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 Intermediates
Intermediates are substances manufactured and consumed within the chemical industry for further transformation into other substances. These substances play a critical role in industrial chemical processes but can pose health or environmental risks if misused or exposed improperly. A Poison Centre Notification (PCN) is required for intermediates that are hazardous under the Classification, Labelling, and Packaging (CLP) regulation to ensure poison centers have the necessary data for proper emergency response and safety measures.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that links the chemical composition of an intermediate substance to its Poison Centre Notification. The UFI must be included on the product label to allow easy identification of the product in case of emergency or accidental exposure.
What is a PCN?
A Poison Centre Notification (PCN) is a submission made to provide detailed product information, such as chemical composition, hazard classification, intended use, and safety precautions, to EU poison centers. This allows poison centers to respond appropriately to emergencies involving intermediates, ensuring that health professionals can provide correct medical treatment and advice when needed.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation ensures that hazardous chemicals, including intermediates, are correctly classified, labelled, and packaged. The CLP regulation also requires that products display hazard symbols, precautionary statements, and the UFI to improve safety and provide proper hazard communication for intermediates.
What is the Poison Centre?
The Poison Centre is a network of national organizations that manage chemical exposure and poisoning cases across Europe. These centers rely on accurate data from Poison Centre Notifications (PCNs) to give timely and effective advice during emergency situations involving hazardous products, including intermediates.
Why is This Needed?
Intermediates can be highly reactive or toxic and may pose significant risks to human health or the environment. Having a PCN ensures that poison centers have immediate access to critical safety information, enabling them to respond swiftly and effectively in the case of exposure or accidents involving intermediates.
Since When is This by Law Obligatory?
The obligation to submit a PCN for hazardous mixtures, including intermediates, was established under Annex VIII of the CLP regulation, and it became mandatory starting January 1, 2021.
FAQ
Question: Do all intermediates require a PCN?
Answer: No, only intermediates classified as hazardous under the CLP regulation require a PCN submission.
Question: What information is required for a PCN submission for intermediates?
Answer: The PCN submission for intermediates must include details such as chemical composition, hazard classification, intended use, packaging information, and the Unique Formula Identifier (UFI).
Question: Where should the UFI be displayed on intermediates?
Answer: The UFI must be printed on the product label, typically near the hazard and precautionary statements, to ensure it is readily available in case of emergency.
Question: Who is responsible for submitting the PCN for intermediates?
Answer: The manufacturer, importer, or downstream user placing the intermediate on the EU market is responsible for submitting the PCN.
Question: What are the consequences of not submitting a PCN?
Answer: Failure to submit a PCN for hazardous intermediates can result in legal consequences, such as fines, product recalls, or restrictions on the sale of the product in the EU.
Question: Are all chemicals used in chemical processing considered intermediates?
Answer: No, only substances that are manufactured for and consumed in chemical processing to be transformed into another substance qualify as intermediates under REACH Article 3(15).
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.
