A poison centre notification PCN is the structured submission of information about a hazardous mixture to the body designated to provide emergency health response in each EU Member State, and for thousands of everyday consumer and professional products it is now a legal precondition for being placed on the market. If you make or import candles, reed diffusers, surface cleaners, detergents or similar formulated products that meet the criteria for a hazardous mixture, the obligation almost certainly applies to you.
The requirement flows directly from the CLP Regulation, sits alongside your classification and labelling duties, and is enforced by national authorities. Getting it wrong does not just risk fines; it can mean a poison centre lacks the data clinicians need to treat someone who has been exposed to your product. This guide explains what PCN is, who must notify, the role of the UFI, how it differs from cosmetic notification, and what happens if you ignore it.
Key takeaways
- PCN is mandated by Annex VIII of CLP (Regulation (EC) No 1272/2008) for mixtures classified as hazardous for health or physical effects.
- The duty falls on the responsible importer or downstream user placing the mixture on the EU market, not on a supplier outside the EU.
- Each notified product must carry a UFI (Unique Formula Identifier) on its label, linking the package to the submitted dossier.
- Submissions are made through the ECHA PCN portal in the harmonised PCN format, per Member State and per language.
- PCN is separate from CPNP cosmetic notification, and a cosmetic product can need both depending on its classification.
- Non-compliance can lead to withdrawal from sale, enforcement action and penalties set by each Member State.
What is PCN and what is the legal basis?
Poison Centre Notification is the process by which information on hazardous mixtures is harmonised and made available to appointed bodies, so that they can give rapid, accurate advice in cases of accidental poisoning or exposure. Before this regime, every Member State collected product data in its own format, leaving emergency responders with patchy, inconsistent information.
The legal foundation is Article 45 of the CLP Regulation, which requires Member States to appoint bodies responsible for receiving information relevant to emergency health response. Annex VIII of CLP then sets out the harmonised content and format of that information. Added by Commission Regulation (EU) 2017/542 and amended several times since, Annex VIII is what turned a fragmented patchwork into a single, EU-wide data standard. If you want the wider context of how classification underpins all of this, our explainer on the CLP Regulation is a useful companion read.
“Poison centre” is shorthand. The legal text refers to “appointed bodies”, which in practice are national poison centres or equivalent toxicology services. The information you submit is held for emergency use and is not a public marketing disclosure.
Who must notify, and when?
The obligation rests with importers and downstream users who place a hazardous mixture on the EU market. In plain terms: if your company is the legal entity bringing a product into EU circulation, the PCN duty is yours. A non-EU manufacturer cannot discharge this obligation from outside the Union, so the EU-based importer typically becomes the responsible party.
Which mixtures trigger the duty
A PCN is required where a mixture is classified as hazardous on the basis of its health or physical effects. That captures a very broad range of hazardous mixtures beyond what most people would think of as “chemicals”. A scented candle classified for skin sensitisation, a reed diffuser classified as an aspiration hazard, or a cleaning concentrate classified as a serious eye irritant all fall in scope. Mixtures classified only for environmental hazards (and not for any health or physical hazard) are currently outside the PCN obligation.
Timing and the staged deadlines
Annex VIII applied in phases according to the intended use of the mixture: consumer products from 1 January 2021, professional-use products from 1 January 2021 (following an earlier alignment), and industrial-use products from 1 January 2024. All of those compliance dates have now passed. The practical takeaway is straightforward: a notification must be in place before the product is placed on the market. There is no grace period for new products launched today.
The role of the UFI
The UFI, or Unique Formula Identifier, is a 16-character alphanumeric code that links a specific product on a shelf to the exact composition in a PCN dossier. When a clinician calls a poison centre about a patient who has swallowed a cleaning product, the UFI on the label lets the centre retrieve the precise formulation in seconds.
The UFI must be printed on, or affixed to, the label of any product that requires a PCN, and it must also be supplied in the notification itself. It is generated free of charge using ECHA’s UFI generator from your company’s VAT number and a self-chosen formulation number. Because the UFI is tied to a specific composition, changing the formulation generally means generating a new UFI and updating the notification. For a deeper walkthrough, see our dedicated guide on what a UFI code is and how to create one.
A common and costly mistake is treating the UFI as a one-off. If you reformulate, change the concentration of a hazardous component beyond the permitted variation, or alter the classification, you must usually create a new UFI, update your PCN and relabel. Selling old stock with a UFI that no longer matches the formulation is a compliance failure.
What information does a PCN require?
An Annex VIII notification is far more detailed than a simple product registration. The dossier must include the full chemical composition of the mixture, identifying components by name and concentration (or concentration ranges, within strict limits), the product’s trade name(s), the UFI, classification and labelling information, toxicological information, the product category using the EuPCS (European Product Categorisation System), the physical state, pH where relevant, and packaging details.
