If you're a company based in the United States (or other country outside EU) distributing products within the European Union (EU) through third parties, understanding and complying with the Poison Centre Notification (PCN) is essential.
Here's a whole breakdown of the PCN, its requirements, and the steps you'll need to take to ensure compliance.
What is the Poison Centre Notification (PCN)?
The Poison Centre Notification (PCN) is a requirement under the EU's Classification, Labeling, and Packaging (CLP) regulation.
It mandates that importers and downstream users placing hazardous mixtures on the EU and European Economic Area (EEA) markets must submit information about the composition and hazards of these mixtures to designated bodies in each member state, known as Poison Centres.
This notification process ensures that healthcare professionals have quick access to accurate information about the substances involved in case of an accident, facilitating more effective treatment for patients.
Is PCN mandatory for me?
The PCN is required for all mixtures classified as hazardous based on their health or physical effects.
If your products are classified as hazardous to the environment but not for health or physical effects, you do not need to submit a PCN. PCN is not needed for hazardous substances.
Key requirements for PCN
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Who is Obligated?
The PCN requirements apply to importers and downstream users who place hazardous mixtures on the EU/EEA market.
A non-EU/EEA-based supplier (such as your company) can only submit voluntary PCNs through a EU/EEA based legal entity (we can do that, since we are an EU-based legal entity).
In that case you get a voluntary UFI code, which you can give to your buyers in the EU/EEA and then they can do the PCN as duty holders (as importers of the mixture), referring to that UFI and must have their own UFI on the label – not the voluntary one.
This is only a means for you to protect the complete composition of the mixture. The voluntary UFI will not be legally valid if placed on the label, as your company is not a duty holder in the EU/EEA.
If you have no problem with disclosing the exact composition to your buyers, then the voluntary submission step is not needed.In that case you only disclose what the importer needs, and they submit the PCN and inform you of their UFI code, so you can already place it on the label/packaging.
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Information Required: The information required includes:
- Company Information
- Safety Data Sheet
- ECHA account
- Contact Person's Name in the Company
- Additional Product Code (»formulation number«)
- Product Use (industrial/professional/consumer)
- Product category from EuPCS
- Packaging types and nominal quantity in packaging
- Registration Countries
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Deadlines:
The PCN has been required for hazardous mixtures for consumer and professional use since January 1, 2021. For mixtures exclusively used for industrial purposes, the notification was required by January 1, 2024. If a mixture had already been notified according to existing national procedures, a transitional period until January 1, 2025, applied. More on why UFI and PCN matter even more after January 1st, 2025 here.
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How to Submit:
The PCN can be submitted via the ECHA submission portal. Some member states also use their national system. You can check it here.
Step-by-step process for US-based distributors
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Determine if your products require PCN:
Check if your mixtures are classified as hazardous based on their health or physical effects under the CLP Regulation. -
Identify your role and responsibilities:
As a non-EU manufacturer, you are not obligated to perform the Poison Centre Notification (PCN) under the CLP regulation. However, you may provide the necessary information to an EU-based importer to carry out the notification process. -
Gather necessary data:
Compile all required information about your product, including its composition, classification, labeling, and intended use. Ensure the accuracy of the data submitted. Work closely with your EU-based importers or downstream users to facilitate this process. -
Limited submission:
A limited submission permits the notifier to utilize compositional information from the Safety Data Sheet under exceptional circumstances. However, all other pertinent information must still be included within the notification. Limited submission can only be chosen in the case of industrial use only and a 24-hour emergency telephone contact must be available in this case. -
Appoint an EU-based entity (if needed):
If the non-EU entity wishes to keep the information confidential, they can assign an EU-based entity to perform a voluntary submission by generating a Unique Formula Identifier (UFI) through a commercial representative in EU. -
Commercial Representation:
A non-European Union (EU) entity is not obligated to perform the Poison Centre Notification (PCN) under the Classification, Labelling and Packaging (CLP) regulation.
However, they may provide the necessary information to an EU-based importer to carry out the notification process. If the non-EU entity wishes to keep the information confidential, they can assign an EU-based entity to perform a voluntary submission by generating a Unique Formula Identifier (UFI) by appointing a commercial representative in EU.
The importer can then submit the mandatory submission, referencing this UFI in relation to the compositional information.
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Prepare and Submit the PCN Dossier:
Your EU-based importer will prepare the PCN dossier using the gathered information. They will submit the dossier through the ECHA submission portal. -
Manage the UFI efficiently:
Generate a Unique Formula Identifier (UFI) & . -
Consider notification updates to take into account changes:
It's important to stay informed about any changes to the regulations and update notifications accordingly. -
Ensure SDS Compliance:
Verify Labels of mixtures and – where needed – Safety Data Sheets (SDS).
By following these steps, you can ensure that your company complies with the EU Poison Centre Notification requirements, contributing to product safety and regulatory compliance within the European market.
If you need help with submitting voluntary PCNs, our team can help your company as well. Just drop us an e-mail at info@bens-consulting.eu and we will get back to you as soon as possible.
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