Poison Centre Notification (PCN)
The Poison Centre Notification (PCN) is a system mandated under the EU's CLP (Classification, Labelling, and Packaging - Regulation (EC) No 1272/2008) Regulation. It requires hazardous chemical mixtures (based on physicochemical and/or health hazards) to be notified to relevant appointed bodies (usually national poison centres) before being placed on the market. This notification ensures that healthcare professionals have quick access to accurate information, enabling effective emergency responses.
What is PCN and Why is it Necessary?
The PCN involves submitting specific information about a hazardous mixture, including its composition, hazard classification, toxicological details, packaging specifications, and usage information. By providing this harmonised information via the ECHA portal to appointed bodies, it significantly aids healthcare responders in determining the appropriate treatment methods during poisoning incidents or accidental chemical exposures. The PCN system plays a critical role in protecting public health and enhancing chemical safety across the EU.
Who is Responsible for PCN Notification?
Manufacturers, importers, and downstream users who formulate and place hazardous mixtures (based on physicochemical and/or health hazards) on the market are responsible for submitting the PCN. This notification must be submitted via the ECHA submission portal to the appointed bodies of each EU Member State where the product is intended to be marketed.
How is the PCN File Prepared?
The PCN submission is prepared using specific software (like IUCLID) and submitted through a centralized PCN Portal managed by the European Chemicals Agency (ECHA). The submission typically includes:
- The full chemical composition of the mixture (within defined concentration ranges).
- A Unique Formula Identifier (UFI) code, which must also be printed on the product label.
- Hazard classification and labeling details (pictograms, statements, etc.).
- The intended use, based on the European Product Categorisation System (EuPCS).
- Toxicological information.
- Details about the product (color, pH, physical state).
- Information on packaging type and size.
- The Member States where the product will be placed on the market.
Compliance Dates and Transition Periods
The mandatory compliance dates for PCN submissions are:
- Consumer and Professional Use Mixtures: January 1, 2021
- Industrial Use Mixtures: January 1, 2024
A transition period until January 1, 2025, applies to mixtures already notified under previous national rules before the respective compliance dates. However, any changes to these products after the compliance date (e.g., composition, classification) require a new notification in the harmonised PCN format before the transition period ends.
In summary, the PCN system is a vital regulatory tool designed to improve the safety management of chemical products and ensure rapid, effective medical responses in emergencies. All responsible parties must prepare and submit accurate and complete PCN information in a timely manner to comply with legal obligations. This practice significantly contributes to enhancing chemical safety standards throughout the European Union.