Submissions are made via the ECHA PCN portal, either by preparing a dossier in IUCLID or by using the portal’s online tools, and exported in the harmonised PCN format. Notifications are made per Member State where the product is placed on the market and in the official language(s) those states require, although ECHA’s central system streamlines multi-country submission considerably.
Composition confidentiality is built into the system. The full formulation is shared securely with appointed bodies for emergency use only; it is not published. This is one reason the regime can demand complete composition data that you would never put on a public label.
PCN versus CPNP: how they relate and differ
Confusion between PCN and CPNP is one of the most frequent issues makers raise, especially those whose products straddle the cosmetic and chemical worlds. They are two distinct notification systems with different legal bases and different purposes, and a single product can require one, the other, or both.
CPNP, the Cosmetic Products Notification Portal, exists under the Cosmetic Products Regulation (EC) No 1223/2009 and is the route for notifying cosmetic products before they go on sale. PCN exists under CLP and concerns hazardous mixtures for emergency health response. The crucial point: most finished cosmetics are exempt from CLP’s PCN obligation, but cosmetic-adjacent or borderline products that are classified as hazardous mixtures under CLP can fall under PCN. Our overviews of CPNP notification and the EU Cosmetic Regulation 1223/2009 set out the cosmetic side in detail.
| Aspect | PCN (Poison Centre Notification) | CPNP (Cosmetic notification) |
|---|---|---|
| Legal basis | Annex VIII of CLP, Regulation (EC) No 1272/2008 | Cosmetic Products Regulation (EC) No 1223/2009 |
| Purpose | Emergency health response for hazardous mixtures | Market surveillance and safety of cosmetic products |
| Portal | ECHA PCN portal | Cosmetic Products Notification Portal (CPNP) |
| Typical products | Candles, diffusers, cleaners, detergents, adhesives | Creams, shampoos, make-up, perfumes |
| Label identifier | UFI required on the label | No UFI; CPNP reference instead |
| Triggered by | Health or physical hazard classification | Being a cosmetic product placed on the market |
Deadlines and the consequences of non-compliance
Because all the Annex VIII transition deadlines have passed, there is no longer a future date to plan around. The rule is simply that a valid PCN, with a matching UFI on the label, must be in place before the product reaches the market. New products and reformulations must be notified up front.
Enforcement is carried out by national market surveillance authorities, and penalties are set by each Member State under Article 47 of CLP. Consequences can include orders to withdraw or recall products, refusal of customs clearance for imports, administrative fines and, in serious cases, criminal liability. Retailers and online marketplaces increasingly demand evidence of compliance before they will list a product, so a missing PCN can quietly close commercial doors well before any regulator gets involved. Treating notification as part of your product launch checklist, rather than an afterthought, is the only safe approach.
Bringing it all together
If your product is a hazardous mixture destined for the EU, PCN is not optional: you need a complete Annex VIII dossier, a correctly generated UFI on every label, and a submission in each market where you sell. The detail is unforgiving, and the overlap with classification, labelling and (for some products) cosmetic rules makes it easy to miss a step.
Lexora handles the whole process end to end, from classifying your mixture to generating UFIs and filing through the ECHA portal. Explore our Poison Centre Notification (PCN) service to get your products notified correctly, or take a broader view with our CLP compliance suite if you also need classification and labelling sorted in one go.
Frequently asked questions
Does my scented candle really need a PCN?
If your candle contains a fragrance load that causes it to be classified as a hazardous mixture for health effects, such as skin sensitisation, then yes, a PCN and a UFI on the label are required before you sell it in the EU. Many fragranced candles and reed diffusers do trigger classification, so it should always be checked rather than assumed.
Who is legally responsible for submitting the PCN?
The importer or downstream user that places the hazardous mixture on the EU market is responsible. A manufacturer based outside the EU cannot file the notification from abroad, so the EU-based company bringing the product into circulation usually carries the duty.
What is a UFI and where does it go?
A UFI is a 16-character Unique Formula Identifier that links your product to its PCN dossier. It must be generated using ECHA’s free UFI generator, printed on or affixed to the product label, and included in the notification itself.
Is PCN the same as cosmetic CPNP notification?
No. PCN sits under CLP and covers hazardous mixtures for emergency health response, while CPNP sits under the Cosmetic Products Regulation and covers cosmetics. Most finished cosmetics are exempt from PCN, but a borderline or cosmetic-adjacent product classified as a hazardous mixture can need a PCN as well.
Do I need a separate PCN for each EU country?
Notifications are made per Member State where the product is placed on the market and in the languages those states require. ECHA’s central submission system lets you target multiple countries from one dossier, which makes multi-market filing far more efficient than doing each individually.
What happens if I sell without a valid PCN?
You risk enforcement by national authorities, including product withdrawal or recall, refused customs clearance for imports, administrative fines and, in serious cases, criminal liability. Retailers and marketplaces also increasingly require proof of PCN before listing, so non-compliance can block sales commercially as well as legally.
