Who must submit a PCN? Duty holders under CLP Article 45

Article 45 of the CLP Regulation names roles. It doesn’t say “somebody in the supply chain” must notify hazardous mixtures to poison centres; it says who. Get the role wrong and one of two things happens: everyone assumes someone upstream filed and nobody did, or two parties file different dossiers for the same product. This guide walks the roles in order: the two classic duty holders, the point where a distributor crosses into holding the duty, the new distributor obligation under Regulation (EU) 2024/2865, and the parties who can never hold the duty at all.

The two classic duty holders

Since Annex VIII took effect, the notification duty has attached to whoever places the mixture on an EU/EEA market in one of two roles:

• The importer. If the mixture physically enters the EU/EEA from outside, the EU-established company importing it holds the duty: no matter who manufactured it or what documentation came with it.
• The downstream user. Most obviously the formulator who blends the mixture. But the category also catches companies that never touch a mixing vessel: the re-brander who sells a supplier’s product under its own name, and the re-labeller or re-packager who changes how it is presented. Putting your identity on the label makes the product yours for Article 45 purposes.

ECHA’s 2025 enforcement pilot (ECHA/NR/26/08) shows what this looks like in the field. Of the notifications inspectors found, downstream users had submitted 44% and importers 19%. Re-branders and re-labellers had filed 4% of them, and accounted for 12% of the missing ones. A targeted enforcement project, not a measure of the whole market. If your business is private label, start from the assumption that the duty is yours. The scope test itself is in do I need to submit a PCN.

When a distributor becomes a duty holder

A pure distributor (buying finished, labelled product from an EU supplier and reselling it unchanged) has historically held no notification duty. The supplier’s notification covered the product, and the distributor’s job was not to break the chain.

The line is crossed the moment the distributor changes the product’s identity: its own brand on the label, a translated or redesigned label, new packaging. At that point it is no longer distributing the supplier’s product; it is placing its own on the market, with a downstream user’s duty, its own notification and normally its own UFI. (The supplier’s UFI can still carry the composition inside the new dossier as a mixture-in-mixture component.)

There was a gap, though: a distributor who moved a compliant product into a member state the supplier never notified. Nobody in the chain held a clear duty for the new market, and the poison centre there had nothing on file. That’s the gap the 2024 CLP revision closes.

The new distributor duty under Regulation (EU) 2024/2865

The revision inserts a new paragraph 1c into Article 45. It’s a conditional duty, not a blanket one. Distributors placing hazardous mixtures (health or physical hazards) on the market must submit the Annex VIII information when either of two things happens:

• they subsequently distribute the mixture in other member states: the cross-border gap above; or
• they re-brand or re-label the mixture, codifying in the regulation what guidance already treated as a duty transfer.

Then the exception: the obligation does not apply if the distributor can demonstrate that the appointed bodies have already received the same information from the importer or downstream user upstream. In practice that makes the duty a verification exercise. Before shipping into a new market, a distributor either gets evidence that the supplier’s notification covers that member state, or makes its own submission. ECHA’s advice to distributors is that pair of options: have the supplier extend their notification, or notify yourself.

The wider revision (digital labels, the staged dates, what stays the same) is covered in Regulation (EU) 2024/2865 explained.

Toll manufacturing: the duty follows the label

In toll or contract manufacturing, one company produces a mixture to another’s specification, and the brand owner sells it. The duty follows the market placement, not the mixing vessel: if the product reaches the market under the brand owner’s name, the brand owner is the duty holder, even though the toll manufacturer knows the composition best. The workable arrangements are either a data flow (the manufacturer discloses composition under confidentiality so the brand owner can notify) or a mixture-in-mixture setup where the manufacturer’s own notified UFI stands in for the full formula. What does not work is each party assuming the other filed. Put the notification responsibility in the tolling contract, by name.

Who cannot hold the duty

A non-EU manufacturer has no Article 45 duty and cannot assume one: the obligation attaches to an EU-established legal entity. When a UK, Swiss, Turkish or US manufacturer sells into the EU, the duty lands on the EU importer, however small that importer is relative to its supplier. The manufacturer can prepare data, fund the work, even draft the dossier. But the notification is submitted by, and legally belongs to, the EU entity. Importers should treat “our manufacturer handles EU compliance” as a claim to verify per member state, not a fact.

Liability stays with the duty holder

Any duty holder can hire the work out: a consultant, a software platform, a parent company’s regulatory team. None of that moves the legal duty. If the dossier is late, wrong or missing, enforcement lands on the importer or downstream user (and from 2027, where paragraph 1c applies, the distributor), not on the service provider. So keep the submission numbers in your own records, not only your provider’s, and when you weigh outsourcing options, judge them on auditability as much as price. The comparison is in do I need a consultant for PCN. UFI Number is tooling, not a duty transfer. It’s built to prepare and send the notification, and the submission number ECHA returns is filed under your legal entity. It’s in private beta.

Who owes the PCN: scenario by scenario

Whichever row you land on, the deliverable is the same: a poison centre notification submitted and validated before the product is placed on each market, and a UFI on the label that matches it.