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 Leather Treatment Products
Leather treatment products are used in the upstream industrial processing of leather, including impregnation products that help protect and enhance leather. These products are crucial in leather manufacturing and processing, but some may contain hazardous chemicals that could pose risks to human health or the environment. A Poison Centre Notification (PCN) is necessary for these products to ensure that safety data is available in case of exposure or emergency. This helps poison centers to provide the necessary guidance during accidents or incidents involving leather treatment products.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that links the composition of a leather treatment product to its Poison Centre Notification (PCN). The UFI helps emergency responders identify the exact product in case of an incident or poisoning, ensuring they have the correct data to respond effectively.
What is a PCN?
A Poison Centre Notification (PCN) is a report submitted to the EU poison centers, providing essential information about a product’s chemical composition, hazard classification, and intended use. This information ensures that poison centers can respond appropriately in case of chemical exposure or accidents involving leather treatment products.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation ensures that hazardous chemicals, including leather treatment products, are classified according to their risks, properly labelled, and packaged with the correct hazard information. Leather treatment products must display hazard symbols, precautionary statements, and the UFI to comply with the CLP regulation.
What is the Poison Centre?
The Poison Centre is a network of national organizations in Europe that respond to chemical exposure and poisoning incidents. By submitting a PCN for leather treatment products, manufacturers provide critical data that helps poison centers offer accurate advice during emergencies, ensuring swift medical intervention and safety measures.
Why is This Needed?
Leather treatment products may contain chemicals that pose a risk to human health or the environment, especially if improperly handled or in case of accidental exposure. A PCN ensures that poison centers have immediate access to the necessary information to respond effectively and provide accurate medical guidance in case of an emergency.
Since When is This by Law Obligatory?
The obligation to submit a PCN for hazardous leather treatment products was introduced under Annex VIII of the CLP regulation, and it became mandatory as of January 1, 2021.
FAQ
Question: Do all leather treatment products require a PCN?
Answer: No, only leather treatment products that are classified as hazardous under the CLP regulation require a PCN submission.
Question: What type of leather treatment products are covered by the PCN requirement?
Answer: The PCN requirement applies to products used in the upstream industrial processing of leather, including impregnation products, but excludes dyes, pigments, and impregnation products for finished leather goods.
Question: What information is required for a PCN submission for leather treatment products?
Answer: The PCN submission requires information about the product’s chemical composition, classification, intended use, packaging, and the Unique Formula Identifier (UFI).
Question: Where should the UFI be displayed on leather treatment products?
Answer: The UFI must be printed on the product label, usually near hazard symbols and precautionary statements, to ensure it can be quickly referenced in emergencies.
Question: Who is responsible for submitting the PCN for leather treatment products?
Answer: The manufacturer, importer, or downstream user responsible for placing the leather treatment product on the EU market is responsible for submitting the PCN.
Question: What happens if a PCN is not submitted for leather treatment products?
Answer: Non-compliance with the PCN requirement can lead to fines, product recalls, or restrictions on the sale of the product within the EU market.
Question: Are dyes and pigments used in leather treated the same as leather treatment products?
Answer: No, dyes and pigments are considered separate and fall under the category of ‘Colourants,’ which has different regulatory requirements. Leather treatment products only refer to products used in the industrial processing of leather.
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.