EU CLP REGULATION UPDATE
The Enforcement Forum of the European Chemicals Agency (ECHA) previously released a report on its pilot project on the enforcement of notifications to the Poison Centres. This enforcement action covered 18 Member States of the EU/EEA.
Between January and June 2025, enforcement authorities inspected a total of 1,597 hazardous mixtures. Of the mixtures subject to mandatory notification in random inspections, 19% had not been notified and 15% lacked the required Unique Formula Identifier (UFI) on their labels.
ECHA emphasized that these violations will directly undermine the emergency response capabilities of national Poison Centres in chemical accidents.
The findings are particularly relevant for distributors preparing for January 1, 2027, when the revised CLP Regulation will explicitly extend the notification duties set out in Article 45 to distributors in specified circumstances. Businesses that distribute across Member States and rebrand or relabel mixtures should verify whether existing notifications cover the relevant products and markets.
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PCN RequirementsCompliance GapsEnforcement ActionsBusiness Implications2027 Distributor DutiesCompliance RecommendationsBackground: EU CLP Regulation and PCN Notification Requirements
According to Article 45 and Annex VIII of the EU CLP Regulation, importers and downstream users who place mixtures classified as posing health or physical hazards on the EU market must submit the necessary information to the relevant national appointed bodies, unless they are exempt.
The UFI is a 16-character alphanumeric code linking the product to its notified mixture information. It usually appears on the product label or inner packaging. According to Annex VIII, the UFI must be included in Section 1.1 of the SDS in certain cases, including for mixtures intended for use on industrial sites and for unpackaged mixtures. However, generating a UFI alone does not fulfil the notification obligation.
The ECHA Enforcement Forum launched this pilot project in the first half of 2025 to assess industry compliance with the above regulations, with a focus on verifying the consistency of UFI across labels, Safety Data Sheets (SDS), and notification dossiers.
Inspected products covered consumer use (83%), professional use (39%), and industrial use (18%), of which 71% were from Small and Medium-sized Enterprises (SMEs).
Major PCN Violations and Compliance Gaps
The enforcement report identified several major PCN compliance issues:
| Type of non-compliance | Mixtures checked | Non-compliant | Rate |
|---|---|---|---|
| PCN not submitted where required | 1,432 | 276 | 19% |
| Notification inconsistent with SDS | 1,272 | 221 | 17% |
| Notification inconsistent with label | 1,272 | 159 | 13% |
| UFI missing from label where required | 1,203 | 178 | 15% |
| UFI missing from SDS where required | 12 | 3 | 25% |
| Invalid UFI | 1,347 | 21 | About 2% |
The denominators differ for each check. In particular, the 25% SDS figure only represents three out of the 12 mixtures for which inclusion of a UFI in the SDS was required. These inspection results should not be used to estimate non-compliance across the entire EU/EEA market.
High Notification Deficiency Rate: Among mixtures required to be notified under the CLP Regulation, 19% failed to submit PCN notifications entirely. Data showed that downstream users were not only the largest group of notifiers (accounting for 44%) but also the group with the highest incidence of failing to fulfill notification obligations (accounting for 28% of violation cases).
Inadequate Label/SDS Compliance: Although in cases where the UFI was labeled, the vast majority (97%) met requirements for placement and format, complete absence of the UFI remained one of the primary violations.
Questionable Information Consistency: In 13% of cases, the information on the product label, such as trade names, pictograms and signal words, differed from the notification. In 17% of cases, the SDS conflicted with the notified information.
The reported discrepancies in SDS were primarily related to composition (63%) and toxicological information (33%). These findings highlight the need for more robust version control between notification dossiers, SDSs and labels.
Company Size and Compliance Rate: Notably, there was little difference in compliance performance between SMEs and large enterprises, with compliance rates ranging from 58% to 59%. This indicates that companies of all sizes face challenges in PCN compliance management.
Enforcement Actions Taken by Member States
In response to violations identified during inspections, the relevant enforcement authorities in various Member States took various enforcement actions. The most common measure was written advice, with 447 such actions taken across 656 non-compliant cases-- equivalent to 68%. Other measures included verbal advice (15%), administrative orders (11%), fines (5%), and criminal complaints or referrals to prosecutors (4%). More than one measure could be recorded for a case.
