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 E-liquids for Electronic Cigarettes
E-liquids for electronic cigarettes are ready-to-use mixtures designed for vaping. These products often contain hazardous components, such as nicotine, which can pose significant risks if ingested, inhaled in large quantities, or come into contact with the skin. A Poison Centre Notification (PCN) is required to ensure that emergency response teams can access detailed product information promptly in case of accidental exposure or misuse.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that links directly to a product’s specific formulation. For e-liquids, the UFI must be printed on the product label to help poison centers quickly identify the mixture in emergencies.
What is a PCN?
A Poison Centre Notification (PCN) is a submission that includes detailed information about a hazardous product, such as its chemical composition, packaging details, intended use, and hazard classification. This information ensures that poison centers can respond effectively during incidents involving e-liquids.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation governs the classification and labeling of chemical products in the EU. E-liquids must comply with CLP requirements, including displaying clear hazard symbols, precautionary statements, and the UFI on the label.
What is the Poison Centre?
The Poison Centre is a network of national organizations that provides medical advice and emergency support in cases of chemical exposure. By submitting a PCN, manufacturers and distributors enable these centers to access accurate product details quickly, enhancing public safety.
Why is This Needed?
E-liquids often contain substances such as nicotine, which are classified as hazardous under the CLP regulation. A PCN ensures that poison centers can provide precise advice and guidance to medical responders in case of accidental ingestion, misuse, or exposure.
Since When is This by Law Obligatory?
Submitting a PCN for hazardous mixtures, including e-liquids, became mandatory on January 1, 2021, for all products sold within the EU. This requirement ensures uniform safety and compliance across member states.
FAQ
Question: Do all e-liquids require a PCN?
Answer: Only e-liquids classified as hazardous under the CLP regulation, such as those containing nicotine, require a PCN. Non-hazardous products are exempt.
Question: Where should the UFI be displayed?
Answer: The UFI must be clearly printed on the product label, typically near the hazard symbols or precautionary statements.
Question: What information is included in the PCN?
Answer: The PCN includes details about the product’s chemical composition, hazard classification, intended use, and packaging specifications.
Question: Who is responsible for submitting the PCN?
Answer: The manufacturer, importer, or distributor of the e-liquid is responsible for submitting the PCN to the relevant poison center authorities.
Question: What are the penalties for not submitting a PCN?
Answer: Failure to comply with PCN requirements can result in fines, product recalls, or restrictions on market access within the EU.
Question: Why is a PCN important for e-liquids?
Answer: A PCN ensures that poison centers have the necessary information to assist medical responders in emergencies involving hazardous e-liquids, such as those containing nicotine.
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.
