Poison Centre Notification (PCN): When You Need It and How to Prepare

Of all the regulatory hurdles a fragrance brand has to clear, Poison Centre Notification (PCN) is the one we get the most confused questions about. Unlike IFRA limits or allergen disclosure, PCN is a relatively recent EU obligation — it didn't fully apply to consumer products until 2021 — and many brands are still catching up.

This article walks through who needs to do it, when, and what's actually involved.

What PCN is

When a consumer accidentally swallows, splashes, or otherwise misuses a product, the local poison centre needs to be able to look up its composition immediately. The faster they can find out what's in the product, the faster they can advise on treatment. Before harmonisation, every EU member state had its own poison centre with its own data format. A French manufacturer selling into Germany had to submit different information in different ways.

PCN — formally "Poison Centre Notification" — is the harmonised EU system that fixes this. It was introduced as Annex VIII to the CLP Regulation (EC) No 1272/2008, with the rules phased in from 2020 to 2025. All notifications go through a single ECHA portal, in a single standardised format (IUCLID), and are then made available to the national poison centres.

When PCN is required

The trigger is straightforward in principle: if you place a hazardous mixture on the EU/EEA market for consumer or professional use, you need to notify before you place it on the market. "Hazardous" here means classified as hazardous under CLP — i.e. carrying any GHS pictogram or H-statement on the label.

For fragrance compounds and finished fragranced products, the most common triggers are:

H317 — May cause an allergic skin reaction. This is by far the most common trigger for fragrances. Almost any compound containing skin-sensitising materials (cinnamal, eugenol, isoeugenol, etc.) above a certain concentration crosses the threshold.
H319 / H318 — Eye irritation / serious eye damage. Common in alcohol-based formulations.
H225 / H226 — Highly flammable / flammable liquid. Anything alcohol-based with a flash point under 60°C.
H400 / H410 / H411 — Aquatic toxicity. Several common fragrance ingredients (musks, some terpenes) are classified for aquatic hazards, and the mixture can inherit the classification via the additivity formula.

If your product carries any of these on its CLP label, PCN applies.

There are exceptions. Cosmetic products notified to CPNP (the Cosmetic Products Notification Portal) used to be exempt — the CPNP submission was deemed sufficient. As of 2024, the position has tightened: the Commission's view is that cosmetics still need a PCN if they're CLP-classified hazardous, even though the CPNP notification covers safety assessment. This is a significant change and many brands are still bringing their portfolios into compliance.

What you need to submit

A PCN dossier contains:

1. Product identification — commercial name(s), language, country of placing on the market.

2. UFI (Unique Formula Identifier) — a 16-character code that links the dossier to the label. We'll come back to this.

3. Submitter details — company name, address, VAT number, contact details.

4. Mixture composition — every component above 0.1% (for hazardous components) or 1% (for non-hazardous), with concentration ranges. Components are identified by CAS or by INCI name.

5. Classification — the full CLP classification of the mixture, with hazard pictograms, signal word, H-statements, and P-statements.

6. Toxicological information — basic acute toxicity data, route of exposure, expected symptoms.

7. Product category — the European Product Categorisation System (EuPCS) code, and the physical form (liquid, paste, gel, aerosol, etc.).

8. Packaging — type and size.

9. pH — for aqueous mixtures.

10. Colour — to help identify the product.

The submission goes via the ECHA PCN portal as an IUCLID (.i6z) file. There are two ways to create one:

Online editor — fill in the form on the ECHA portal directly. Workable for one or two products, painful at scale.
IUCLID client (offline) — install the desktop app, build the dossier locally, upload. More efficient if you have many products but the learning curve is steep.
API export from your compliance tool — many compliance platforms (including ScentShield) can generate a valid IUCLID XML file you can upload directly.

The UFI

The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that links a specific product on the market to its PCN dossier. The format looks like VVVV-VVVV-V00V-VVVV — four blocks of four characters, separated by hyphens.

The UFI is generated using the ECHA UFI Generator (a free web tool) from two inputs:

Your VAT number (or a similar company identifier).
A formulation number that you assign — typically a sequential integer.

The UFI must appear on the product label, prefixed with "UFI:" and printed in legible font near the supplier identity. It must be at least 1.8 mm tall, in a contrasting colour.

Critically: the UFI is unique per formulation. If you reformulate the product, you need a new UFI and a new PCN submission. If you sell the same product under different brand names, the same UFI can be used for all of them as long as the formulation is identical.

"Mixture in mixture" (MiM) rules

Here's where it gets complicated for fragrance brands. A finished cosmetic product might contain a fragrance compound supplied by a fragrance house. The brand owner doesn't necessarily know the exact composition of that compound — that's the supplier's IP.

CLP Annex VIII handles this with the mixture in mixture (MiM) mechanism. If you're notifying a finished product that contains a fragrance compound from a third-party supplier, you can:

1. Ask your supplier to provide the UFI of the fragrance compound (the supplier needs to have notified the compound separately).

2. Reference that UFI in your own PCN, instead of disclosing the full composition.

The supplier's PCN dossier remains confidential to the poison centres, and the brand owner only needs to know the UFI and the concentration of the compound in the finished product.

This is the most common workflow for fragranced consumer products. Make sure your supplier contracts include an obligation to provide and maintain the compound's UFI and PCN status.

When to submit and what changes trigger an update

The notification must be in place before the product is placed on the market. There's no grace period for new launches.

You need to update the PCN if any of the following changes:

The composition (by more than the tolerances allowed in Annex VIII — typically 1-30% relative depending on concentration band).
The product identification (commercial names).
The classification (e.g. you reformulate to remove a sensitiser and the H317 disappears).
The packaging (new size, new format).

Each update generates a new UFI and a new dossier version.

What ScentShield does

ScentShield runs the PCN gating check automatically as part of every compliance run. We tell you which markets need a PCN, generate the IUCLID XML in the right format, and capture the additional metadata (physical form, colour, pH, packaging) that the PCN portal requires. When the regulation changes — and it does, regularly — we re-flag the affected formulas so you can re-submit.

PCN is one of the easiest places to drop the ball. Get the workflow right once and it becomes a non-event. Get it wrong and you're explaining to a national authority why your product is on the market without notification.

Check your formulas against these requirements instantly with ScentShield. Our 9-checkpoint compliance engine runs IFRA, CLP, REACH, allergens, PCN, and 4 more checkpoints across every market in seconds. Start a free trial →