ECHA Poison Centre Notification (PCN) Services

Ensure Compliance with EU Poison Centre Notification Requirements

If you manufacture, import or place hazardous mixtures on the European market, you may be required to submit a Poison Centre Notification (PCN) before your products can be legally sold.

The PCN obligation is established under Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008 and applies to certain hazardous mixtures intended for consumer, professional or industrial use. The objective is to provide poison centres across the European Union with the information necessary to respond quickly and effectively in the event of accidental exposure.

At Biorius, we help companies determine whether their products require a PCN and support the preparation and submission of compliant notifications through the European Chemicals Agency (ECHA) portal.

Understanding the CLP Regulation

The Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008 is the European legislation governing the classification of chemical substances and mixtures according to their hazards.

Under CLP, companies placing hazardous products on the EU market must:

Classify substances and mixtures according to their physical, health and environmental hazards
Label products with the appropriate hazard statements, precautionary statements and pictograms
Package products in accordance with applicable safety requirements
Communicate hazards throughout the supply chain through Safety Data Sheets (SDS) where required
Submit Poison Centre Notifications (PCN) for applicable hazardous mixtures

Compliance with CLP is essential for many products marketed under GPSR and sector specific legislation, including detergents, cleaning products, air fresheners, reed diffusers and other chemical mixtures.

What Is a Poison Centre Notification (PCN)?

A Poison Centre Notification is a harmonized submission of information on hazardous mixtures to poison centres across the European Union.

The notification includes detailed information about the product composition, hazards and intended use, allowing medical professionals to provide appropriate advice and treatment in case of accidental exposure.

The information is submitted through the ECHA Submission Portal and made available to poison centres in the relevant EU Member States.

What Information Is Required?

Preparing a compliant notification requires detailed product information, including:

Product identification details
Full mixture composition
Hazard classification under CLP
Toxicological information
Packaging details
pH of the mixture
Intended use category

Any changes to the formulation or information included in the notification may require an update to the PCN dossier.

How Biorius Can Help

Our regulatory experts support companies throughout the PCN process.

Does My Product Require a PCN?

A PCN may be required if your product:

Products commonly requiring a PCN include:

Products Generally Exempt

Products commonly requiring a PCN include:

Related Regulatory Requirements

A Poison Centre Notification (PCN) is often only one part of your regulatory obligations. Depending on your product type and intended market, additional requirements may apply, including Safety Data Sheet (SDS) obligations under REACH and CLP, compliance with the EU Detergents Regulation for detergents and cleaning products, and broader product safety requirements under the General Product Safety Regulation (GPSR). Biorius can help you navigate these related regulatory frameworks and ensure a coordinated compliance strategy across your products and markets.

Streamline Compliance Across Your Entire Product Portfolio with MyApps

Managing regulatory obligations for both cosmetic and non-cosmetic products can be challenging, but with MyApps, Biorius makes it simple.

MyApps is our exclusive, secure digital platform that allows you to oversee all regulatory projects in one place, whether they concern cosmetics, detergents, general consumer goods (GPSR), or safety data sheets (SDS). Designed to centralize and simplify your compliance journey, MyApps gives you full control and real-time visibility over your entire portfolio.

Frequently asked questions

What is the relationship between CLP and PCN?

PCN requirements are established under Annex VIII of the CLP Regulation. A PCN is therefore a compliance obligation arising from CLP for certain hazardous mixtures.

What is a UFI?

The Unique Formula Identifier (UFI) is a unique 16 character code linking a hazardous mixture to its Poison Centre Notification.

Who is responsible for submitting a PCN?

The obligation generally falls on the importer or EU based entity placing the hazardous mixture on the market.

Do all products require a PCN?

No. The requirement depends on the product classification, intended use and applicable regulatory exemptions.

What happens if a PCN is not submitted?

Non-compliance may result in enforcement actions by national authorities, including restrictions on placing products on the market, fines or product withdrawals.