PCN Inspection to Begin in Early 2025

ECHA's Enforcement Forum will initiate a project to check if suppliers have notified hazardous chemical mixtures to the poison centres from January 2025. The inspections will last for six months, with the final report expected to be published at the end of 2025. Inspectors will check that poison center notifications have been submitted and the accuracy of labels and Safety Data Sheets (SDS) for mixtures.

Purpose

This inspection campaign aims to enforce the obligation of duty holders to notify national authorities about hazardous mixtures, with the ultimate goal of protecting human health. In emergencies, poison centers can use this information to provide advice to citizens or medical personnel. Therefore, poison centers must have accurate information on hazardous mixtures to respond appropriately in emergencies.

Under Article 45 of the CLP Regulation, importers and downstream users placing hazardous mixtures (posing physical or health hazards) on the market within the EU are required to submit detailed information on 100% of the mixture's composition, along with other necessary details, to the poison centers. Non-EU suppliers wishing to protect their trade secrets may designate a legal entity within the EU to submit a voluntary notification. In such cases, it is possible to maintain confidentiality of the mixture's components by providing only a Unique Formula Identifier (UFI).

PCN Submissions Typically Include the Following Four Sections:

• Submitter Information: This includes the business name, address, telephone number, email, and VAT number;
• Product Information: Details such as the market of placement, trade name, direct use, end-use by downstream users, and packaging type and size are required;
• Mixture Information: This section covers the mixture's name, physical state, color, pH, complete composition, classification and labeling information, and toxicological data; and
• UFI Number: The unique identifier for the formulation.

As of January 1, 2024, the transition period for PCN for mixtures used in professional, consumer, or industrial contexts has ended. Existing national notifications remain valid until January 1, 2025, but changes to product composition or identifiers require a new PCN in a harmonized format. With targeted PCN compliance inspections starting, the focus will be on products and the consistency of their PCN, labels, and Safety Data Sheets (SDS). Businesses must ensure their Unique Formula Identifier (UFI) is correctly included in SDS and labels to avoid non-compliance issues.

Individuals responsible for PCN matters should quickly review their products and prepare documentation, especially if submissions are pending, to ensure they meet the early 2025 inspection requirements.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

Have You Included a UFI Code in Your SDS when Exporting Mixtures to EU?

Enforcement Authorities will check poison center notifications