The PCN dossier — section by section

The order below follows how the sections build on each other: identity first, then composition, then the hazard picture, then what a poison centre would actually need to act on a call. Every section is checked against every other one before a submission is accepted, so treat this as one connected document rather than eight separate forms filled in by whoever happens to hold the relevant file.

1.1 Dossier information

This is where the submission declares what kind of filing it is — a standard notification, a limited submission for an industrial-use mixture, a group submission, or a voluntary one — together with the UFI or UFIs it covers and the member states it is being sent to. The most common slip here is picking the standard submission type out of habit when the mixture actually qualifies for something narrower, or selecting a shorter list of member states than the mixture is actually placed on the market in. Both the submission types on offer and how member state coverage works are covered in full on our Submission Portal page.

1.2 Submitter information

Name, full address, phone number and email address of the company submitting the dossier, and this has to match what appears on the physical label rather than a head-office address used for other paperwork. Companies also get this section wrong by naming whichever entity holds the formulation, when Annex VIII puts the obligation on whoever actually places the mixture on the market — which is not always the same company. Our page on who must submit a PCN works through where that duty lands across a typical supply chain.

1.3 Mixture information

The full trade name — including any brand, variant or private-label name that appears on a pack — and whether the mixture is intended for consumer, professional or industrial use. A frequent mistake is leaving out a variant name that shows up on a smaller pack size at the point of sale.

1.4 Mixture composition

Every component that has to be identified under Annex VIII, its concentration or concentration range, and its own hazard classification. This is the section most likely to fail validation outright, usually because a declared range is wider than the maximum a component's hazard band allows, or because a low-concentration component has been dropped without checking whether that omission is actually justified. Our composition and concentration ranges page walks through the exact bands and the naming rules component by component.

1.5 Product information

The EuPCS product category assigned to the mixture, the packaging types and sizes it is actually sold in, its colour, physical state and pH where relevant, and confirmation of which markets it reaches. Companies tend to describe packaging in general terms rather than listing every pack variant carrying the UFI in question — a refill pouch sold alongside the primary bottle, for instance — which then surfaces as a validation warning rather than a clean pass. The same applies to product category: registering a single generic category for a mixture that is genuinely sold for more than one intended use surfaces the same way. How to pick the right category is covered on our EuPCS page. This links back to the same submission mechanics as 1.1: see the Submission Portal page for how multimarket coverage is handled once the product details are in.

1.6 Labelling

The hazard pictogram codes, signal word, hazard statement codes and precautionary statement codes that appear on the physical label, together with the UFI itself in its mandatory printed form. The failure mode here is a dossier and a label that quietly drift apart — a formulation tweak updates the label but not the submission, or the other way round — so that the two no longer describe the same product. Placement, format and the UFI prefix rules for the physical label are covered on our UFI label page.

1.7 Classification

How the mixture is classified under CLP for health and physical effects, assigned as a whole rather than inherited automatically from any single ingredient. Where a mixture in mixture is used as a component, its own hazard classification also has to be carried through rather than absorbed silently into the parent mixture's figures — a distinction our mixture in mixture page covers on its own terms. A classification that does not follow logically from the concentrations declared in 1.4 is one of the more difficult validation failures to trace back to its cause.

1.8 Toxicological information

The health effects a poison centre would need to know about, for the mixture itself or for its individual components, drawn from the same information a safety data sheet already carries. This section is often the thinnest part of a dossier simply because nobody thought to carry the SDS content across into the submission in full. What satisfies this requirement, and where the data is meant to come from, is covered on our toxicological information page.

Because every section is cross-checked, building the dossier in the tool ECHA expects — IUCLID 6, exported as a PCN format file — catches most of these mismatches before submission rather than after. See how that build and validation process works.