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Downstream users can use substances, irrespectively of whether they have been (pre-)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. Q&A 40 explains the need for substances to be (pre-)registered in order to be placed on the market.
Please note that for the use of substances (whether (pre-)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 at: http://echa.europa.eu/guidance-documents/guidance-on-reach
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.
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.
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
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 REACH.
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.
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.
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).
The list of pre-registered substances has been published on the ECHA website at: https://echa.europa.eu/information-on-chemicals/pre-registered-substances
On this page, you can find out if and when a substance you use, as such or in preparations, is intended to be registered.
If a substance you use is not on the list, you can express your interest in the substance to the Agency (see Chapter 3 of the Guidance for downstream users - http://guidance.echa.europa.eu).
ECHA will then publish the name of the substance on its website. If a potential registrant requests, the Agency will provide them with your contact details.
Please note that if your supplier has not pre-registered, you cannot place the substances concerned on the market until they are registered. You may also want to seek another supplier that pre-registered the substance. ECHA is, however, not in a position to provide you with any list of potential registrants that pre-registered your substance.
More Q&As on pre-registration can be found at: https://echa.europa.eu/support/qas-support/browse/-/qa/70Qx/view/scope/REACH/Pre-registration
It could be. There may be a valid reason for not having registered the substance yet – for example, if the substance is a phase-in substance and suppliers are manufacturing/importing it at less than 100 tonnes/year, the registration deadline is not until 2018.
However, if you suspect that your supplier should have registered the substance already, we recommend that you contact them immediately to check. Make sure that substances critical to your business will be registered by the 31 May 2018 deadline and that your uses will be covered. See https://echa.europa.eu/regulations/reach/downstream-users/other-issues-affecting-downstream-users/registration-and-downstream-users.
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.
Have a look at the lead registrant list, which is frequently updated. It shows the substances for which the registration process has been started and those to which a registration number has already been assigned. You can also check the list of registered substances on ECHA’s website. However, do note that not all registration dossiers have yet been published, as some are still being processed by ECHA.
You can see the names of registrants by viewing the information on ECHA’s website. The company names appear at the bottom of the ‘General Information’ section. However, in some cases, this may not include your specific supplier, such as when:
- your supplier is not the one manufacturing or importing the substance; or
- the registrant has successfully claimed the name as confidential or is an importer covered by a representative of the non-EU exporter.
The most reliable information should come from your supplier. Again, the longer the supply chain, the longer it will take for this confirmation to arrive to you.
You have several options, ranging from asking your supplier to include your use in their registration to preparing your own chemical safety report or adapting/stopping the use of the substance:
- 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 make such an assessment. Your sector organisation may have developed a convenient means of supplying this information specifically to your sector.
- Implement the conditions of use described in the exposure scenario you have received. This option may require changes to your processes or products.
- Eliminate the substance or activity or substitute it with a safer alternative.
- Find another supplier who can provide the substance with a safety data sheet and an exposure scenario covering your use.
- 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. You will have to notify ECHA about this.