PCN & UFI for Laboratory Reagents & Chemicals

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 Reagents and Laboratory Chemicals

Reagents and laboratory chemicals are essential for various applications in chemical analysis and reactions. These products are manufactured with a high degree of purity to ensure their accuracy and effectiveness in scientific and industrial environments. Since these chemicals often pose potential hazards due to their composition and intended use, it is required by law to submit a Poison Centre Notification (PCN) to ensure that accurate safety information is available to poison centres in the event of emergencies.

What is a UFI?

The Unique Formula Identifier (UFI) is a unique alphanumeric code that links a specific chemical formulation to the Poison Centre Notification (PCN) for a product. This code is essential for reagents and laboratory chemicals because it allows poison centres to rapidly identify the exact chemical mixture involved in an emergency situation and provide accurate advice for treatment.

What is a PCN?

A Poison Centre Notification (PCN) is a legal requirement in the European Union for hazardous products, including reagents and laboratory chemicals. The PCN ensures that accurate and necessary safety data, such as hazard classifications and emergency treatment instructions, is provided to the relevant authorities. It is crucial that all hazardous chemicals, including reagents and laboratory chemicals, are registered with the Poison Centres to ensure public safety and regulatory compliance.

What is CLP?

The Classification, Labelling, and Packaging (CLP) regulation is a European Union framework that governs how hazardous chemicals should be classified, labelled, and packaged. For reagents and laboratory chemicals, CLP ensures that all necessary hazard symbols, signal words, precautionary statements, and the UFI are included on the product label to inform users of the risks and necessary safety measures. This regulation ensures that products are communicated clearly, mitigating potential hazards.

What is the Poison Centre?

The Poison Centre is a network of national poison centres across Europe that provide emergency advice and guidance in cases of chemical exposure. These centres rely on the data from PCNs to ensure they can provide accurate and timely advice in situations where exposure to reagents and laboratory chemicals occurs, especially in industrial or laboratory environments.

Why is This Needed?

Due to the hazardous nature of many reagents and laboratory chemicals, a Poison Centre Notification (PCN) is essential to ensure that poison centres have all the necessary information to act in case of an emergency. By registering hazardous chemicals, manufacturers and importers help ensure that immediate and correct actions can be taken to manage chemical exposure risks. This is critical in safeguarding human health and the environment.

Since When is This by Law Obligatory?

The legal obligation to submit a PCN for hazardous mixtures, including reagents and laboratory chemicals, became mandatory as of January 1, 2021, under Annex VIII of the CLP Regulation. All hazardous chemical products must now be registered with the Poison Centres before being placed on the market.

FAQ

Question: Do all reagents and laboratory chemicals require a PCN?

Answer: No, only those reagents and laboratory chemicals that are classified as hazardous under the CLP regulation require a PCN. If the chemical mixture is deemed hazardous, it must have a PCN to ensure regulatory compliance and safety.

Question: What information is needed to complete a PCN for reagents and laboratory chemicals?

Answer: To complete a PCN for reagents and laboratory chemicals, 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 in case of an emergency.

Question: Where should the UFI be displayed on the product?

Answer: The UFI must be clearly displayed on the product label, alongside the hazard and precautionary information, to ensure it is easily accessible for poison centre identification and in case of an emergency.

Question: Who is responsible for submitting the PCN for reagents and laboratory chemicals?

Answer: The manufacturer, importer, or distributor placing the reagent or laboratory chemical 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: Failure to submit a PCN for hazardous reagents and laboratory chemicals can result in fines, market restrictions, or removal of the product from the market. Compliance ensures that the product can be sold within the EU and guarantees safety during use.

Question: Are all reagents and laboratory chemicals subject to the CLP and PCN regulations?

Answer: No, only those reagents and laboratory chemicals that are classified as hazardous according to the CLP regulation need to comply with the PCN and labelling requirements. Non-hazardous products are generally not subject to these 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.