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 Polymer Preparations and Compounds
Polymer preparations and compounds are used in a variety of industries, including manufacturing plastics, coatings, adhesives, and sealants. These products may contain substances that could pose a potential risk to human health or the environment, making it essential for them to be properly regulated. As part of EU regulations, polymer preparations and compounds are required to undergo a Poison Centre Notification (PCN). This ensures that poison centers have access to critical safety data in case of exposure, making it easier to manage emergencies and safeguard public health.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that is used to link the composition of a product, such as a polymer preparation or compound, to its Poison Centre Notification. It must be included on the product label to allow quick identification in emergency situations, ensuring poison centers can provide accurate advice when needed.
What is a PCN?
A Poison Centre Notification (PCN) is a formal report submitted to the Poison Centres that contains detailed information about the chemical composition, classification, hazards, and intended use of a product. For polymer preparations and compounds, this includes the types of chemicals used, their hazards, and the safety measures necessary for proper handling. The submission of a PCN ensures that poison centers are equipped with the necessary data to assist in case of accidents or exposure.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation is a key part of the EU’s efforts to ensure that chemicals are properly classified and labeled. It provides guidelines on how hazardous substances, including polymer preparations and compounds, should be handled, labeled, and packaged. Products must be classified based on their potential risks and display appropriate warning symbols, precautionary statements, and the UFI as required under CLP regulations.
What is the Poison Centre?
The Poison Centre is a network of national poison control centers that are responsible for providing accurate, timely medical advice in cases of chemical exposure or poisoning. When manufacturers and importers submit a PCN, poison centers are given critical information, enabling them to respond quickly and effectively in emergency situations.
Why is This Needed?
Polymer preparations and compounds can contain hazardous chemicals that pose a risk to health or the environment, especially in the event of exposure. The submission of a PCN ensures that poison centers have the necessary information to respond appropriately in the case of an emergency, whether it be an accidental spill, ingestion, or contact. This regulatory requirement helps ensure public safety and allows effective emergency management.
Since When is This by Law Obligatory?
The obligation for submitting a Poison Centre Notification for hazardous mixtures, including polymer preparations and compounds, became mandatory on January 1, 2021. This requirement was introduced under Annex VIII of the CLP Regulation, aiming to improve safety and emergency responses across the EU.
FAQ
Question: Do all polymer preparations and compounds require a PCN?
Answer: No, only those classified as hazardous under the CLP regulation require a PCN submission. If a product contains hazardous chemicals, a PCN must be submitted to the Poison Centres.
Question: What information is needed for a PCN?
Answer: A PCN submission requires information such as the product’s chemical composition, hazard classification, intended use, and packaging. The UFI must also be included as part of the product’s labeling.
Question: Where should the UFI be displayed?
Answer: The UFI must be clearly displayed on the product label, typically near the hazard symbols and precautionary statements, to allow quick identification in emergencies.
Question: Who is responsible for submitting the PCN?
Answer: The manufacturer, importer, or downstream user placing the polymer preparation or compound on the EU market is responsible for submitting the PCN.
Question: What are the penalties for not complying with the PCN requirements?
Answer: Non-compliance with PCN regulations can result in fines, product recalls, or restrictions on the sale of the product within the EU market. It is important to ensure all hazardous products are properly notified to avoid these penalties.
Question: Are non-hazardous polymer preparations exempt from PCN requirements?
Answer: Yes, products that are not classified as hazardous under the CLP regulation do not require a PCN submission.
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.