EU UFI and PCN Registration Guide
Date：2026-06-11 10:21:08 Classification
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EU UFI and PCN Registration Guide
I. Basic Concepts
UFI (Unique Formula Identifier): A 16-character unique formula identifier, it serves as the "identity card" for hazardous mixtures and must be printed on the product label.
PCN (Poison Centre Notification): A mandatory obligation under Article 8 of the EU CLP Regulation (EC No 1272/2008) to notify member states' poison centers of product information, fully implemented from January 1, 2021.
II. Scope of Applicable Products
Products requiring PCN notification include:
1. Hazardous mixtures: Mixtures classified as hazardous to health or physically according to CLP regulations.
2. Biocidal products: Disinfectants, preservatives, insecticides, etc.
3. Plant protection products: Pesticides, fungicides, herbicides, etc.
Exempted products:
Pure substances (applicable only to substance notifications)
Mixtures hazardous only to the environment (in some cases)
Products regulated by specific regulations, such as cosmetics, medical devices, pharmaceuticals, food, and animal feed.
Pure chemicals for industrial use.
III. Preparatory Work Before Registration
1. Obtaining a UFI Code
Generate a UFI code using the European Chemicals Agency (ECHA) UFI generator.
Each product formulation corresponds to a unique UFI.
Multiple UFIs can be applied for in bulk under a company's name.
2. Prepare Product Information
Core information required includes:
Product Identification: Product name, UFI code, color, state, pH value, etc.
Ingredient Information: Chemical name, CAS number, EC number, and concentration range of all components (including non-hazardous components).
Hazard Classification: CLP classification label information.
Toxicological Information: Acute toxicity data for the mixture as a whole and its components.
Usage Information: Application category, usage scenario, packaging type and size.
Company Information: Detailed contact information for importers/downstream users.
3. Prepare Safety Data Sheet (SDS)
Provide an SDS that complies with REACH regulations.
IV. Detailed Registration Process
Step 1: Determine Notifying Member States
Determine the countries to be notified based on the EU member states where the product is placed. Each member state needs to notify individually, but can submit a unified notification through ECHA.
Step 2: Create an ECHA Account
Register a corporate account on the ECHA website (echa.europa.eu)
Obtain S2S (System to System) or online submission permissions
Step 3: Prepare the IUCLID Dataset
Download and install the IUCLID software
Create a PCN notification dataset
Complete the notification according to the OECD harmonized template format
Step 4: Submit the Notification
Two submission methods:
Method 1: Submit via the ECHA Submission Portal (Recommended)
Log in to the ECHA Submission Portal
Select "Poison Centre Notification"
Upload the IUCLID file
One submission can notify multiple member states.
Method 2: Submit directly through the member state's national system
Germany: BfR Database
France: ANSES
Belgium: Antigifcentrum/Centre Antipoisons
Requirements vary by country
Step 5: Payment
ECHA unified submission: Free
Some member country systems may charge fees
Step 6: Obtain Notification Confirmation
Receive ECHA confirmation email
UFI can be officially used on the product
V. Key Time Limits
| Situation | Notification Deadline
| General Consumer Goods | Complete before market launch
| Industrial Use Products | Complete before market launch
| Product Formula Change | Update within 45 days of the change
| New Ingredient Addition | Update notification immediately
VI. Application Method Options
1. Self-processing by the company
Advantages: Low cost, access to core data
Challenges: Requires specialized regulatory knowledge, time-consuming
Suitable for: Companies with few product lines and large scale
2. Engaging a professional service agency
Advantages: Professional team, efficient and accurate
Challenges: Service fees required
Suitable for: Companies with complex product lines and urgent market entry needs
Services include: Formula review, UFI generation, IUCLID submission, and follow-up.
3. Engage a local EU legal entity/OR (Only Representative)
Non-EU companies must designate an OR
The OR can handle all notification work on their behalf
VII. Precautions
1. Formula Confidentiality: Ingredient information is protected by confidentiality, but must be disclosed to the Poison Center in emergency situations.
2. Multilingual Requirements: The product label should include an emergency contact number next to the UFI (Universal Information File).
3. Data Updates: Changes in ingredients, concentrations, suppliers, etc., must be promptly updated in the notification.
4. Transitional Period Regulations: Products already on the market must complete their first notification before January 1, 2021.
5. Penalty Risks: Failure to notify as required may result in product removal from shelves, fines, etc. The amount of fines varies by member state (usually several thousand to tens of thousands of euros).
VIII. Fee Reference
ECHA System Submission: Free
Third-Party Service Fee: Depending on the complexity of the product, typically RMB 500-2000 per product.
IUCLID Software: Free to use.
Annual Maintenance Fee: Additional fees may apply if notification updates are required.
IX. Suggested Procedures
1. 1. Compliance Diagnosis: Assess whether the product requires PCN notification.
2. Data Compilation: Organize product formulation and classification information.
3. UFI Planning: Assign UFI to each product formulation.
4. Choosing a Processing Method: Select to process the notification yourself or through a third party, depending on the company's situation.
5. Notification Submission: Submit through ECHA or member country systems.
6. Label Update: Print the UFI on the product label (near the "Emergency Contact Number" label).
7. Continuous Compliance: Establish a product change tracking mechanism and update notifications promptly.
For further information on specific national requirements or special regulations for certain product categories, please consult us. It is recommended to initiate the registration process 6 months before product launch to ensure sufficient time to address various situations.
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