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 Tattoo Inks
Tattoo inks, including permanent inks used for artistic or other purposes, are considered chemical products that can present certain health risks, particularly when improperly handled or used. Due to their potential hazards, it is required by law that manufacturers of tattoo inks submit a Poison Centre Notification (PCN) for each product sold in the European Union. The PCN provides critical information about the composition, classification, and safety measures of tattoo inks to help emergency responders and healthcare professionals deal with any exposure or incident involving these products.
What is a UFI?
The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that uniquely identifies a chemical product. For tattoo inks, the UFI helps ensure that first responders, healthcare providers, and poison control centers can quickly identify the specific product involved in an emergency. The UFI provides vital information on the ink’s chemical composition and the potential hazards associated with it, ensuring a fast and accurate response in case of exposure.
What is a PCN?
A Poison Centre Notification (PCN) is a detailed report that includes essential information about a chemical product, including its composition, hazard classification, and labeling details. For tattoo inks, submitting a PCN helps ensure that the European Poison Centres have up-to-date safety data. This allows emergency responders and medical professionals to effectively handle any incidents involving the product, such as skin irritation, allergic reactions, or accidental ingestion.
What is CLP?
The Classification, Labelling, and Packaging (CLP) regulation sets out the rules for classifying, labeling, and packaging chemicals within the European Union. CLP ensures that tattoo inks are properly labeled with hazard symbols, precautionary statements, and safety instructions. This helps to protect consumers and professionals by ensuring the safe use of these products, preventing misuse, and alerting users to the potential risks associated with tattoo inks.
What is the Poison Centre?
The Poison Centre is a network of national poison control centers across Europe that provide emergency support in cases of chemical exposure or poisoning. The Poison Centre plays a key role in ensuring that emergency responders have access to detailed information on the hazardous properties of products like tattoo inks. The data submitted in the PCN helps poison centers provide accurate and timely advice in the event of an accident involving tattoo inks.
Why is This Needed?
Tattoo inks, due to their chemical composition and potential for skin reactions, require a Poison Centre Notification to ensure the safety of consumers and professionals. The submission of a PCN allows for better preparation in case of emergencies, ensuring that emergency responders have immediate access to accurate safety information. This is vital for providing the correct treatment in cases of allergic reactions, skin irritation, or accidental exposure to the ink.
Since When is This by Law Obligatory?
As of January 1, 2021, the European Union has required that all hazardous chemicals, including tattoo inks, submit a Poison Centre Notification (PCN) in compliance with the CLP Regulation. This legal requirement helps to ensure that all products placed on the EU market are safe for use and that the necessary safety information is available to emergency responders in case of an emergency.
FAQ
Question: Do I need to submit a PCN for tattoo inks?
Answer: Yes, tattoo inks are classified as hazardous products, and it is mandatory to submit a PCN for each ink product you sell in the European Union. The PCN helps emergency responders access vital safety data in case of accidents or exposure.
Question: What information do I need to provide in the PCN for tattoo inks?
Answer: The PCN for tattoo inks should include the UFI, a list of chemical ingredients, hazard classification under CLP, label information, and safety instructions. This data ensures that emergency responders are informed about the product’s potential risks and how to manage exposure effectively.
Question: What happens if I don’t submit a PCN for tattoo inks?
Answer: Failing to submit a PCN can result in legal penalties, including fines and the removal of your product from the market. Additionally, without a PCN, emergency responders will not have access to important safety information in case of an emergency involving the product.
Question: How do I submit a PCN for tattoo inks?
Answer: To submit a PCN, you will need to provide the necessary information about your tattoo ink, including its chemical composition, UFI, CLP classification, and hazard labels. Our company offers comprehensive services to help you navigate the process and ensure that your products comply with EU regulations.
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.
