▪︎ CLP, PCN notifications
Greater Clarity for Retailers Regarding Toxicology Reports
The European Chemicals Agency (ECHA) has published two updates regarding poison information reports and UFI labeling. First, the responsibilities of distributors under Article 45 of the CLP Regulation have been further clarified. Second, the guidance on Annex VIII regarding the UFI labeling of imported mixtures has been corrected.
When Is a PCN Submission Required?
Companies placing mixtures on the market that are classified as hazardous due to their health or physical effects are required under Article 45 of the CLP Regulation to submit information about these products to the relevant national authorities. The requirements for Poison Centre Notifications (PCN) are set out in Annex VIII of the CLP Regulation. A key element of this harmonized notification system is the Unique Formula Identifier (UFI), a 16-character alphanumeric code assigned to each reportable mixture that must be displayed on the product label or, where applicable, on the inner packaging.
Clarified Responsibilities for Distributors Starting in 2027
Beginning January 1, 2027, distributors will be explicitly addressed in connection with the requirements of Article 45 of the CLP Regulation. One reason for this change is that, in practice, the notification obligation has sometimes been interpreted to mean that distributors are generally exempt from PCN requirements. The updated provisions are intended to provide greater clarity regarding distributors’ role in poison centre notifications and to reduce existing information gaps within the supply chain.
The need for this clarification is reflected in the findings of a FORUM pilot project in early 2026. According to the results, 19% of the products inspected were not linked to any poison centre notification. In addition, 15% of the products lacked a UFI on the label. Further analysis showed that in more than one-third of the cases where notifications were missing, corrective action by distributors would have been required.
Actions Required by Distributors
Based on the information published, distributors must take action whenever they intend to market a mixture in an EU member State for which no existing notification has been submitted. This applies in particular when a distributor places a mixture on the market under its own name, brand, or labeling. In such cases, the distributor is responsible for fulfilling the applicable PCN notification requirements.
In addition, ECHA recommends verifying compliance with the relevant notification requirements before placing a product on the market. To facilitate this review, suppliers may provide a Submission Report together with the Safety Data Sheet (SDS). The report contains information on the UFI, the relevant market territories, and other general details concerning the notified product.
Update to the Guidance on Annex VIII
Through a corrigendum to the Guidance on Annex VIII, ECHA has further clarified responsibilities related to the UFI labeling of imported mixtures. Products must be appropriately labeled as soon as they enter the European Union. Responsibility for ensuring that the UFI appears on the product label rests with the EU importer.
Where products are labeled before being placed on the EU market, ECHA recommends using the UFI assigned by the relevant EU importer. The importer should also determine whether a product notification is required.
According to ECHA, this corrigendum does not introduce any new legal obligations. Rather, its purpose is to ensure that the respective roles of EU importers and suppliers located outside the European Union are described consistently and accurately throughout the regulatory framework.
We can provide you with comprehensive advice on the PCN notification. For more information, please contact us at sales@kft.de or use our contact form.
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