Under Article 45 of the EU CLP Regulation, importers and downstream users are required to notify hazardous mixtures to appointed bodies (such as poison centers) using a compliant format before placing these mixtures on the EU market. This regulation covers professional, consumer, and industrial use categories. Throughout the transitional period, companies were given the opportunity to complete their notifications, and now enforcement actions are about to begin.

Scope and Process of Inspections

Inspections across EU member states will begin in January 2025 and continue for six months. Although the full extent of these inspections is still being defined, the focus areas are expected to include:

• Evaluation of PCN Submissions: Notifications will be reviewed both qualitatively and quantitatively.
• Label and SDS Verification: The accuracy of mixture labels and, where applicable, Safety Data Sheets (SDS) will be checked.
• Compliance with UFI and Updates: The use of the Unique Formula Identifier (UFI) and the currency of SDS updates will be closely examined.

Confidentiality and Limited Submissions

Limited submissions apply solely to industrial-use mixtures, allowing companies to protect composition or formulation details referenced in Section 3 of the SDS. For consumer or professional uses, full composition details must be disclosed.

Role of Non-EU Manufacturers and Formulators

Non-EU manufacturers are not required to directly submit PCNs under the CLP Regulation but can support EU-based importers or downstream users by providing necessary information. To maintain confidentiality, non-EU companies may appoint an EU-based representative to create a UFI and make voluntary submissions.

Key Tips for Preparing Your PCNs

When preparing your PCN submissions, consider the following:

• Select the appropriate use category for your mixture.
• Clearly define your role in the supply chain and ensure data accuracy.
• If limited submissions are involved, verify that the SDS aligns with CLP requirements.
• Manage your UFI effectively and adhere to the specified deadlines.
• Incorporate updates as needed to stay compliant with changing regulations.

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