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 Uncategorised Chemical Products
Some chemical products do not fit into predefined categories but still require regulatory compliance if they contain hazardous substances. These uncategorised chemical products must be registered with the Poison Centre through a Poison Centre Notification (PCN). This ensures that in case of accidental exposure, poison centers and medical professionals have access to essential product information to provide appropriate treatment.
What is a UFI?
The Unique Formula Identifier (UFI) is a mandatory 16-character alphanumeric code that links a product’s composition to its poison centre notification. The UFI must be displayed on product labels and safety data sheets to enable quick identification in an emergency.
What is a PCN?
A Poison Centre Notification (PCN) is a submission to the Poison Centre containing detailed product information, including formulation, hazard classification, and safety instructions. This ensures that poison centers can assist effectively in case of incidents involving hazardous chemical mixtures.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation standardizes hazard communication across the EU. It requires manufacturers to classify their products, label them correctly, and ensure that all safety information is available to end-users and emergency responders.
What is the Poison Centre?
The Poison Centre is a regulatory body responsible for managing chemical exposure cases. By maintaining a database of hazardous products, it allows medical professionals to respond quickly and effectively to poisoning incidents.
Why is This Needed?
Even if a chemical product does not fall under a specific use category, it may still pose health risks. A PCN ensures that authorities and healthcare providers can access critical information about the product, improving safety and emergency response.
Since When is This by Law Obligatory?
As of January 1, 2021, all hazardous chemical mixtures sold in the EU must be registered under Annex VIII of the CLP regulation. This includes uncategorised chemical products if they contain hazardous substances.
FAQ
Question: How do I know if my chemical product needs a PCN?
Answer: If your product contains hazardous substances classified under CLP regulations, a PCN submission is mandatory, regardless of whether it fits into a specific category.
Question: What happens if my product does not have a UFI?
Answer: Without a UFI, emergency responders may not be able to identify your product in a poisoning case, which can lead to delays in treatment. Additionally, failure to include a UFI can result in regulatory penalties.
Question: How do I submit a PCN for an uncategorised chemical product?
Answer: PCN submissions must be made via the European Chemicals Agency (ECHA) portal. Our company provides a complete service, including UFI creation, CLP-compliant labeling, PCN report preparation, and product registration with the Poison Centre.
Question: Are there penalties for not registering my chemical product?
Answer: Yes, non-compliance can lead to fines, legal liabilities, and potential sales restrictions within the EU market.
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.
