Who must submit a PCN?

A single phrase carries the whole scope test for who is obliged to notify: the duty falls on the company that places the mixture on the EU market for the first time. That single event — the first sale, transfer or import — is what creates the obligation, and it can land on different companies depending on where the mixture is manufactured and how it moves through a supply chain before it reaches a customer. What follows works through the roles that come up most often.

Importers

A company that brings a classified mixture into the EU from outside it — buying finished product from a non-EU manufacturer and putting it on the EU market under its own name or someone else's — is the notifier for that mixture. This is the most direct case: the importer is the first company placing the product on the EU market, so the duty is theirs by default, and it does not transfer to whichever company supplied them the finished product from outside the EU.

An importer bringing in the same formulation from more than one non-EU supplier, or bringing in a formulation that changes slightly between shipments, needs to track those variations against its notified composition — a supplier-side change that shifts the concentration ranges on file can trigger the same update duty as a deliberate reformulation would.

Downstream users, including formulators and re-labellers

A downstream user that formulates a mixture — blending substances or other mixtures into a new product — and places that product on the market is the notifier for it, in exactly the same way an importer is for a product brought in from outside the EU. This covers the straightforward case of a company manufacturing its own branded product, but it also covers a company that takes someone else's formulation and re-labels it under a different trade name: a change in trade name is itself an event Annex VIII treats as placing a distinct product on the market, which is what creates a fresh notification duty rather than letting the re-labelled product ride on the original notifier's dossier.

Where more than one company touches the formulation before it reaches an end customer — a contract manufacturer, a brand owner, and a private-label reseller, for instance — the notification duty tracks whoever is actually placing that specific labelled product on the market, which is not always the company that did the chemistry.

Distributors

A distributor that resells a mixture exactly as received — same composition, same trade name, same packaging, same label — is not the notifier. The company further up the chain that first placed that product on the market already carries the duty, and a distributor moving it onward without changing anything about it is not creating a new placing-on-the-market event.

That default flips the moment a distributor changes the trade name or the packaging. Repackaging a mixture into different containers, or selling it under the distributor's own brand instead of the manufacturer's, both count as the distributor placing a distinct product on the market — at which point the distributor becomes the notifier for that version of the product, with its own dossier and its own UFI, independent of whatever the original manufacturer filed for the unmodified version.

Non-EU manufacturers

A manufacturer based outside the EU is not, on its own, the notifier — it has no direct Annex VIII obligation, because the duty attaches to placing the mixture on the EU market, and a company outside the EU selling to an EU-based buyer is not the one doing that. The obligation sits with whichever EU-based company brings the product in: normally the importer described above.

In practice this makes the non-EU manufacturer dependent on its EU importer for compliance, which creates a real risk on both sides: the manufacturer's product cannot legally reach the EU market without a notification it does not itself control, and the importer cannot notify accurately without composition and toxicological data that only the manufacturer holds. A non-EU manufacturer that wants to keep control of its own formulation confidentiality, rather than disclosing a full composition to every importer it sells through, can use a mixture-in-mixture UFI to pass the identifying code down the chain without disclosing the underlying composition to the importer directly.

Who carries the duty in practice

Stripped of the role labels, the test is always the same: find the company whose action — importing, formulating, re-labelling, repackaging, rebranding — is what first puts this specific version of the product on the EU market, and the notification duty sits there. It can move partway through a supply chain if a distributor changes packaging, and it can sit with more than one company at once if the same base formulation is sold under several distinct trade names by several different companies. What it does not do is sit by default with whichever company is largest, most visible to the end customer, or most obviously "the brand" — Annex VIII tracks the placing-on-the-market event, not brand ownership.

Once you have identified which company holds the duty for a given product, the next question is what exactly has to be notified — covered on our PCN scope page — and by when, covered on our deadlines page.