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 and Mixtures for Electronic Cigarettes
E-liquids and mixtures for electronic cigarettes often contain chemical components, including nicotine and flavorings, which can pose risks if misused or accidentally ingested. A Poison Centre Notification (PCN) is essential to ensure that poison centers across the EU have immediate access to detailed information about these products. This enables effective medical assistance in the event of accidental exposure, especially since these products are commonly used by consumers.
What is a UFI?
The Unique Formula Identifier (UFI) is a mandatory alphanumeric code linked to the product’s exact chemical formulation. For e-liquids and mixtures for electronic cigarettes, the UFI must be displayed on the product label, allowing poison centers to identify the product quickly during emergencies.
What is a PCN?
A Poison Centre Notification (PCN) is a detailed submission containing all relevant information about a hazardous chemical product, including its ingredients, hazard classification, and intended use. For e-liquids, the PCN ensures that poison centers can respond effectively to accidental exposure, ingestion, or misuse.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation ensures that chemical products are appropriately classified and labeled according to their hazards. E-liquids, particularly those containing nicotine, often fall under hazardous classification and must comply with CLP requirements, including clear hazard labeling, precautionary statements, and the UFI.
What is the Poison Centre?
The Poison Centre is a network of national organizations that provide emergency medical advice and support in cases of chemical exposure. By submitting a PCN, manufacturers and distributors enable these centers to access accurate product information swiftly, enhancing public safety.
Why is This Needed?
E-liquids for electronic cigarettes often contain nicotine and other substances that can be hazardous if swallowed, inhaled in large quantities, or come into contact with the skin. A PCN ensures poison centers can provide accurate and timely advice in emergencies, protecting users and ensuring compliance with EU safety standards.
Since When is This by Law Obligatory?
The requirement to submit a PCN for hazardous mixtures, including e-liquids, became obligatory as of January 1, 2021. This regulation applies to all products classified as hazardous under the CLP regulation and sold within the EU.
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 on e-liquids?
Answer: The UFI must be printed on the product label, typically near hazard symbols or precautionary statements, ensuring easy identification in case of emergencies.
Question: What information is included in the PCN?
Answer: The PCN submission includes the product’s chemical composition, intended use, hazard classification, packaging details, and safety instructions.
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 consequences of not submitting a required PCN?
Answer: Non-compliance can lead to fines, product recalls, or market restrictions. Products cannot be sold within the EU until they meet regulatory requirements.
Question: Why is a PCN important for e-liquids?
Answer: E-liquids often contain hazardous substances like nicotine. A PCN ensures that poison centers have all the necessary information to guide medical responders in case of accidental ingestion or exposure.
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.
