PCN & UFI for Soluble Colourants

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:

*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 Dyes (Soluble Colourants)

Dyes (soluble colourants) are chemical substances used to impart color to products such as textiles, leather, paper, or various other materials. While they may appear benign, many dyes contain components that can be hazardous if improperly handled. Under EU regulations, any dye classified as hazardous requires a Poison Centre Notification (PCN). By filing a PCN, manufacturers and distributors ensure that poison centers have quick access to the product’s chemical composition, hazard classification, and first-aid measures. This information enables prompt and effective treatment in case of accidental exposure.

What is a UFI?

The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that ties a hazardous product to its exact formulation. For soluble dyes, the UFI must be clearly visible on the product label, often near any hazard or warning statements. Poison centers rely on this code to immediately identify the product’s composition in an emergency, guiding accurate medical assistance.

What is a PCN?

A Poison Centre Notification (PCN) is a mandatory submission for hazardous chemical mixtures marketed in the EU. By submitting a PCN for dyes, manufacturers and distributors provide poison centers with essential product data, including the dye’s composition, usage instructions, hazard classification, and packaging details. This ensures healthcare professionals can respond efficiently in accidental exposure incidents.

What is CLP?

The Classification, Labelling, and Packaging (CLP) regulation is an EU framework that standardizes the classification and labeling of chemicals. If a dye meets certain hazard criteria, it must display specific hazard symbols, precautionary statements, and the UFI on its label. This labeling scheme helps users recognize potential risks and adopt safe handling practices.

What is the Poison Centre?

The Poison Centre is a network of national poison centers offering immediate guidance in chemical exposure emergencies. By registering hazardous dyes with a PCN, companies ensure that poison centers can quickly retrieve the product’s composition and hazard data, enabling accurate medical advice should an incident occur.

Why is This Needed?

Even though dyes are primarily intended to add color, many soluble colourants contain substances that could harm humans or the environment if not managed correctly. Submitting a PCN ensures that poison centers are equipped with thorough safety information, reducing the risk of severe outcomes from accidental ingestion, inhalation, or skin/eye contact.

Since When is This by Law Obligatory?

Since January 1, 2021, EU regulations mandate that all hazardous chemical mixtures, including certain dyes, must be registered through a Poison Centre Notification. This requirement ensures uniform safety standards and efficient emergency protocols throughout EU member states.

FAQ

Question: Do all dyes require a PCN?

Answer: Only dyes classified as hazardous under the CLP regulation require a PCN. Products that are not deemed hazardous do not need registration.

Question: Where is the UFI placed on the product label?

Answer: The UFI is typically displayed near hazard symbols or safety instructions, making it easy for emergency responders to identify the product’s exact formulation.

Question: What does a PCN submission include for dyes?

Answer: A PCN must contain the dye’s chemical composition, hazard classification, packaging details, recommended first-aid measures, and usage guidelines to aid poison centers in exposure incidents.

Question: Who is responsible for submitting the PCN?

Answer: Typically, the manufacturer, importer, or distributor placing the hazardous dye on the EU market must submit the PCN if it meets the CLP criteria.

Question: What are the risks if a dye is not properly registered?

Answer: Non-compliance can result in legal penalties, fines, or restrictions on selling the dye in the EU until the PCN requirements are satisfied. It also delays emergency response in accidental exposure scenarios.

Question: What happens after a PCN is submitted?

Answer: Once the PCN is filed, the dye’s safety data is stored in poison center databases. In emergencies, healthcare professionals can swiftly access this information and provide correct treatment or advice.

Question: When did the PCN requirement start for hazardous dyes?

Answer: The obligation began on January 1, 2021, aligning with EU CLP regulations for hazardous chemical mixtures.

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.