By Chiara Corino
Introduction
The mandatory information defined by Annex VIII of the CLP to be included in the notification of mixtures consists of:
Identification of the product and notifier
- The mixture’s UFI code
- Classification and labelling elements of the product
- Physical state, color, pH (if not available, the reason must be stated)
- Toxicological information (section 11 of the SDS)
- Product composition
- Packaging used
- Predominant use according to the EuPCS coding
- Final uses (industrial, professional, or consumer use)
- Destination markets
This information must be presented in the form of a dossier (PCN dossier) according to the required format (PCN Format).
The prepared dossier can then be submitted to ECHA via the online portal or a S2S software that interfaces with the ECHA portal.
Automated Submission of the Dossier and Information on Destination Countries
In addition to the almost completely automated creation of PCN dossiers, one of the most helpful features we offer is the ability to automatically submit notification dossiers to ECHA, without having to download the dossier from the program and upload it to the ECHA portal, thus avoiding the use of IUCLID.
For each product, the user can choose to:
- directly submit the notification dossier with a click on “Send Now”; or
- let the software send the submission, scheduling it with a desired delay after the dossier preparation and/or within a specific time slot.
The PCN module not only reduces the time needed for submission but also ensures that the documentation is transmitted correctly, without errors or omissions that could compromise the validity of the dossier. In fact, the module includes a dossier validation function based on the technical standards defined by ECHA: if required information is missing for the notification, it is flagged with a warning specifying the missing data, and the dossier will not be sent until the documentation is complete. This ensures that only final and correct dossiers are submitted from the module!
Once the dossier is transmitted, confirmation of its proper receipt from ECHA is required, which, if positive, will forward the dossier to the target markets included in the notification. For most EU Member States, validation and receipt by ECHA are sufficient for placing mixtures on the market. However, for Belgium, France, Italy, Germany, and Spain, in addition to validation by ECHA, receipt of the dossiers by the designated national bodies is also required.
With the epyPCN module, users can track the notifications sent for each target market, with special attention to those countries requiring confirmation of dossier, with just one click!
Upcoming Sessions
In the next and final article, we will take a look at the PCN dossier updates, which are always carried out automatically by the epyPCN module! Learn more about the module and how it can help you save time and avoid stress!
If you already have our module and want to deepen your knowledge of its use, have you spoken with one of our regulatory experts? They are ready to assist you with any questions you may have!
