,What is PCN ?
Under the CLP Regulation (Regulation (EC) No 1272/2008), companies placing hazardous mixtures on the EU market are legally required to submit a Poison Centre Notification (PCN) to the relevant national appointed bodies. This ensures timely and accurate information is available to poison centres to support emergency health response.
Who Needs to Notify?
- EU Importers of hazardous mixtures
- EU Manufacturers formulating hazardous products
- Downstream Users placing private-label or repackaged products on the EU market
- Distributors, depending on product modifications and market placement
At Freyr, we offer comprehensive EU PCN services tailored to your business needs, whether you manufacture, import, or distribute hazardous mixtures. Our expert-led solutions help you meet your obligations efficiently, avoid regulatory pitfalls, and ensure market continuity across the European Economic Area (EEA).
Our PCN Services Include:
Our PCN authoring services include:
Data Compilation & Validation
End-to-end data compilation and validation: trade names, UFI generation, mixture classification, full composition disclosure, physico-chemical & toxicological information, packaging specifics, and product category and use descriptors
Product & Regulatory Assessment
Assess CLP product classification, check EU PCN requirement and exemptions, identify deadlines and submission routes per product type and member state regulations
UFI code generator & Labelling Guidance
Generate Unique Formula Identifiers (UFI) via secure systems and assist with UFI placement on product labels in compliance with CLP requirements
PCN Dossier Preparation & Submission
Compile IUCLID dossiers per ECHA standards, adapt and translate for member state specific needs, and submit via ECHA Submission Portal or national systems
Ongoing Maintenance & Updates
Manage changes for reformulated or renamed products, monitor regulatory updates and obligations continuously, and maintain version control with proper documentation archiving
Multi-Market Compliance
Enable single or group submissions across various countries and products, harmonize language and content for multilingual compliance, and design notification strategies aligned with your product’s distribution footprint
Regulatory Strategy & Exemption Assessment
Assess whether your mixture qualifies for exemptions(e.g., only environmentally hazardous, cosmetic or medicinal use, etc.) and strategize submissions for products with multiple uses or complex supply chains
Why Choose Freyr for eSDS Support
- Toxicology Expertise: Our team includes EUROTOX-ERT and DABT-certified toxicologists, ensuring scientific and regulatory accuracy.
- Regulatory Insight: Up-to-date knowledge of evolving ECHA Poison Centre Notification requirements, including PCN formats, deadlines, and member state nuances.
- Technology-Driven Efficiency: Use of validated digital tools to automate UFI generation, IUCLID dossier compilation, and secure submissions.
- Confidentiality Assured: We safeguard your confidential business information (CBI) through strict data privacy protocols and secure handling.
- Global Reach, Local Knowledge: We support clients across sectors, from chemicals and detergents to biocides and cosmetics, with region-specific expertise.
Ensure compliance with EU CLP Article 45-Accurate. Timely. Hassle-Free
If you’re placing hazardous mixtures on the European market, Poison Centre Notification (PCN) compliance is mandatory. Our expert services support importers and downstream users to meet their obligations under the EU Hazard Classification, EU CLP Annex VIII compliance, helping you avoid costly non-compliance penalties while ensuring public health protection.
Frequently Asked Questions (FAQs) on Poison Centre Notification (PCN) Services
We are here to provide you with the information you need quickly and efficiently.
01. What is a Poison Centre Notification (PCN)?
A PCN is the process by which companies submit detailed information about hazardous mixtures to a centralized European database, enabling Poison Centres across the EU to provide rapid, life-saving medical advice in cases of exposure.
02. Who Must Submit a PCN?
If you are an importer or downstream user placing hazardous mixtures on the market-whether for consumer, professional, or industrial use-you are required to submit a Poison Centre Notification.
03. What is a UFI?
A UFI is a Unique Formula Identifier used to link a mixture’s composition to its Poison Centre Notification, ensuring accurate emergency response information.
04. Which mixtures need PCN?
Mixtures classified as hazardous to health or physical effects require PCN. Mixtures hazardous only to the environment or individual hazardous substances are exempt.
05. What is the deadline?
PCN is mandatory for consumer and professional-use mixtures since 1 Jan 2021, and for industrial-use mixtures from 1 Jan 2024. Transitional national notifications expire 1 Jan 2025.
06. How to submit via ECHA?
PCNs can be submitted directly through the ECHA Submission Portal or via IUCLID using the harmonised format under CLP Annex VIII before placing products on the market.
07. When does one need to re-notify?
Re-notification is required when composition, classification, UFI, product identifiers, or use types change, or if updated information is needed for Poison Centre accuracy.
08. Can Freyr act as a 3rd party representative?
Yes. Freyr can act as an EU-based representative to generate UFI and submit PCNs on behalf of non-EU companies while safeguarding confidential business information.
