- Creación de un expediente de registro
- Cómo crear un expediente de registro con la nube de IUCLID
Cómo crear un expediente de registro con la nube de IUCLID
If you are an SME or a consultant for an SME, you can take advantage of the IUCLID Cloud for SMEs to create your dossier in the IUCLID format.
To use the service, you will need an ECHA account and to subscribe to the IUCLID Cloud service. To do so:
- Go to ‘ECHA Cloud services’ web page. Here you will find a brief description of the services and a set of useful resources.
- Select ‘Access ECHA Cloud services’ from the right-hand side menu.
- Select ‘Login’ and enter your login username and password if you already have an account. If you do not have an account, create one by selecting ‘Register’ and then:
- enter some basic information to identify your account, and
- create your legal entity. The system will then send you a confirmation email, which you will need to verify.
- Subscribe to IUCLID Cloud by clicking subscribe to the service ‘IUCLID Cloud for SMEs’. You are asked to read and accept the terms and conditions for the service.
- After you have subscribed you can then select ‘Access service’, which will take you to the web interface of IUCLID Cloud.
These are the main steps to follow when creating your registration dossier in the IUCLID Cloud.
The first thing to do in 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 If you have included any information in your substance dataset that should not be published on ECHA’s website, you need to indicate this by using confidentiality flags.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 clicking on ‘Validate’ from your main substance view. This will show you if your dataset is complete or whether you need to adjust it.
The validation report 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. Future updates of IUCLID 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 information about the type of your registration.
To create your dossier, you need to fill out the dossier header information of your substance dataset and then select ‘Create dossier’.
When editing your dossier header information, pay attention to the following:
- Submission type: choose the correct submission type. 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 as confidential, such as your tonnage band or registration number.
- If you are eligible for a fee waiver for 1-10 tonne per year dossiers, you also need to indicate this information 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 ‘Dossier name’. The dossier 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 created your dossier from your substance dataset you should review it one more time. Even if the Validation Assistant showed no failures when you ran it on the substance dataset, it is important that you also validate your final dossier – you may have added some information during dossier creation that can result in a different completeness outcome.
Once you are satisfied with the data in your IUCLID dossier, select ‘Export’ from the top corner of the main dossier view to save your dossier onto your computer before submitting it to ECHA using REACH-IT.
You are now able to select which dossier you would like to submit directly in REACH-IT.