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:
| Belgium | (BE) | Spain | (ES) | Hungary | (HU) | Slovakia | (SK) |
| Bulgaria | (BG) | France | (FR) | Malta | (MT) | Finland | (FI) |
| Czechia | (CZ) | Croatia | (HR) | Netherlands | (NL) | Sweden | (SE) |
| Denmark | (DK) | Italy | (IT) | Austria | (AT) | Germany | (DE) |
| Cyprus | (CY) | Poland | (PL) | Iceland | (IS) | Estonia | (EE) |
| Latvia | (LV) | Portugal | (PT) | Liechtenstein | (LI) | Ireland | (IE) |
| Lithuania | (LT) | Romania | (RO) | Norway | (NO) | Greece | (EL) |
| Luxembourg | (LU) | Slovenia | (SI) | Switzerland* | (CH) |
*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 Pigments (Insoluble Colourants)
Pigments—insoluble colourants used to impart color to materials such as plastics, coatings, or printed goods—often contain chemical components that can pose health or environmental risks if mishandled. Under EU regulations, any pigments classified as hazardous require a Poison Centre Notification (PCN). This ensures poison centers have real-time access to the product’s specific chemical formulation, aiding swift and accurate response in case of accidental exposure or misuse.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code linking a hazardous product to its exact chemical formulation. For pigments deemed hazardous, the UFI must appear on the product label, typically near any hazard or safety warnings. Poison centers rely on this UFI during emergencies to identify the product’s composition and deliver precise medical guidance.
What is a PCN?
A Poison Centre Notification (PCN) is a legal requirement under EU law for hazardous chemical mixtures. By submitting a PCN for pigments, manufacturers and distributors provide poison centers with essential data about the product, including its composition, hazard classification, and recommended first-aid measures. This enables healthcare providers to quickly address incidents involving accidental exposure.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation ensures chemical hazards are uniformly identified and communicated across EU member states. Hazardous pigments must display hazard symbols, risk/precautionary statements, and the UFI on their labels. This labeling helps users recognize potential dangers and adhere to safe handling practices.
What is the Poison Centre?
The Poison Centre is a network of national poison centers dedicated to giving guidance and medical advice when chemical exposures occur. Registering hazardous pigments with a PCN allows poison centers to retrieve product data rapidly, improving the speed and effectiveness of emergency interventions.
Why is This Needed?
Although insoluble, pigments can contain substances that are hazardous if inhaled, ingested, or allowed contact with skin or eyes. A PCN ensures poison centers can reference the product’s detailed safety and composition data immediately, reducing health risks and reinforcing compliance with EU regulations.
Since When is This by Law Obligatory?
As of January 1, 2021, any hazardous chemical mixture, including pigments deemed hazardous, must be notified through a PCN under EU CLP regulations. This harmonized approach promotes consistent safety and rapid response throughout EU member states.
FAQ
Question: Do all pigments require a PCN?
Answer: Only pigments classified as hazardous under CLP regulations need a PCN. Non-hazardous pigments are exempt from this requirement.
Question: Where should the UFI be located on the product label?
Answer: The UFI is typically placed near hazard symbols or safety instructions on the label, ensuring quick identification in an emergency situation.
Question: What details does a PCN submission include for pigments?
Answer: A PCN must include the product’s chemical composition, hazard classification, packaging information, recommended first-aid measures, and usage instructions.
Question: Who is responsible for submitting the PCN?
Answer: The manufacturer, importer, or distributor placing the hazardous pigment on the EU market typically handles the PCN if the pigment meets the CLP criteria.
Question: What if I don’t submit a PCN for a hazardous pigment?
Answer: Non-compliance can lead to legal penalties, such as fines or product restrictions, until the PCN requirements are met. It also delays poison centers’ ability to respond accurately in emergencies.
Question: Since when do I need to include the UFI on hazardous pigment labels?
Answer: The requirement to display a UFI and register hazardous pigments under PCN has been in force since January 1, 2021, per 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.
