Check this article for guidance on how to prepare a SCIP dossier.
What is a SCIP Dossier?
A SCIP dossier is the so-called SCIP notification, which product manufacturers and other duty holders must prepare and submit to the SCIP database. It represents a compressed file containing information on SVHC in articles in a concentration higher than 0.1% w/w. The SCIP dossier’s format must be XML-based compatible with IUCLID and have the i6z extension.
Companies must be cautious when assembling their SCIP dossiers because SCIP dossiers cannot be modified and re-submitted once submitted. The dossier of an article as such is assembled from a dataset that includes the information related to the Candidate List substance present in the article. However, the SCIP dossier of a complex object incorporates one or several link components datasets of either an article as such or complex objects. It includes the information related to the Candidate List substance present in each of the complex object’s components.
Each document in the final SCIP dossier must have a numeric Universal Unique Identifier (UUID), which acts as an unequivocal identifier. In Addition, the dossier itself must be associated with a different UUID (a.k.a Snapshot UUID) each time it is created to be submitted to ECHA. All this is done to ensure the data’s referential integrity and preserve the correct relationship between the different documents in the final SCIP dossier.
What Type of Information Do do You Need to Prepare a SCIP Dossier?
To prepare a SCIP dossier, you need to have information that allows the identification of the article as such or in a complex object:
- Main article name
- Other names, such as brand, model and type allowing consumers to identify the concerned article unequivocally
- Primary article identifier assigned to the article
- Other article identifiers, such as EAN, GTIN, GPC, part number, etc.
- Article category
- Place of production or assembly in the EU
- Visual identification of the article, such as a photo
- Characteristics, such as height, width, density, colour, unit of measure, etc.
- Safe use information, such as instructions for use and disassembling manual.
You should also be able to provide data about the Candidate list substances present in the concerned article. For instance, you must know the Candidate list substance’s name, EC and CAS numbers, and concentration range in the article. Additionally, you are required to specify the material the article is made of and the mixture category from the EuPCS (European Product Categorisation System).
Lastly, the dossier must also include a dossier header and a manifest file (“manifest.xml”). The latter must contain a table of contents with all the data files and documents available in the dossier. The dossier header should contain administrative and technical information required to process correctly the information received by ECHA.
How to Prepare a SCIP Dossier in 8 Steps?
Preparing a SCIP dossier can be pretty challenging for both newbies and more experienced duty holders. For that reason, follow these steps to ensure your dossier is assembled correctly and is ready for submission.
#1. Start by collecting in one place all the information you need to include in the SCIP dossier.
#2. Create a table of content (TOC) to easily and logically organize the different documents in datasets. This will later allow you to re-use the individual datasets in different SCIP notifications if needed. Currently, the SCIP format supports a single TOC, including the main article as the starting point for creating a SCIP dossier.
#3. Create a dataset for the concerned article as such. If you have a complex object, built a dataset for each component/article of the complex object. A dataset represents a central core of information, which contains information for a specific article, its components and concern elements.
#4. Build a dossier header document containing administrative and technical information that will allow ECHA to correctly process the SCIP notification information.
#5. Create an XML manifest file containing a table of contents with all the data files and documents available in the dossier. For instance: dossier description, article description, reference substance description, other attachments, etc.
#6. Double-check if all the data is entered and stored in logical datasets and no unsupported data types have been used. Only the following data types are supported: text (text area, single-line and multi-line), picklist (single), check box, multi-select list, numeric, decimal, and attachment.
#7. When all the data has been prepared and encoded correctly, assemble all the documents (datasets, dossier header, manifest file) in a final compressed file.
#8. Name the dossier and submit it to ECHA.
Use a Software Solution to Manage Your SCIP Notification Duties
The software solution allows you to easily collect the information about your articles as such and complex objects from your suppliers and then prepare the mandatory SCIP dossier. It offers features such as workflow management, report creation, custom data collection forms’ creation, and more. In Addition, the supplier compliance solution can also fully integrate with the product compliance management system of Clever Compliance. For requesting a free demo or simply getting more information, send an email to [email protected].