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As with any regulatory update, the first and most important questions to answer are: What changed, and how long until the changes are mandatory? With the latest update to the EU CLP, 2024/2865, that question is not easy to answer in a concise manner. This is because 36 of 61 Articles and 4 of 8 Annexes were amended in some way. The timeline for when these changes become effective ranges from 10 December 2024 all the way until 1 January 2027. Since many of the updates are clarifying changes, and since the updates are spread throughout the entire regulation, the focus here will be on some of the changes in these areas: Poison Centre Notification (PCN), labeling, and, lastly, harmonized classifications.

For a detailed overview of these regulatory changes and how you can comply, make sure to check out our webinar, where the Sphera regulatory experts take you through how you can address these regulations effectively.

For PCN, the requirements have been changed so that distributors can now have obligations to notify where they distribute to another Member State, rebrand, or relabel mixtures and can't demonstrate that the appointed body/bodies already received the same information from importers or downstream users.

The broadest impact of this update on companies placing products on the market in the EU is the new requirements for label font size. This change will impact labels for all products that fall under the scope of CLP. The reality is that labels have always been a significant practical challenge, considering what it takes to get the right information from the person or system determining the label content onto the package that is on the market.

Minimum dimensions of labels and pictograms and minimum font size

Source: Regulation - EU - 2024/2865 - EN - EUR-Lex

Sphera has been discussing these changes to labels with our users for quite some time. The latest update to our solutions supports compliance with these new labeling requirements.

Regarding harmonized classification and labeling, there were a number of updates. In the near term, it’s important to know that by 11 June 2026, there will be updates to Annex VI, Table 3, to include classifications for the new hazard classes (endocrine disruptor for human health, endocrine disruptor for the environment, persistent, bioaccumulative, toxic, very persistent, very bioaccumulative – PBT/vPvB) that will come from work already done related to the Candidate List, Plant Protection Products (PPP), and Biocidal Products Regulations (BPR).

Of interest for the longer term are changes to the Classification and Labelling Inventory. Specifically, ATE information will now be included in C&L notifications; more information will be made available to the public with the notifications, including identity of the submitter and date of last update; and the agency can now also request the notifier to correct an entry when it is incomplete, incorrect, or obsolete. In the long term, these changes will likely make the C&L Inventory more useful.