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 Processing Aids
Processing aids are essential substances used across various industries for modifying or controlling the characteristics of materials during their processing. These include substances like pH-regulators, flocculants, precipitants, neutralisation agents, catalysts, emulsifiers, solubilisers, and dispersing agents. For these types of products, it is crucial to submit a Poison Centre Notification (PCN) to comply with EU regulations. This ensures that poison centers have access to accurate safety data in case of emergencies or accidental exposure to these chemicals.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that links the chemical composition of a product to its Poison Centre Notification (PCN). For processing aids, the UFI must be included on the product label so that poison centers can easily identify the product and provide precise guidance in case of an emergency.
What is a PCN?
A Poison Centre Notification (PCN) is a submission that provides essential safety and hazard information about a product, including its chemical composition and intended use. For processing aids, the PCN ensures that poison centers have all the relevant data to respond efficiently to incidents involving exposure to hazardous substances used during the industrial processing of materials.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation ensures that all hazardous chemicals are appropriately classified, labelled, and packaged to inform users about potential dangers. For processing aids, the CLP regulation mandates that the product label must include hazard symbols, precautionary statements, and the UFI to communicate the risks associated with the product and provide necessary safety information.
What is the Poison Centre?
The Poison Centre is a network of national organizations that provide expert advice and guidance on how to deal with chemical exposure incidents. Poison centres rely on the data provided in PCNs to quickly access the necessary safety information about hazardous substances, such as processing aids, and give accurate recommendations for medical treatment or emergency responses.
Why is This Needed?
Processing aids are used across various industries, and many of these substances may be hazardous to human health or the environment. A PCN submission ensures that poison centers have all the information they need to handle emergencies and mitigate risks associated with the exposure to these chemicals. It helps prevent accidents and ensures that proper emergency protocols are followed in case of chemical exposure.
Since When is This by Law Obligatory?
The obligation to submit a PCN for hazardous mixtures, including processing aids, became legally mandatory on January 1, 2021, under Annex VIII of the CLP Regulation. Compliance with this requirement is crucial for ensuring that the safety of workers, consumers, and the environment is maintained.
FAQ
Question: Do all processing aids require a PCN?
Answer: No, only processing aids that are classified as hazardous under the CLP regulation require a PCN. If the product contains hazardous chemicals, it must have a PCN to comply with EU regulations.
Question: What information is needed to complete a PCN for processing aids?
Answer: To complete a PCN for processing aids, you must provide information on the product’s chemical composition, hazard classification, intended use, and packaging. The UFI must also be included on the product label for identification during emergencies.
Question: Where should the UFI be displayed?
Answer: The UFI must be displayed on the product label, along with the hazard and precautionary information, to ensure it is readily accessible during emergencies and for poison center identification.
Question: Who is responsible for submitting the PCN for processing aids?
Answer: The manufacturer, importer, or downstream user placing the processing aid on the EU market is responsible for submitting the PCN to the Poison Centres.
Question: What are the consequences of non-compliance with PCN requirements?
Answer: Non-compliance with the PCN regulations can lead to fines, product recalls, or restrictions on the sale of the product within the EU. Submitting a PCN ensures that your product complies with legal requirements and remains available on the market.
Question: Are all types of processing aids subject to PCN submission?
Answer: No, only those processing aids that are classified as hazardous under the CLP regulation require a PCN. Non-hazardous processing aids are generally not subject to the same requirements.
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.