EU CLP-PCN-UFI registration application and poison center notification
Date：2025-09-11 10:25:40 Classification
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The UFI is the Unique Formula Identifier for a mixture, a unique alphanumeric code used to link submitted formulation information to a specific mixture. The complete process and key points for EU CLP-PCN-UFI registration applications and poison center notifications are compiled based on the latest regulatory requirements and authoritative sources:
I. Applicable Products and Obligated Parties
1. Products Subject to Mandatory Notification:
- Hazardous Mixtures: Chemical mixtures that present physical hazards (e.g., flammability, corrosiveness) or health hazards (e.g., carcinogenicity, sensitization), including cleaning agents, adhesives, paints, e-cigarette liquids, industrial solvents, etc.
- End-of-Use Classification:
- Consumer/Professional Use: Mandatory notification effective January 1, 2021;
- Industrial Use: Transition period ends January 1, 2024, with full compliance effective January 1, 2025.
- Specialty Products: Biocides and plant protection products are required to be notified; cosmetics, pharmaceuticals, and radioactive substances are exempt.
2. Responsible Parties:
- Within the EU: Importers and downstream users (configurators) bear the primary notification obligation. Distributors also need to notify if they modify packaging or expand markets.
- Non-EU companies: They may entrust an EU-recognized body (such as an OR) to submit on their behalf to protect formula confidentiality.
II. Core Process Detailed Explanation
Step 1: Determine Obligations and Prepare Information
- Product Self-Inspection: Confirm whether the mixture is classified as a physical/health hazard (refer to Section 2 of the SDS).
- Materials Collection:
- Company Information (Name, Address, EU VAT Number);
- Product Information (Name, Application, Packaging Size, Target Country);
- Formulation Information (100% Ingredients, Concentration, Toxicological Data).
Step 2: Generate UFI Code
- UFI Format: 16-digit alphanumeric string (e.g., `UFI:VDU1-414F-1003-XXXX`).
- Creation Method:
- VAT-paying companies: Enter your VAT number + formulation number (between 0 and 268435455);
- Non-VAT-paying companies: Create a randomly generated number.
- Online Tool: Generate through the ECHA website or a third-party platform (such as CIRS).
Step 3: Submit a Poison Center Notification (PCN)
- Notification Platform: ECHA Poison Center Notification Portal (PCN Portal).
- Dossier Requirements:
- Use the IUCLID format and include the UFI, ingredient hazard data, and first aid measures.
- Must be in the official language of the target market (e.g., German for Germany).
- Turnaround Time: 5-7 working days (expedited processing can be reduced to 4 days).
Step 4: Label Updates and Compliance Maintenance
- Label Printing: The UFI must be clear and indelible, and positioned close to other hazard symbols.
- Dynamic Updates:
- When the formula changes or the SVHC list is updated, the UFI must be regenerated and notified;
- Check the ECHA official website annually to avoid omissions.
III. Key Considerations
1. Information Confidentiality Policy:
- Non-EU companies can conceal the formula through "Voluntary Notification" and only provide the UFI to importers.
2. Consistency with SDS:
- SDSs must comply with the new regulation (EU) 2020/878 and include information on UFIs, nanomaterials, and other materials. Products not updated after 2023 will be banned from EU import.
3. Exemptions and Special Scenarios:
- Industrial bulk products can indicate the UFI in the SDS without labeling;
- Items containing mixtures (such as ink cartridges) require notification, but the items themselves (such as batteries) do not.
IV. FAQs
- Q: Does the UFI require official certification?
→ No, companies can generate it independently, and it will take effect upon successful notification.
- Q: How should mixed-use products be handled?
→ Execute by the earliest deadline (if industrial applications are included, completion must be before 2025).
- Q: What happens if the notification fails?
→ This is often due to incomplete ingredient data, requiring additional toxicology testing (e.g., acute toxicity LD50).
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