Successfully Submitted PCN Dossiers
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EuroChem Consulting Services is your trusted partner for chemical documentation and regulatory compliance within the EU market. Our dedicated team of experts specializes in preparing and submitting Poison Centre Notification (PCN) dossiers, generating Unique Formula Identifiers (UFIs), and providing comprehensive regulatory guidance. Our mission is to streamline your compliance processes, ensuring your products meet all EU legal requirements for safe and efficient market entry. At EuroChem Consulting Services, we pride ourselves on delivering reliable, professional, and timely solutions tailored to your specific needs, allowing you to focus on your core business activities while we manage the complexities of regulatory compliance.
A Unique Formula Identifier (UFI) is a distinctive alphanumeric code assigned to hazardous mixtures within the EU to facilitate precise identification. The UFI is a key component of the CLP Regulation and is mandatory for mixtures classified for health or physical hazards. It enhances the ability of Poison Centres to provide accurate medical advice in the event of an emergency by linking the specific chemical composition of a product to its UFI.
Generating a UFI involves using the UFI generator tool provided by the European Chemicals Agency (ECHA). Once generated, the UFI must be included on the product label and in the Safety Data Sheet (SDS). To connect the UFI to a PCN dossier, the code must be entered into the dossier submission to the ECHA portal, along with detailed product information, such as composition, hazard classification, and toxicological data. This ensures that the UFI is accurately linked to the product, enabling effective communication and emergency response across the EU.
Collect all necessary information about your chemical mixture, including product identifiers, full composition, and intended use. Ensure that you have detailed data on the concentration of each component and relevant safety data sheets (SDS).
Determine the hazard classification of your mixture according to the CLP Regulation. This involves identifying the health, physical, and environmental hazards associated with each component and the mixture as a whole.
Use the UFI generator tool provided by the European Chemicals Agency (ECHA) to create a Unique Formula Identifier (UFI) for your mixture. This code will uniquely identify your product in all regulatory and emergency contexts.
Compile all gathered information into the PCN dossier, including the UFI, full composition, hazard classification, toxicological data, and emergency health response measures. Ensure the dossier meets the format and content requirements specified by ECHA.
Submit the prepared PCN dossier to the ECHA submission portal, ensuring that all required fields are accurately completed. Double-check that all information is current and that the UFI is correctly included.
Regularly review and update the PCN dossier as needed, especially if there are changes in the product formulation, classification, or new data becomes available. Ensure that any updates are promptly submitted to the ECHA portal to remain compliant.
info@eurochemconsulting.com
Zagreb, Croatia
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