A client recently asked us a question that comes up surprisingly often:
“Our product is manufactured in Turkey and exported to the EU. Do we need to submit a PCN in Turkey as well?”
At first glance, the answer might seem obvious. But in reality, many companies are working with mixed or outdated information about the Turkish requirements.
Before taking any action, it helps to clarify one simple question:
On which market are you placing your product?
Because depending on the answer, very different legal obligations may apply.
1. What is PCN and when does it apply?
PCN (Poison Centre Notification) is the system used in the European Economic Area (EEA) to provide poison centres with information about hazardous mixtures placed on the market.
This requirement is established under CLP Regulation (EC) No. 1272/2008 – Annex VIII.
The goal is straightforward: when a poisoning incident occurs, medical professionals must be able to quickly access reliable information about the mixture involved.
A typical PCN submission includes:
- Identification and classification of the mixture
- Product category and intended use (consumer, professional or industrial)
- Detailed compositional and toxicological information needed for emergency response
In the EU/EEA, these submissions are made through the ECHA Submission Portal, and each notified mixture must be linked to a UFI (Unique Formula Identifier) that appears on the product label or Safety Data Sheet.
2. What about Turkey?
Turkey regulates classification, labelling and packaging of chemicals under the SEA Regulation, which is largely aligned with the EU CLP framework.
In 2020, Turkey amended the SEA Regulation and introduced Article 44/A, which establishes a national obligation to provide certain information on hazardous mixtures to the Turkish Ministry of Health's National Poison Information Centre (UZEM).
The regulation states that manufacturers and importers placing relevant mixtures on the Turkish market must provide detailed information on composition and hazard properties for emergency health response purposes.
The provision entered into force on 1 January 2025.
In practical terms, this means Turkey now has a national legal basis for poison-centre type notifications, and companies placing hazardous mixtures on the Turkish market may have obligations to provide mixture information to the competent authority.
However, the Turkish system is separate from the EU PCN system managed by ECHA.
3. Turkey vs the EEA: where does the obligation sit?
To determine what you actually need to do, the key question is: Where is the product being placed on the market?
If the product is placed only on the Turkish market:
Companies must comply with Turkish national requirements under the SEA Regulation. EU PCN submissions through the ECHA portal are not required for products that are only placed on the Turkish market.
If the product is placed on the EEA market:
Then the EU PCN requirements apply, regardless of where the product is manufactured. In this case:
- The product must be notified through the ECHA PCN portal
- A UFI must be assigned
- The submission must meet Annex VIII requirements
The legal obligation lies with the EU-based company placing the mixture on the EEA market, typically the EU importer or an EU downstream user.
4. What this means in practice for Turkish manufacturers
If you manufacture mixtures in Turkey and export them to the EU, your EU customer will usually be the duty holder for the PCN submission. However, they will need information from you, such as:
- Detailed composition data
- Toxicological information
- Classification details
- Mixture identifiers used to generate the UFI
In other words, while the legal obligation sits with the EU importer, the technical information often comes from the manufacturer.
Key points to remember
- EU PCN and UFI requirements apply only to mixtures placed on the EEA market.
- Turkey regulates hazardous mixtures under the SEA Regulation and introduced poison-centre information requirements via Article 44/A.
- The EU PCN obligation sits with the EU-based importer or downstream user.
- Manufacturers outside the EU typically support the process by providing the necessary mixture information.
How we can help?
At BENS Consulting, we support regulatory teams with EU PCN submissions across all EEA jurisdictions, Annex VIII compliance checks, preparation and alignment of data with Safety Data Sheets, and clarification of regulatory obligations across multiple markets.
If you're unsure where your obligations apply or need support with PCN submissions, feel free to contact me at urska.poje@bens-consulting.eu.
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