How to get organised for dossier updates
How to get organised for dossier updates
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 are responsible for keeping your registration up to date. The information about your company, the composition of the substance as you manufacture or import it, and the uses of your customers, for example, are the parts of your registration that you need to maintain yourself.
You need to have processes, systems and alerts in place in your company, so that you can identify when you have to make changes to your registration. For example, you need to set up a process to receive and analyse feedback from your customers, and follow up the scientific literature concerning your substance.
You must update your dossier, in IUCLID format, for example in the following cases:
- You change your raw material, production process or supplier, and as a result your substance now contains different (hazardous) impurities or (minor) constituents.
- You change the import or production volume of your substance. Your dossier must always contain the latest tonnage information, so report both decreases and increases.
- If your volume increases and moves up to the next tonnage band, there are two possible situations:
- The required data is already available through the joint registration: Inform your co-registrants (including the lead) which additional studies you need, and get access to the necessary data from them, for example, by buying the relevant letter of access.
- The data is not available through the joint registration: Submit an inquiry to ECHA. You will get i) information what data is is available in the joint registration and ii) data submitted more than 12 years before.
If neither applies, you need to consider how to fill in the data gaps.
- You learn of new uses from your customers. In such a case, you may also need to update the chemical safety report.
- You need to update the information related to a property which you have opted out from in the joint submission.
- Your supplier reformulates a mixture that you are importing. You may need to notify a cease of import for a substance.
- You become aware of new information on the properties of your substance that needs to be brought to the attention of your co-registrants and the lead registrant. You need to agree on how to update the joint part of the registration.
You have to submit all updates of your registration to ECHA through REACH-IT without undue delay.
Most dossier updates are free of charge. However, there is a fee for a tonnage band upgrade.
All co-registrants (lead and member registrants) have a shared responsibility to keep the joint part of the registration up to date. It comprises of information about the physico-chemical, toxicological and eco-toxicological properties of the substance, classification and labelling, and guidance on safe use.
You need to have a collaboration agreement in place to manage the work. In addition, some of the updates lead to new costs, so you need to have a mechanism to agree with your co-registrants on how these costs are shared.
The joint part of the registration has to be updated, in IUCLID format, for example in the following cases:
- You become aware of new hazardous properties for the substance, for example, during the regular literature review or following the communication of new information by a customer.
- A jointly submitted chemical safety report needs to be updated, following the identification of new uses or uses advised against for the substance, for example.
- The classification and labelling of your substance changes, for example as a result of changes in the Classification and Labelling (CLP) Regulation or when new information on the hazardous properties becomes available.
- A company in the joint submission increases their production volume and moves to a higher tonnage band. If the information needed for registration in the higher tonnage band is not yet available in the joint submission, it will need to be generated and included in the dossier. The co-registrants have to agree on the approach. At the very least, you have to ask all registrants in the joint submission if they have any relevant information or also intend to move to a higher tonnage band.
- ECHA or a Member State requests additional information from the co-registrants during dossier or substance evaluation. The co-registrants need to agree on the approach.
All updates to the joint part of the registration have to be submitted by the lead registrant through REACH-IT without undue delay or by the deadline stated in the authority’s decision.
These dossier updates are free of charge, except if you make a request for specific information to be kept confidential.