Our EU Poison Centre Notification (PCN) and UFI Code Services
PCN Notification – EU Poison Centre Notification Service
PCN & UFI notification
A Fast and Sustainable Solution with Doruksistem & DorukWell
UFI, EuPCS, IUCLID dossier and PCN notification for safe access to the EU market: complete and fast, from a single point of contact.
At Doruksistem, we manage end to end, on behalf of both manufacturers and importers, the Poison Centre Notification (PCN) processes that are mandatory for placing hazardous mixtures on the EU/EEA market.
For manufacturers in Türkiye, we offer a full PCN solution through our company DorukWell GmbH (Germany), using the EU-established “authorised notifier / third-party representative” model.
Why Are Poison Centre Notifications (PCN) Important?
Stay Compliant with EU Legislation
PCN notifications are not just a safety procedure; they are a legal requirement for hazardous mixtures in the EU.
These notifications are clearly defined under the CLP Regulation (EC) No 1272/2008 and the REACH Regulation (EC) No 1907/2006 to ensure that your products meet the European Union’s public health and product safety standards.
CLP Regulation (EC) No 1272/2008
The CLP Regulation requires hazardous chemical mixtures to be correctly classified, labelled and packaged.
Member States are responsible for collecting the information received from manufacturers and importers and passing it on to poison centres.
CLP Annex VIII harmonised the notification process across all EU countries and introduced a standard notification format for PCN.
As a result, a single, common notification structure now applies across the EU.
Since 1 January 2025, all mixtures must be notified in the harmonised PCN format, typically via the ECHA PCN portal.
REACH Regulation (EC) No 1907/2006
Under REACH, manufacturers and importers must ensure that Safety Data Sheets (SDS) include emergency information and poison centre contact details.
Emergency contact details must be clearly stated in SDS Section 1.4.
Conclusion: Compliance, Safety and Sustainability Together
For both manufacturers exporting to the EU and importers, PCN notification is a critical step that ensures:
Full regulatory compliance of products,
Accurate and fast information sharing in health emergencies,
EU-wide standardisation of label and SDS information,
Smooth progress in inspections and market surveillance.
As Doruksistem and Germany-based DorukWell GmbH, we manage all these processes on your behalf accurately, quickly and cost-effectively.
What Is PCN and Who Must Submit It?
A Poison Centre Notification (PCN) is a notification made mandatory by the EU under Article 45 and Annex VIII of the CLP Regulation. It is submitted to provide EU poison centres with information on mixtures classified as hazardous on the basis of their health or physical effects, for use in emergency health response.
Parties legally responsible for PCN (duty holders):
- The importer placing the mixture on the EU market
- The downstream user (formulator / re-brander) formulating the mixture in the EU or placing it on the market under its own brand
A third-party submitter established in the EU may also submit the notification on behalf of the duty holders; however, legal responsibility remains with the importer or downstream user. Manufacturers outside the EU, such as in Türkiye, are not PCN duty holders. To help their EU importers fulfil their obligations while protecting formula confidentiality, DorukWell manages the notification process on behalf of the manufacturer and importer through its legal presence in the EU.
Which Mixtures Are Covered by PCN?
PCN is mandatory where the mixture:
- Has a health hazard classification
- Has a physical hazard classification (flammability, oxidising properties, etc.)
- Is placed on the EU/EEA market
- Is intended for consumer, professional or industrial use
The EuPCS product category is assigned (e.g. PC-CLN, PC-TEC, PC-ADM, PC-INK).
Specific exemptions apply to certain mixtures that are classified for environmental hazards only.
Doruksistem carries out this assessment for you.
PCN Requirements for Non-EU Legal Entities: What You Need to Know
Non-EU suppliers placing hazardous mixtures on the EU market may choose to make a voluntary PCN submission. Even though the non-EU supplier has no legal obligation to notify under Article 45, this allows it to provide EU importers and authorities with the necessary information while protecting its confidential business information.
When Should a Voluntary Poison Centre Notification (PCN) Be Considered?
