Now that we’ve covered the benefits, challenges, and pitfalls of voluntary Poison Centre Notification (PCN), let’s break down the step-by-step process of how to submit one properly.
Step 1: Determine if a voluntary PCN is right for you
Before starting, confirm that a voluntary PCN is the right approach. Consider:
- Are you a non-EU manufacturer looking to support your EU customers?
- Do you want to protect your formula while providing compliance assistance?
- Are your importers capable of handling their own mandatory PCNs?
If the answer is yes, a voluntary PCN could be beneficial.
Step 2: Gather the necessary data
You will need the following:
- Product formulation details (full composition).
- Toxicological information to assess health risks.
- Classification and labeling details under CLP regulation.
- Product identifiers, including trade name and packaging specifications.
- Intended end uses of the product (consumer, professional, or industrial).
Step 3: Find a legal entity, based in EU/EEA or Northern Ireland, that will submit the voluntary PCN on your behalf (we can act as such legal entity on your behalf)
Step 4: Generate a Unique Formula Identifier (UFI)
A UFI is a 16-character alphanumeric code that links your product to its specific formulation. You can generate one using ECHA’s UFI generator tool by entering:
- Your company VAT number (or a designated legal entity's VAT number).
- A unique formulation number assigned to the product.
This step of generating UFIs will be usually done by the legal entity based in EU/EEA or Northern Ireland, that will submit the Voluntary PCN on your behalf.
Step 5: Create the PCN dossier
Use the ECHA Submission Portal (or a specialized chemical compliance app such as Chemius) to create a PCN dossier. The submission should include:
- The generated UFI.
- All required product details (from Step 2).
- A selection of EU countries where the notification is relevant.
- The legal entity submitting the notification (an EU-based partner may be needed).
Step 6: Submit the notification via the ECHA Portal
Once your PCN dossier is complete, submit it through the ECHA Submission Portal (This can be done though our Chemius application as well). You will receive confirmation of receipt, and the data will be available for Poison Centres.
Step 7: Inform importers and distributors
Since a voluntary PCN does not replace importers’ obligations, communicate clearly with your partners. Provide them with the UFI and notification details so they can handle their own compliance requirements.
Step 8: Maintain and update the PCN as needed
If your formulation changes, your importers change, or new markets are added, you may need to update your PCN. Keep track of regulatory changes and maintain compliance.
Final thoughts: Is submitting a voluntary PCN worth it?
A voluntary PCN can be an effective compliance tool, but only when done correctly. It requires careful coordination with importers, precise data management, and a clear understanding of its limitations.
In our next post, we’ll discuss EEA-wide PCN vs. country-specific PCN. I believe this will help you decide which approach best fits your needs.
Back to posts
