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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.
It could be. There may be a valid reason for not having registered the substance yet – for example, the tonnage is below one tonne per year.
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 are registered and that your uses are 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.
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.
The pre-registrations are not valid as of 1 January 2020 following the Commission Implementing Regulation (EU) 2019/1692.
Companies must register substances that they manufacture or import in quantities of more than one tonne per year in the EU/EEA before they start these activities, unless the substances are exempt from registration.
Your registration remains your responsibility, so keep it always up-to-date.
Safety Data Sheet
If you need to give your customers safety data sheets, you will need to include your registration number in the safety data sheets the next time you update them. In addition, if you have conducted a chemical safety assessment and needed to develop exposure scenarios, you have to attach them to the safety data sheet, outlining the use-specific conditions of safe use of the substance. This needs to be done as soon as possible.
If you have claimed you are an SME and have benefited from the reduced registration fees, ECHA may verify the size of your company. Make sure that your REACH-IT account includes all the necessary documentation to justify the size of your company.
Joint Submission management and Data sharing
We strongly recommended that you put in place a mechanism discuss within your joint submission and for dossier update, when necessary. For example, you must also share data and give access to the joint submission to newcomers. You can charge for access to the data by sharing the costs in a fair, transparent and non-discriminatory way.
ECHA will check the compliance of at least 20% of the received registration dossiers to verify that the information submitted is compliant with the legal requirements. The outcome of this dossier evaluation may be a request for additional information. Additionally, ECHA will examine the testing proposals included in the dossiers. This will happen by 1 June 2022 for registrations submitted for the deadline of 31 May 2018, and within 180 days for other registrations.
ECHA will communicate with you via REACH-IT, if the information of your registration dossier is being assessed, so we invite you to check your account regularly.
The first place is the lead registrant list, which shows the substances for which the registration process has been initiated and those to which a registration number has already been assigned.
Another option is the list of registered substances on ECHA’s website.
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. In some cases, the list may not include your specific supplier, because:
• your supplier is not the one manufacturing or importing the substance; or
• the registrant has successfully claimed the name as confidential or
• the registrant is an importer covered by a representative of the non-EU exporter.
The most reliable information should come from your supplier. You should be aware, however, that information can travel slowly along long supply chains.
There can be a number of reasons for this. Have a look at the scenarios below.
If you submitted your registration on time, you can continue to manufacture or import your substance even if you have not yet received your registration number. You would need to cease manufacture or import only if ECHA rejects your registration.
Your dossier is considered as ‘submitted’ when it passes the business rules step. You are informed about it through your REACH-IT account and ECHA then assigns a submission number and a submission date to your dossier. The proof that you have submitted a registration dossier is this submission number and submission date that you have received in your submission report in REACH-IT. If you are a lead registrant, it is only after your lead registrant dossier has passed the business rules check that the member registrants can submit their own dossiers.
If your dossier has failed the business rules check, you have also been informed about it through your REACH-IT account. In this case, you have missed the legal deadline and are not entitled to manufacture, import or market the substance in the EU/EEA. You can only start manufacturing or importing again once you have submitted a complete registration dossier and received a registration number from ECHA. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40). Submit a registration dossier as a matter of urgency! Document your submission attempts so that you can demonstrate that you took corrective action as soon as you could.
Scenario 1: ECHA is still processing your dossier
ECHA has until the end of August 2018 to verify the completeness of the dossiers that were submitted in April and May 2018. Keep track of the progress through your REACH-IT account. In the meantime, you can continue manufacturing or importing your substance.
Scenario 2: You have not paid the registration fee
Your registration will only be complete once ECHA has confirmed that your registration includes all the required information and you have paid the fee indicated in the invoice you have received through your REACH-IT account.
If you do not pay by the initial payment deadline indicated in the invoice, you will automatically be granted an extension. However, if you do not pay by this extended deadline, ECHA will reject your registration. You will have to cease manufacturing or importing activities, as you can only legally manufacture, import or market your substance once you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).
Scenario 3: Your dossier has failed the first technical completeness check
In this scenario, we will tell you what needs to be done and what the deadline is for submitting the missing information. You will have at least four months for this, so invest time in fixing the errors reported before resubmitting the full information as an update. You only have this one last chance to update your dossier so that it passes the technical completeness check. Make sure that you follow the instructions carefully and provide all the information requested, and only resubmit when you are sure you have addressed all failures.
Use the Validation assistant tool in IUCLID to avoid the risk of failing again – you will not get a third chance. If you still have questions, contact ECHA to make sure you understand what you need to do to complete your dossier.
Scenario 4: Your dossier has been rejected as it has failed the technical completeness check a second time
You will have to start the registration process all over again and resubmit your dossier as an initial submission. Any fee that you paid in connection with your failed first registration will not be refunded.
You will have to stop manufacturing or importing activities, as you can only legally manufacture, import or market your substance if you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).
31 May 2018 was the last chance to submit a registration for existing (phase-in) substances manufactured or imported in amounts of more than one tonne per year. If the registration obligation applied to you, but you did not submit your dossier by then, as of 1 June you can no longer manufacture or import your substance legally in the EU/EEA. You may, however, continue placing on the market any stock that was manufactured/imported before the deadline.
If you missed the deadline, you should make yourself compliant without delay:
- If you have pre-registered or inquired about your phase-in substance, you can register it directly (until further notice, you can still use the pre-registration number).
- If you have not pre-registered or inquired about your phase-in substance, you need to submit an inquiry before registering it.
If you submit your dossier after 31 May, you will need to wait until you receive your registration number before resuming or starting manufacture or import of your substance.