Regulation (EU) 2024/2865: what the CLP revision changes for poison centre notifications

Regulation (EU) 2024/2865 — adopted 23 October 2024, published in the Official Journal on 20 November 2024 — is the first broad revision of the CLP Regulation since it took effect. Most of it concerns classification and labelling at large: label formatting, refill sales, online offers, fold-out labels. But three strands matter directly to anyone responsible for poison centre notifications: a new duty for distributors under Article 45, a legal framework for digital labelling, and a set of staged application dates — the first of which, 1 July 2026, has just arrived. This article covers what changes for PCN work, when, and what deliberately stays the same.

What the revision is

The revision amends Regulation (EC) No 1272/2008 — the CLP Regulation that carries Article 45 and Annex VIII, the legal spine of the poison centre system. It entered into force in December 2024, but almost none of it applied immediately: Article 2 of the amending regulation staggers the substance over several years. That “in force but not yet applicable” structure is the source of most confusion about it, so the dates deserve their own section.

One more moving part: in late 2025 the EU adopted a targeted “stop-the-clock” amendment, Regulation (EU) 2025/2439, which deferred parts of the revision — but, importantly, none of the poison-centre parts.

The application dates

The precise mechanics: Article 2(2) of 2024/2865 applies most provisions from 1 July 2026; Article 2(3) applies the Article 45 and Annex VIII amendments from 1 January 2027, with a transitional derogation letting companies follow the old rules until 31 December 2026. The 2025/2439 amendment moved the formatting, advertising and distance-sales items to 1 January 2028 and explicitly left the health-protection provisions — the poison-centre dates included — unchanged.

Distributor duties under Article 45

The headline change for poison centre work: from 1 January 2027, distributors become duty holders in defined cases. The rewritten Article 45 separates the actors: paragraph 1b restates the familiar duty of importers and downstream users; new paragraph 1c adds distributors who place hazardous mixtures on the market and either subsequently distribute them in other member states or re-brand or re-label them. The duty is waived where the distributor can demonstrate the appointed bodies already received the same information from upstream — which converts it, operationally, into an evidence-of-coverage obligation.

The target is a real gap: mixtures moved cross-border by distributors into markets the original notifier never covered, leaving that country’s poison centre blind to a product on its shelves. ECHA’s guidance to distributors is to resolve it one of two ways — have the supplier extend their notification to the new market, or submit your own. Who counts as a distributor, re-brander or downstream user in the first place is mapped in who must submit a PCN.

The same date brings the Annex VIII amendments, which align the annex’s wording with the new cast of duty holders and sharpen the update obligation: notifiers must keep poison centres informed of changes relevant to emergency health response — packaging type, product category, contact details — not only composition changes. The update triggers as they stand today are covered in how to update a PCN.

Digital labelling

From 1 July 2026, CLP has a legal framework for digital labels: new Article 34a allows suppliers to provide certain label information in digital form, and Article 34b sets the conditions — accessible in no more than two clicks, free, without registration or app installation, searchable, and available to all users in the Union.

The realistic reading for mixture suppliers: this is a framework, not a migration. Only a narrow set of label elements listed in the amended Annex I may move to the digital label exclusively; the core hazard communication stays physical, and anything provided digitally-only must also be supplied on request. For poison-centre work specifically, nothing about the UFI’s presence in the notification changes; label placement rules for the code are covered in UFI label requirements. Treat digital labelling as an option to evaluate with your label supplier, not a compliance deadline.

What does not change

Just as important as the changes is the list of things the revision leaves alone:

• Existing notifications remain valid. There is no re-notification exercise; dossiers submitted under the current rules stand, subject to the ordinary update triggers.
• The PCN format is not rewritten.Format versions come from ECHA’s IUCLID release cycle, not from this regulation — version 8 has been current since April 2026 regardless (see PCN format versions).
• Importers’ and downstream users’ duties continue unchanged. If you already hold the duty, 2024/2865 adds neighbours, not requirements — your obligation has been continuous since the original deadlines passed (see PCN deadlines).
• The UFI system is untouched — same algorithm, same format, same one-UFI-one-composition rule.

What to do this quarter

With the July 2026 tranche live and the poison-centre tranche six months out, the useful work for Q3 2026 is specific:

1. Distributors: map every mixture you move into a member state your supplier may not have notified. For each, obtain written confirmation of coverage (markets and UFIs) or plan your own submission — the evidence has to exist by 1 January 2027.
2. Suppliers selling through distributors: expect coverage queries; answering them once, in writing, beats a winter of ad hoc requests.
3. All duty holders: confirm your update discipline covers the non-composition triggers (packaging, category, contacts) the amended Annex VIII emphasises.
4. Label owners: decide whether digital labelling is worth piloting — an option from 1 July 2026, an obligation never.
5. Everyone:watch ECHA’s guidance updates tracking the revision, and treat vendor claims about “new 2026 PCN requirements” with the dates above in hand.

None of this requires panic purchasing; it requires an inventory, some correspondence and, where gaps surface, submissions. If those submissions are the bottleneck, Ufi Number handles the dossier-and-dispatch part at €20 per mixture — format changes handled, acknowledgement returned — while the role-and-coverage analysis above stays, unavoidably, yours.