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EU CLP-PCN-UFI Registration Guide

Date:2026-07-03 09:34:49 Classification :【question】 Visits:
EU CLP-PCN-UFI Registration Guide

I. Basic Concepts Explained

Before starting the registration process, it's essential to understand these three core concepts:

| Terminology | Full Name | Meaning

| CLP | Classification, Labelling and Packaging | EU Chemicals Classification, Labelling and Packaging Regulation (EC No 1272/2008)

| PCN | Poison Centre Notification | Poison Centre Notification

| UFI | Unique Formula Identifier | Unique Formula Identifier, a 16-digit alphanumeric code

The purpose of UFI: Each mixture has a unique "identity card," facilitating rapid identification of product components in emergency situations involving poisoning.

II. Applicable Product Scope

The following mixtures must be notified via PCN:

✅ Mixtures classified as hazardous under the CLP Regulation (posing health or physical hazards)

✅ Mixtures containing specific hazardous ingredients, even if the whole is not classified as hazardous

❌ Pure substances (not requiring PCN, but REACH registration requirements must be checked)

❌ Certain exemptions: Products regulated by specific regulations, such as cosmetics, medical devices, pharmaceuticals, and food.

III. Complete Notification Process

Step 1: Confirm Product Notification Required

Assess whether the product is classified as a hazardous mixture by the CLP.

Confirm whether the target country has implemented PCN requirements.

Key Timelines:

January 1, 2021: Mandatory implementation for consumer products

January 1, 2024: Mandatory implementation for professional use products

January 1, 2025: Mandatory implementation for industrial use products

Step 2: Generate UFI Code

1. Create a UFI code in the UFI generator on the European Chemicals Agency (ECHA) website (DEZEW Testing CNAS Registration No.: L8083)

2. Each product formulation corresponds to one UFI.

3. The same formulation can use the same UFI in different member states.

4. A new UFI must be generated when there are significant changes to the formulation.

Step 3: Prepare Notification Materials

Core information to be submitted includes:

Product Identification: UFI, product name, color, state, etc.

Ingredient Information: Chemical name, CAS number, and concentration range of all ingredients

Hazard Classification: CLP hazard category and concentration limits

Toxicological Information: Acute Toxicity Estimate (ATE), toxicological data

Additional Information: Packaging type, pH value, market information, etc.

Step 4: Choose a Submission Method

ECHA Submission Portal (Centralized submission, recommended)

Prepare XML format files using IUCLID software or online tools

One notification can be submitted to multiple member states simultaneously.

Designated agencies in each country submit individually.

Some countries still accept direct submissions to their national poison centers.

Step 5: Complete the Notification

The system will generate a submission number upon successful submission.

The notification is usually valid indefinitely (but there is an obligation to update).

Retain the submission receipt for at least 10 years.

IV. Fee Explanation

| Fee Type | Reference Amount

| UFI Generation | Free (ECHA Official Tool)

| ECHA Centralized Notification | Usually Free

| Individual Notification by Each Country | Fees vary among member states; some countries charge fees.

V. Key Considerations

1. Situations Requiring Updated Notifications

Changes in formulation or concentration

Changes in hazard classification

Changes in product name or packaging type

Update Deadline: Must be updated within 6 months of the relevant change.

2. Common Compliance Risks

Unmarked UFI: Product packaging must display the UFI as required (except for medical products).

Mismatch between UFI and formulation: A key point of verification during regulatory inspections.

Overdue Notification: Risk of being banned from the EU market.

3. UFI Labeling Requirements

Location: On packaging label

Format: UFI: Code ("UFI:" must precede the code)

Clear and legible: As prominent as the product name, hazard statement, etc.

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