Regulation (EC) No 1272/2008 requires importers and downstream users operating in the EU and EEA to make a Poison Centre Notification (PCN) for mixtures classified for health or physical hazards. This obligation is a condition for placing the mixture on the market and must be fulfilled by the duty holder.
When an importer established in the EU sources mixtures classified as hazardous under the regulation from a non-EU supplier and places them on the EU market, it has an obligation to make a Poison Centre Notification (PCN) for that mixture in its Member State. Under this obligation, the importer may ask you for the full formulation and composition of the mixture.
In this case, the following process can be followed:
The voluntary notification process is an optional mechanism available to non-EU suppliers. It offers non-EU suppliers the following advantages:
- Formulation confidentiality: protecting the confidential formulation information of the mixture.
- Protection of composition: avoiding direct disclosure of the full composition of the substances.
In the voluntary notification process:
- An EU-based legal entity makes a voluntary PCN submission on behalf of the non-EU supplier.
- The voluntary notification contains all the required composition information, as in a normal PCN dossier.
- Each voluntary notification receives its own Unique Formula Identifier (UFI) code.
- Importers and downstream users in the EU refer to this UFI code in their own mandatory PCN notifications, which allows them to fulfil their obligations without access to the full formulation.
Who Can Make a Voluntary PCN Notification?
Only a legal entity established in the EU/EEA can legally make a voluntary submission on behalf of a non-EU supplier.
UFI and Labelling – A Key Element of PCN
The UFI (Unique Formula Identifier) is the unique identification code of a mixture.
It must appear on the label and in SDS Section 1.1.
In this process, Doruksistem:
Generates the UFI code
Places it correctly on the label
Develops a UFI strategy for private-label products
Checks that the label meets the language requirements of the EU countries concerned
What Is PCN? What Is UFI? Why Was 1 January 2025 Important for PCN?
For answers to these questions and more, we recommend watching the video we prepared on PCN notification and UFI (in Turkish).
DorukWell by Your Side
“Through the cooperation of DorukWell GmbH (Cologne, Germany) and Doruksistem A.Ş., we provide end-to-end compliance solutions under all EU REACH, CLP, PCN, SCIP, cosmetics, biocides and detergents legislation. We support Turkish exporters with safe, sustainable and cost-effective growth in the European market.”
How Do Our PCN Notification Processes Work?
In this process, our EU-established legal entity DorukWell enables applications to be made in line with regulatory requirements, and we carefully follow all the necessary steps on your behalf.
Step 1: Obtaining Product Information The process starts with obtaining from you the product information needed for the notification. This information is the basis for preparing a correct and complete PCN dossier.
Step 2: Creating the Unique Formula Identifier (UFI) Based on the information provided, a unique formula identifier (UFI) is created for each product. The UFI identifies your product in the PCN notification process and protects formulation confidentiality.
Step 3: Preparing the Dossier and Ensuring Format Compliance Based on the information collected and the UFI, your dossier is brought into line with the PCN portal format and its compliance is ensured. At this stage, we make sure the dossier is complete, correct and compliant with the regulations.
Step 4: Submitting the Dossier and Obtaining the Notification Number The prepared dossier is submitted to the PCN portal and the PCN submission number is obtained. This number shows that the official notification for the product has been completed.
Step 5: Updates and Information Where necessary, voluntary PCN notifications are updated, and you are kept informed at every stage of the process. This keeps your notifications up to date and compliant with the regulations.
Aim: All these steps are designed to ease your obligations and run a well-organised, clear and efficient process together with you.
Mandatory PCN for Legal Entities in the EU: What Can We Do for You?
It should be remembered that all importers and downstream users who are duty holders under the CLP Regulation must make the mandatory PCN notification.
Every organisation placing a mixture on the European Union market is directly responsible for making the Poison Centre Notification (PCN) in each EU Member State where the mixture is placed on the market.
DorukWell follows all these processes in each Member State and supports you in achieving full compliance.