EU CLP-PCN-UFI Registration Core Entity Requirements
Date：2026-01-08 10:12:39 Classification
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EU CLP-PCN-UFI registration is a mandatory compliance requirement under the EU's Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation) for hazardous mixtures. Its core function is to achieve product traceability and emergency response management by generating a Unique Formulation Identifier (UFI) and completing a Poison Center Notification (PCN). The following is a comprehensive guide to registration:
I. Scope of Application and Exemptions
(I) Products Requiring Registration
Mixtures that simultaneously meet the following three conditions require mandatory registration:
1. Product Type: Chemical mixtures, such as adhesives, cleaning agents, detergents, fuels, e-cigarette liquids, paints, garden chemicals, printer inks, etc.;
2. Hazard Properties: Classified as having physical or health hazards (e.g., flammability, corrosiveness, carcinogenicity, irritant, etc.);
3. Market Scope: Placed on the EU market (including consumer use, professional use, or industrial use).
(II) Exemptions
1. Mixtures not classified as hazardous do not require registration, but low concentrations of hazardous substances may still require labeling;
2. Pharmaceuticals, food, radioactive materials, and other special categories are exempt;
3. Products placed on the market before January 1, 2025, must complete supplementary registration by the end of 2025.
II. Requirements for Core Registration Entities
EU Companies: Manufacturers and importers can submit applications directly as the registration entity;
Non-EU Companies: Must entrust a third-party agency/importer with a VAT number within the EU to handle the registration. This satisfies regulatory requirements and protects trade secrets such as product formulas (a range of component concentrations can be provided upon submission; precise values are not required).
III. Complete Registration Process
Phase 1: Preliminary Preparation
1. Confirm Product Hazard Classification (must comply with the GHS classification standards of the CLP Regulation);
2. Prepare Documents:
Company Information: Name, Address, EU VAT Number (non-EU companies should provide the VAT number of their agent), Contact Information;
Product Information: Formulation ingredients and concentrations, hazard classification label, Safety Data Sheet (SDS), Packaging Specifications, Country of Placement and Instructions for Use;
Toxicological Data: Health hazard related test data for the mixture (consistent with the SDS).
Phase 2: Generating a UFI Code
A UFI is a 16-character alphanumeric combination, formatted as ~UFI:XXXX-XXXX-XXXX-XXXX~, and is globally unique.
1. Generation Methods:
Method 1 (Recommended): Generate a UFI by entering the EU company's VAT number plus any number within the range of 0-268435455 through the official ECHA platform or a third-party compliance platform.
Method 2: If no VAT number is available, generate a UFI online by entering random numbers within the range of 0-268435455.
2. Required Rules: Products with the same formula use the same UFI. Formula changes (adjustments to ingredients, concentrations, etc.) require the generation of a new UFI.
Phase 3: Submission of Poison Center Notification (PCN)
The UFI only becomes effective after PCN notification is completed following generation:
1. Submission Channel: Submit through the ECHA Unified Portal (PCN Portal) or a system designated by an EU member state;
2. Notification Content: UFI code, mixture hazard information, formulation details, packaging specifications, first aid measures, and company/agent contact information (must be completely consistent with the UFI in the SDS);
3. Language Requirements: Documents must be submitted in the official language of the country where the product is intended for sale.
Phase 4: Label Compliance and Subsequent Maintenance
1. Label Requirements: The UFI must be clearly printed/affixed to the product label and ensure it is indelible; for industrial bulk products (without packaging), the UFI must be indicated in Section 1.1 of the SDS;
2. Information Updates: If product formulation, hazard classification, company contact information, or other information changes, the PCN notification must be updated within 7 working days, and a new UFI (if the formulation has changed) must be generated simultaneously, along with updated labels and the SDS.
IV. Timeframe and Fee Reference
1. Registration Timeframe: The standard process takes 5-7 business days (including UFI generation + PCN notification and review); some agencies offer expedited services, which can be completed in 2-3 business days, requiring an additional expedited fee.
2. Fee Range: Fees vary depending on the complexity of the product formula and the type of agency service. The standard product registration fee is approximately 1,000 RMB, with expedited services incurring an additional 30%-50% charge.
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