Implications of the ECHA PCN Enforcement Pilot for Businesses
The final Annex VIII transition period ended on January 1, 2025. Any in-scope mixtures that are still being placed on the market, including stock supplied by distributors, must comply with the relevant notification and UFI requirements. The 2027 distributor provisions do not allow for an additional transition period for products that are already non-compliant.
The report also identified gaps requiring action by distributors in more than one-third of cases where effective notification coverage was lacking. Therefore, checking that a UFI is printed on a product is only the first step: the notification must also cover the relevant product identity and destination market.
PCN Obligations for Distributors from January 1, 2027
Regulation (EU) 2024/2865 introduces Article 45(1c), which explicitly addresses the issue of distributors of mixtures that are classified as hazardous for health or physical effects. The relevant provisions will apply from January 1, 2027. The postponement of certain CLP requirements to 2028 does not affect this PCN date. See the consolidated regulation, Article 1(24)(b) and Article 2(3).
The duty is triggered when a distributor supplies the mixtures in other Member States, or rebrands or relabels them. However, a separate notification is not required if the distributor can demonstrate that the relevant appointed bodies have already received the necessary information from the importers or downstream users.
Cross-border distribution
Before supplying a new Member State, check whether the existing notification covers that country and the product as sold. Notifications made for one market do not automatically provide coverage for every EU Member State.
Rebranding and relabelling
For private-label products or changes to the trade name or label, ensure that the notification includes the required identifiers and product information. An unchanged formulation alone does not prove that a product sold under a new name is covered.
Two ways to address a notification gap
Work with the upstream notifier. Ask the importer or downstream user to extend or update its notification to include the additional markets, trade names and relevant UFI information. Obtain evidence that the required information has reached the relevant appointed bodies.
Submit the required information. If adequate upstream coverage cannot be demonstrated, the distributor must arrange its own notification in accordance with Annex VIII. This requires sufficient information on the composition, hazard, product and uses; a UFI code alone is not a complete dossier.
Role classification also matters. A business that transfers a mixture into another container as a repackager or refiller is a downstream user with direct notification responsibilities, rather than merely a distributor. These obligations should not be deferred until 2027.
Compliance Recommendations from REACH24H
In light of the results of this pilot project and the upcoming distributor provisions, importers, downstream users and distributors are advised to take the following measures:
1. Verify notification and market coverage
Importers and downstream users should immediately verify the PCN notification status of all in-scope hazardous mixtures on sale to ensure no omissions. In particular, for products placed on the market before 2025, confirm compliance with the applicable Annex VIII requirements.
Distributors and retailers should record the supplier, trade name, UFI and countries of sale for each product, including existing stock. Prioritise products that are supplied across borders and those that are sold under a private label.
2. Keep PCN dossiers, SDSs and labels aligned
Establish internal audit mechanisms to ensure strict consistency and timely updates of information (including trade names, composition details, hazard classification, toxicological information, etc.) across PCN notification dossiers, SDS, and labels.
Assess any changes to the formulation, classification, toxicological information or relevant physical properties, including pH, against the updated criteria in Annex VIII. Coordinate any necessary updates to notifications, SDSs and labels before the affected product is placed on the market.
3. Strengthen supplier agreements and retain evidence
Importers: Sign clear commercial agreements with non-EU suppliers to ensure access to sufficient formulation information for notifications. Alternatively, arrange suitable voluntary submissions through EU-based entities. Such arrangements must support the importer's own obligations and do not automatically transfer its legal responsibility.
Distributors: Request relevant submission reports and supporting confirmation of the notified markets, trade names and UFIs. Agree who will update the notification in the event of a change to the destination market or product identity. Evidence tied to the actual product and country of sale is more useful than a generic statement that a product is 'PCN compliant'.
4. Manage the UFI throughout the product lifecycle
Review any changes to formulation against the Annex VIII criteria to determine whether a new UFI and an updated notification are required. Do not assume that every administrative change requires a new code, or that an existing code is still appropriate following a change to the material composition.
Companies preparing for 2027 should close existing gaps now and document how future changes will be communicated across the supply chain. ECHA's guidance and training resources can help teams to understand their roles and prepare the necessary information.
Planning a PCN compliance review?
Explore REACH24H's EU UFI and PCN services for assistance with notification preparation, UFI generation and post-notification updates. For more information and inquiries, please feel free to contact us at customer@reach24h.com.
