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 Medical Devices for Cleaning or Disinfection
Products used for the cleaning, disinfection, or sterilisation of medical devices (excluding biocidal or cleaning products) must comply with EU regulations to ensure safety and proper handling in emergencies. A Poison Centre Notification (PCN) is required for these products to provide emergency responders with crucial information regarding their chemical composition and potential risks. By submitting a PCN, manufacturers ensure that healthcare professionals and emergency teams are prepared to respond effectively in case of accidental exposure to hazardous chemicals used in the disinfection or sterilisation process.
What is a UFI?
The Unique Formula Identifier (UFI) is a unique code assigned to a chemical mixture, such as those used in medical device cleaning or disinfection products. This code is part of the product label and helps emergency responders quickly identify the mixture’s chemical components. The UFI plays a critical role in ensuring that appropriate safety measures are taken in emergency situations.
What is a PCN?
A Poison Centre Notification (PCN) is a submission that contains detailed information about a product’s chemical composition, hazards, and emergency response procedures. For products used in the cleaning or disinfection of medical devices, the PCN includes information about the chemical ingredients and their classification under the CLP Regulation. This enables emergency responders to access important data for managing exposure risks quickly and effectively.
What is CLP?
The Classification, Labelling, and Packaging (CLP) Regulation governs the classification and labelling of hazardous chemicals. It ensures that products, including cleaning and disinfection solutions for medical devices, are appropriately labelled with hazard symbols, signal words, and precautionary statements. CLP is vital for informing users of the risks associated with these products and ensuring proper handling to avoid accidents and injuries.
What is the Poison Centre?
The Poison Centre is a network responsible for collecting and distributing information about hazardous substances used in products across Europe. By registering products with the Poison Centre, manufacturers ensure that accurate safety information is available to healthcare professionals and emergency responders in case of an accidental exposure or health incident involving medical device cleaning or disinfection products.
Why is This Needed?
The PCN for medical device cleaning or disinfection products is essential to ensure that emergency responders have all the necessary information in case of exposure to hazardous chemicals. These products may contain potentially harmful ingredients that require proper identification and emergency handling procedures. By submitting a PCN, manufacturers contribute to a safer environment for healthcare professionals and patients, ensuring rapid and accurate responses in case of accidents.
Since When is This by Law Obligatory?
As of January 1, 2021, the EU CLP Regulation Annex VIII requires all hazardous mixtures, including products for the cleaning, disinfection, or sterilisation of medical devices (excluding biocidal products), to submit a Poison Centre Notification (PCN). This regulation helps ensure that safety information about these chemicals is available to emergency responders, improving safety and response times across the EU.
FAQ
Question: Do I need to submit a PCN for my medical device cleaning or disinfection product?
Answer: Yes, if your product contains hazardous substances and is used for cleaning, disinfection, or sterilisation of medical devices, you are required to submit a PCN. This ensures that emergency responders have the necessary safety information in case of an exposure incident.
Question: What happens if I don’t submit a PCN for my product?
Answer: Failure to submit a PCN can result in legal penalties, including fines or removal of your product from the market. Additionally, emergency responders may not have the information they need to respond appropriately in case of exposure, potentially leading to more serious health risks.
Question: How do I submit a PCN for my medical device cleaning product?
Answer: To submit a PCN, you must provide detailed information about the product’s chemical composition, classification under the CLP Regulation, and emergency response measures. We offer services to help you prepare the UFI, product label, and PCN submission to ensure full compliance with EU 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.
