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 Impregnation Products for Finished Textiles and Leather Goods
Impregnation products intended for waterproofing or repelling dirt on finished textiles and leather goods often contain specialized chemicals such as fluoropolymers or silicone-based agents. While these agents enhance the durability and protective qualities of garments, shoes, or bags, they can also present health hazards if ingested, inhaled, or improperly handled. Under EU regulations, any such product classified as hazardous must be registered via a Poison Centre Notification (PCN). This ensures that poison centers have swift access to detailed safety data, enabling accurate support and medical advice in emergencies.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character code that directly links a hazardous product to its specific chemical formulation. For impregnation products used on finished textiles and leather goods, the UFI must be printed on the product label, typically near hazard symbols or safety instructions. In an emergency, poison centers refer to this code to quickly and reliably identify the product’s composition.
What is a PCN?
A Poison Centre Notification (PCN) is a legally required submission for hazardous chemical mixtures marketed in the EU. By submitting a PCN for an impregnation product, manufacturers and distributors provide poison centers with essential information about the product’s composition, potential hazards, and recommended emergency measures. This mechanism ensures that healthcare professionals have reliable data in case of accidental exposures.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation harmonizes how chemicals are classified and labeled throughout the EU. Impregnation products deemed hazardous under the CLP framework must display relevant hazard symbols, precautionary statements, and the UFI on their labels. This labeling system helps users understand possible risks and adopt safe handling practices.
What is the Poison Centre?
The Poison Centre is a cooperative network of national institutions that offer guidance in chemical exposure events. Registering your impregnation product through a PCN ensures that, in an incident, poison centers can promptly access the product’s formulation data and provide accurate assistance to healthcare providers and consumers.
Why is This Needed?
Impregnation products for finished textiles and leather goods may contain substances that pose risks if misused—such as respiratory irritation from inhaled aerosols or skin and eye irritations from direct contact. Filing a PCN guarantees poison centers have detailed composition and safety instructions at their disposal, minimizing harm and promoting consumer protection.
Since When is This by Law Obligatory?
Since January 1, 2021, all hazardous chemical mixtures, including impregnation products for finished textiles and leather, must comply with the PCN requirement under the EU’s CLP regulation. This step enhances overall safety and uniformity across member states.
FAQ
Question: Are all impregnation products for textiles and leather goods subject to a PCN?
Answer: Only those classified as hazardous under the CLP regulation require a PCN. If the product is not classified as hazardous, it is exempt from this requirement.
Question: Where should the UFI be placed on an impregnation product?
Answer: The UFI must be visibly located on the product label, typically alongside hazard symbols and safety guidelines, so emergency responders can access it swiftly if needed.
Question: What information is typically included in a PCN for impregnation products?
Answer: A PCN contains the product’s chemical composition, hazard classification, usage instructions, first-aid measures, and packaging details, allowing poison centers to respond efficiently in emergencies.
Question: Are industrial impregnation products also covered here?
Answer: No, the products discussed here exclude those used in industrial processing. Industrial-use items fall under ‘Textile treatment products’ or ‘Leather treatment products.’
Question: What are the penalties for failing to submit a PCN for a hazardous product?
Answer: Non-compliance can result in legal penalties, fines, and restrictions on the product’s sale within the EU until the PCN requirements are fulfilled.
Question: Who is responsible for filing the PCN?
Answer: The manufacturer, importer, or distributor placing the hazardous product on the EU market typically assumes responsibility for the PCN submission.
Question: When did the PCN requirement become mandatory?
Answer: The obligation to submit a PCN for hazardous chemical mixtures, including impregnation products for finished textiles and leather, has been in force since January 1, 2021, in accordance with 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.
