How to apply for EU CLP-PCN-UFI registration for chemical reagents?
Date：2026-06-25 09:50:14 Classification
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Chemical Reagent CLP-PCN-UFI Registration Process
Prerequisites
If the chemical reagent is a pure substance (single chemical), PCN-UFI registration is not required; only SDS and label compliance under CLP are necessary. PCN-UFI notification is only required when the chemical reagent is a mixture (e.g., reagent kits, chromogenic solutions, mixed standard solutions) and poses health or physical hazards to humans (e.g., flammability, corrosivity, irritation, sensitization).
I. Processing Procedure (5 steps)
Step 1: Determine if product registration is required
Confirm product classification (acute toxicity, corrosivity, irritation, sensitization, flammability, etc.)
Pure substances are not applicable; multi-component mixtures containing health/physical hazard components require registration.
Research reagents, industrial reagents, and chemical raw materials exported to or sold to the EU are included.
Step 2: Generate UFI code
Log in to the ECHA website → UFI Generator
Enter your company's VAT number (domestic companies should provide the VAT number from their EU agent).
Automatically generate a 16-digit unique identifier.
This UFI is unique throughout the EU and corresponds to a specific formulation.
Step 3: Prepare Notification Data
The following core information is required:
Product Identification: Name, UFI Code, Product Type
Ingredient Information: All ingredients (CAS number, EC number, concentration range)
Hazard Classification: GHS classification and labeling elements
Toxicological Information: Acute Toxicity Estimate (ATE), Sensitization Information
Packaging Information: Color, Shape, Volume
Use Category: Industrial/Professional/Consumer Use
Usually, using pre-prepared SDS (Safety Data Sheets) data directly can reduce redundant work.
Step 4: Submit via the ECHA Portal
Log in to the ECHA Submission Portal (PCN Submission Portal)
Select XML format file submission (generated using IUCLID or IT tools)
Or select manual online completion (suitable for simple products)
The system will generate a submission number as proof after submission.
Cost: Officially free, but consultation fees may apply for data preparation.
Step 5: Label with UFI + Continuous Compliance
Mark the UFI code prominently on the product label (usually along with the emergency contact number).
Specify the sales country when submitting (select each country separately).
Regulatory Transition Period: Fully enforced regulations for consumer products until January 2021, professional products until January 2021, and industrial products until January 2024.
II. Key Considerations
1. UFI tied to formulation: If the formulation changes (including concentration or component adjustments), a new UFI must be generated and reported.
2. Mixed product kits: If a kit contains multiple different formulations, a separate UFI must be applied for for each formulation.
3. EU Responsible Agent Person: Non-EU companies must submit through their EU representative or sole representative.
4. Data Confidentiality: Data submitted through PCN is for the exclusive use of the Poisoning Center and is protected by confidentiality agreements.
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