Complete EU CLP-PCN-UFI Registration Process
Date：2025-12-02 10:04:42 Classification
：【question】 Visits：
The EU CLP-PCN-UFI registration process is indeed a crucial step in product compliance, directly impacting whether hazardous mixtures can legally enter the EU market. The complete process mainly consists of three core stages: preliminary preparation, UFI generation and notification, and labeling and compliance management.
Phase 1: Preliminary Preparations (Compliance Foundation)
- Confirm Registration Entity
- EU Companies: Manufacturers and importers can register directly.
- Non-EU Companies: Must appoint an agent within the EU (such as an importer or third-party organization). The agent must possess an EU VAT number.
- Required Documents List
| Material Type | Specific Content
| Company Information | Name, Address, EU VAT Number (For non-EU companies, provided by the agent)
| Product Data | Complete formulation list (ingredient names, CAS numbers, concentration ranges), hazard classification report (physical/health hazards)
| Technical Documents | SDS (Safety Data Sheet) conforming to (EU) 2020/878 standard (including toxicology and first aid measures)
- Scope of Application and Exemptions
✅ Registration Required: Mixtures containing physical/health hazards (such as cleaning agents, paints, adhesives, etc.)
❌ Exemption: Non-hazardous mixtures, pharmaceuticals, food, radioactive materials, and other special products.
Phase 2: UFI Generation and PCN Notification (Core Operation)
1. UFI Code Generation
- Generation Methods
- Method 1 (Recommended): Generate using the official ECHA tool by entering the company's VAT number + any number (0-268435455).
- Method 2: Randomly generate if no VAT number is available (Example format: `~UFI:J200-U0CW-500U-XXXX~`).
- Note: UFI is linked to the product formulation; a new UFI must be generated if the formulation changes.
2. Poison Center Notification (PCN)
- Submission Platform: ECHA Unified Portal (PCN Portal) or member state systems (e.g., German BfR, French ANSES)
- Notification Content
- Basic Information: UFI code, product name, packaging specifications
- Technical Information: Ingredient concentration, hazard classification, first aid measures (must be consistent with SDS)
- Language Requirements: Use the official language of the country of sale (e.g., German for Germany, French for France)
- Processing Time
- Standard: 4-7 business days (including platform review)
- Expedited: Some institutions support 2-3 business days (additional fee applies)
Phase Three: Labeling and Compliance Management (Market Access)
- UFI Labelling Requirements
- Location: Product label or inner packaging (must be adjacent to other safety markings)
- Format: Clearly displayed in `~UFI:XXX~` (e.g., `~UFI:N1QV-R02N-J00M-WQD5~`)
- Durability: Must be indelible; font size is not mandatory but must be clearly visible.
- Subsequent Maintenance Obligations
- Information Updates: When the formulation, hazard classification, or company contact information changes, the PCN notification must be updated within 7 business days.
- SDS Synchronization: Ensure that the UFI in the Safety Data Sheet is consistent with the notification information.
- Record Retention: PCN submission documents must be retained for at least 10 years.
Key Considerations
1. Non-EU companies: Must submit through an EU agent; the agent is responsible for the accuracy of the notification information.
2. 3. **Trade Secret Protection:** Formulation concentration can provide a range (e.g., 10-30%), precise values are not required.
4. **Transitional Policy:** Products already on the market before January 1, 2025, must complete supplementary registration by the end of 2025.
5. **Member Country Differences:** Some countries, such as Germany and France, require additional language versions (e.g., German SDS).
**Process Summary (Simplified Version)**
1. Prepare SDS and company information → 2. Generate UFI through ECHA → 3. Submit PCN notification (including UFI and formulation) → 4. Label with UFI → 5. Regularly update information
**Core Value:** UFI acts as a product's "safety ID card," ensuring that toxicology centers can quickly locate risks in the event of an incident. It is a mandatory requirement for EU market access.
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