Poison centre notification (PCN): the Article 45 duty explained

A poison centre notification (PCN) is the dossier a company submits about a hazardous mixture before the first unit goes on sale in an EU/EEA country. It holds the full composition, the classification, toxicological information, the product category and the packaging, all tied to the UFI code on the label. When someone is exposed to the product and a poison centre takes the call, this is what the person answering reads.

Legally, it’s a duty under Article 45 of the CLP Regulation. People sometimes call it UFI registration, but nothing is registered and nothing is approved. You notify, and the poison centres get the data.

What is a PCN?

Technically, it’s an electronic dossier in ECHA’s harmonised PCN format: a structured data set, packaged as an IUCLID file and sent through ECHA’s central portal to the appointed bodies of the countries you choose. Each EU/EEA country appoints a body under Article 45, and that body makes the data available to its poison centres.

Legally, it’s a precondition for sale. Annex VIII Part A is plain about it: the information is provided before the mixture is placed on the market. There’s no evaluation step and no certificate. The portal checks that the dossier is built correctly, not that your product is in order. A missing notification can still be enforced directly, the same way a missing hazard label can. The order is fixed: notification first, market second.

Where the duty comes from: Article 45 and Annex VIII

Two texts work as a pair:

• Article 45 of CLP (Regulation (EC) No 1272/2008) has each country appoint a body to receive information for emergency health response. It has importers and downstream users send that information for mixtures classified for health or physical hazards.
• Annex VIII, added by Commission Regulation (EU) 2017/542 and fully replaced by Delegated Regulation (EU) 2020/1677, fills in what Article 45 left open: which information, in which format, from which dates, and how the UFI ties the label to the submission.

This is a CLP duty. It sits apart from REACH registration and from the REACH duty to provide safety data sheets, so having your REACH paperwork in order doesn’t cover it. Each country sets its own penalties under Article 47 of CLP, and the country guides list them. How the annex itself is built is in Annex VIII explained.

What goes into a PCN

The list is in Annex VIII Part B, and it asks for more than most companies publish anywhere else:

• Identification. Every trade name as it appears on the label, the UFI or UFIs, other identifiers, and the submitter’s contact details.
• Full composition. Every component, with exact concentrations or narrow permitted ranges, much tighter than the ranges a safety data sheet allows. Components of major concern get the tightest limits.
• Classification and label elements. The health and physical hazard classification, pictogram codes, signal word, and hazard and precautionary statements.
• Toxicological information. What’s in section 11 of the safety data sheet.
• Product characteristics. Physical state, colour, pH where applicable, and packaging types and sizes.
• Use. The intended use as an EuPCS category, and whether the product is for consumer, professional or industrial use.

If I were warning a first-timer about one thing, it would be the composition. A PCN tells the authorities what the SDS is allowed to blur, because a poison centre treating a child who swallowed a cleaner needs percentages, not “< 30%”. Every field is listed in what information a PCN requires.

Who has to notify

The duty sits with whoever places the mixture on the market:

• Importers bringing mixtures into the EU/EEA from outside.
• Downstream users: formulators who blend mixtures, and companies that rebrand or repackage a mixture under their own name. Putting your own label on someone else’s formulation makes you a submitter.
• Distributors aren’t covered by Article 45 today. From 1 January 2027, under Regulation (EU) 2024/2865, distributors who rebrand or relabel a mixture, or distribute it into another EU/EEA country, must make sure it is notified for their product name and market. Either the supplier extends its notification or the distributor notifies, unless the appointed body already has the same information.

Whether it applies to a given product comes down to classification, not product type. Mixtures classified for health or physical hazards are in scope. Mixtures classified only for environmental hazards aren’t, though you can notify them voluntarily. The exemptions and borderline cases, such as samples, research mixtures, and radioactive and medicinal products, are worked through in do I need to submit a PCN.

How a PCN gets to ECHA: three routes

ECHA runs one central intake with three ways in. None of them costs anything at ECHA’s end.

