Keeping your dossier up to date
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Registration phases
- 1. Your registration obligations
- 2. Finding your co-registrants
- 3. Get organised with your co-registrants
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4. Assessing hazard and risk
- Information requirements: 1 to 10 tonnes per year
- Information requirements: 10 to 100 tonnes per year
- Information requirements: 100 to 1000 tonnes per year
- Information requirements: 1000 tonnes or above per year
- Adaptations to the standard information requirements
- How to avoid unnecessary testing on animals
- Strategy for gathering your data
- 5. Creating your registration dossier
- 6. Submitting your registration dossier
- 7. Keeping your dossier up to date
Keeping your dossier up to date
The registration dossier has to reflect the current knowledge on how your substance can be used safely at production sites and by users throughout the supply chain. This means that after you have successfully submitted a registration and received your registration number, you still have work to do.
You have to update your registration – or contribute to the update of the joint part of your registration when:
- Your knowledge on the substance or its use changes e.g. higher tonnage band, new uses, change in composition of the substance, etc.
- You receive an evaluation decision requesting you to add information to your registration.
Changes that will impact your dossier updates
Changes in information requirements for registering chemicals under REACH, might have an impact on your dossier updates. You should also pay attention to the changes of the harmonised classification and labelling of hazardous substances which is updated through an ‘Adaptation to Technical Progress (ATP)’ and issued yearly by the European Commission.
ECHA may perform IT screening campaigns on dossiers to highlight the aspects of registrations that can be improved. As a result, ECHA may remind a registrant to perform an update of their registration dossier to address the highlighted concerns, as well as to improve the quality of data in future submissions. However, it remains the registrant’s responsibility to keep their data up to date. As a registrant, you should consider your dossier as a ‘living document’ and update it whenever new information is available.
Below is a set of practical points to consider when updating your registration dossier. This list contains only recommendations and should not be considered as the sole source of guidance when verifying if a dossier update is needed or not.
Check if you still manufacture/import the substance
If you are no longer manufacturing/importing the substance, cease manufacture/import of the registration in your REACH-IT account.
Check that your tonnage band is still correct
Check if your registered tonnage band is still up to date. The tonnage to be considered is the quantity manufactured/imported for the previous calendar year (i.e., no longer the average of 3 previous years).
You would need to update your dossier if:
- Your imported or manufactured tonnages have decreased
- Your tonnage band has exceeded or is likely to exceed your currently registered tonnage band.
At a higher tonnage band, more information is required in your registration dossier. Verify with the lead registrant whether you have access to those.
Make sure that your contact details are up to date in REACH-IT
It is important to make sure that contact details linked to your registrations and joint submissions within REACH-IT are up to date. When necessary, ECHA will use that information to get in touch with you. Furthermore, these contact information (in case of contact details for a lead registrant) are also used by potential registrants to get in touch with you.
Has there been any change in your substance composition that has an impact on your registration dossier?
Make sure that the composition of your substance falls within the boundary composition of the jointly submitted data. If not, you need to either agree with the lead registrant to broaden the boundary composition or you need to opt-out from the jointly submitted data and provide the necessary information on your own.
Are all your uses of the substance covered in the registration dossier(s)?
If the CSR is provided jointly by the lead registrant, make sure that all your uses are reported in the lead dossier, as well as in your own. You have to report the uses from the whole life cycle of the substance (e.g., uses of your downstream users).
If the CSR is not provided jointly, you should report in your registration dossier only the uses in your supply chain (i.e., yours and your downstream users’).
Communicate relevant changes within the supply chain
Certain changes to your registration should be communicated within your supply chain, including, but not limited to changes in (e)SDS (extended Safety Data Sheet), hazard classifications or Guidance on Safe Use.
What duties do you have following a successful registration?
Registration dossiers must be kept up to date. Co-registrants have the duty to contribute to the registration dossier updating process. This includes data and cost-sharing obligations. Make sure you contact your lead registrant to verify that you comply with all applicable data-sharing and cost-sharing obligations under REACH.
What is the deadline to update your dossier?
The implementing regulation on dossier update clarified the deadlines to submit a dossier update. Detailed information on that can be found in the ‘Respect the deadlines for updating’ section of the Phase 7 pages.
