PCN required information: the complete data checklist

Annex VIII Part B of the CLP Regulation specifies exactly what a poison centre notification must contain. It is a fixed list — not a judgement call — and the PCN format turns each item into structured fields with validation rules behind them. This checklist walks the requirements in the order the dossier itself is organised, so you can use it both to plan data collection and to review a dossier before submission.

One framing note before the list: the single biggest gap between what companies have and what the PCN needs is composition detail. A safety data sheet discloses hazardous components above cut-off thresholds; a standard PCN wants every component, hazardous or not, with exact concentrations or narrowly permitted ranges. Budget your effort accordingly.

Submitter identity

The dossier identifies the duty holder — the importer or downstream user placing the mixture on the market — with name, full address, phone and email. This legal entity must match the identity behind your UFI and, where relevant, your S2S account. A contact for the notification can be added; for limited submissions (below), a contact for rapid access to additional product information becomes mandatory rather than optional.

Product identifiers

Three identifiers pin the product down:

• Trade name(s) — every name the mixture is sold under in the notified markets. Multiple trade names can sit in one notification if the composition is identical.
• UFI — the 16-character code linking the label to this notification. One UFI maps to exactly one composition; a product family with different recipes needs different UFIs. See what is a UFI.
• EuPCS category — exactly one category from the European Product Categorisation System (~250 categories over 5 levels, list v4.0), describing the intended use. Miscategorisation is a common validation and authority-query trigger; see the EuPCS category guide.

Full composition

The core of the notification. Every component is declared with its identifiers (name, CAS and/or EC number) and its concentration, either as an exact percentage or within the ranges Annex VIII permits— the maximum permitted width of a range depends on the component’s concentration band, so you cannot simply declare “1–30%” and move on. Components are listed in descending order, by mass or volume.

For components of major concern— substances whose classification drives the acute medical response, listed by ECHA — the permitted ranges are tighter still. These are the concentrations a poison centre doctor actually doses against, so precision here is a patient-safety requirement, not bureaucracy. Check your components against ECHA’s components of major concern page before deciding whether ranges or exact values are the easier path.

If an ingredient is itself a bought-in mixture whose full recipe you do not know — a fragrance, a pigment dispersion, a purchased base — Annex VIII provides the mixture-in-mixture (MiM) mechanism: identify the MiM by its own UFI (or its supplier and SDS data) instead of dissolving it into components you cannot obtain. The conditions and the fallback hierarchy have their own guide: mixture-in-mixture (MiM) in a PCN.

Toxicological information

The dossier carries the toxicological information of the mixture as sold, in practice derived from section 11 of the safety data sheet: relevant effects by route of exposure (oral, dermal, inhalation, eye contact) and the symptoms poison centre staff should expect. This is free-text plus structured records, and it must describe the mixture, not merely paste the component substances’ data. If your SDS section 11 is thin or boilerplate, fix that before it becomes the weakest section of your notification.

Classification and label elements

The mixture’s full CLP classification (hazard classes and categories) and the label elements: hazard pictograms, signal word, hazard statements and precautionary statements. This must match the actual label and SDS section 2 — divergence between the notified classification and the label is exactly the kind of inconsistency inspectors cross-check.

Packaging types and sizes

Every packaging type and size the mixture is sold in: 500 ml trigger spray, 5 l canister, 200 l drum — each combination listed. New pack sizes later mean an update to the notification. Consumer and professional products cannot be waved through with a generic entry; the packaging list is one of the fields poison centres use to judge plausible exposure quantities.

Use type, colour, physical state and pH

The notification records the use type — consumer, professional and/or industrial, which also determined the original compliance deadline and governs whether the limited-submission option exists (see consumer, professional and industrial use) — plus the physical characteristics a call handler can verify with the caller: colour, physical state and, where applicable, pH. If the pH is not measurable or not relevant, the dossier must say so explicitly with the “pH not available” flag rather than leaving the field empty.

Market area

Finally, the member states where the mixture is placed on the market, with the submission provided in the languages those states require (many accept English; a substantial minority insist on official languages). The selection drives national fees and receipt requirements — details per country in our country guides.

What a limited submission drops (industrial-only mixtures)

For mixtures placed on the market for industrial use only, Annex VIII allows a reduced data set. In a limited submission, the composition may be restricted to the components disclosed in SDS section 3.2 — you do not have to declare the full recipe. In exchange, two things are mandatory: a contact providing rapid access to detailed product information (available in an emergency, so a poison centre can obtain the full composition when a case demands it), and the limited-submission flag set in the dossier header. Every other requirement — identifiers, toxicology, classification, packaging, market area — applies unchanged.

Using this checklist

A practical sequencing tip: collect composition first (it has the longest supplier lead times, especially where MiM UFIs must be requested), then toxicology and classification from the SDS, then the product and packaging facts, which you already own. When every block above has an owner and a source document, you are ready to build the dossier — the mechanics are in how to submit a PCN. This data-gathering stage is also the part Ufi Number structures for you: the form maps one-to-one onto these blocks, and the dossier in ECHA’s current format is generated from it.