1. Online in the ECHA Submission portal. You build the dossier in the browser with IUCLID Cloud. There’s nothing to install, and every field is typed by hand. It works for a few products.
2. IUCLID 6 offline, then upload. You prepare the dossier in the desktop IUCLID application, export it and upload it to the portal. You get more control, the same typing, and software to keep up to date.
3. System-to-system. Your own software builds the dossier and sends it straight to ECHA, with access keys that ECHA issues. There are no portal screens. It’s the route commercial tools use, and the one UFI Number is built to send through, in your company’s name. Sending to ECHA is not live yet.

Whichever route you take, the dossier goes through the same validation and on to the appointed bodies of the countries you chose. The routes differ in effort, not legal effect, so the right one depends on how many mixtures you notify and how often they change. A few countries add their own conditions, such as fees, confirmation of receipt before sale, or language rules, and the country guides map them. The steps are in how to submit a PCN.

What poison centres do with it

The whole system exists for one moment: a call about an exposure. Say a parent rings the national poison centre because a toddler drank from a bottle of descaler, or a site nurse calls about a worker splashed with a two-part adhesive. The person answering asks for the UFI on the label, or failing that the trade name, and pulls up the notified record: exact composition, classification, toxicology, physical state and packaging. Treatment advice then starts from the actual formulation, not from a guess based on the label or an old SDS.

Mixtures notified under the limited submission option for industrial use carry less composition detail. In exchange, the dossier has to name a contact who can be reached 24 hours a day, 7 days a week, and who can supply the rest during an incident. That’s why the option exists only for industrial settings, where such a contact is realistic.

The data has one other permitted use. Under Article 45(2), the appointed bodies must keep it confidential, and a country can ask for it to be used for statistical analysis, to see where better risk management is needed. It never becomes market intelligence. Competitors don’t see your compositions, which is exactly why a PCN can ask for what an SDS never could.

Chris Van den hole, who chaired the Enforcement Forum working group behind the 2025 pilot, put the reason plainly: “Missing notifications of the necessary information to the poison centres undermine the effectiveness of emergency response.”

When the duty started

Annex VIII phased the duty in by type of use. Every date has now passed:

So there’s no deadline left to prepare for. Since 1 January 2025 the duty is simply continuous: it applies from the day a mixture in scope goes on a market, and it follows the product through reformulations and new markets as updates. National notifications made before 2021 stopped counting on 1 January 2025.

What inspectors found in 2025

ECHA’s Enforcement Forum ran a pilot project on PCN enforcement and published the results on 11 February 2026 (ECHA/NR/26/08). Inspectors in 18 EU/EEA countries checked 1,597 mixtures between January and June 2025:

• 19% of the 1,432 mixtures that required a PCN had none.
• 15% of checked mixtures lacked a required UFI on the label.
• 71% of inspected mixtures came from SMEs.

A targeted enforcement project, not a measure of the whole market. Most of the 656 cases found ended in advice: written advice in 68% of them and verbal advice in 15%. Formal measures were less common. PCN enforcement breaks them down, along with how inspections work and what inspectors ask for.

Common misconceptions

• “We have a UFI, so we’re covered.” It’s an understandable reading, because the code is the part you can see. On its own, though, a UFI is a very tidy dead end: it points to a record the poison centre doesn’t have, and the pilot inspectors checked for exactly this. A UFI has no legal effect until the mixture is notified.
• “Our SDS already covers it.” The SDS is a REACH document you owe your customer. The PCN is a CLP submission you owe the appointed bodies, in a different format and with stricter composition detail. Neither stands in for the other.
• “We only sell to businesses, so it doesn’t apply.” Professional use has been in scope since 1 January 2021, and industrial use since 1 January 2024. Industrial-only mixtures can use a limited submission, with less data and a 24/7 contact, but that’s a lighter submission, not an exemption.
• “We notified once, so we’re done.” A composition change beyond the permitted ranges, a new classification, new toxicological data or a new market all need an update before the changed product ships.
• “It passed ECHA’s validation, so the content is approved.” Passing validation means the dossier is built correctly, nothing more. The content stays the responsibility of the company that submitted it.

You can do all of this yourself in ECHA’s portal, and it’s free. If you notify a few stable products a year, that may be all you need. UFI Number is built for the repeat: the UFI, the notification in ECHA’s current format, and sending it through ECHA’s system-to-system route, with ECHA’s submission number coming back to you. It’s in private beta.