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

A poison centre notification (PCN) is the structured dossier about a hazardous mixture that a company must submit to the authorities of every EU/EEA country where it sells that mixture — before the first unit reaches the market. It contains the full composition, the classification, toxicological information, the product category and the packaging, all keyed to the UFI code printed on the label. When someone is exposed to the product and a poison centre takes the call, this dossier is what the responder reads.

It is worth being precise about what kind of obligation this is. The PCN is not a registration scheme, not a product approval, and not an optional courtesy to emergency services. It is a legal duty under Article 45 of the CLP Regulation, and placing a mixture in scope on the market without a valid notification is an infringement in every member state — one that inspectors started checking systematically in 2025.

What a PCN is

Technically, a PCN is an electronic dossier in ECHA’s harmonised PCN format — an XML data set packaged as an .i6zfile — submitted through ECHA’s central portal and dispatched to the appointed bodies of the member states you select. Each member state designates such a body under Article 45; the appointed body makes the data available to its national poison centres.

Legally, a PCN is a precondition for sale. Annex VIII Part A states the rule plainly: submitters shall provide the information before placing mixtures on the market. There is no evaluation step and no certificate — the portal validates the dossier’s structure, not your compliance — but the absence of a notification is directly enforceable, the same way a missing hazard label is. Notify first, sell second.

The legal basis: Article 45 and Annex VIII

The duty rests on two texts that work as a pair:

• Article 45 of CLP (Regulation (EC) No 1272/2008) obliges member states to appoint bodies for receiving information relevant to emergency health response, and obliges importers and downstream users to submit that information for mixtures classified as hazardous on the basis of their health or physical effects.
• Annex VIII, added by Commission Regulation (EU) 2017/542 and fully replaced by Delegated Regulation (EU) 2020/1677, specifies what Article 45 left open: exactly which information, in which format, on which dates, and how the UFI ties the label to the submission.

Note the regulatory family: this is a CLP obligation, separate from REACH registration and separate from the REACH duty to provide safety data sheets. A company can be fully REACH-compliant and still be in breach of Article 45. Penalties are set nationally under Article 47 of CLP and vary widely — from administrative fines to, in some member states, criminal liability. The structure of the annex itself is covered in Annex VIII explained.

What data a PCN contains

The information requirements sit in Annex VIII Part B, and they go well beyond what most companies publish anywhere else:

• Identification.All trade names as they appear on the label, the UFI(s), other identifiers, and the submitter’s contact details.
• Full composition. Every component, with exact concentrations or narrow permitted ranges — much tighter than the broad ranges allowed in a safety data sheet. Components of major concern carry the tightest precision requirements.
• Classification and label elements.The mixture’s health and physical hazard classification, pictogram codes, signal word, hazard and precautionary statements.
• Toxicological information. The content of section 11 of the safety data sheet.
• Product characteristics. Physical state, colour, pH where applicable, packaging types and sizes.
• Use profile. The intended use expressed as an EuPCS category, and whether the product is for consumer, professional or industrial use.

The composition depth is the point people underestimate. A PCN discloses to authorities what the SDS deliberately blurs, because a poison centre treating a child who swallowed a cleaner needs percentages, not “< 30%”. The field-by-field breakdown lives in what information a PCN requires.

Who must submit

The duty holders are the companies that place 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 label on someone else’s formulation makes you a submitter.
• Distributors are currently outside Article 45, but Regulation (EU) 2024/2865 extends duties to them in certain supply-chain situations — those Article 45 amendments apply from 1 January 2027.

The product-side trigger is classification: mixtures classified for health or physical hazards are in scope; mixtures classified only for environmental hazards are not, though they may be notified voluntarily. Scope tests, exemptions and the borderline cases — samples, research mixtures, radioactive and medicinal products — are worked through in do I need to submit a PCN.

The three submission routes

ECHA operates one central intake with three ways in — all free at ECHA level:

1. Online in the ECHA Submission portal. You fill in the dossier in the browser using IUCLID Cloud. No installation, suited to low volumes; every field is typed in by hand.
2. IUCLID 6 offline, then upload. You prepare the dossier in the desktop IUCLID application, export the .i6z file and upload it to the portal. More control, same manual data entry, plus software to maintain.
3. System-to-system (S2S).Your software builds the dossier and submits it directly to ECHA’s S2S gateway using ECHA-issued access keys — no portal screens at all. This is the route commercial tools, including Ufi Number, use on your behalf.

