News Brief

Recently, the Enforcement Forum of the European Chemicals Agency (ECHA) released the forum report of the pilot project on the enforcement of the 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. The results showed that 19% of the inspected mixtures failed to submit PCN notifications as required, and 15% lacked the mandatory Unique Formula Identifier (UFI) on their product labels. 

ECHA emphasized that these violations will directly undermine the emergency response capabilities of national Poison Centres in chemical accidents. 

Background: EU CLP Regulation and PCN Notification Requirements

Under Article 45 and Annex VIII of the EU CLP Regulation, companies placing specific hazardous mixtures (e.g., products with health or physical hazards) on the EU market must submit detailed product composition and hazard information to the designated authorities of the relevant Member States (i.e., PCN notification) and affix the UFI on product labels. 

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: 

• 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: Among mixtures requiring UFI labeling, 15% lacked the UFI on product labels, and 25% lacked the UFI on SDS. 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: Enforcement authorities focused on verifying the consistency between notified data and physical product information. The results revealed:

  1) In 13% of cases, product label information (e.g., trade name, pictograms, signal words) was inconsistent with PCN notification content;

  2) In 17% of cases, SDS (especially sections on composition and toxicological information) conflicted with PCN notification details. 

• 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, enforcement authorities in various Member States took enforcement actions of varying degrees. Written rectification advice was the most common, accounting for 68% of all enforcement measures, followed by verbal advice (15%), administrative orders (11%), fines (5%), and criminal prosecutions (4%). 

Implications of the ECHA PCN Enforcement Pilot for Businesses

The report specifically noted that with the end of the final transition period on January 1, 2025, all hazardous mixtures on sale (including inventory on distributors’ shelves) must be labeled with the UFI. This means compliance pressure in the distribution link will increase significantly, and non-compliant products will face the risk of being banned from further sales. 

Compliance Recommendations from REACH24H

Based on the results of this pilot project, relevant EU-bound enterprises and supply chain participants are advised to take the following measures: 

1. Comprehensive Self-Check of Notification Status: Importers and downstream users should immediately verify the PCN notification status of all hazardous mixtures on sale to ensure no omissions. In particular, for products placed on the market before 2025, confirm compliance with the latest requirements. 

2. Ensure "Three-Point Consistency": 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. 

3. Strengthen Supply Chain Management: 

- Importers: Sign clear commercial agreements with non-EU suppliers to ensure access to sufficient formulation information for notifications, or require suppliers to complete voluntary notifications through EU-based entities. 

- Distributors: Although distributors generally have no direct notification obligations, they must ensure that products sold comply with CLP labeling requirements. Discontinue sales of hazardous mixtures without UFI labels and contact suppliers for resolution. 

4. Focus on UFI Lifecycle Management: Avoid using the same UFI for mixtures with changed compositions. If significant formula modifications occur, generate a new UFI and submit a new PCN notification. 

This ECHA enforcement report sends a clear signal: regulatory authorities are shifting from "popularizing regulations" to "substantive enforcement." PCN notification is not merely an administrative procedure but a key line of defense for protecting public health and safety in the EU. Enterprises are advised to fully utilize ECHA’s online verification tools, update compliance data in a timely manner, and avoid product recalls or legal penalties due to minor oversights.

For more information and inquiries, please feel free to contact us at customer@reach24h.com.