Creating a Poison Centre Notification Dossier
As you may be aware Article 45 Annex VIII of the CLP regulation includes a provision to submit Poison Centre Notifications and this applies only in the EU. EU companies that supply hazardous CLP goods must make a Notification and provide a UFI (Unique Formula Identifier) on Safety Data Sheets and labels.
GB adopted CLP and accidentally included the regulation on mandatory Poison Centre Notifications, but this regulation is going to be reversed. GB companies do not have to make a Notification (unless they are in NI in which case they do)
Companies selling into the EU have no legal responsibility under CLP because it does not apply to ‘outside the EU’, however, if you want to sell in the EU, you must provide sufficient information to the importer (i.e. the first link in the supply chain that is in the EU). Companies can give the Formulation to the EU Importer (not an ideal business practice) or alternatively make a voluntary Notification and pass on the UFI for the Importer to use.
Making a valid EU Notification from outside the EU is not possible, therefore, it is required for a company outside the EU to use an EU Legal Entity (OR Only Representative) to act on their behalf and submit any required dossier. Some Formpak Users based outside the EU use a third party to submit Formpak generated dossiers on their behalf.
Formpak Poison Centre Notification generation is an additional module and if you require further information on implementation, please contact us via the support email address support@formpak-software.com
PCN Initial set up
Importing a Legal Entity File to the Default TO.
Excluding non-hazardous accumulator Items with Property PCNEXCLUDECOMP.
Creating a Template Formulation to copy ‘standard’ PCN requirements.
For more information on initial set up please click here.
Generate a Dossier for a Formulation.
Navigate to ‘Add a New Cross Reference’.
Select a Company.
Select an Item.
Select Code Cross Reference Sequence (Automatic, or Manual if you wish to add your own code)
Add Cross Reference Name.
Add a UFI – Unique Formula Identifiers may be generated free-of-charge from the ECHA website
Save.
Navigate to ‘Generate a Poison Centre Notification for an Item’.
Select the Item.
Enter the same Company that was used in the Cross Reference.
Select the Cross Reference you added (and not a previous Cross Reference)
Do not change the TO or the Language (Default is the only TO with Legal Entity uploaded, and language is automatically selected)
Click Generate.
In just a few seconds the dossier should be generated.
By clicking the link, it may be saved and then submitted to the ECHA Portal or viewed in a third party application.
Once a dossier has been successfully submitted to the ECHA Portal it may not be re-submitted as an initial submission, however, it may be submitted with a different Cross Reference.
July 2024