Whichever route you take, the dossier lands in the same validation pipeline and is forwarded to the appointed bodies of the countries you declared. The routes differ in effort, not legal effect: the sensible choice is a function of how many mixtures you notify and how often they change — portal entry is workable for a handful of stable products and becomes the bottleneck somewhere around your second reformulation season. A handful of member states add national wrinkles — fees, confirmation-of-receipt requirements before sale, language rules — which are mapped per country in our country guides. The step-by-step process is covered in how to submit a PCN.

What poison centres do with the data

The system exists for one scenario: an exposure call. A parent phones the national poison centre because a toddler drank from a bottle of descaler; a site nurse calls about a worker splashed with a two-component adhesive. The responder asks for the UFI on the label — or failing that, the trade name — and retrieves the notified record: exact composition, classification, toxicological information, physical state, packaging. Treatment advice starts from the actual formulation instead of educated guesses from a label or an out-of-date SDS.

For mixtures notified under the industrial-use limited submission option, the dossier contains less composition detail but must name a contact reachable 24 hours a day, 7 days a week who can supply the rest during an incident. That trade-off is the reason the option exists only for industrial settings, where such a contact is realistic.

The data has one sanctioned secondary use. Under Article 45(2), the appointed bodies must guarantee confidentiality, and the information may additionally be used — where a member state requests it — for statistical analysis to identify where improved risk-management measures may be needed. What it may never become is market intelligence: your competitors do not see your compositions, which is precisely why the PCN can demand disclosure the SDS never could.

The stakes are why enforcement bodies treat gaps seriously. As Chris Van den hole, chair of the Enforcement Forum working group that ran the 2025 pilot, put it: “Missing notifications of the necessary information to the poison centres undermine the effectiveness of emergency response.”

Compliance dates — all passed

Annex VIII phased the duty in by use type. Every date is now behind us:

There is no upcoming calendar deadline to prepare for. Since 1 January 2025 the obligation is simply continuous: it attaches the day you place a mixture in scope on a market, and it follows the product through reformulations and market extensions via submission updates. If you are still relying on a pre-2021 national notification, that cover expired.

The enforcement reality

For years the honest description of PCN enforcement was “sparse”. That changed with the ECHA Enforcement Forum’s pilot project, whose results ECHA published on 11 February 2026 (news item ECHA/NR/26/08). Inspectors in 18 EU/EEA countries checked 1,597 mixtures during the operational phase from January to June 2025:

• 19% were not notified — calculated on the 1,432 mixtures where a PCN was actually required.
• 15% had no UFI on the label.
• 71% of the inspected mixtures came from SMEs — this is overwhelmingly a small-company compliance gap.

Across the 656 non-compliant cases, inspectors issued written rectification advice in 68% and verbal advice in 15% — but also administrative orders in 11% (72 cases), fines in 5% (30 cases) and criminal complaints in 4% (29 cases). The first wave leaned corrective; the escalation instruments are plainly in use.

How inspections work, what inspectors ask for and how national penalties differ is covered in PCN enforcement.

Common misconceptions

• “We generated a UFI, so we are compliant.” The UFI is a label element and a lookup key — it has no legal effect until the matching notification is submitted. A UFI on the label with no PCN behind it is itself a finding; the pilot inspectors cross-checked exactly this.
• “Our SDS already covers it.” The SDS is a REACH document owed to your customer; the PCN is a CLP submission owed to appointed bodies, in a different format, with a stricter composition disclosure. One does not substitute for the other in either direction.
• “We only sell B2B, so it does not apply.” Professional use has been in scope since 1 January 2021 and industrial use since 1 January 2024. Industrial-only mixtures may use a limited submission — less data, plus a 24/7 contact — but that is a reduced submission, not an exemption.
• “We notified once, so we are done.” Composition changes beyond the permitted ranges, reclassification, new toxicological data and new market countries all trigger submission updates before the changed product ships.
• “ECHA accepted the dossier, so the content is approved.” Passing portal validation means the dossier is structurally valid, nothing more. Responsibility for the content stays with the submitter.

None of this requires a consultant or an enterprise suite. ECHA’s portal is free and legitimate; its cost is your time and its 130+ validation rules. Ufi Number automates the same job — UFI, dossier in the current required format, submission and the acknowledgement to prove it — for €20 per mixture.