Besides an automated data validation, ECHA does not perform any other checks on the dossiers submitted to the portal. However, ECHA’s IT tools allow you to validate your own information before you submit. The validation results appear in a validation report.
You can ensure that your notification will be accepted in the ECHA Submissions Portal by validating your dossier before you proceed with your submission.
Regardless of the support offered by ECHA’s automated validation tool, it will not replace the quality, accuracy, completeness and robustness of the information submitted which remains the responsibility of duty holders.
A third party can create an ECHA account to submit data to the SCIP database on behalf of a duty holder. A link between the third party and the duty holder accounts can be made using the foreign user functionality in ECHA Accounts: the agreement reached between both parties is based on intra-party arrangements.
A foreign user can perform actions on behalf of the company that grants him or her permission to use an account, through an appointment made by the company’s Legal Entity manager, from their own ECHA account. For more information, please consult Q&A 960. Practical details on how to set up a foreign user link can be found in the chapters “User roles” and “How to add a foreign user” of the ECHA Accounts manual.
A foreign user needs to pay special attention to changing to the duty holder account before a notification to the SCIP database is made.
Duty holders will remain responsible for the notifications submitted to the SCIP database: since a notification must be submitted using the duty holder account, a duty holder can verify at any time the list of notifications submitted to the SCIP database. Duty holders that establish a foreign user link give visibility to the content of their account based on the roles selected. In addition, duty holders can remove the foreign user link at any time.
If you wish to update your SCIP notification and you are using IUCLID 6 to prepare your notification, you need to:
1. Update the information included in your dataset. The primary article identifier (type and value) in the dossier needs to remain the same.
2. Validate the updated dataset.
3. Create a new IUCLID dossier.
4. Submit the dossier created in step 3 on the ECHA submission portal.
If you wish to update your SCIP notification and you are using the System-to-system service, you need to:
1. Update the information and create a new dossier (.i6z file). The primary article identifier (type and value) in the dossier needs to remain the same.
2. Validate the updated dossier.
3. Submit the dossier on the ECHA submission portal
The submission of this dossier via the ECHA Submissions portal will be considered automatically as an update if:
a. The submission is made using the same ECHA account; and
b. The same primary article identifier (type and value) is part of your dossier.
Note: The SCIP number remains the same in the case where the duty holder submits an updated dossier. For further details please see Q&A 1695.
Using IUCLID 6
1. Download the reference substance package available in the Candidate List package and save these files in your desktop.
- If you are importing the Candidate List package for the first time, we recommend to import a specific substance dataset or all together by using the latest version of the “individual reference substance datasets” compilation. Import the reference substance dataset in the same IUCLID version you are using as available in the candidate list package.
- If you have already imported reference substances from the previous SCIP Candidate List package you can use the “Delta package reference substance datasets” compilation to import the new and updated reference substances.
- Note: The updated reference substances will overwrite its previous version in your IUCLID instance.
2. Open your IUCLID instance and import the reference files (or drag and drop them). You will now be able to find a Candidate List substance when you need to report it in the concern element section of your dossier.
If you are using System-to-system make sure that you use the reference substance of the same IUCLID format version as the rest of the submission.
The ECHA submission portal will check the number of documents that each IUCLID dossier includes.
Each file created in a IUCLID dossier counts as one document. The files of a dossier can be a dataset of an article as such, a reference substance used to identify the substance, a dataset of a complex object (each layer created in the article hierarchy), a picture and a disassembling instructions file.
The number of documents can be counted by uncompressing the IUCLID i6z file. Each file contained in the IUCLID dossiers counts as one document. The files in a dossier can be: *.i6d files (representing a dataset of an article as such / complex object, a reference substance used to identify the Candidate List substance, the dossier, the attachment description file), picture and/or disassembling instructions files, XML schema files, the css file or the manifest.xml file. For more details please see the Developers' Guide to the IUCLID i6z Format.
In order to find out more about ECHA Account roles and how to add a role using your ECHA Account you can refer to the ECHA Accounts Manual, chapters 3.3 and 6.4 respectively.