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.
Registering Industrial Formulations with the EU Poison Centre
Industrial formulations, referred to as ‘original mixtures,’ are chemical mixtures intended to be further formulated into other mixtures and not for direct end-use. These mixtures must be registered with the EU Poison Centre to ensure that emergency responders have access to crucial safety data in case of accidental exposure. The Poison Centre Notification (PCN) process ensures that the relevant hazard classifications and toxicological profiles are readily available for medical professionals and authorities.
What is a UFI?
A Unique Formula Identifier (UFI) is a 16-character alphanumeric code used to uniquely identify a chemical mixture. It must be printed on the product label and included in the Safety Data Sheet (SDS). The UFI allows poison centers to quickly retrieve safety and toxicological information about the mixture in case of an incident.
What is a PCN?
A Poison Centre Notification (PCN) is a regulatory submission that contains detailed safety and toxicological data about hazardous mixtures. The PCN includes information such as the mixture’s composition, classification, hazard warnings, and emergency response measures. It is mandatory for any hazardous mixture being placed on the EU market.
What is CLP?
CLP (Classification, Labelling, and Packaging) is an EU regulation (EC No 1272/2008) that ensures chemical products are classified and labeled according to their hazards. It aligns with the UN Globally Harmonized System (GHS) and ensures that all hazardous mixtures have appropriate warning labels and safety instructions.
What is the EU Poison Centre?
The EU Poison Centre is an official body that collects and stores safety information about hazardous mixtures. Healthcare professionals and emergency responders rely on the Poison Centre to provide accurate chemical safety data in case of accidental exposure or poisoning incidents.
Why is This Needed?
Industrial formulations often contain hazardous chemicals that require clear identification in emergency scenarios. By submitting a PCN, businesses ensure that poison centers and medical professionals have immediate access to relevant information, improving safety outcomes in the event of exposure.
Since When is It by Law Obligatory?
The legal requirement to submit a PCN for hazardous mixtures came into effect on January 1, 2021. For industrial formulations used exclusively in further processing, compliance has been mandatory since January 1, 2024.
FAQ
Question: What is a UFI, and why do I need it for my industrial formulation?
Answer: A UFI (Unique Formula Identifier) is a required code for hazardous mixtures that allows poison centers to identify the product in emergency cases. It is an essential component of the Poison Centre Notification (PCN) process.
Question: Do I need to submit a PCN for all industrial formulations?
Answer: Yes, if your formulation contains hazardous substances, it must be registered with the EU Poison Centre to comply with CLP regulations.
Question: What does CLP mean for my industrial formulation?
Answer: CLP ensures that all hazardous mixtures are correctly classified and labeled with hazard symbols and safety instructions, making it easier for users and emergency responders to handle chemicals safely.
Question: What is the EU Poison Centre, and why do I need to register my formulation?
Answer: The EU Poison Centre is a regulatory body that ensures emergency responders have immediate access to critical safety information about hazardous mixtures. Registration helps prevent incidents and ensures a swift response if exposure occurs.
Question: When did it become mandatory to submit a PCN for industrial formulations?
Answer: The requirement to submit a Poison Centre Notification (PCN) for industrial formulations became mandatory on January 1, 2024, ensuring improved safety compliance across the EU.
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.