Where member states still differ under Annex VIII

A PCN dossier built for one member state is built exactly the same way for another: same eight sections, same UFI, same IUCLID export. That is what Annex VIII harmonised, and it is why the rest of this site treats the dossier and the UFI as one process rather than one process per country. But harmonising the format was never the same as harmonising every requirement around it, and the implementing rules left three things as national decisions: what language the free-text parts of the dossier have to be written in, what a country charges for receiving the notification, and which body actually receives it. None of those three change what goes into the dossier. All three can change whether a specific submission to a specific country goes through cleanly.

Annex VIII is harmonised — but not everything is

Before the harmonised format, the same problem showed up in slightly different shapes in every country: separate systems, separate formats, and inconsistent information reaching medical staff depending on which member state happened to answer the call. The fix was a shared format and a shared submission route — not a single EU authority that receives every dossier on Europe's behalf. Member states still designate their own appointed body, still set their own expectations for the language of the parts of the dossier that are free text rather than structured data, and still decide independently whether receiving a notification costs the notifier anything. Those choices sit outside the harmonised data set on purpose: Annex VIII fixed what information travels and how it is structured, not who administers it inside a given country or what that administration costs.

Languages

Most of a PCN dossier is structured data — concentration ranges, hazard classes, a EuPCS category chosen from a fixed list — and structured data does not need translating. What does need translating is the free text: use descriptions, product context, any toxicological narrative that is not covered by a standard field. Whether that free text has to appear in the national language, or can stay in English, is a country-by-country decision, and both answers are common. A number of member states accept English alongside their own language; others accept only their own, which means the same phrase has to exist in the notification in that language before a submission to that country will go through — a translation step that has nothing to do with whether the underlying composition data is correct. At least one member state goes further and asks for the free text in two official languages at once, so a mixture sold there is not complete until both versions are in.

National fees

Submitting through the ECHA Submission Portal itself does not cost anything. The fee question sits a level down, at the national body that receives the routed dossier. Some appointed bodies charge nothing for either an initial notification or an update. Others charge per notification, per year, or per update, and the amount and the invoicing body are set by that country's own rules rather than by ECHA. This is the one axis on this page we are deliberately not putting figures to: a national fee schedule is exactly the kind of detail a member state can revise on its own timeline, and a number that was accurate when this page was written could be wrong by the time it is read. What matters operationally is that a submission plan covering several member states should budget for the possibility of a national fee on some of them, on top of the notifier's own preparation costs — not assume the notification is a single flat cost across every market it reaches.

Appointed bodies

Article 45 requires every member state to designate a body — in some cases more than one — responsible for receiving this information and using it to support emergency response. What that body actually is varies more than the name suggests. In some countries it is the poison centre itself, taking submissions directly into the same system its own clinicians work from during a call. In others it is a separate national agency or institute that receives and manages the notification data, then makes it available to the poison centres operating in that country rather than running the calls itself. Neither model changes what a notifier has to submit, but it does mean the appointed body a dossier is routed to is not a uniform kind of organisation across the EU — it is whichever structure that country chose when it implemented Article 45.

The same national-level pattern shows up again once a notification is missing rather than filed: enforcement is handled per member state too, not centrally, which is covered in full on our page about what happens if you do not notify.

Selecting member states in your submission

None of the differences above are handled automatically by the portal, and none of them are visible until a member state is actually added to a submission — the portal does not warn a notifier in advance that a market requires a second language or carries its own fee. The mechanics of adding member states to a submission, choosing between a standard, limited or group submission, and reading the validation report that comes back are covered on our page about the ECHA Submission Portal. What sits underneath that process is what this page has been about: why the same dossier can go through cleanly in one country and come back needing a translation or a payment step in another, even though the composition itself has not changed. Back to what a PCN notification covers everywhere.