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Article related to: REACH
REACH 2018: Create your registration dossier
The fifth step in preparing a successful REACH registration is to create your dossier in IUCLID. You need to structure the data you have on your substance so you are ready to submit it to ECHA.
Before you start working with IUCLID, it is important that you get familiar with how the registration information is structured and with the terminology used in the application. You can do this by trying out the tool with test data before creating a real dossier. You can also read the user manual: How to prepare registration and PPORD dossiers.
In addition, you should have all the data you need at hand. Advice on identifying your requirements and collecting data is available through step four of the REACH 2018 Roadmap: Assess hazards and risks of your substances.
What do I need?
If you are registering a substance that other companies are also registering, you need to work together with them and prepare a joint registration.
For a joint registration, two types of dossiers can be prepared:
- A lead registrant dossier, which includes the identity of the substance that has been agreed by all the registrants, the information on the properties of the substance and the company-specific information of the lead registrant; and
- Member dossiers, where all the other registrants include their company-specific information, like contact details, exact substance identification, the volumes produced or imported, and the uses made of the chemical by their customers.
To create the lead registrant dossier, you need to install the IUCLID software. Once you have completed your dossier, you need to export it and submit it to ECHA through REACH-IT.
If you are a member and are relying solely on the data provided by the lead registrant (you have nothing extra to add, nor do you dissent from anything included), you can prepare your IUCLID dossier either in IUCLID or directly in REACH-IT.
The main steps to follow
1. Download and install IUCLID
You can download IUCLID free-of- charge from https://iuclid6.echa.europa.eu/download. If you are the only person in your company working on the dossier, you will most likely find it convenient to work with the desktop version on your own computer. Alternatively, if you use the server version, several people in your company can access and work on the same IUCLID data at the same time.
2. Create your substance dataset
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. 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 is confidential and you do not want it published on ECHA’s website, you need to indicate this by using ‘confidentiality flags’. Each confidentiality claim needs to have a robust justification.
Before going any further, check the completeness of your substance dataset by running the Validation Assistant plug-in of IUCLID. You can do this easily by right-clicking on the substance dataset in the Navigation panel, and selecting ‘Validate’. It will show if your dataset is complete or whether you need to improve it. The Validation Assistant marks the fields you need to take a closer look at. To successfully submit your dossier to ECHA, you need to address the weaknesses identified.
3. Create your 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, together with administrative information about the type of registration. By right-clicking on your substance dataset and choosing ‘Create Dossier’, you will launch the dossier creation wizard, which will guide you through the process. In addition, by pressing F1 anywhere inside the application, the online help system will appear and point you to relevant support.
While creating your registration dossier in IUCLID, pay attention to the following:
- Submission type: are you registering a substance for standard uses (your substance is used as it is, or in mixtures) and with standard information requirements? Does your registration cover a substance for intermediate uses only (your substance is used to make another substance)? Are you a lead registrant or a member? Choose the correct submission type in the dossier creation wizard.
- Administrative information: in this step, you can claim information, such as your tonnage band or registration number, confidential. If you register below 10 tonnes per year, you may be eligible for a reduced fee. You need to indicate it here by claiming a fee waiver.
- Name your dossier: under additional administrative information, you should give a name to your dossier, which enables you to easily identify it in your own system. Do not use confidential information in the name, as it will be seen by anyone you share the dossier with.
4. Review your dossier
After you have inserted all the information in your dossier, you can review it. Then, open the Validation Assistant and run it on your dossier one more time. Even if the Validation Assistant showed no failures when you ran it on the substance dataset, it is essential that you also run it on the final dossier – you may have added some information during dossier creation that can result in a different completeness outcome.
5. Run the dissemination preview to see what will be published online
Most parts of a registration dossier are made publicly available. With the Dissemination preview plug-in, you can see in advance what will be published. In addition, ECHA will check any confidentiality claims you may 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.
6. Export and submit your dossier
Once you are satisfied with the data in your IUCLID dossier, export it and submit it to ECHA using REACH-IT.
Creating a dossier in REACH-IT
If you are a member registrant and you agree with all the information submitted by the lead on your behalf, you can fully prepare your registration in REACH-IT. In this case, you do not have to install IUCLID.
The REACH-IT dossier creation wizard will guide you through the process and fields that you need to complete. You will need to provide the following:
- Substance identity and composition
- Classification and labelling (if different from the lead)
- PBT (persistent, bioaccumulative and toxic) assessment summary
- Estimated substance quantities, sites, uses
- Guidance on the safe use of the chemical or a chemical safety report (CSR) (if you do not rely on the joint CSR submitted by the lead and submit your own)
- Basic administrative information about your company
Practical help and a hands-on webinar to show you how to prepare your dossier will be available at the beginning of October.
What is IUCLID?
Phase 5: Prepare your registration as a IUCLID dossier
REACH 2018 webinars
Assess hazard and risk
Get organised with your co-registrants
Reduced information requirements
IUCLID 6 is available, News item 29 April 2016
Multilingual explanations of terms
Text by Hanna-Kaisa Torkkeli, Annika Mälkiä
Top image: ECHA
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