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

Article 45 of the CLP Regulation does not say “somebody in the supply chain” must notify hazardous mixtures to poison centres — it names roles. Get the role analysis wrong and two failure modes follow: everyone assumes someone upstream filed (nobody did), or two parties file inconsistent dossiers for the same product. This guide walks the roles in order: the two classic duty holders, the point where a distributor crosses the line into holding the duty, the new distributor obligation arriving 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-branderwho 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 shows what this looks like in the field: of the notifications inspectors found, downstream users had submitted 44% and importers 19%. It also shows where the gaps concentrate — re-branders and re-labellers filed just 4% of the notifications but accounted for 12% of the missing ones. If your business model 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, however, a structural gap: 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 gap is what the 2024 CLP revision closes.

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

The revision inserts a new paragraph 1c into Article 45. Its logic is worth stating precisely, because it is 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.

And then the escape valve: the obligation does not apply if the distributor can demonstrate that the appointed bodies have already received the same informationfrom the importer or downstream user upstream. In practice that turns the duty into a verification exercise: before shipping into a new market, a distributor must either obtain evidence that the supplier’s notification covers that member state — or make its own submission. ECHA’s advice to distributors is exactly 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’sname, 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 bites, the distributor), not on the service provider. The practical consequences: keep the submission numbers and acknowledgements in your own records, not only your provider’s; and when weighing outsourcing options, judge them on auditability as much as price — a comparison we lay out honestly in do I need a consultant for PCN. Ufi Number sits in that landscape as tooling, not as a duty transfer: it automates the dossier and submission at €20 per mixture, and the acknowledgement it returns is filed under your legal entity.

Who owes the PCN: scenario by scenario

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