EU CLP-PCN-UFI Registration Process and Timeline
Date：2025-11-10 10:28:53 Classification
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The specific procedures for EU CLP-PCN-UFI registration are crucial for chemical products entering the EU market. EU CLP-PCN-UFI registration is a core step in the compliance of hazardous mixtures, requiring the completion of two main steps: UFI code generation and Poison Center Notification (PCN).
I. Core Process of EU CLP-PCN-UFI Registration
1. Confirming Scope and Exemption Conditions
- Mandatory Registration:
Products are chemical mixtures (e.g., cleaning agents, adhesives, coatings, fuels, etc.);
Classified as physical/health hazards by the CLP Regulation (e.g., flammable, corrosive, carcinogenic, etc.);
Intended for placement on the EU market (including consumer, professional, or industrial use).
- Exemption Conditions:
❌ Mixtures not classified as hazardous (e.g., common water-based solutions);
❌ Pure substances (must comply with REACH Regulation, not CLP-PCN);
❌ Pharmaceutical/veterinary products (subject to other regulations).
2. Generate UFI Code (Unique Formulation Identifier)
- Coding Rules:
- 16-character alphanumeric combination, formatted as `UFI:XXXX-XXXX-XXXX-XXXX` (e.g., `UFI:J200-U0CW-500U-A1B2`);
- Generated based on the company's EU VAT number + internal product code, ensuring global uniqueness.
- Generation Methods:
1. Official Tool: UFI generator via the ECHA website (requires a VAT number, recommended for compliant companies);
2. Third-Party Platform: Online generation services provided by organizations such as Dezewei Testing (suitable for companies without a VAT number, generates randomly);
3. Note: The same UFI is used for the same formulation product. A new UFI must be generated for any formulation changes (component/concentration changes > 10%).
3. Prepare PCN Notification Materials
- Core Document Checklist:
| Material Type | Specific Requirements
| SDS (Safety Data Sheet) | Compliant with the latest revision of CLP (EU 2020/878), including UFI code, nanomaterial information, endocrine disruptors, etc.
| Product Formulation | Ingredient name (CAS number), concentration range, hazard classification (e.g., H225 flammable)
| Company Information | Name, address, and contact information of the EU representative (non-EU companies must designate an authorized EU representative)
| Label Sample | Must include UFI code, hazard pictogram, and precautionary instructions (e.g., "Keep away from heat")
4. Submit a Poisoning Center Notification (PCN)
- Notification Channels:
- Official Platform: Submit via ECHA's PCN Portal;
- National Systems: Some member states (e.g., Germany, France) have independent submission platforms, which must be completed in the local language.
- Notification Content:
Hazard information for the mixture (e.g., acute toxicity, first aid measures);
UFI code and corresponding product batch;
Company contact information (to ensure the toxicology center can contact you quickly in an emergency).
5. Review and Labeling Compliance
- Review Period: 5-7 business days (primarily automatic review by the official platform; quick approval is granted if information is complete);
- Labeling Requirements:
- UFI must be clearly marked on the product label or inner packaging (cannot be erased; recommended to be adjacent to the hazard label);
- Format Example: `UFI:J200-U0CW-500U-A1B2` (No font/color restrictions, but must be legible).
II. Registration Cycle and Key Timelines
| Process Stage | Time Consumption | Notes
| UFI Code Generation | 1 Business Day | Generated instantly by online tools; VAT number and formula consistency must be verified.
| Material Preparation (SDS, etc.) | 3-5 Business Days | SDS must be prepared by an EU-accredited body to ensure compliance with (EU) 2020/878 amendment requirements.
| PCN Notification Submission | 5-7 Business Days | Non-EU companies are advised to use an agency to submit the notification to avoid delays due to language barriers.
| Review and Label Update | 1-2 Business Days | No notification will be given if the review is successful; an email notification will be sent if the review is unsuccessful (e.g., missing information, incorrect UFI format).
| Total Cycle | 10-15 Days | Expedited service can be reduced to 5-7 days (an additional 30% fee applies, limited to third-party assistance).
III. Common Issues and Compliance Points
1. UFI and Formula Changes
- If the ingredient concentration change is ≤10% The hazard classification remains unchanged, and the original UFI can be used.
- If a new hazardous component is added or the concentration change is greater than 10%, a new UFI must be generated and re-notified.
2. Operation for Non-EU Companies
- An authorized representative (OR) must be designated to submit the PCN. The OR must be registered within the EU and bear legal responsibility.
- It is recommended to choose member states with high notification efficiency, such as Germany and France, as the reporting entity (average processing speed is 2-3 days faster).
3. Cost Reference
- UFI generation: 800-1000 RMB (third-party agent);
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