PCN Notifications: What responsibilities will distributors have from 1 January 2027?

Annex VIII to the CLP Regulation (Regulation (EC) No 1272/2008) requires the submission of harmonised information to appointed bodies and poison centres for mixtures classified as hazardous based on their health or physical hazards. This information is made available to medical personnel and enables them to assess the risks associated with accidental exposure and determine the most appropriate medical response.

While manufacturers and importers have historically been regarded as the main actors subject to these obligations, recent amendments to the CLP Regulation further clarify the role of distributors within the supply chain.

Until now, distributors already had responsibilities under Article 4(10), which provides that mixtures may only be placed on the market if they comply with the requirements of the CLP Regulation.

From 1 January 2027, Regulation (EU) 2024/2865 explicitly clarifies the situations in which distributors become responsible for ensuring compliance with the notification requirements laid down in Article 45.

What is meant by a "Distributor"?

Within the context of notifications to poison centres under Article 45 of the CLP Regulation, the concept of a distributor should be interpreted broadly.

It is not limited to operators involved solely in the sale or resale of a chemical product. It also covers retailers, companies marketing a mixture under their own brand or private label, and operators making changes to labelling or trade names without modifying the composition of the product.

Where an operator makes a mixture available on the market under a commercial identity different from that covered by the original submission, or under marketing conditions not covered by the existing notification, that operator may be required to fulfil specific obligations relating to PCN submissions.

This approach aims to ensure that the information available to poison centres accurately reflects the products as they are marketed and identified by users and healthcare professionals.

Clarification of responsibilities within the supply chain

The obligation to notify poison centres is based on the principle that every hazardous mixture placed on the market must be covered by a submission containing the information required under Annex VIII to the CLP Regulation.

In practice, European enforcement authorities have identified compliance gaps in situations involving distributors. The most common cases concern mixtures marketed under private labels, under trade names different from those used by the original supplier, or in Member States not covered by the supplier's submission.

The amendment introduced by Regulation (EU) 2024/2865 therefore seeks to remove any ambiguity regarding distributors' responsibilities and to ensure that poison centres have access to the information necessary in the event of accidental exposure.

In which situations must a distributor ensure PCN compliance?

From 1 January 2027, distributors will need to verify that an appropriate notification covers the products they place on the market where:

• The mixture is marketed under a trade name different from that included in the original submission;
• The product is sold under a private label or distributor brand;
• The mixture is distributed in one or more Member States not covered by the supplier's submission.

It should be noted that even a purely marketing-related change, such as the introduction of a new trade name or brand, may have a direct impact on the validity of the PCN notification associated with the product.

What options are available to distributors?

Requesting that suppliers update their existing notifications

One option is to request that the supplier updates its existing submission to incorporate:

• the additional trade names used by the distributor;
• the relevant brands;
• the Member States in which the product will be marketed.

This approach is particularly relevant where the same mixture is distributed under several brands across the European Union, as it avoids the need for multiple submissions covering an identical formulation.

Submitting their own distributor notification

A distributor may submit its own PCN notification through the ECHA Submission Portal.

This approach allows the distributor to retain direct control of compliance in the Member States concerned and to ensure that the trade names actually used on the market are correctly reflected in the submission.

Depending on the arrangements agreed with the supplier, the distributor may in some cases rely on the UFI (Unique Formula identifier) already assigned to the mixture.

The importance of documentary traceability

The fact that a supplier may take responsibility for the submission does not relieve the distributor of its obligations.

Authorities may require evidence that the products actually placed on the market are covered by a valid and up-to-date submission. Consequently, distributors should maintain documentation demonstrating such regulatory coverage.

Relevant documentation may include:

• Written agreements concluded with suppliers;
• Confirmations that submissions have been updated;
• Correspondence demonstrating that additional trade names have been incorporated into the PCN dossier;
• Documents confirming coverage of the relevant Member States.

Such documentation may constitute essential evidence during a regulatory inspection.

A particular point of attention: Labelling

The application of these new provisions reinforces the need to ensure consistency between the information appearing on the label and that contained in the PCN dossier.

Distributors should in particular verify that:

• All trade names appearing on the packaging are covered by an active notification;
• The countries in which the product is marketed are included within the scope of the submission;
• The UFI displayed on the label corresponds to the relevant mixture;
• Supporting evidence demonstrating compliance is available and appropriately archived.

These checks should be integrated into procedures governing labelling changes, the launch of new brands, and the geographical expansion of commercial activities.

Actions that should be taken without delay

The application date of these provisions is now rapidly approaching. From 1 January 2027, affected distributors will need to be able to demonstrate that the mixtures they place on the market are appropriately covered by a compliant PCN notification.

Companies marketing products under private labels, under multiple trade names, or in several Member States should, if they have not already done so, complete a review of their product portfolio without delay. This assessment should make it possible to identify the products concerned, verify the coverage provided by existing submissions, and formalise any agreements or confirmations required from suppliers.

In a context of increased compliance enforcement across the European Union, businesses that have not secured compliance with their PCN obligations before the deadline may face regulatory risks identified during inspections or following requests from the competent authorities. The period before entry into application therefore represents the final opportunity to verify that trade names, marketing territories and associated UFIs are properly covered by existing submissions.

Would you like to find out more about PCNs? Take a look at our previous article, ‘PCN Notification: Why notification to poison control centers is not always enough’.

Ecomundo can support you in assessing your PCN obligations, verifying the coverage of your existing submissions and ensuring compliance of your products before these new provisions become applicable. Contact us!