, regulatory

Can downstream users continue to use a substance, if it has not been registered?

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.

The workers of transport companies can be exposed to chemicals, for example while loading and unloading chemicals, or fitting and opening of transfer pipelines. Should transport companies be regarded as downstream users in these cases?

The carriage of hazardous substances and mixtures by rail, road, inland waterway, sea or air is exempted from the scope of the REACH Regulation (see Article 2(1)(d)). Transporting activities (including loading and unloading) by transport companies are not "uses" under REACH.

The loading and unloading operations performed by the workers of the transport company are covered by the Carriage of Dangerous Goods legislation, and hence they are outside of the scope of the REACH Regulation. Compared to that, the site-related activities before loading and after unloading will often be "uses" under REACH, which may need an exposure scenario and a chemicals safety assessment.

It is also important to note that the transfer of substances and mixtures occurring exclusively within an industrial plant is covered by REACH, even if this includes transportation carried out by an external company.

What information can a downstream user communicate to his suppliers in order to cooperate in preparing for REACH registration?

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

What are my downstream user obligations, when I use substances subject to authorisation or restriction?

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.

How do I document that my suppliers have appointed an only representative?

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".

B. Downstream users, SDS and eSDS

What are my downstream user (DU) obligations as a DU of a substance for which an extended safety data sheet is required?
As a downstream user you should follow the risk management advice and the operational conditions of use described in the extended safety data sheet (eSDS) received from the supplier, including the exposure scenarios. If relevant, forward the advice to actors further down the supply chain. If you as a downstream user produce a mixture, you must ensure that the eSDS for that mixture includes all relevant information received from the suppliers of the individual components. Please note: This was also a duty of downstream users under previous legislation. The new element under REACH is the receiving and forwarding of use-specific risk management advice and risk management measures relating to exposure to humans or the environment.
 
If as a downstream user you receive information from your customers intended for the purpose of making a use known, you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the preparation and eventually carry out your own downstream user Chemical Safety Assessment (CSA).
 
If you as a downstream user hold information that puts into question the hazard or risk management information received from a supplier, you should communicate this information to the supplier.
 
An overview of the possible obligations of downstream users can be found in ECHA website: http://echa.europa.eu/regulations/reach/downstream-users
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.
My substance has been registered by my supplier. What are the implications for me as a downstream user?

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.

Downstream users (DU) have 12 months to fulfil their duties related to the exposure scenario (ES) attached to a safety data sheet (SDS). Does the 12 months start as soon as the DUs receive the ES or when they receive the registration number?

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.

What are the obligations of a downstream user when their use or their conditions of use are not covered by the supplier’s registration and are not included in the eSDS?

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).

C. Downstream user report

I am a downstream user. When do I need to report to ECHA?

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.

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.
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 Q&A 491. 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.

D. Downstream user report, technical

How do I submit a downstream user report?
There are two options 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
  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
  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.
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. 

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.

What are my downstream user obligations when my use is not covered by the eSDS?

If as a downstream user you use the substance (as such or in a mixture) outside the conditions communicated to you in the extended safety data sheet (eSDS), or the use is not covered at all in the eSDS, you may choose one of the following options:

  • Adapt your conditions of use to those described in the eSDS.
  • Implement or recommend an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to you. Make the use known to the supplier with the aim of making it an identified use based on the manufacturer's chemical safety assessment.
  • Perform your own chemical safety assessment for that particular use and record it in a Chemical Safety Report - CSR (if the total amount used is 1 tonne/year or more). Notify your use, including the information specified in Article 38(2) of the REACH Regulation to ECHA.
  • Switch to another supplier of the substance if that supplier covers your specific use in his eSDS.

If as a downstream user you receive information from your customers intended to make a use known you should forward this information to the supplier up the supply chain or assess if the use is covered in the existing exposure scenario for the mixture and eventually carry out your own downstream user Chemical Safety Assessment (CSA).

If as downstream user you hold information that puts into question the hazard or risk management information received from the supplier you need to communicate this information to the supplier.

An overview of how to decide whether or not your use is covered by the exposure scenario can be found in section 6-'Deciding if the use is not covered by the exposure scenario' in the Guidance for downstream users. Information on how to make a downstream user chemical safety report is given in Section 7-'Making a downstream user chemical safety report' of the same guidance available at the ECHA website: https://echa.europa.eu/guidance-documents/guidance-on-reach

 

Is a downstream user or distributor obliged to check the registration status of the substances on their own or in a mixture they place on the market according to the REACH Regulation?

Downstream users or distributors must check the registration status of the substances on their own or in a mixture they place on the market, in order to comply with the obligation imposed by Article 5 of REACH to place on the market only substances that comply with the registration requirements under REACH.

Manufacturers and importers of a substance on its own or in a mixture are encouraged to communicate with the downstream users or distributors of the substance with regard to whether and by when they intend to register the substance to enable the downstream user or distributor to seek alternative sources of supply if necessary. Once the substance has been registered, there is an obligation for the supplier to communicate the registration number down the supply chain either in the safety data sheet according to Article 31 or, if applicable, according to Article 32 of REACH.

 

What are the obligations of a Downstream User (DU) who uses a registered substance, as such or in a mixture, for the purpose of product and process orientated research and development (PPORD)?

The obligations under REACH for a DU using a substance for the purpose of PPORD may differ, depending on whether or not the PPORD activity is covered by a PPORD notification made by the manufacturer or importer of the substance.

A DU, who is listed in a PPORD notification submitted by the manufacturer or importer as one of the customers, operates under the responsibility of his supplier and must respect any conditions set in accordance with Article 9(4) of REACH and/or communicated to him by his supplier. If the DU stops using the substance for the purpose of PPORD and, by this, ends the cooperation with his supplier, he needs to inform his supplier, as the supplier will need to update his notification to remove the DU from the list of customers.

Alternatively, a DU can use a substance for the purpose of PPORD under his own responsibility and initiative. Since a DU does not have the registration obligation of Articles 5 and 6 of REACH, there is no need for the DU to submit a notification under Article 9 of REACH to be exempted from the registration obligation.

If he adequately controls the risks to human health and the environment in accordance with the requirements of legislation for the protection of workers and the environment, the DU is not required to prepare a DU CSR, even if his conditions of use are not covered in the extended SDS of his supplier or  the use is advised against (Article 37 (4) (f)). According to Art 38(1)(b), the DU must report to ECHA if using a registered substance at greater than 1 tonne for the purposes of PPORD and availing of the exemption in Art. 37(4)(f).
 

Categories Display