- Creating your registration dossier
- How to create your registration dossier with IUCLID
How to create your registration dossier with IUCLID
These are the main steps to follow when creating your registration dossier with IUCLID.
You can download IUCLID free-of-charge from the IUCLID website. If you are the only person in your company working on the dossier, it is probably most convenient to work with the desktop version on your own computer. Alternatively, you can use the server version, which means that several people in your company can access and work on the same IUCLID data at the same time.
The first thing to do in IUCLID is to create your substance dataset, which includes the administrative and scientific data for the substance you are registering. It is the basis for your registration and you need to include all the required information on the properties, use and exposure of the substance. You can edit the dataset at any time in the future, for example, if you find new information on your substance.
If you have included any information in your substance dataset that should not be published on ECHA’s website, you need to indicate this by using confidentiality flags. Each confidentiality claim needs to be strongly justified.
Before going any further, check the completeness of your substance dataset by running the Validation Assistant plug-in of IUCLID. It will show if your dataset is complete or whether you need to adjust it.
The Validation Assistant marks the fields you need to take a closer look at. To successfully submit your dossier to ECHA, you will need to correct all submission checks. Quality checks are there to help you improve the quality of your data. The future updates of IUCLID 6 will introduce more quality checks to help you create a high-quality dossier.
The file that you submit to ECHA to register your substance is called a dossier. A dossier is a read-only copy of your substance dataset, complemented with administrative information about the type of registration.
By right clicking on your substance dataset and choosing 'Create Dossier', you launch the dossier creation wizard that will guide you through the process.
While creating your registration dossier in IUCLID, pay attention to the following:
- Submission type: choose the correct submission type in the dossier creation wizard: are you registering a substance for standard uses (substance is used as such or in mixtures) and with standard information requirements? Does your registration cover a substance for intermediate uses (substance is used to make another substance) only? Are you a lead registrant or a member?
- Administrative information: you can claim information, such as your tonnage band or registration number, confidential.
- If you are eligible for a fee waiver for 1-10 tonne per year dossiers, you also need to indicate it here. This is the case if you voluntarily provide the standard information package for your substance although you would be able to register with a reduced set of information.
- Name your dossier: you should give a name to your dossier under additional administrative information. The name should enable you to easily identify the dossier in your own system. Do not use confidential information in the name, as it will be seen by anyone you share the dossier with.
After you have inserted all the information in your dossier, you can review it. Then open the Validation Assistant one more time and run it now on your dossier. Even if the Validation Assistant showed no failures when you ran it on the substance dataset, it is important that you run it also on the final dossier – you may have added some information during dossier creation that can result in a different completeness outcome.
Large parts of a registration dossier are made publicly available by law, but you can claim certain information confidential. With the dissemination preview plug-in you can see in advance what will be published based on the claims you have inserted in the dossier.
ECHA will check the confidentiality claims you have placed in the dossier. If your claim is rejected, you will be given an opportunity to improve your reasoning. If a claim is not adequately justified, the information will be published.
Once you are satisfied with the data in your IUCLID dossier, export it first to your computer before submitting it to ECHA using REACH-IT.