Poison Centre Notification (PCN) Solutions

Appointed bodies (poison centres) are responsible for collecting relevant information about hazardous mixtures in order to provide medical advice in health emergencies such as poisoning incidents. Article 45 of the CLP Regulation outlines the notification obligations for importers and downstream users wishing to place hazardous chemical mixtures on the EU market.

Due to inconsistencies in the notification systems and information requirements across various countries in the EU, ANNEX VIII of the CLP Regulation was implemented to address this issue. This update aims to harmonise the format and the hazardous information that must be submitted to appointed bodies in order to improve poison centre emergency responses.

What is required?

• Assign a Unique Formulation Identifier (UFI)
• Provide full chemical composition and toxicological data 
• Product categorization must be completed according to the new EU product categorization system (EU PCS)
• Provide product label information and SDSs
• Provide details of the submitter
• Other information (i.e. packaging and distribution information may be required)

The required information needs to be submitted through the PCN Portal or directly to the Member States’ appointed bodies before placing the product on the EU market. Companies should be aware of the upcoming deadlines to notify their products:

• January 1, 2021 – mixtures for professional and consumer use
• January 1, 2024 – mixtures for industrial use 
• January 1, 2025 – regulation applies to all products 

Failing to submit the required information by the specified deadlines will result in non-compliance, applicable fines, or the potential ban of a product from the market.

Our global team of experts have a strong background and knowledge of the PCN requirements and relevant legislation to be able to analyze your chemical portfolio and assist in notifying hazardous mixtures. We work closely with our clients to compile all the required information for the electronic submission, providing total peace of mind for our customers.

Our services include:

• Portfolio screening for uses and their notification timelines
• Portfolio clustering for group/single submissions
• Requesting and assigning UFI Codes
• Screening for missing notification information, e.g. Mixture in Mixture information
• Data gathering by communication with supplier outside of the EU
• Prepare and submit notification
• Update notifications
• Strategic and regulatory advice on how best to fulfill obligations

Related Services

Safety Data Sheet (SDS) Services for CLP Regulation Compliance
European Classification, Labelling and Packaging Regulation Services
Regulatory Consulting and Strategy Services
Due Diligence and Clearance to Supply for Consumer Products