PCN & UFI for Colourants (Textiles & Leather)

How does the UFI creation and PCN notification service work?

After purchasing this service, you will receive access to the secure portal. This portal contains an overview of all steps. You fill in your product details and we will get to work.

Poison Center Notification & UFI

We will provide:

• Your product’s Unique Formula Identifier (UFI)
• A Poison Centre Notification (PCN) report
• Registration of your product with the relevant national Poison Centres via ECHA.

Countries for PCN registration

You can count the number of countries in which you want to register your product. This is the number of countries you need to purchase. You will be able to select the specific countries within the portal. If you plan to expand the sales of your products to new countries at a later date, then you can always order additional PCN country registrations.
The EU has 27 countries and the EEA has 30 (EU+Lichtenstein, Norway and Iceland) In the portal you can select these countries:

*For Switzerland we can create the PCN dossier, with all the needed information to make a submission in the Swiss portal. Contact us for more information.

CLP Label Information

We offer the option to purchase a CLP compliant product label, containing all mandatory information as required by the EU CLP Regulation. This will be provided as a PDF. This is not a design, but a summery of the required information. This will enable you to integrate the necessary information into your product label design. You can also order the CLP label creation separately. Already have a label? — We can do a CLP label compliance check of your label in accordance with current CLP requirements. We will provide detailed feedback and corrections to ensure your label meets all regulatory standards.

Poison Centre Notification for Colourants (End-Use Products for Textiles or Leather)

Colourants intended for end-use, such as dyes or pigments applied directly to textiles, leather, or similar materials, may contain chemical substances that can pose risks if accidentally ingested, inhaled, or handled improperly. Under EU regulations, any colourants classified as hazardous must undergo a Poison Centre Notification (PCN). This registration process ensures that poison centers have ready access to the product’s chemical composition, hazard details, and safety measures, facilitating swift and accurate responses to potential exposure incidents.

What is a UFI?

The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that ties a hazardous product to its exact chemical formulation. For end-use colourants, the UFI must be visibly placed on the product label, typically near hazard symbols or safety warnings. In an emergency, poison centers consult the UFI to identify the product’s composition and advise on appropriate medical interventions.

What is a PCN?

A Poison Centre Notification (PCN) is a mandatory submission for hazardous chemical mixtures sold within the EU. By submitting a PCN for colourants, manufacturers or distributors provide poison centers with critical data, including chemical makeup, hazard classification, recommended first aid, and usage guidelines. This information supports healthcare professionals in delivering prompt and informed assistance should an accidental exposure occur.

What is CLP?

The Classification, Labelling, and Packaging (CLP) regulation standardizes how chemicals are classified and labeled across EU member states. Colourants meeting the hazard classification must display relevant hazard symbols, risk statements, and the UFI on their labels. This labeling scheme helps end users recognize potential dangers and adopt safe handling practices.

What is the Poison Centre?

The Poison Centre is a network of national poison centers that provide emergency guidance and treatment recommendations for chemical exposure incidents. Registering hazardous colourants with the Poison Centre ensures these professionals can retrieve product details instantly, speeding up response times in emergencies and protecting public health.

Why is This Needed?

Even though colourants are designed to impart colour to textiles or leather, the chemicals involved can carry health hazards if users come into contact with them. By adhering to PCN requirements, companies guarantee that poison centers have direct access to composition and hazard data, enhancing consumer safety and facilitating compliance with EU regulations.

Since When is This by Law Obligatory?

Since January 1, 2021, all hazardous chemical mixtures—including end-use colourants—must be registered via a PCN according to the EU CLP regulation. This harmonized approach ensures consistent emergency responses and safety measures across EU member states.

FAQ

Question: Do all colourants require a PCN?

Answer: Only colourants classified as hazardous under CLP regulations need a PCN. If the product is not deemed hazardous, it is exempt from this requirement.

Question: Where do I place the UFI on the product label?

Answer: The UFI is generally printed near the hazard symbols or precautionary statements, making it easily visible to emergency responders.

Question: What is included in a PCN for colourants?

Answer: A PCN must detail the product’s chemical composition, hazard classification, packaging format, usage instructions, and recommended first-aid measures, enabling poison centers to respond efficiently.

Question: Are colourants for further formulation also covered here?

Answer: No, colourants used solely as raw materials (“F – Mixtures for further formulation”) fall under a different category and are not covered in this context.

Question: Who is responsible for filing the PCN?

Answer: Typically, the manufacturer, importer, or distributor placing the hazardous product on the EU market must file the PCN if it meets the CLP hazard criteria.

Question: What are the penalties for failing to submit a PCN?

Answer: Non-compliance can result in fines, product recalls, or legal actions that may prevent the product from being sold within the EU until requirements are met.

Question: When did the PCN requirement become mandatory for hazardous colourants?

Answer: The PCN requirement for hazardous chemical products took effect on January 1, 2021, under EU CLP regulations.

Question: How long does it take to submit the UFI and PCN notification?

It takes us a few days’ work. As soon as you upload the documentation, we will get started right away.

Question: Am I the owner of the PCN notification?

Yes, you are the owner of the PCN notification. You retain full ownership of the data you provided. The PCN notification will be accessible in your ECHA account.

Question: Is this service for one product or more?

The service is for one product.

Question: Why do I have to pay to create a UFI?

The service we offer is not just about providing a UFI. The UFI is a component within a much more extensive process. The core service we provide is the preparation and submission of your Poison Centre Notification (PCN) to national appointed bodies through ECHA portal, which is a mandatory requirement under the EU CLP Regulation for placing hazardous mixtures on the market. Generating a UFI is simplest part.  The PCN report, however, is complex. It demands detailed ingredient review—chemical classifications—formatted precisely for Poison Centre submission via ECHA.

Question: My company is not based in the EU, how can I submit a PCN?

We provide a solution for companies which are not based in the EU. You can find more information on the PCN & UFI for non-EU companies page.

Question: Can you provide Safety Data Sheets in full compliance with EU Regulation (REACH & CLP)?

Yes, we can create Safety Data Sheets (SDS)— also known as Material Safety Data Sheets (MSDS)— tailored to your product and compliant with the latest EU regulations. Whether you are manufacturing chemical mixtures, importing products into the EU, or distributing under a private label, a compliant SDS is legally required and essential for safe use throughout the supply chain. You will find more on the Safety Data Sheet (MSDS/SDS) Creation Service page.