Poison Centre Notifications (PCN) remain highly relevant, especially for chemicals manufactured outside the EU. If a PCN has not been submitted and a UFI code is not assigned (and shown on the label), the chemical cannot be imported into the EU.
That’s why we continue to receive many questions about PCN and UFI. Recently, a supplier asked about PCN requirements in several countries, including Bosnia and Herzegovina and North Macedonia.
Although the client assumed that PCN notification is not required in North Macedonia, they had no doubts about Bosnia and Herzegovina—they were convinced it is required. But is that actually the case?
Let’s review: A PCN notification is a process in which a manufacturer or importer of hazardous mixtures into the EU submits specific information about these mixtures to the European Poison Centre. The obligation applies to mixtures classified as hazardous to human health (H3XX) or that present physical hazards (H2XX).
This obligation must be fulfilled by manufacturers or importers placing hazardous mixtures on the market in the European Economic Area (European Union, Norway, Iceland, and Liechtenstein).
Therefore, a PCN notification is not required for chemicals marketed outside the EU/EEA. This applies to North Macedonia and Bosnia and Herzegovina, as well as Serbia and Montenegro.
The UFI code (Unique Formula Identifier) is a 16-character code printed on the label of hazardous mixtures marketed in the EU/EEA. This code links the product to the information provided in the PCN notification.
Displaying this code on products placed on the markets of North Macedonia, Bosnia and Herzegovina, and other countries outside the EU/EEA is not mandatory. But it's also not wrong. You may leave it on the label if you’ve already submitted a PCN in the EU.
However, we can’t say that companies outside the EU/EEA have no obligations regarding PCN. They must support their customers in the EU/EEA by providing the necessary data to complete the PCN notification.
There is another option for manufacturers outside the EU/EEA: Voluntary PCN notification. This is submitted by a company that is not legally required to submit a PCN (a non-EU/EEA company) to assist its customers in meeting their obligations.
A voluntary submission does not fulfill the importers’ legal obligation in the EU/EEA—they must still submit their own PCN. But this method helps manufacturers protect their formulation secrets, which is crucial for many.
To conclude: If you are placing hazardous mixtures on the market in Bosnia and Herzegovina or North Macedonia, a PCN notification is not required. In fact, it’s not even possible, as it's not covered by local chemical regulations.
Still, keep in mind: these countries are EU candidates, which means they must align their laws with EU regulations. Therefore, we can expect that PCN and UFI requirements will be introduced in the future. Full implementation will likely come with EU membership.
If you are a manufacturer of hazardous mixtures from Serbia, Montenegro, or Albania, a PCN notification is required for mixtures sold in the EU. But if your target market is Bosnia and Herzegovina, PCN is not among the obligations. In that case, you need to register the chemicals in the Chemical Inventory.
The same applies to EU manufacturers placing hazardous mixtures on the markets of Bosnia and Herzegovina, North Macedonia, Serbia, Montenegro, and other non-EU/EEA countries. A PCN is not required, but national procedures in those countries must be followed.
If you have other questions about PCN notifications, visit our blog. We’ve already covered many topics. And if we’ve missed something, email me at nina.pajovic@bens-consulting.eu. We’ll surely find the right answer.
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