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 Fuel Additives and Fuel Components
Fuel additives and fuel components are used to enhance or suppress certain properties in fuels, such as improving combustion efficiency, preventing corrosion, or reducing emissions. These additives are crucial for optimizing fuel performance, but they can also present risks to human health and the environment if mishandled or misused. In compliance with EU regulations, manufacturers and importers of fuel additives are required to submit a Poison Centre Notification (PCN) to ensure that poison centres have access to the necessary safety data for responding to potential exposure or emergencies.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that uniquely identifies the composition of a fuel additive or fuel component. The UFI helps poison centres quickly access the relevant safety data in case of an emergency. It must be displayed on the product label, ensuring that emergency responders can efficiently identify and respond to exposure incidents.
What is a PCN?
A Poison Centre Notification (PCN) is a mandatory submission of product data, including chemical composition, hazard classification, intended use, and packaging details, to the Poison Centres. The data helps poison centres provide immediate, accurate medical advice and emergency responses in case of exposure to hazardous chemicals, such as fuel additives and fuel components.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation ensures that all hazardous products are correctly classified based on their physical, health, and environmental hazards. Fuel additives and fuel components must adhere to CLP requirements, displaying hazard symbols, precautionary statements, and the UFI on their labels to inform users of the potential risks associated with their use.
What is the Poison Centre?
The Poison Centre is a network of national organizations responsible for managing incidents involving chemical exposure. By accessing the data provided through the PCN, poison centres can offer accurate guidance and medical assistance during emergencies, ensuring public safety in situations involving hazardous substances like fuel additives.
Why is This Needed?
Fuel additives and fuel components often contain hazardous chemicals that can cause serious health or environmental risks if misused or improperly handled. The PCN ensures that poison centres have timely access to crucial product information, allowing them to respond quickly and accurately to any exposure incidents. This helps protect public health and supports effective emergency response protocols.
Since When is This by Law Obligatory?
The requirement to submit a PCN for fuel additives and fuel components became mandatory on January 1, 2021, as part of Annex VIII of the CLP regulation. This obligation ensures that poison centres can access the necessary safety data for responding to potential chemical exposure or poisoning incidents.
FAQ
Question: Do all fuel additives need a PCN?
Answer: Yes, all fuel additives and fuel components that are classified as hazardous under the CLP regulation require a PCN submission.
Question: What information do I need to provide in a PCN submission for fuel additives?
Answer: A PCN submission for fuel additives must include the chemical composition, hazard classification, intended use, packaging details, and the UFI code for the product.
Question: Where should the UFI be displayed on fuel additives?
Answer: The UFI must be included on the product label, alongside hazard symbols and precautionary statements, or in the safety data sheet (SDS) accompanying the product.
Question: Who is responsible for submitting the PCN for fuel additives?
Answer: The manufacturer, importer, or downstream user placing the fuel additive or fuel component on the EU market is responsible for submitting the PCN.
Question: What are the consequences of failing to submit a PCN?
Answer: Failure to submit a PCN can lead to fines, product recalls, or restrictions on the sale of fuel additives within the EU market.
Question: Are heat transfer fluids subject to the same PCN requirements?
Answer: No, heat transfer fluids are excluded from the category of fuel additives and fuel components and are subject to separate regulatory requirements. Refer to the “Heat Transfer Fluids” category for more information.
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.